Sample records for unique product labeling

  1. Audit of manufactured products: use of allergen advisory labels and identification of labeling ambiguities.

    PubMed

    Pieretti, Mariah M; Chung, Danna; Pacenza, Robert; Slotkin, Todd; Sicherer, Scott H

    2009-08-01

    The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels. We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy. Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices. Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (> or = 40%). Categorically, advisory warnings included "may contain" (38%), "shared equipment" (33%), and "within plant" (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as "natural flavors" and "spices," were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of "contains" and "may contain" for the same allergen, among others. Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.

  2. LCA – Unique and Controversial Case Studies

    EPA Science Inventory

    This session will focus on case studies and applications that have a unique or controversial aspect. Some of the most recent topics that seem to have significant interest include: LCA-based product declarations, LCA-based standards, LCA-based labels, alternative energy, agricul...

  3. Labeling milk along its production chain with DNA encapsulated in silica.

    PubMed

    Bloch, Madeleine S; Paunescu, Daniela; Stoessel, Philipp R; Mora, Carlos A; Stark, Wendelin J; Grass, Robert N

    2014-10-29

    The capability of tracing a food product along its production chain is important to ensure food safety and product authenticity. For this purpose and as an application example, recently developed Silica Particles with Encapsulated DNA (SPED) were added to milk at concentrations ranging from 0.1 to 100 ppb (μg per kg milk). Thereby the milk, as well as the milk-derived products yoghurt and cheese, could be uniquely labeled with a DNA tag. Procedures for the extraction of the DNA tags from the food matrixes were elaborated and allowed identification and quantification of previously marked products by quantitative polymerase chain reaction (qPCR) with detection limits below 1 ppb of added particles. The applicability of synthetic as well as naturally occurring DNA sequences was shown. The usage of approved food additives as DNA carrier (silica = E551) and the low cost of the technology (<0.1 USD per ton of milk labeled with 10 ppb of SPED) display the technical applicability of this food labeling technology.

  4. High Yield Production and Radiochemical Isolation of Isotopically Pure Arsenic-72 and Novel Radioarsenic Labeling Strategies for the Development of Theranostic Radiopharmaceuticals.

    PubMed

    Ellison, Paul A; Barnhart, Todd E; Chen, Feng; Hong, Hao; Zhang, Yin; Theuer, Charles P; Cai, Weibo; Nickles, Robert J; DeJesus, Onofre T

    2016-01-20

    Radioisotopes of arsenic are of considerable interest to the field of nuclear medicine with unique nuclear and chemical properties making them well-suited for use in novel theranostic radiopharmaceuticals. However, progress must still be made in the production of isotopically pure radioarsenic and in its stable conjugation to biological targeting vectors. This work presents the production and irradiation of isotopically enriched (72)Ge(m) discs in an irrigation-cooled target system allowing for the production of isotopically pure (72)As with capability on the order of 10 GBq. A radiochemical separation procedure isolated the reactive trivalent radioarsenic in a small volume buffered aqueous solution, while reclaiming (72)Ge target material. The direct thiol-labeling of a monoclonal antibody resulted in a conjugate exhibiting exceptionally poor in vivo stability in a mouse model. This prompted further investigations to alternative radioarsenic labeling strategies, including the labeling of the dithiol-containing chelator dihydrolipoic acid, and thiol-modified mesoporous silica nanoparticles (MSN-SH). Radioarsenic-labeled MSN-SH showed exceptional in vivo stability toward dearsenylation.

  5. High Yield Production and Radiochemical Isolation of Isotopically Pure Arsenic-72 and Novel Radioarsenic Labeling Strategies for the Development of Theranostic Radiopharmaceuticals

    PubMed Central

    Ellison, Paul A.; Barnhart, Todd E.; Chen, Feng; Hong, Hao; Zhang, Yin; Theuer, Charles P.; Cai, Weibo; Nickles, Robert J.; DeJesus, Onofre T.

    2016-01-01

    Radioisotopes of arsenic are of considerable interest to the field of nuclear medicine with unique nuclear and chemical properties making them well-suited for use in novel theranostic radiopharmaceuticals. However, progress must still be made in the production of isotopically pure radioarsenic and in its stable conjugation to biological targeting vectors. This work presents the production and irradiation of isotopically enriched 72Ge(m) discs in an irrigation-cooled target system allowing for the production of isotopically pure 72As with capability on the order of 10 GBq. A radiochemical separation procedure isolated the reactive trivalent radioarsenic in a small volume buffered aqueous solution, while reclaiming 72Ge target material. The direct thiol-labeling of a monoclonal antibody resulted in a conjugate exhibiting exceptionally poor in vivo stability in a mouse model. This prompted further investigations to alternative radioarsenic labeling strategies, including the labeling of the dithiol-containing chelator dihydrolipoic acid, and thiol-modified mesoporous silica nanoparticles (MSN-SH). Radioarsenic-labeled MSN-SH showed exceptional in vivo stability toward dearsenylation. PMID:26646989

  6. Inconsistencies in emergency instructions on common household product labels.

    PubMed

    Cantrell, F Lee; Nordt, Sean Patrick; Krauss, Jamey R

    2013-10-01

    Human exposures to non-pharmaceutical products often results in serious injury and death annually in the United States. Studies performed more than 25 years ago described inadequate first aid advice on the majority of household products. The current study evaluates contemporary non-pharmaceutical products with respect to location, uniformity and type of their first aid and emergency contact instructions. A random, convenience sample of commercial product label information was obtained from local retail stores over an 8 month period. Twelve common non-pharmaceutical product categories, with large numbers of annual human exposures, were identified from National Poison Data Systems data. A minimum of 10 unique products for each category utilized. The following information identified: product name and manufacturer, location on container, presence and type of route-specific treatment, medical assistance referral information. A total of 259 product labels were examined. First aid/contact information was located on container: rear 162 (63 %), side 28 (11 %), front 3 (1 %), bottom 2 (0.77 %), behind label 14 (5 %), missing entirely 50 (19 %). Fifty-five products (21 %) lacked any first aid instructions. Suggested contacts for accidental poisoning: none listed 75 (29 %), physician 144 (56 %), poison control centers 102 (39 %), manufacturer 44 (17 %), "Call 911" 10 (4 %). Suggested contacts for unintentional exposure and content of first aid instructions on household products were inconsistent, frequently incomplete and at times absent. Instruction locations similarly lacked uniformity. Household product labels need to provide concise, accurate first aid and emergency contact instructions in easy-to-understand language in a universal format on product labels.

  7. 16 CFR 1102.12 - Manufacturer comments.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Content Requirements... private labeler in the Database if such manufacturer comment meets the following requirements: (1... that is submitted for publication in the Database. (2) Unique identifier. A manufacturer comment must...

  8. Bottlenose dolphins can use learned vocal labels to address each other

    PubMed Central

    King, Stephanie L.; Janik, Vincent M.

    2013-01-01

    In animal communication research, vocal labeling refers to incidents in which an animal consistently uses a specific acoustic signal when presented with a specific object or class of objects. Labeling with learned signals is a foundation of human language but is notably rare in nonhuman communication systems. In natural animal systems, labeling often occurs with signals that are not influenced by learning, such as in alarm and food calling. There is a suggestion, however, that some species use learned signals to label conspecific individuals in their own communication system when mimicking individually distinctive calls. Bottlenose dolphins (Tursiops truncatus) are a promising animal for exploration in this area because they are capable of vocal production learning and can learn to use arbitrary signals to report the presence or absence of objects. Bottlenose dolphins develop their own unique identity signal, the signature whistle. This whistle encodes individual identity independently of voice features. The copying of signature whistles may therefore allow animals to label or address one another. Here, we show that wild bottlenose dolphins respond to hearing a copy of their own signature whistle by calling back. Animals did not respond to whistles that were not their own signature. This study provides compelling evidence that a dolphin’s learned identity signal is used as a label when addressing conspecifics. Bottlenose dolphins therefore appear to be unique as nonhuman mammals to use learned signals as individually specific labels for different social companions in their own natural communication system. PMID:23878217

  9. Geological characterization of agricultural terraces as a tool for the territorial safeguard and for the valorization of "Terroir"

    NASA Astrophysics Data System (ADS)

    Brancucci, Gerardo; Brancucci, Michele; Marescotti, Pietro; Poggi, Eugenio; Solimano, Monica; Vegnuti, Roberto; Giostrella, Paola; Tarolli, Paolo

    2017-04-01

    The progressive abandonment of the terraced areas of Liguria (NW Italy) is determining an inexorable land degradation, which causes, among other things, the erosive processes and the slope failure. Several studies highlighted the need of strategies for the recovery of abandoned agricultural lands by encouraging the productive reuse. Nevertheless, it is well known that agricultural activities in rural areas with steep slopes are strongly penalized by the high production costs determined by the adverse geomorphological conditions. For these reasons, one of the possible solutions is to encourage the production of high-quality agricultural crops, and to promote the uniqueness of the products. The uniqueness of the local products can be promoted not only by means of marketing strategy, mostly based on historical and traditional aspects of the productions, but also by correlating the product with the geological features (e.g., lithology, mineralogy and geochemistry) of the agricultural soils and parental rocks. These features are typically peculiar of a geographic area and thus strictly correlated with the site of production. This approach, together with the biological characterization of the crop, can link the cultivar to the geographical area of production thus evidencing peculiarities that are inimitable elsewhere. With this work we present the experimental results of investigations performed on several types of agricultural products (grapes and wines, olives and olive oils, apples) as well as on wild mushroom of the Boletus family. The analyses have been carried out either in laboratory and by means of field portable instruments (FP-EDXRF and FP-FTIR) which permitted a large number of in situ analyses, in a cost efficient and timely manner, thus allowing the realization of high spatial resolution compositional maps. This analytical approach also resulted particularly effective to improve the information obtained by traditional pedological and agronomical investigations. The results allowed to realize the "geological label of the product®" which is an assurance label that certifies the peculiar geological features of the area of production. The label contains a QRcode which allows to obtain detailed information about the soil composition, geological and geomorphological information and their relationships with the organoleptic characteristics of the product. The geological label of the product may have significant implications for the sales and marketing chain since it allows to commercialize higher value product characterized by: i) organoleptic and environmental quality; ii) uniqueness of the area of production; iii) geographical identity of the crops. By associating these information with the valorization of the terroir, the territorial marketing may be strongly improved ensuring the development of the territories and the realization of a closer relationship between the customer, the Company and consumers. The value created by this potential brand can attract investment for the recovery of abandoned agricultural lands and for the agricultural terraces management with positive effects on the increase of productivity and, consequently, on the maintenance, management and territorial safeguard.

  10. Patient-reported outcomes to support medical product labeling claims: FDA perspective.

    PubMed

    Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

    2007-01-01

    This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

  11. One-to-one quantum dot-labeled single long DNA probes.

    PubMed

    He, Shibin; Huang, Bi-Hai; Tan, Junjun; Luo, Qing-Ying; Lin, Yi; Li, Jun; Hu, Yong; Zhang, Lu; Yan, Shihan; Zhang, Qi; Pang, Dai-Wen; Li, Lijia

    2011-08-01

    Quantum dots (QDs) have been received most attention due to their unique properties. Constructing QDs conjugated with certain number of biomolecules is considered as one of the most important research goals in nanobiotechnology. In this study, we report polymerase chain reaction (PCR) amplification of primer oligonucleotides bound to QDs, termed as QD-based PCR. Characterization of QD-based PCR products by gel electrophoresis and atomic force microscopy showed that QD-labeled long DNA strands were synthesized and only a single long DNA strand was conjugated with a QD. The QD-based PCR products still kept fluorescence properties. Moreover, the one-to-one QD-labeled long DNA conjugates as probes could detect a single-copy gene on maize chromosomes by fluorescence in situ hybridization. Labeling a single QD to a single long DNA will make detection of small single-copy DNA fragments, quantitative detection and single molecule imaging come true by nanotechnology, and it will promote medical diagnosis and basic biological research as well as nano-material fabrication. Copyright © 2011 Elsevier Ltd. All rights reserved.

  12. Fluorescent Photo-conversion: A second chance to label unique cells.

    PubMed

    Mellott, Adam J; Shinogle, Heather E; Moore, David S; Detamore, Michael S

    2015-03-01

    Not all cells behave uniformly after treatment in tissue engineering studies. In fact, some treated cells display no signs of treatment or show unique characteristics not consistent with other treated cells. What if the "unique" cells could be isolated from a treated population, and further studied? Photo-convertible reporter proteins, such as Dendra2 , allow for the ability to selectively identify unique cells with a secondary label within a primary labeled treated population. In the current study, select cells were identified and labeled through photo-conversion of Dendra2 -transfected human Wharton's Jelly cells (hWJCs) for the first time. Robust photo-conversion of green-to-red fluorescence was achieved consistently in arbitrarily selected cells, allowing for precise cell identification of select hWJCs. The current study demonstrates a method that offers investigators the opportunity to selectively label and identify unique cells within a treated population for further study or isolation from the treatment population. Photo-convertible reporter proteins, such as Dendra2 , offer the ability over non-photo-convertible reporter proteins, such as green fluorescent protein, to analyze unique individual cells within a treated population, which allows investigators to gain more meaningful information on how a treatment affects all cells within a target population.

  13. UNiquant, a program for quantitative proteomics analysis using stable isotope labeling.

    PubMed

    Huang, Xin; Tolmachev, Aleksey V; Shen, Yulei; Liu, Miao; Huang, Lin; Zhang, Zhixin; Anderson, Gordon A; Smith, Richard D; Chan, Wing C; Hinrichs, Steven H; Fu, Kai; Ding, Shi-Jian

    2011-03-04

    Stable isotope labeling (SIL) methods coupled with nanoscale liquid chromatography and high resolution tandem mass spectrometry are increasingly useful for elucidation of the proteome-wide differences between multiple biological samples. Development of more effective programs for the sensitive identification of peptide pairs and accurate measurement of the relative peptide/protein abundance are essential for quantitative proteomic analysis. We developed and evaluated the performance of a new program, termed UNiquant, for analyzing quantitative proteomics data using stable isotope labeling. UNiquant was compared with two other programs, MaxQuant and Mascot Distiller, using SILAC-labeled complex proteome mixtures having either known or unknown heavy/light ratios. For the SILAC-labeled Jeko-1 cell proteome digests with known heavy/light ratios (H/L = 1:1, 1:5, and 1:10), UNiquant quantified a similar number of peptide pairs as MaxQuant for the H/L = 1:1 and 1:5 mixtures. In addition, UNiquant quantified significantly more peptides than MaxQuant and Mascot Distiller in the H/L = 1:10 mixtures. UNiquant accurately measured relative peptide/protein abundance without the need for postmeasurement normalization of peptide ratios, which is required by the other programs.

  14. UNiquant, a Program for Quantitative Proteomics Analysis Using Stable Isotope Labeling

    PubMed Central

    Huang, Xin; Tolmachev, Aleksey V.; Shen, Yulei; Liu, Miao; Huang, Lin; Zhang, Zhixin; Anderson, Gordon A.; Smith, Richard D.; Chan, Wing C.; Hinrichs, Steven H.; Fu, Kai; Ding, Shi-Jian

    2011-01-01

    Stable isotope labeling (SIL) methods coupled with nanoscale liquid chromatography and high resolution tandem mass spectrometry are increasingly useful for elucidation of the proteome-wide differences between multiple biological samples. Development of more effective programs for the sensitive identification of peptide pairs and accurate measurement of the relative peptide/protein abundance are essential for quantitative proteomic analysis. We developed and evaluated the performance of a new program, termed UNiquant, for analyzing quantitative proteomics data using stable isotope labeling. UNiquant was compared with two other programs, MaxQuant and Mascot Distiller, using SILAC-labeled complex proteome mixtures having either known or unknown heavy/light ratios. For the SILAC-labeled Jeko-1 cell proteome digests with known heavy/light ratios (H/L = 1:1, 1:5, and 1:10), UNiquant quantified a similar number of peptide pairs as MaxQuant for the H/L = 1:1 and 1:5 mixtures. In addition, UNiquant quantified significantly more peptides than MaxQuant and Mascot Distiller in the H/L = 1:10 mixtures. UNiquant accurately measured relative peptide/protein abundance without the need for post-measurement normalization of peptide ratios, which is required by the other programs. PMID:21158445

  15. Comprehensive and accurate tracking of carbon origin of LC-tandem mass spectrometry collisional fragments for 13C-MFA.

    PubMed

    Kappelmann, Jannick; Klein, Bianca; Geilenkirchen, Petra; Noack, Stephan

    2017-03-01

    In recent years the benefit of measuring positionally resolved 13 C-labeling enrichment from tandem mass spectrometry (MS/MS) collisional fragments for improved precision of 13 C-Metabolic Flux Analysis ( 13 C-MFA) has become evident. However, the usage of positional labeling information for 13 C-MFA faces two challenges: (1) The mass spectrometric acquisition of a large number of potentially interfering mass transitions may hamper accuracy and sensitivity. (2) The positional identity of carbon atoms of product ions needs to be known. The present contribution addresses the latter challenge by deducing the maximal positional labeling information contained in LC-ESI-MS/MS spectra of product anions of central metabolism as well as product cations of amino acids. For this purpose, we draw on accurate mass spectrometry, selectively labeled standards, and published fragmentation pathways to structurally annotate all dominant mass peaks of a large collection of metabolites, some of which with a complete fragmentation pathway. Compiling all available information, we arrive at the most detailed map of carbon atom fate of LC-ESI-MS/MS collisional fragments yet, comprising 170 intense and structurally annotated product ions with unique carbon origin from 76 precursor ions of 72 metabolites. Our 13 C-data proof that heuristic fragmentation rules often fail to yield correct fragment structures and we expose common pitfalls in the structural annotation of product ions. We show that the positionally resolved 13 C-label information contained in the product ions that we structurally annotated allows to infer the entire isotopomer distribution of several central metabolism intermediates, which is experimentally demonstrated for malate using quadrupole-time-of-flight MS technology. Finally, the inclusion of the label information from a subset of these fragments improves flux precision in a Corynebacterium glutamicum model of the central carbon metabolism.

  16. A review of the supply of liquid propellants and other fluids in support of the Space Shuttle Program

    NASA Technical Reports Server (NTRS)

    Churchwell, Stacy E.; Bain, A. L.

    1989-01-01

    In this study, over twenty significant liquid propellants and other fluids were reviewed as to their supply in support of the Space Shuttle Program (SSP), primarily at KSC. The uniqueness of most of the products, either by their application or production characteristics, present a variety of supply issues to contend with. Each, however, is critical to the success of the SSP. It becomes necessary to formulate, and maintain, a logistic approach to assure a continued availability of each product. For convenience, two categories were established. One, labeled limited-availability, represents those products wherein they are single sourced, have production restrictions and/or there has been a history of supply problems. The other, labeled universally-available, is characteristic of those having several sources and/or having little, if any, historical supply problems. This last category was not examined in depth. Through concepts of establishing stockpile inventories, multiple supply contracts, or other arrangements, the supply of liquid propellants and other fluids can be assured.

  17. DNA-labeled micro- and nanoparticles: a new approach to study contaminant transport in the subsurface

    NASA Astrophysics Data System (ADS)

    McNew, C.; Wang, C.; Kocis, T. N.; Murphy, N. P.; Dahlke, H. E.

    2017-12-01

    Though our understanding of contaminant behavior in the subsurface has improved, our ability to measure and predict complex contaminant transport pathways at hillslope to watershed scales is still lacking. By utilizing bio-molecular nanotechnology developed for nano-medicines and drug delivery, we are able to produce DNA-labeled micro- and nanoparticles for use in a myriad of environmental systems. Control of the fabrication procedure allows us to produce particles of custom size, charge, and surface functionality to mimic the transport properties of the particulate contaminant or colloid of interest. The use of custom sequenced DNA allows for the fabrication of an enormous number of unique particle labels (approximately 1.61 x 1060 unique sequences) and the ability to discern between varied spatial and temporal applications, or the transport effect of varied particle size, charge, or surface properties. To date, this technology has been utilized to study contaminant transport from lab to field scales, including surface and open channel flow applications, transport in porous media, soil retention, and even subglacial flow pathways. Here, we present the technology for production and detection of the DNA-labeled particles along with the results from a current hillslope study at the Sierra Foothills Research and Extension Center (SFREC). This field study utilizes spatial and temporal variations in DNA-labeled particle applications to identify subsurface pollutant transport pathways through the four distinct soil horizons present at the SFREC site. Results from this and previous studies highlight the tremendous potential of the DNA-labeled particle technology for studying contaminant transport through the subsurface.

  18. Isotope labeling for studying RNA by solid-state NMR spectroscopy.

    PubMed

    Marchanka, Alexander; Kreutz, Christoph; Carlomagno, Teresa

    2018-04-12

    Nucleic acids play key roles in most biological processes, either in isolation or in complex with proteins. Often they are difficult targets for structural studies, due to their dynamic behavior and high molecular weight. Solid-state nuclear magnetic resonance spectroscopy (ssNMR) provides a unique opportunity to study large biomolecules in a non-crystalline state at atomic resolution. Application of ssNMR to RNA, however, is still at an early stage of development and presents considerable challenges due to broad resonances and poor dispersion. Isotope labeling, either as nucleotide-specific, atom-specific or segmental labeling, can resolve resonance overlaps and reduce the line width, thus allowing ssNMR studies of RNA domains as part of large biomolecules or complexes. In this review we discuss the methods for RNA production and purification as well as numerous approaches for isotope labeling of RNA. Furthermore, we give a few examples that emphasize the instrumental role of isotope labeling and ssNMR for studying RNA as part of large ribonucleoprotein complexes.

  19. Traditional biotechnology for new foods and beverages.

    PubMed

    Hugenholtz, Jeroen

    2013-04-01

    The food and beverage industry is re-discovering fermentation as a crucial step in product innovation. Fermentation can provide various benefits such as unique flavor, health and nutrition, texture and safety (shelf life), while maintaining a 100% natural label. In this review several examples are presented on how fermentation is used to replace, modify or improve current, artificially produced, foods and beverages and how also fermentation can be used for completely novel consumer products. Copyright © 2013 Elsevier Ltd. All rights reserved.

  20. Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles.

    PubMed

    Bailey, Steven; Singh, Ajay; Azadian, Robert; Huber, Peter; Blum, Michael

    2010-02-01

    The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not been elucidated. To analyse the number and types of disproportionately reported product-event combinations (DRPECs), as well as the final disposition of each, in order to understand the potential utility and resource implications of routinely conducting data mining in the US FDA Adverse Event Reporting System (AERS). We generated DRPECs from AERS for six of Wyeth's products, prospectively tracked their dispositions and evaluated the appropriate DRPECs in the company's safety database. We chose EB05 (the lower bound of the 90% confidence interval around the Empirical Bayes Geometric Mean) > or =2 as the appropriate metric, employing stratification based on age, sex and year of report. A total of 861 DRPECs were identified - the average number of DRPECs was 144 per product. The proportion of unique preferred terms (PTs) in AERS for each drug with an EB05 > or =2 was similar across the six products (5.1-8.5%). Overall, 64.0% (551) of the DRPECs were closed after the initial screening (44.8% labelled, 14.3% indication related, 4.9% non-interpretable). An additional 9.9% (85) had been reviewed within the prior year and were not further reviewed. The remaining 26.1% (225) required full case review. After review of all pertinent reports and additional data, it was determined which of the DRPECs necessitated a formal review by the company's ongoing Safety Review Team (SRT) process. In total, 3.6% (31/861) of the DRPECs, yielding 16 medical concepts, were reviewed by the SRT, leading to seven labelling changes. These labelling changes involved 1.9% of all DRPECs generated. Four of the six compounds reviewed as part of this pilot had an identified labelling change. The workload required for this pilot, which was driven primarily by those DRPECs requiring review, was extensive, averaging 184 hours per product. The number of DRPECs identified for each drug approximately correlated with the number of unique PTs in the database. Over one-half of DRPECs were either labelled as per the company's reference safety information (RSI) or were under review after identification by traditional pharmacovigilance activities, suggesting that for marketed products these methods do identify adverse events detected by traditional pharmacovigilance methods. Approximately three-quarters of the 861 DRPECs identified were closed without case review after triage. Of the approximately one-quarter of DRPECs that required formal case review, seven resulted in an addition to the RSI for the relevant products. While this pilot does not allow us to comment on the utility of routine data mining for all products, it is significant that several new safety concepts were identified through this prospective exercise.

  1. Fluorescent Photo-conversion: A second chance to label unique cells

    PubMed Central

    Mellott, Adam J.; Shinogle, Heather E.; Moore, David S.; Detamore, Michael S.

    2014-01-01

    Not all cells behave uniformly after treatment in tissue engineering studies. In fact, some treated cells display no signs of treatment or show unique characteristics not consistent with other treated cells. What if the “unique” cells could be isolated from a treated population, and further studied? Photo-convertible reporter proteins, such as Dendra2, allow for the ability to selectively identify unique cells with a secondary label within a primary labeled treated population. In the current study, select cells were identified and labeled through photo-conversion of Dendra2-transfected human Wharton's Jelly cells (hWJCs) for the first time. Robust photo-conversion of green-to-red fluorescence was achieved consistently in arbitrarily selected cells, allowing for precise cell identification of select hWJCs. The current study demonstrates a method that offers investigators the opportunity to selectively label and identify unique cells within a treated population for further study or isolation from the treatment population. Photo-convertible reporter proteins, such as Dendra2, offer the ability over non-photo-convertible reporter proteins, such as green fluorescent protein, to analyze unique individual cells within a treated population, which allows investigators to gain more meaningful information on how a treatment affects all cells within a target population. PMID:25914756

  2. Radiesse: Advanced Techniques and Applications for a Unique and Versatile Implant.

    PubMed

    Eviatar, Joseph; Lo, Christopher; Kirszrot, James

    2015-11-01

    Radiesse is a well-tolerated facial injectable with unique filling and lifting capabilities. Although initially approved for facial volumizing in HIV-related lipodystrophy patients, it quickly gained wide acceptance for aesthetic facial rejuvenation. In the USA, the Food and Drug Administration has approved several new indications for its use. This synopsis presents the experience and injection techniques currently favored by the primary author after many years of use in thousands of patients. The anecdotal practice of an experienced injector is presented along with the current Food and Drug Administration-approved standards of Radiesse injection. Radiesse has many on- and off-label applications that can be thoughtfully incorporated into clinical practice. Its unique chemical composition allows for immediate lifting and filling with long-term collagen stimulation. The product can be reconstituted to increase its versatility and minimize adverse events. Injections can be performed in the supraperiosteal space and the subcutaneous layer and are best administered in small, calculated doses to prevent nodules or vascular occlusion. Various techniques for Radiesse injection in specific areas are discussed in detail. Radiesse is a versatile injectable implant and a valuable tool for short- and long-term cosmetic and reconstructive treatments. In addition to various off-label uses, this injectable is often used in conjunction with botox, other injectables, collagen stimulators and tightening devices. A customized reconstitution of product increases its versatility for natural appearing and long lasting results that are both economical and effective for full facial rejuvenation.

  3. Methods for nanoparticle labeling of ricin and effect on toxicity

    NASA Astrophysics Data System (ADS)

    Wark, Alastair W.; Yu, Jun; Lindsay, Christopher D.; Nativo, Paola; Graham, Duncan

    2009-09-01

    The unique optical properties associated with nanostructured materials that support the excitation of surface plasmons offer many new opportunities for the enhanced optical investigation of biological materials that pose a security threat. In particular, ricin is considered a significant bioterrorism risk due to its high toxicity combined with its ready availability as a byproduct in castor oil production. Therefore, the development of optical techniques capable of rapid on-site toxin detection with high molecular specificity and sensitivity continues to be of significant importance. Furthermore, understanding of the ricin cell entry and intracellular pathways remains poor due to a lack of suitable bioanalytical techniques. Initial work aimed at simultaneously tackling both these issues is described where different approaches for the nanoparticle labeling of ricin are investigated along with changes in ricin toxicity associated with the labeling process.

  4. Identifying Objects via Encased X-Ray-Fluorescent Materials - the Bar Code Inside

    NASA Technical Reports Server (NTRS)

    Schramm, Harry F.; Kaiser, Bruce

    2005-01-01

    Systems for identifying objects by means of x-ray fluorescence (XRF) of encased labeling elements have been developed. The XRF spectra of objects so labeled would be analogous to the external bar code labels now used to track objects in everyday commerce. In conjunction with computer-based tracking systems, databases, and labeling conventions, the XRF labels could be used in essentially the same manner as that of bar codes to track inventories and to record and process commercial transactions. In addition, as summarized briefly below, embedded XRF labels could be used to verify the authenticity of products, thereby helping to deter counterfeiting and fraud. A system, as described above, is called an encased core product identification and authentication system (ECPIAS). The ECPIAS concept is a modified version of that of a related recently initiated commercial development of handheld XRF spectral scanners that would identify alloys or detect labeling elements deposited on the surfaces of objects. In contrast, an ECPIAS would utilize labeling elements encased within the objects of interest. The basic ECPIAS concept is best illustrated by means of an example of one of several potential applications: labeling of cultured pearls by labeling the seed particles implanted in oysters to grow the pearls. Each pearl farmer would be assigned a unique mixture of labeling elements that could be distinguished from the corresponding mixtures of other farmers. The mixture would be either incorporated into or applied to the surfaces of the seed prior to implantation in the oyster. If necessary, the labeled seed would be further coated to make it nontoxic to the oyster. After implantation, the growth of layers of mother of pearl on the seed would encase the XRF labels, making these labels integral, permanent parts of the pearls that could not be removed without destroying the pearls themselves. The XRF labels would be read by use of XRF scanners, the spectral data outputs of which would be converted to alphanumeric data in a digital equivalent data system (DEDS), which is the subject of the previous article. These alphanumeric data would be used to track the pearls through all stages of commerce, from the farmer to the retail customer.

  5. 21 CFR 830.360 - Records to be maintained by the labeler.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Records to be maintained by the labeler. 830.360 Section 830.360 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES UNIQUE DEVICE IDENTIFICATION Global Unique Device Identification Database § 830...

  6. Characterization and relative quantification of phospholipids based on methylation and stable isotopic labeling[S

    PubMed Central

    Cai, Tanxi; Shu, Qingbo; Liu, Peibin; Niu, Lili; Guo, Xiaojing; Ding, Xiang; Xue, Peng; Xie, Zhensheng; Wang, Jifeng; Zhu, Nali; Wu, Peng; Niu, Lili; Yang, Fuquan

    2016-01-01

    Phospholipids (PLs), one of the lipid categories, are not only the primary building blocks of cellular membranes, but also can be split to produce products that function as second messengers in signal transduction and play a pivotal role in numerous cellular processes, including cell growth, survival, and motility. Here, we present an integrated novel method that combines a fast and robust TMS-diazomethane-based phosphate derivatization and isotopic labeling strategy, which enables simultaneous profiling and relative quantification of PLs from biological samples. Our results showed that phosphate methylation allows fast and sensitive identification of the six major PL classes, including their lysophospholipid counterparts, under positive ionization mode. The isotopic labeling of endogenous PLs was achieved by deuterated diazomethane, which was generated through acid-catalyzed hydrogen/deuterium (H/D) exchange and methanolysis of TMS-diazomethane during the process of phosphate derivatization. The measured H/D ratios of unlabeled and labeled PLs, which were mixed in known proportions, indicated that the isotopic labeling strategy is capable of providing relative quantitation with adequate accuracy, reproducibility, and a coefficient of variation of 9.1%, on average. This novel method offers unique advantages over existing approaches and presents a powerful tool for research of PL metabolism and signaling. PMID:26733148

  7. Fluorescent kapakahines serve as non-toxic probes for live cell Golgi imaging.

    PubMed

    Rocha, Danilo D; Espejo, Vinson R; Rainier, Jon D; La Clair, James J; Costa-Lotufo, Letícia V

    2015-09-01

    There is an ongoing need for fluorescent probes that specifically-target select organelles within mammalian cells. This study describes the development of probes for the selective labeling of the Golgi apparatus and offers applications for live cell and fixed cell imaging. The kapakahines, characterized by a common C(3)-N(1') dimeric tryptophan linkage, comprise a unique family of bioactive marine depsipeptide natural products. We describe the uptake and subcellular localization of fluorescently-labeled analogs of kapakahine E. Using confocal microscopy, we identify a rapid and selective localization within the Golgi apparatus. Comparison with commercial Golgi stains indicates a unique localization pattern, which differs from currently available materials, therein offering a new tool to monitor the Golgi in live cells without toxic side effects. This study identifies a fluorescent analog of kapakahine E that is rapidly uptaken in cells and localizes within the Golgi apparatus. The advance of microscopic methods is reliant on the parallel discovery of next generation molecular probes. This study describes the advance of stable and viable probe for staining the Golgi apparatus. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Biomolecular Deuteration for Neutron Structural Biology and Dynamics.

    PubMed

    Haertlein, Michael; Moulin, Martine; Devos, Juliette M; Laux, Valerie; Dunne, Orla; Forsyth, V Trevor

    2016-01-01

    Neutron scattering studies provide important information in structural biology that is not accessible using other approaches. The uniqueness of the technique, and its complementarity with X-ray scattering, is greatest when full use is made of deuterium labeling. The ability to produce tailor-made deuterium-labeled biological macromolecules allows neutron studies involving solution scattering, crystallography, reflection, and dynamics to be optimized in a manner that has major impact on the scope, quality, and throughput of work in these areas. Deuteration facilities have now been developed at many neutron centres throughout the world; these are having a crucial effect on neutron studies in the life sciences and on biologically related studies in soft matter. This chapter describes methods that have been developed for the efficient production of deuterium-labeled samples for a wide range of neutron scattering applications. Examples are given that illustrate the use of these samples for each of the main techniques. Perspectives for biological deuterium labeling are discussed in relation to developments at current facilities and those that are planned in the future. © 2016 Elsevier Inc. All rights reserved.

  9. Metabolic De-Isotoping for Improved LC-MS Characterization of Modified RNAs

    NASA Astrophysics Data System (ADS)

    Wetzel, Collin; Li, Siwei; Limbach, Patrick A.

    2014-07-01

    Mapping, sequencing, and quantifying individual noncoding ribonucleic acids (ncRNAs), including post-transcriptionally modified nucleosides, by mass spectrometry is a challenge that often requires rigorous sample preparation prior to analysis. Previously, we have described a simplified method for the comparative analysis of RNA digests (CARD) that is applicable to relatively complex mixtures of ncRNAs. In the CARD approach for transfer RNA (tRNA) analysis, two complete sets of digestion products from total tRNA are compared using the enzymatic incorporation of 16O/18O isotopic labels. This approach allows one to rapidly screen total tRNAs from gene deletion mutants or comparatively sequence total tRNA from two related bacterial organisms. However, data analysis can be challenging because of convoluted mass spectra arising from the natural 13C and 15 N isotopes present in the ribonuclease-digested tRNA samples. Here, we demonstrate that culturing in 12C-enriched/13C-depleted media significantly reduces the isotope patterns that must be interpreted during the CARD experiment. Improvements in data quality yield a 35 % improvement in detection of tRNA digestion products that can be uniquely assigned to particular tRNAs. These mass spectral improvements lead to a significant reduction in data processing attributable to the ease of spectral identification of labeled digestion products and will enable improvements in the relative quantification of modified RNAs by the 16O/18O differential labeling approach.

  10. Live-Cell Imaging of Early Steps of Single HIV-1 Infection.

    PubMed

    Francis, Ashwanth C; Melikyan, Gregory B

    2018-05-19

    Live-cell imaging of single HIV-1 entry offers a unique opportunity to delineate the spatio-temporal regulation of infection. Novel virus labeling and imaging approaches enable the visualization of key steps of HIV-1 entry leading to nuclear import, integration into the host genome, and viral protein expression. Here, we discuss single virus imaging strategies, focusing on live-cell imaging of single virus fusion and productive uncoating that culminates in HIV-1 infection.

  11. Introduction to Pesticide Labels

    EPA Pesticide Factsheets

    Pesticide product labels provide critical information about how to safely and legally handle and use pesticide products. Unlike most other types of product labels, pesticide labels are legally enforceable. Learn about pesticide product labels.

  12. 9 CFR 381.400 - Nutrition labeling of poultry products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. (a) Nutrition labeling shall be provided for all poultry products intended...

  13. A novel GMO biosensor for rapid ultrasensitive and simultaneous detection of multiple DNA components in GMO products.

    PubMed

    Huang, Lin; Zheng, Lei; Chen, Yinji; Xue, Feng; Cheng, Lin; Adeloju, Samuel B; Chen, Wei

    2015-04-15

    Since the introduction of genetically modified organisms (GMOs), there has been on-going and continuous concern and debates on the commercialization of products derived from GMOs. There is an urgent need for development of highly efficient analytical methods for rapid and high throughput screening of GMOs components, as required for appropriate labeling of GMO-derived foods, as well as for on-site inspection and import/export quarantine. In this study, we describe, for the first time, a multi-labeling based electrochemical biosensor for simultaneous detection of multiple DNA components of GMO products on the same sensing interface. Two-round signal amplification was applied by using both an exonuclease enzyme catalytic reaction and gold nanoparticle-based bio-barcode related strategies, respectively. Simultaneous multiple detections of different DNA components of GMOs were successfully achieved with satisfied sensitivity using this electrochemical biosensor. Furthermore, the robustness and effectiveness of the proposed approach was successfully demonstrated by application to various GMO products, including locally obtained and confirmed commercial GMO seeds and transgenetic plants. The proposed electrochemical biosensor demonstrated unique merits that promise to gain more interest in its use for rapid and on-site simultaneous multiple screening of different components of GMO products. Copyright © 2014 Elsevier B.V. All rights reserved.

  14. 9 CFR 381.400 - Nutrition labeling of poultry products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. (a) Nutrition labeling must be provided for all poultry products intended for...

  15. 9 CFR 381.400 - Nutrition labeling of poultry products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. (a) Nutrition labeling must be provided for all poultry products intended for...

  16. The effect of traffic lights and regulatory statements on the choice between complementary and conventional medicines in Australia: results from a discrete choice experiment.

    PubMed

    Spinks, Jean; Mortimer, Duncan

    2015-01-01

    It has been suggested that complementary medicines are currently 'under-regulated' in some countries due to their potential for harm as a direct result from side-effects or interactions; from delaying more effective care; or from the economic cost of purchasing an ineffective or inappropriate treatment. The requirement of additional labelling on complementary medicine products has been suggested in Australia and may provide additional information to consumers at the point of purchase. This paper details a unique way of testing the potential effects on consumer behaviour of including either a traffic light logo or regulatory statement on labels. Using a discrete choice experiment, data were collected in 2012 in a sample of 521 Australians with either type 2 diabetes or cardiovascular disease. We find that additional labelling can affect consumer behaviour, but in unpredictable ways. The results of this experiment are informative to further the dialogue concerning possible regulatory mechanisms. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Click-electron microscopy for imaging metabolically tagged non-protein biomolecules

    PubMed Central

    Ngo, John T.; Adams, Stephen R.; Deerinck, Thomas J.; Boassa, Daniela; Rodriguez-Rivera, Frances; Palida, Sakina F.; Bertozzi, Carolyn R.; Ellisman, Mark H.; Tsien, Roger Y.

    2016-01-01

    Electron microscopy (EM) has long been the main technique to image cell structures with nanometer resolution, but has lagged behind light microscopy in the crucial ability to make specific molecules stand out. Here we introduce “Click-EM,” a labeling technique for correlative light microscopy and EM imaging of non-protein biomolecules. In this approach, metabolic labeling substrates containing bioorthogonal functional groups are provided to cells for incorporation into biopolymers by endogenous biosynthetic machinery. The unique chemical functionality of these analogs is exploited for selective attachment of singlet oxygen-generating fluorescent dyes via bioorthogonal “click chemistry” ligations. Illumination of dye-labeled structures generates singlet oxygen to locally catalyze the polymerization of diaminobenzidine into an osmiophilic reaction product that is readily imaged by EM. We describe the application of Click-EM in imaging metabolically tagged DNA, RNA, and lipids in cultured cells and neurons, and highlight its use in tracking peptidoglycan synthesis in the Gram-positive bacterium Listeria monocytogenes. PMID:27110681

  18. A Long Journey in Lanthanide Chemistry: From Fundamental Crystallogenesis Studies to Commercial Anticounterfeiting Taggants.

    PubMed

    Guillou, Olivier; Daiguebonne, Carole; Calvez, Guillaume; Bernot, Kevin

    2016-05-17

    Lanthanide ions have unique physical properties and are essential for numerous technological devices. Indeed, much research has been undertaken in order to understand and optimize their luminescent behavior. From a chemical and more specific point of view, lanthanides can be used to build coordination polymers (CPs). CPs are materials in which metal ions are associated with organic molecules (ligands) to form extended networks. They present great structural diversity and a wide range of unique properties such as great porosity, strong catalytic activities, and original magnetic and luminescent behaviors. In this Account, we highlight recent research advances obtained by our team in the field of lanthanide-based CPs. However, rather than present a simple chronological description of successive investigations, we have chosen present our own experience in order to show how standard academic studies can be successfully turned into applied research and finally into a viable startup that commercializes these products as anticounterfieting taggants. A taggant is a compound that can be dispersed in a host matrix at parts per million rates for it to be labeled. Its economic advantages over traditional anticounterfeiting techniques (labels, chips, etc.) are its very low cost and its ability to label a raw material at every stage of its processing, unlike traditional techniques that label only the final product. It thus permits traceability of a given material over a wide range of suppliers/subcontractors/sellers or customers at every step of its life. After 15 years of fundamental crystallogenesis research, we identified a very stable phase of lanthanide-based CPs in which strong lanthanide luminescence can be observed. We investigated this phase further and showed that a heteronuclear approach can give access to billions of different compositions and makes it possible to turn these powders into taggants. After the creation of a startup, we refocused on fundamental studies in order to ensure its future development. This permitted the design of future generations of taggants and provided brightness- or color-tunable compounds as well as temperature-sensitive and soluble taggants. We hope to demonstrate here that strong fundamental research is a very effective tool to create a technological breakthrough that allows the development of efficient applicative research and competitive products and finally contributes to economic growth.

  19. Genetic code expansion for multiprotein complex engineering.

    PubMed

    Koehler, Christine; Sauter, Paul F; Wawryszyn, Mirella; Girona, Gemma Estrada; Gupta, Kapil; Landry, Jonathan J M; Fritz, Markus Hsi-Yang; Radic, Ksenija; Hoffmann, Jan-Erik; Chen, Zhuo A; Zou, Juan; Tan, Piau Siong; Galik, Bence; Junttila, Sini; Stolt-Bergner, Peggy; Pruneri, Giancarlo; Gyenesei, Attila; Schultz, Carsten; Biskup, Moritz Bosse; Besir, Hueseyin; Benes, Vladimir; Rappsilber, Juri; Jechlinger, Martin; Korbel, Jan O; Berger, Imre; Braese, Stefan; Lemke, Edward A

    2016-12-01

    We present a baculovirus-based protein engineering method that enables site-specific introduction of unique functionalities in a eukaryotic protein complex recombinantly produced in insect cells. We demonstrate the versatility of this efficient and robust protein production platform, 'MultiBacTAG', (i) for the fluorescent labeling of target proteins and biologics using click chemistries, (ii) for glycoengineering of antibodies, and (iii) for structure-function studies of novel eukaryotic complexes using single-molecule Förster resonance energy transfer as well as site-specific crosslinking strategies.

  20. 21 CFR 801.30 - General exceptions from the requirement for the label of a device to bear a unique device...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... structure or any function of the body of man. (8) A device intended for export from the United States. (9) A... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Labeling...

  1. Inferring product healthfulness from nutrition labelling. The influence of reference points.

    PubMed

    van Herpen, Erica; Hieke, Sophie; van Trijp, Hans C M

    2014-01-01

    Despite considerable research on nutrition labelling, it has proven difficult to find a front-of-pack label which is informative about product healthfulness across various situations. This study examines the ability of different types of nutrition labelling schemes (multiple traffic light label, nutrition table, GDA, logo) to communicate product healthfulness (a) across different product categories, (b) between options from the same product category, and (c) when viewed in isolation and in comparison with another product. Results of two experiments in Germany and The Netherlands show that a labelling scheme with reference point information at the nutrient level (e.g., the traffic light label) can achieve all three objectives. Although other types of labelling schemes are also capable of communicating healthfulness, labelling schemes lacking reference point information (e.g., nutrition tables) are less effective when no comparison product is available, and labelling schemes based on overall product healthfulness within the category (e.g., logos) can diminish consumers' ability to differentiate between categories, leading to a potential misinterpretation of product healthfulness. None of the labels affected food preferences.

  2. Inferring Product Healthfulness from Nutrition Labelling: The Influence of Reference Points.

    PubMed

    Herpen, Erica van; Hieke, Sophie; van Trijp, Hans C M

    2013-10-25

    Despite considerable research on nutrition labelling, it has proven difficult to find a front-of-pack label which is informative about product healthfulness across various situations. This study examines the ability of different types of nutrition labelling schemes (multiple traffic light label, nutrition table, GDA, logo) to communicate product healthfulness (a) across different product categories, (b) between options from the same product category, and (c) when viewed in isolation and in comparison with another product. Results of two experiments in Germany and The Netherlands show that a labelling scheme with reference point information at the nutrient level (e.g., the traffic light label) can achieve all three objectives. Although other types of labelling schemes are also capable of communicating healthfulness, labelling schemes lacking reference point information (e.g., nutrition tables) are less effective when no comparison product is available, and labelling schemes based on overall product healthfulness within the category (e.g., logos) can diminish consumers' ability to differentiate between categories, leading to a potential misinterpretation of product healthfulness. None of the labels affected food preferences. Copyright © 2013. Published by Elsevier Ltd.

  3. Do nutrition labels influence healthier food choices? Analysis of label viewing behaviour and subsequent food purchases in a labelling intervention trial.

    PubMed

    Ni Mhurchu, Cliona; Eyles, Helen; Jiang, Yannan; Blakely, Tony

    2018-02-01

    There are few objective data on how nutrition labels are used in real-world shopping situations, or how they affect dietary choices and patterns. The Starlight study was a four-week randomised, controlled trial of the effects of three different types of nutrition labels on consumer food purchases: Traffic Light Labels, Health Star Rating labels, or Nutrition Information Panels (control). Smartphone technology allowed participants to scan barcodes of packaged foods and receive randomly allocated labels on their phone screen, and to record their food purchases. The study app therefore provided objectively recorded data on label viewing behaviour and food purchases over a four-week period. A post-hoc analysis of trial data was undertaken to assess frequency of label use, label use by food group, and association between label use and the healthiness of packaged food products purchased. Over the four-week intervention, study participants (n = 1255) viewed nutrition labels for and/or purchased 66,915 barcoded packaged products. Labels were viewed for 23% of all purchased products, with decreasing frequency over time. Shoppers were most likely to view labels for convenience foods, cereals, snack foods, bread and bakery products, and oils. They were least likely to view labels for sugar and honey products, eggs, fish, fruit and vegetables, and meat. Products for which participants viewed the label and subsequently purchased the product during the same shopping episode were significantly healthier than products where labels were viewed but the product was not subsequently purchased: mean difference in nutrient profile score -0.90 (95% CI -1.54 to -0.26). In a secondary analysis of a nutrition labelling intervention trial, there was a significant association between label use and the healthiness of products purchased. Nutrition label use may therefore lead to healthier food purchases. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. The power of putting a label on it: green labels weigh heavier than contradicting product information for consumers' purchase decisions and post-purchase behavior.

    PubMed

    Hahnel, Ulf J J; Arnold, Oliver; Waschto, Michael; Korcaj, Liridon; Hillmann, Karen; Roser, Damaris; Spada, Hans

    2015-01-01

    Green products are appealing. Thus, labeling products as environmentally friendly is an effective strategy to increase sales. However, the labels often promise more than the products can actually deliver. In the present research, we examined the expectation that consumers with high ecological motivation have strong preferences for green-labeled products - even when presented product information contradicts the label's image. This unsettling hypothesis is grounded in the labels' potential to create a cognitive match between the labeled product and consumers' motives. For labels indicating environmental friendliness (green product labels), this link should be strongest when consumers' ecological motivation is high. Findings in a series of three experiments support our assumption, showing that consumers with high ecological motivation had strong preferences (i.e., product evaluations, purchase intentions, and simulated purchase decisions) for green-labeled products as compared to consumers with low ecological motivation (Studies 1-3). Crucially, these preferences were robust, despite contradicting environmental product information (Studies 1 and 2). We extended our findings by additionally examining the impact of product labels and motivation on moral self-regulation processes. This was established by assessing participants' pro-social behavior after the purchase task: participants with high ecological motivation acted, consistent with their motives, more pro-socially in post-decision occasions. In accordance with moral cleansing effects, pro-social behavior was intensified after purchasing conventional products (Studies 2 and 3). Green labels protected participants with high ecological motivation from moral threats due to the purchase, thus making pro-social behavior less likely. Findings suggest that highly ecologically motivated consumers are most susceptible to green labels, which may override detailed product information.

  5. Site-specific labeling of proteins by using biotin protein ligase conjugated with fluorophores.

    PubMed

    Sueda, Shinji; Yoneda, Sawako; Hayashi, Hideki

    2011-06-14

    Biotin protein ligase (BPL) mediates the covalent attachment of biotin to a specific lysine residue of biotin carboxyl carrier protein (BCCP). This biotinylation in Sulfolobus tokodaii is unique in that BPL forms a tight complex with the product, biotinylated BCCP, and this property was exploited for fluorescent labeling of a membrane protein. Thus, the truncated form of BCCP (BCCPΔ100, 69 residues) was fused to either the N or C terminus of the bradykinin B2 receptor (B2R). The resulting fusion proteins, BCCPΔ100-B2R and B2R-BCCPΔ100, respectively, were separately expressed in mammalian HEK293 cells, and labeled with BPL conjugated with a fluorophore: either fluorescein, DyLight549 or green fluorescent protein. The fusion proteins were biotinylated and bound to BPL, thereby giving rise to strong fluorescence along the periphery of the cell. Some were capable of binding bradykinin and an antagonist. When stimulated with the former, the receptor translocated to the cytosol; this suggests that the labeled receptor retains its integrity in terms of ligand-binding and translocation. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  6. New horizons in cardiac innervation imaging: introduction of novel 18F-labeled PET tracers.

    PubMed

    Kobayashi, Ryohei; Chen, Xinyu; Werner, Rudolf A; Lapa, Constantin; Javadi, Mehrbod S; Higuchi, Takahiro

    2017-12-01

    Cardiac sympathetic nervous activity can be uniquely visualized by non-invasive radionuclide imaging techniques due to the fast growing and widespread application of nuclear cardiology in the last few years. The norepinephrine analogue 123 I-meta-iodobenzylguanidine ( 123 I-MIBG) is a single photon emission computed tomography (SPECT) tracer for the clinical implementation of sympathetic nervous imaging for both diagnosis and prognosis of heart failure. Meanwhile, positron emission tomography (PET) imaging has become increasingly attractive because of its higher spatial and temporal resolution compared to SPECT, which allows regional functional and dynamic kinetic analysis. Nevertheless, wider use of cardiac sympathetic nervous PET imaging is still limited mainly due to the demand of costly on-site cyclotrons, which are required for the production of conventional 11 C-labeled (radiological half-life, 20 min) PET tracers. Most recently, more promising 18 F-labeled (half-life, 110 min) PET radiopharmaceuticals targeting sympathetic nervous system have been introduced. These tracers optimize PET imaging and, by using delivery networks, cost less to produce. In this article, the latest advances of sympathetic nervous imaging using 18 F-labeled radiotracers along with their possible applications are reviewed.

  7. Using DNA-labelled nano- and microparticles to track particle transport in the environment

    NASA Astrophysics Data System (ADS)

    McNew, Coy; Wang, Chaozi; Dahlke, Helen; Lyon, Steve; Walter, Todd

    2017-04-01

    By utilizing bio-molecular nanotechnology developed for nano-medicines and drug delivery, we are able to produce DNA-labelled nano- and microparticle tracers for use in a myriad of environmental systems. The use of custom sequenced DNA allows for the fabrication of an enormous number of uniquely labelled tracers with identical transport properties (approximately 1.61 x 1060 unique sequences), each independently quantifiable, that can be applied simultaneously in any hydrologic system. By controlling the fabrication procedure to produce particles of custom size and charge, we are able to tag each size-charge combination uniquely in order to directly probe the effect of these variables on the transport properties of the particles. Here we present our methods for fabrication, extraction, and analysis of the DNA nano- and microparticle tracers, along with results from several successful applications of the tracers, including transport and retention analysis at the lab, continuum, and field scales. To date, our DNA-labelled nano- and microparticle tracers have proved useful in surface and subsurface water applications, soil retention, and even subglacial flow pathways. The range of potential applications continue to prove nearly limitless.

  8. 21 CFR 801.50 - Labeling requirements for stand-alone software.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Labeling requirements for stand-alone software....50 Labeling requirements for stand-alone software. (a) Stand-alone software that is not distributed... in packaged form, stand-alone software regulated as a medical device must provide its unique device...

  9. Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints.

    PubMed

    Kesselheim, Aaron S; Mello, Michelle M; Studdert, David M

    2011-04-01

    Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing. We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%). Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.

  10. Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints

    PubMed Central

    Kesselheim, Aaron S.; Mello, Michelle M.; Studdert, David M.

    2011-01-01

    Background Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing. Methods and Findings We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996–October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non–mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non–mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%). Conclusions Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches. Please see later in the article for the Editors' Summary PMID:21483716

  11. 9 CFR 317.300 - Nutrition labeling of meat or meat food products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Nutrition labeling of meat or meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat or meat food products. (a) Nutrition labeling shall be...

  12. 9 CFR 317.300 - Nutrition labeling of meat and meat food products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of meat and meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat and meat food products. (a) Nutrition labeling must be...

  13. 9 CFR 317.300 - Nutrition labeling of meat and meat food products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of meat and meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat and meat food products. (a) Nutrition labeling must be...

  14. The power of putting a label on it: green labels weigh heavier than contradicting product information for consumers’ purchase decisions and post-purchase behavior

    PubMed Central

    Hahnel, Ulf J. J.; Arnold, Oliver; Waschto, Michael; Korcaj, Liridon; Hillmann, Karen; Roser, Damaris; Spada, Hans

    2015-01-01

    Green products are appealing. Thus, labeling products as environmentally friendly is an effective strategy to increase sales. However, the labels often promise more than the products can actually deliver. In the present research, we examined the expectation that consumers with high ecological motivation have strong preferences for green-labeled products – even when presented product information contradicts the label’s image. This unsettling hypothesis is grounded in the labels’ potential to create a cognitive match between the labeled product and consumers’ motives. For labels indicating environmental friendliness (green product labels), this link should be strongest when consumers’ ecological motivation is high. Findings in a series of three experiments support our assumption, showing that consumers with high ecological motivation had strong preferences (i.e., product evaluations, purchase intentions, and simulated purchase decisions) for green-labeled products as compared to consumers with low ecological motivation (Studies 1–3). Crucially, these preferences were robust, despite contradicting environmental product information (Studies 1 and 2). We extended our findings by additionally examining the impact of product labels and motivation on moral self-regulation processes. This was established by assessing participants’ pro-social behavior after the purchase task: participants with high ecological motivation acted, consistent with their motives, more pro-socially in post-decision occasions. In accordance with moral cleansing effects, pro-social behavior was intensified after purchasing conventional products (Studies 2 and 3). Green labels protected participants with high ecological motivation from moral threats due to the purchase, thus making pro-social behavior less likely. Findings suggest that highly ecologically motivated consumers are most susceptible to green labels, which may override detailed product information. PMID:26441767

  15. 16 CFR 1211.24 - Product certification and labeling by manufacturers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1211.24 Section 1211.24 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.24 Product certification and labeling by manufacturers. (a) Form of permanent label of...

  16. 21 CFR 801.40 - Form of a unique device identifier.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Automatic identification and data capture (AIDC) technology. (b) The UDI must include a device identifier... evident upon visual examination of the label or device package, the label or device package must disclose... label and device packages is deemed to meet all requirements of subpart B of this part. The UPC will...

  17. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

  18. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

  19. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

  20. 21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

  1. 9 CFR 317.308 - Labeling of meat or meat food products with number of servings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of meat or meat food products... SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY... Nutrition Labeling § 317.308 Labeling of meat or meat food products with number of servings. The label of...

  2. 9 CFR 317.308 - Labeling of meat or meat food products with number of servings.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labeling of meat or meat food products... SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY... Nutrition Labeling § 317.308 Labeling of meat or meat food products with number of servings. The label of...

  3. 9 CFR 381.400 - Nutrition labeling of poultry products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition labeling of poultry products. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) Nutrition...

  4. The Doubly Labeled Water Method for Measuring Human Energy Expenditure: Adaptations for Spaceflight

    NASA Technical Reports Server (NTRS)

    Schulz, Leslie O.

    1991-01-01

    It is essential to determine human energy requirements in space, and the doubly labeled water method has been identified as the most appropriate means of indirect calorimetry to meet this need. The method employs naturally occurring, stable isotopes of hydrogen (H-2, deuterium) and oxygen (O-18) which, after dosing, mix with body water. The deuterium is lost from the body as water while the O-18 is eliminated as both water and CO2. The difference between the two isotope elimination rates is therefore a measure of CO2 production and hence energy expenditure. Spaceflight will present a unique challenge to the application of the doubly labeled water method. Specifically, interpretation of doubly labeled water results assumes that the natural abundance or 'background' levels of the isotopes remain constant during the measurement interval. To address this issue, an equilibration model will be developed in an ongoing ground-based study. As energy requirements of women matched to counterparts in the Astronauts Corps are being determined by doubly labeled water, the baseline isotope concentration will be changed by consumption of 'simulated Shuttle water' which is artificially enriched. One group of subjects will be equilibrated on simulated Shuttle water prior to energy determinations by doubly labeled water while the others will consume simulated Shuttle water after dosing. This process will allow us to derive a prediction equation to mathematically model the effect of changing background isotope concentrations.

  5. 21 CFR 333.150 - Labeling of first aid antibiotic drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of first aid antibiotic drug products... First Aid Antibiotic Drug Products § 333.150 Labeling of first aid antibiotic drug products. (a... identifies the product as a “first aid antibiotic.” (b) Indications. The labeling of the product states...

  6. 9 CFR 381.500 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. (a) The following poultry products are exempt from nutrition labeling: (1...

  7. 9 CFR 381.500 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. (a) The following poultry products are exempt from nutrition labeling: (1...

  8. 9 CFR 381.500 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. (a) The following poultry products are exempt from nutrition labeling: (1...

  9. PRN Notice 96-6: Pet Pesticide Product Label Statements

    EPA Pesticide Factsheets

    This notice specifies statements that should be added to the labels of pesticide products registered for use on dogs and/or cats. These label statements will help to ensure that products bear labeling to reduce the potential for misuse of pet products.

  10. Identification of cellular MMP substrates using quantitative proteomics: isotope-coded affinity tags (ICAT) and isobaric tags for relative and absolute quantification (iTRAQ).

    PubMed

    Butler, Georgina S; Dean, Richard A; Morrison, Charlotte J; Overall, Christopher M

    2010-01-01

    Identification of protease substrates is essential to understand the functional consequences of normal proteolytic processing and dysregulated proteolysis in disease. Quantitative proteomics and mass spectrometry can be used to identify protease substrates in the cellular context. Here we describe the use of two protein labeling techniques, Isotope-Coded Affinity Tags (ICAT and Isobaric Tags for Relative and Absolute Quantification (iTRAQ), which we have used successfully to identify novel matrix metalloproteinase (MMP) substrates in cell culture systems (1-4). ICAT and iTRAQ can label proteins and protease cleavage products of secreted proteins, protein domains shed from the cell membrane or pericellular matrix of protease-transfected cells that have accumulated in conditioned medium, or cell surface proteins in membrane preparations; isotopically distinct labels are used for control cells. Tryptic digestion and tandem mass spectrometry of the generated fragments enable sequencing of differentially labeled but otherwise identical pooled peptides. The isotopic tag, which is unique for each label, identifies the peptides originating from each sample, for instance, protease-transfected or control cells, and comparison of the peak areas enables relative quantification of the peptide in each sample. Thus proteins present in altered amounts between protease-expressing and null cells are implicated as protease substrates and can be further validated as such.

  11. Efficient enzymatic synthesis and dual-colour fluorescent labelling of DNA probes using long chain azido-dUTP and BCN dyes

    PubMed Central

    Ren, Xiaomei; El-Sagheer, Afaf H.; Brown, Tom

    2016-01-01

    A sterically undemanding azide analogue of dTTP (AHP dUTP) with an alkyl chain and ethynyl attachment to the nucleobase was designed and incorporated into DNA by primer extension, reverse transcription and polymerase chain reaction (PCR). An azide-modified 523 bp PCR amplicon with all 335 thymidines replaced by AHP dU was shown to be a perfect copy of the template from which it was amplified. Replacement of thymidine with AHP dU increases duplex stability, accounting in part for the high incorporation efficiency of the azide-modified triphosphate. Single-stranded azide-labelled DNA was conveniently prepared from PCR products by λ-exonuclease digestion and streptavidin magnetic bead isolation. Efficient fluorescent labelling of single and double-stranded DNA was carried out using dyes functionalized with bicyclo[6.1.0]non-4-yne (BCN) via the strain-promoted alkyne-azide cycloaddition (SPAAC) reaction. This revealed that the degree of labelling must be carefully controlled to achieve optimum fluorescence and avoid fluorescence quenching. Dual-coloured probes were obtained in a single tube fluorescent labelling reaction; and varying the ratios of the two dyes provides a simple method to prepare DNA probes with unique fluorescent signatures. AHP dUTP is a versatile clickable nucleotide with potentially wide applications in biology and nanotechnology including single molecule studies and synthesis of modified aptamer libraries via SELEX. PMID:26819406

  12. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  13. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  14. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  15. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  16. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  17. 9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

  18. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  19. 9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

  20. Attitude and Behavior Factors Associated with Front-of-Package Label Use with Label Users Making Accurate Product Nutrition Assessments.

    PubMed

    Roseman, Mary G; Joung, Hyun-Woo; Littlejohn, Emily I

    2018-05-01

    Front-of-package (FOP) labels are increasing in popularity on retail products. Reductive FOP labels provide nutrient-specific information, whereas evaluative FOP labels summarize nutrient information through icons. Better understanding of consumer behavior regarding FOP labels is beneficial to increasing consumer use of nutrition labeling when making grocery purchasing decisions. We aimed to determine FOP label format effectiveness in aiding consumers at assessing nutrient density of food products. In addition, we sought to determine relationships between FOP label use and attitude toward healthy eating, diet self-assessment, self-reported health and nutrition knowledge, and label and shopping behaviors. A between-subjects experimental design was employed. Participants were randomly assigned to one of four label conditions: Facts Up Front, Facts Up Front Extended, a binary symbol, and no-label control. One hundred sixty-one US primary grocery shoppers, aged 18 to 69 years. Participants were randomly invited to the online study. Participants in one of four label condition groups viewed three product categories (cereal, dairy, and snacks) with corresponding questions. Adults' nutrition assessment of food products based on different FOP label formats, along with label use and attitude toward healthy eating, diet self-assessment, self-reported health and nutrition knowledge, and label and shopping behaviors. Data analyses included descriptive statistics, χ 2 tests, and logistical regression. Significant outcomes were set to α=.05. Participants selected the more nutrient-dense product in the snack food category when it contained an FOP label. Subjective health and nutrition knowledge and frequency of selecting food for healthful reasons were associated with FOP label use (P<0.01 and P<0.05, respectively). Both Facts Up Front (reductive) and binary (evaluative) FOP labels appear effective for nutrition assessment of snack products compared with no label. Specific attitude and behavior factors were associated with label use. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  1. Risk management strategies in the Physicians' Desk Reference product labels for pregnancy category X drugs.

    PubMed

    Uhl, Kathleen; Kennedy, Dianne L; Kweder, Sandra L

    2002-01-01

    Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians' Desk Reference (PDR), a widely used source of drug information by American clinicians and patients. To review product labelling in the electronic PDR for the pregnancy category X products for pregnancy prevention risk management components in labelling. The electronic version of the 2001 and 2002 PDR was searched for 'pregnancy category X' products using the full text search feature. All product labels identified were retrieved and reviewed for trade name, generic name, manufacturer and indication. Product labels were manually searched for any pregnancy prevention risk management strategies included in labelling. Those labels that had specific pregnancy prevention risk management strategies were further evaluated. One hundred and seventeen pregnancy category X products were obtained from 2249 products searched in the 2001 PDR database and 124 pregnancy category X products were obtained from the 2150 products in the 2002 PDR database. All pregnancy category X products identified were drug products. The label/package insert for each drug was reviewed to identify risk management strategies for pregnancy prevention. The majority of the labels include as the sole risk management strategy either a black box warning and/or a contraindication for use in women who are or may become pregnant. Only 13 drugs contained specific pregnancy prevention risk management strategies in the label directing the clinician and/or patient, e.g. frequency of pregnancy testing, number and type of contraception methods. Two drugs, bexarotene capsules and gel, were only included in the 2001 PDR. Three drugs, isotretinoin, acitretin, and thalidomide, have formal pregnancy prevention risk management programmes. This study demonstrates the varied risk management approaches in labelling for pregnancy prevention for pregnancy category X drugs. There is a need for consistency in the classification of pregnancy category X products and the pregnancy prevention risk management strategies utilised in the labelling for them.

  2. 7 CFR 205.303 - Packaged products labeled “100 percent organic” or “organic.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., verifying organic certification of the operations producing such ingredients, and: Provided further, That... (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Labels, Labeling, and Market Information § 205.303 Packaged products labeled “100 percent organic” or “organic.” (a) Agricultural products...

  3. 9 CFR 381.400 - Nutrition labeling of poultry products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition labeling of poultry products... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.400 Nutrition... was delayed until Mar. 1, 2012, at 76 FR 76890, Dec. 9, 2011. (a) Nutrition labeling shall be provided...

  4. Consumer involvement: effects on information processing from over-the-counter medication labels.

    PubMed

    Sansgiry, S S; Cady, P S; Sansgiry, S

    2001-01-01

    The objective of this study was to evaluate the effects of consumer involvement on information processing from over-the-counter (OTC) medication labels. A sample of 256 students evaluated simulated OTC product labels for two product categories (headache and cold) in random order. Each participant evaluated labels after reading a scenario to simulate high and low involvement respectively. A questionnaire was used to collect data on variables such as label comprehension, attitude-towards-product label, product evaluation, and purchase intention. The results indicate that when consumers are involved in their purchase of OTC medications they are significantly more likely to understand information from the label and evaluate it accordingly. However, involvement does not affect attitude-towards-product label nor does it enhance purchase intention.

  5. Composition, disintegrative properties, and labeling compliance of commercially available taurine and carnitine dietary products.

    PubMed

    Bragg, Rebecca R; Freeman, Lisa M; Fascetti, Andrea J; Yu, Zengshou

    2009-01-15

    To test the quality, disintegration properties, and compliance with labeling regulations for representative commercially available taurine and carnitine dietary products. Evaluation study. 11 commercially available taurine and 10 commercially available carnitine products. For each product, the amount of taurine or carnitine was determined and compared with the label claim. All products were evaluated for concentrations of mercury, arsenic, and selenium. Disintegration properties of 5 taurine and 8 carnitine products were determined in vitro. Labels were evaluated for compliance with FDA guidelines. 10 of 11 taurine and 10 of 10 carnitine products were within 10% of the stated label claim. Three of 11 taurine and 6 of 10 carnitine products were within 5% of the stated label claim. The median percentage difference between laboratory analysis and label claim was -5.7% (range, -26.3% to 2.5%) for taurine and 3.6% (range, -2.6% to 8.8%) for carnitine. No substantial amount of contamination with mercury, arsenic, or selenium was found in any of the products. During disintegration testing, 1 of 5 taurine products and 5 of 8 carnitine products did not disintegrate within 45 minutes during at least 1 test. Disintegration time for those that did disintegrate ranged from 1.7 to 37.0 minutes. All product labels conformed with FDA regulations. Taurine and carnitine products evaluated in this study closely adhered to manufacturer claims and labeling guidelines. However, disintegration testing suggested high variability in some products, possibly limiting uptake and use by animals that receive them.

  6. 9 CFR 317.300 - Nutrition labeling of meat or meat food products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition labeling of meat or meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat or meat food products. Link to an amendment published at 75...

  7. 9 CFR 317.300 - Nutrition labeling of meat or meat food products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition labeling of meat or meat... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.300 Nutrition labeling of meat or meat food products. Link to an amendment published at 75...

  8. 78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.

  9. Targeted, Site-specific quantitation of N- and O-glycopeptides using 18O-labeling and product ion based mass spectrometry.

    PubMed

    Srikanth, Jandhyam; Agalyadevi, Rathinasamy; Babu, Ponnusamy

    2017-02-01

    The site-specific quantitation of N- and O-glycosylation is vital to understanding the function(s) of different glycans expressed at a given site of a protein under physiological and disease conditions. Most commonly used precursor ion intensity based quantification method is less accurate and other labeled methods are expensive and require enrichment of glycopeptides. Here, we used glycopeptide product (y and Y0) ions and 18 O-labeling of C-terminal carboxyl group as a strategy to obtain quantitative information about fold-change and relative abundance of most of the glycoforms attached to the glycopeptides. As a proof of concept, the accuracy and robustness of this targeted, relative quantification LC-MS method was demonstrated using Rituximab. Furthermore, the N-glycopeptide quantification results were compared with a biosimilar of Rituximab and validated with quantitative data obtained from 2-AB-UHPLC-FL method. We further demonstrated the intensity fold-change and relative abundance of 46 unique N- and O-glycopeptides and aglycopeptides from innovator and biosimilar samples of Etanercept using both the normal-MS and product ion based quantitation. The results showed a very similar site-specific expression of N- and O-glycopeptides between the samples but with subtle differences. Interestingly, we have also been able to quantify macro-heterogeneity of all N- and O-glycopetides of Etanercept. In addition to applications in biotherapeutics, the developed method can also be used for site-specific quantitation of N- and O-glycopeptides and aglycopeptides of glycoproteins with known glycosylation pattern.

  10. Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization.

    PubMed

    Berlin, Robert J

    2009-09-01

    I examined the relationship between the Food and Drug Administration's (FDA's) use of special regulatory designations and the frequency with which labels of oncology drugs are revised to explore how the FDA's designation of products relates to product development and refinement. One hundred oncology drugs, designated by the FDA as accelerated approval, priority review, orphan drug, or traditional review, were identified from publicly available information. Drug information for each product was evaluated to assess the rate at which manufacturers revised product labeling. Rates were compared between specially categorized products and traditional review products (e.g., orphan vs nonorphan drugs) to produce revision rate ratios for each special category. Labeling for accelerated approval and priority review products are revised significantly more frequently than are labels for traditional products. Accelerated approval products are approved based on surrogate endpoints; this approval process anticipates subsequent labeling refinement. Priority review products, however, are approved through a process that is ostensibly as rigorous as traditional review. Their higher than expected label revision rate may suggest deficiencies in the FDA's current priority review evaluation processes.

  11. Can nanotechnology help advance glaciological research?

    NASA Astrophysics Data System (ADS)

    Dahlke, H. E.; McNew, C.; Wang, C.; McLaughlin, S.; Kocis, T. N.

    2017-12-01

    In a rapidly changing cryosphere, identifying sources, pathways, and residence times of snow and glacier meltwater is critical to developing improved understanding of watershed-stream connections and hydrological/glaciological melt models. Traditionally, glaciologists have used a variety of tracers, including chloride, microparticles, and dyes, to identify the structure and morphology of subglacial drainage systems. However, minimum detection limits, tracer expense, and the ability of watersheds to retain a memory of past tracer inputs have restricted both the scale of tracer application and the repeated or simultaneous use of most known tracers, thus limiting our ability to study complex glacial systems. These shortcomings in hydrologic tracers can be overcome by utilizing a tracer that allows for the unique identification between spatial and temporal inputs while maintaining identical transport characteristics. Here, we present the use of DNA-labeled nanoparticles, developed for nano-medicine and drug delivery, as environmental tracers. The DNA-labeled particle tracers consist of short DNA strands encapsulated within biodegradable polymer microspheres, which allow for repeatable production of numerous uniquely labelled tracers of pre-determined size and physical transport properties. Each batch of tracers are independently quantifiable; even a single DNA molecule can be detected with cost-effective quantitative polymerase chain reaction (qPCR). We have tested our tracer technology in complex systems such as valley glaciers in Sweden and Alaska and in both laboratory and field studies of channel flow, overland flow, and flow in porous media; these proof-of-concept studies indicate that nanotechnology allows for powerful characterization, description, and, ultimately, prediction of flow pathways in glacial systems and the environment.

  12. Effects of a Voluntary Front-of-Pack Nutrition Labelling System on Packaged Food Reformulation: The Health Star Rating System in New Zealand

    PubMed Central

    Eyles, Helen; Choi, Yeun-Hyang

    2017-01-01

    Interpretive, front-of-pack (FOP) nutrition labels may encourage reformulation of packaged foods. We aimed to evaluate the effects of the Health Star Rating (HSR), a new voluntary interpretive FOP labelling system, on food reformulation in New Zealand. Annual surveys of packaged food and beverage labelling and composition were undertaken in supermarkets before and after adoption of HSR i.e., 2014 to 2016. Outcomes assessed were HSR uptake by food group star ratings of products displaying a HSR label; nutritional composition of products displaying HSR compared with non-HSR products; and the composition of products displaying HSR labels in 2016 compared with their composition prior to introduction of HSR. In 2016, two years after adoption of the voluntary system, 5.3% of packaged food and beverage products surveyed (n = 807/15,357) displayed HSR labels. The highest rates of uptake were for cereals, convenience foods, packaged fruit and vegetables, sauces and spreads, and ‘Other’ products (predominantly breakfast beverages). Products displaying HSR labels had higher energy density but had significantly lower mean saturated fat, total sugar and sodium, and higher fibre, contents than non-HSR products (all p-values < 0.001). Small but statistically significant changes were observed in mean energy density (−29 KJ/100 g, p = 0.002), sodium (−49 mg/100 g, p = 0.03) and fibre (+0.5 g/100 g, p = 0.001) contents of HSR-labelled products compared with their composition prior to adoption of HSR. Reformulation of HSR-labelled products was greater than that of non-HSR-labelled products over the same period, e.g., energy reduction in HSR products was greater than in non-HSR products (−1.5% versus −0.4%), and sodium content of HSR products decreased by 4.6% while that of non-HSR products increased by 3.1%. We conclude that roll-out of the voluntary HSR labelling system is driving healthier reformulation of some products. Greater uptake across the full food supply should improve population diets. PMID:28829380

  13. Effects of a Voluntary Front-of-Pack Nutrition Labelling System on Packaged Food Reformulation: The Health Star Rating System in New Zealand.

    PubMed

    Mhurchu, Cliona Ni; Eyles, Helen; Choi, Yeun-Hyang

    2017-08-22

    Interpretive, front-of-pack (FOP) nutrition labels may encourage reformulation of packaged foods. We aimed to evaluate the effects of the Health Star Rating (HSR), a new voluntary interpretive FOP labelling system, on food reformulation in New Zealand. Annual surveys of packaged food and beverage labelling and composition were undertaken in supermarkets before and after adoption of HSR i.e., 2014 to 2016. Outcomes assessed were HSR uptake by food group star ratings of products displaying a HSR label; nutritional composition of products displaying HSR compared with non-HSR products; and the composition of products displaying HSR labels in 2016 compared with their composition prior to introduction of HSR. In 2016, two years after adoption of the voluntary system, 5.3% of packaged food and beverage products surveyed ( n = 807/15,357) displayed HSR labels. The highest rates of uptake were for cereals, convenience foods, packaged fruit and vegetables, sauces and spreads, and 'Other' products (predominantly breakfast beverages). Products displaying HSR labels had higher energy density but had significantly lower mean saturated fat, total sugar and sodium, and higher fibre, contents than non-HSR products (all p -values < 0.001). Small but statistically significant changes were observed in mean energy density (-29 KJ/100 g, p = 0.002), sodium (-49 mg/100 g, p = 0.03) and fibre (+0.5 g/100 g, p = 0.001) contents of HSR-labelled products compared with their composition prior to adoption of HSR. Reformulation of HSR-labelled products was greater than that of non-HSR-labelled products over the same period, e.g., energy reduction in HSR products was greater than in non-HSR products (-1.5% versus -0.4%), and sodium content of HSR products decreased by 4.6% while that of non-HSR products increased by 3.1%. We conclude that roll-out of the voluntary HSR labelling system is driving healthier reformulation of some products. Greater uptake across the full food supply should improve population diets.

  14. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...

  15. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...

  16. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...

  17. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...

  18. 21 CFR 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Magnesium sulfate heptahydrate; label declaration... Drug Products § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or...

  19. 9 CFR 112.2 - Final container label, carton label, and enclosure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... carton; (10) In the case of a product which contains an antibiotic added during the production process... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Final container label, carton label, and enclosure. 112.2 Section 112.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION...

  20. Detection and traceability of genetically modified organisms in the food production chain.

    PubMed

    Miraglia, M; Berdal, K G; Brera, C; Corbisier, P; Holst-Jensen, A; Kok, E J; Marvin, H J P; Schimmel, H; Rentsch, J; van Rie, J P P F; Zagon, J

    2004-07-01

    Both labelling and traceability of genetically modified organisms are current issues that are considered in trade and regulation. Currently, labelling of genetically modified foods containing detectable transgenic material is required by EU legislation. A proposed package of legislation would extend this labelling to foods without any traces of transgenics. These new legislations would also impose labelling and a traceability system based on documentation throughout the food and feed manufacture system. The regulatory issues of risk analysis and labelling are currently harmonised by Codex Alimentarius. The implementation and maintenance of the regulations necessitates sampling protocols and analytical methodologies that allow for accurate determination of the content of genetically modified organisms within a food and feed sample. Current methodologies for the analysis of genetically modified organisms are focused on either one of two targets, the transgenic DNA inserted- or the novel protein(s) expressed- in a genetically modified product. For most DNA-based detection methods, the polymerase chain reaction is employed. Items that need consideration in the use of DNA-based detection methods include the specificity, sensitivity, matrix effects, internal reference DNA, availability of external reference materials, hemizygosity versus homozygosity, extrachromosomal DNA, and international harmonisation. For most protein-based methods, enzyme-linked immunosorbent assays with antibodies binding the novel protein are employed. Consideration should be given to the selection of the antigen bound by the antibody, accuracy, validation, and matrix effects. Currently, validation of detection methods for analysis of genetically modified organisms is taking place. In addition, new methodologies are developed, including the use of microarrays, mass spectrometry, and surface plasmon resonance. Challenges for GMO detection include the detection of transgenic material in materials with varying chromosome numbers. The existing and proposed regulatory EU requirements for traceability of genetically modified products fit within a broader tendency towards traceability of foods in general and, commercially, towards products that can be distinguished from each other. Traceability systems document the history of a product and may serve the purpose of both marketing and health protection. In this framework, segregation and identity preservation systems allow for the separation of genetically modified and non-modified products from "farm to fork". Implementation of these systems comes with specific technical requirements for each particular step of the food processing chain. In addition, the feasibility of traceability systems depends on a number of factors, including unique identifiers for each genetically modified product, detection methods, permissible levels of contamination, and financial costs. In conclusion, progress has been achieved in the field of sampling, detection, and traceability of genetically modified products, while some issues remain to be solved. For success, much will depend on the threshold level for adventitious contamination set by legislation. Copryright 2004 Elsevier Ltd.

  1. The UNIQUe Label: Supporting a Culture of Innovation and Quality in Higher Education

    NASA Astrophysics Data System (ADS)

    Boonen, Annemie; Bijnens, Helena

    European higher education institutions will need significant reforms, in order to guarantee their leading role in a globalized knowledge economy. These reforms can be enhanced by improving the way in which traditional universities integrate new technologies both in their educational activities and throughout their strategic and operational processes. The UNIQUe institutional accreditation scheme, analyzed and described in this chapter, intends to support this process of integrating the use of new technologies in higher education. With its specific open approach to quality in e-Learning, UNIQUe emphasizes innovation and creativity in a process that includes self-assessment and constructive dialog with peers and stakeholders involved. UNIQUe intends to use the institutional quality label as a catalyst for continuous improvement and change while setting up collaborative bench learning processes among universities for the adoption and integration of e-Learning.

  2. Production of 64Cu and 67Cu radiopharmaceuticals using zinc target irradiated with accelerator neutrons

    NASA Astrophysics Data System (ADS)

    Kawabata, Masako; Hashimoto, Kazuyuki; Saeki, Hideya; Sato, Nozomi; Motoishi, Shoji; Nagai, Yasuki

    2014-09-01

    Copper radioisotopes have gained a lot of attention in radiopharmaceuticals owing to their unique decay characteristics. The longest half-life β emitter, 67Cu, is thought to be suitable for targeted radio-immunotherapy. Adequate production of 67Cu to meet the demands of clinical studies has not been fully established. Another attractive copper isotope, 64Cu has possible applications as a diagnostic imaging tracer combined with a therapeutic effect. This work proposes a production method using accelerator neutrons in which two copper radioisotopes can be produced: 1) 68Zn(n,x)67Cu and 2) 64Zn(n,p)64Cu using ~14 MeV neutrons generated by natC(d, n) reaction, both from natural or enriched zinc oxides. The generated 64,67Cu were separated from the target zinc oxide using a chelating and an anion exchange columns and were labelled with two widely studied chelators where the labelling efficiency was found to be acceptably good. The major advantage of this method is that a significant amount of 64,67Cu with a very few impurity radionuclides are produced which also makes the separation procedure simple. Provided an accelerator supplying an Ed = ~ 40 MeV, a wide application of 64,67Cu based drugs in nuclear medicine is feasible in the near future. We will present the characteristics of this production method using accelerator neutrons including the chemical separation processes.

  3. Considerations and Future Research Directions for E-Cigarette Warnings-Findings from Expert Interviews.

    PubMed

    Wackowski, Olivia A; Hammond, David; O'Connor, Richard J; Strasser, Andrew A; Delnevo, Cristine D

    2017-07-14

    Tobacco warning labels are important sources of risk information but research historically has been cigarette-centric. This qualitative study aimed to inform future direction and research on warnings for e-cigarettes. Between June and August 2016, we conducted interviews with 10 researchers with expertise in tobacco warning label research. Interviewees were registrants of a 2016 National Cancer Institute grantee meeting on tobacco warnings. Several participants agreed that the Food and Drug Administration's new nicotine addiction warning for e-cigarettes could be informative but that it might not resonate with young people. Many agreed that more than one warning would be important as e-cigarette science evolves and that research on additional warning themes (e.g., nicotine exposure, harmful constituents) and execution styles (including use of pictorials) was important. Participants were somewhat mixed about the use of reduced-risk messages within e-cigarette warnings, but agreed that research on how to communicate about cigarette/e-cigarette relative risks was needed. Overall, more research is needed on tobacco warnings for non-cigarette products, including on the message content, placement, execution and potential impact on audiences' product knowledge, risk perceptions and use intentions. This is particularly needed for products such as e-cigarettes which may have harm-reduction potential relative to cigarettes and require unique considerations.

  4. Considerations and Future Research Directions for E-Cigarette Warnings—Findings from Expert Interviews

    PubMed Central

    Wackowski, Olivia A.; Hammond, David; O’Connor, Richard J.; Strasser, Andrew A.; Delnevo, Cristine D.

    2017-01-01

    Tobacco warning labels are important sources of risk information but research historically has been cigarette-centric. This qualitative study aimed to inform future direction and research on warnings for e-cigarettes. Between June and August 2016, we conducted interviews with 10 researchers with expertise in tobacco warning label research. Interviewees were registrants of a 2016 National Cancer Institute grantee meeting on tobacco warnings. Several participants agreed that the Food and Drug Administration’s new nicotine addiction warning for e-cigarettes could be informative but that it might not resonate with young people. Many agreed that more than one warning would be important as e-cigarette science evolves and that research on additional warning themes (e.g., nicotine exposure, harmful constituents) and execution styles (including use of pictorials) was important. Participants were somewhat mixed about the use of reduced-risk messages within e-cigarette warnings, but agreed that research on how to communicate about cigarette/e-cigarette relative risks was needed. Overall, more research is needed on tobacco warnings for non-cigarette products, including on the message content, placement, execution and potential impact on audiences’ product knowledge, risk perceptions and use intentions. This is particularly needed for products such as e-cigarettes which may have harm-reduction potential relative to cigarettes and require unique considerations. PMID:28708124

  5. A Comparison of the Sodium Content of Supermarket Private-Label and Branded Foods in Australia.

    PubMed

    Trevena, Helen; Neal, Bruce; Dunford, Elizabeth; Haskelberg, Hila; Wu, Jason H Y

    2015-08-21

    Supermarket private-label products are perceived to be lower quality than their branded counterparts. Excess dietary sodium in foods contributes to high blood pressure and cardiovascular disease. Sodium concentrations in products are an important indicator of quality. We compared the sodium content of 15,680 supermarket private-label and branded products, available in four Australian supermarkets between 2011-2013, overall and for 15 food categories. Mean sodium values were compared for: (1) all products in 2013; (2) products in both 2011 and 2013; and (3) products only in 2013. Comparisons were made using paired and unpaired t tests. In each year the proportion of supermarket private-label products was 31%-32%, with overall mean sodium content 17% (12%-23%) lower than branded products in 2013 (p ≤ 0.001). For products available in both 2011 and 2013 there was a ≤2% (1%-3%) mean sodium reduction overall with no difference in reformulation between supermarket private-label and branded products (p = 0.73). New supermarket private-label products in 2013 were 11% lower in sodium than their branded counterparts (p = 0.02). Supermarket private-label products performed generally better than branded in terms of their sodium content. Lower sodium intake translates into lower blood pressure; some supermarket private-label products may be a good option for Australians needing to limit their sodium intake.

  6. A Comparison of the Sodium Content of Supermarket Private-Label and Branded Foods in Australia

    PubMed Central

    Trevena, Helen; Neal, Bruce; Dunford, Elizabeth; Haskelberg, Hila; Wu, Jason H. Y.

    2015-01-01

    Supermarket private-label products are perceived to be lower quality than their branded counterparts. Excess dietary sodium in foods contributes to high blood pressure and cardiovascular disease. Sodium concentrations in products are an important indicator of quality. We compared the sodium content of 15,680 supermarket private-label and branded products, available in four Australian supermarkets between 2011–2013, overall and for 15 food categories. Mean sodium values were compared for: (1) all products in 2013; (2) products in both 2011 and 2013; and (3) products only in 2013. Comparisons were made using paired and unpaired t tests. In each year the proportion of supermarket private-label products was 31%–32%, with overall mean sodium content 17% (12%–23%) lower than branded products in 2013 (p ≤ 0.001). For products available in both 2011 and 2013 there was a ≤2% (1%–3%) mean sodium reduction overall with no difference in reformulation between supermarket private-label and branded products (p = 0.73). New supermarket private-label products in 2013 were 11% lower in sodium than their branded counterparts (p = 0.02). Supermarket private-label products performed generally better than branded in terms of their sodium content. Lower sodium intake translates into lower blood pressure; some supermarket private-label products may be a good option for Australians needing to limit their sodium intake. PMID:26308047

  7. Cluster optical coding: from biochips to counterfeit security

    NASA Astrophysics Data System (ADS)

    Haglmueller, Jakob; Alguel, Yilmaz; Mayer, Christian; Matyushin, Viacheslav; Bauer, Georg; Pittner, Fritz; Leitner, Alfred; Aussenegg, Franz R.; Schalkhammer, Thomas G.

    2004-07-01

    Spatially tuned resonant nano-clusters allow high local field enhancement when exited by electromagnetic radiation. A number of phenomena had been described and subsequently applied to novel nano- and bionano-devices. Decisive for these types of devices and sensors is the precise nanometric assembly, coupling the local field surrounding a cluster to allow resonance with other elements interacting with this field. In particular, the distance cluster-mirror or cluster-fluorophore gives rise to a variety of enhancement phenomena. High throughput transducers using metal cluster resonance technology are based on surface-enhancement of metal cluster light absorption (SEA). The optical property for the analytical application of metal cluster films is the so-called anomalous absorption. At a well defined nanometric distance of a cluster to a mirror the reflected electromagnetic field has the same phase at the position of the absorbing cluster as the incident fields. This feedback mechanism strongly enhances the effective cluster absorption coefficient. The system is characterised by a narrow reflection minimum. Based on this SEA-phenomenon (licensed to and further developed and optimized by NovemberAG, Germany Erlangen) a number of commercial products have been constructed. Brandsealing(R) uses the patented SEA cluster technology to produce optical codings. Cluster SEA thin film systems show a characteristic color-flip effect and are extremely mechanically and thermally robust. This is the basis for its application as an unique security feature. The specific spectroscopic properties as e.g. narrow band multi-resonance of the cluster layers allow the authentication of the optical code which can be easily achieved with a mobile hand-held reader developed by november AG and Siemens AG. Thus, these features are machine-readable which makes them superior to comparable technologies. Cluster labels are available in two formats: as a label for tamper-proof product packaging, and as a direct label, where label and logo are permanently applied directly and unremovable to the product surface. Together with Infineon Technologies and HUECK FOLIEN, the SEA technology is currently developed as a direct label for e.g. SmartCards.

  8. 76 FR 76890 - Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-09

    .... FSIS-2005-0018] Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry... (FSIS) is delaying the effective date of the final regulations that require nutrition labeling of the... December 29, 2010, FSIS published the final rule, ``Nutrition Labeling of Single-Ingredient Products and...

  9. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ...] Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance provides recommendations on the design of label comprehension...

  10. Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.

    PubMed

    1993-08-03

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.

  11. 21 CFR 336.50 - Labeling of antiemetic drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... labeled for use in adults and for those products that can be and are labeled for use in children under 12... enlargement of the prostate gland.” (ii) For those products that can be and are labeled only for children under 12 years of age. “Do not give this product to children who have a breathing problem such as...

  12. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  13. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  14. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  15. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  16. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

    PubMed

    Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

    2013-01-26

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.

  17. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

    PubMed Central

    2013-01-01

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. PMID:23351881

  18. Questioning the Long-Term English Learner Label: How Categorization Can Blind Us to Students' Abilities

    ERIC Educational Resources Information Center

    Thompson, Karen D.

    2015-01-01

    Background/Context: The label long-term English learner (LTEL) is increasingly used to describe students who have been educated in the United States for many years but have not met criteria to be considered proficient in English. Though created to draw awareness to the unique needs of a particular group of students, the LTEL label has acquired…

  19. 9 CFR 112.10 - Special packaging and labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Special packaging and labeling. 112.10... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.10 Special packaging and labeling. A biological product, which requires special packaging and/or...

  20. Combined in vitro transcription and reverse transcription to amplify and label complex synthetic oligonucleotide probe libraries.

    PubMed

    Murgha, Yusuf; Beliveau, Brian; Semrau, Kassandra; Schwartz, Donald; Wu, Chao-Ting; Gulari, Erdogan; Rouillard, Jean-Marie

    2015-06-01

    Oligonucleotide microarrays allow the production of complex custom oligonucleotide libraries for nucleic acid detection-based applications such as fluorescence in situ hybridization (FISH). We have developed a PCR-free method to make single-stranded DNA (ssDNA) fluorescent probes through an intermediate RNA library. A double-stranded oligonucleotide library is amplified by transcription to create an RNA library. Next, dye- or hapten-conjugate primers are used to reverse transcribe the RNA to produce a dye-labeled cDNA library. Finally the RNA is hydrolyzed under alkaline conditions to obtain the single-stranded fluorescent probes library. Starting from unique oligonucleotide library constructs, we present two methods to produce single-stranded probe libraries. The two methods differ in the type of reverse transcription (RT) primer, the incorporation of fluorescent dye, and the purification of fluorescent probes. The first method employs dye-labeled reverse transcription primers to produce multiple differentially single-labeled probe subsets from one microarray library. The fluorescent probes are purified from excess primers by oligonucleotide-bead capture. The second method uses an RNA:DNA chimeric primer and amino-modified nucleotides to produce amino-allyl probes. The excess primers and RNA are hydrolyzed under alkaline conditions, followed by probe purification and labeling with amino-reactive dyes. The fluorescent probes created by the combination of transcription and reverse transcription can be used for FISH and to detect any RNA and DNA targets via hybridization.

  1. Comparison of two front-of-package nutrition labeling schemes, and their explanation, on consumers' perception of product healthfulness and food choice.

    PubMed

    Lundeberg, Pamela J; Graham, Dan J; Mohr, Gina S

    2018-06-01

    Front-of-package (FOP) nutrition labels are increasingly used to present nutritional information to consumers. A variety of FOP nutrition schemes exist for presenting condensed nutrition information. The present study directly compared two symbolic FOP labeling systems - traffic light and star-based schemes - with specific regard to healthfulness perception and purchase intention for a variety of products. Additionally, this study investigated which method of message framing (gain, loss, gain + loss) would best enable individuals to effectively utilize the FOP labels. College students (n = 306) viewed food packages featuring either star or traffic light FOP labels and rated the healthfulness of each product and their likelihood of purchasing the product. Within each label type, participants were presented with differently-framed instructions regarding how to use the labels. Participants who viewed the star labels rated products with the lowest healthfulness as significantly less healthful and rated products with the highest healthfulness as significantly more healthful compared to participants who viewed those same products with traffic light labels. Purchase intention did not differ by label type. Additionally, including any type of framing (gain, loss, or gain + loss) assisted consumers in differentiating between foods with mid-range vs. low nutritional value. Star-based labels led more healthful foods to be seen as even more healthful and less healthful foods to be seen as even less healthful compared to the same foods with traffic light labels. Additionally, results indicate a benefit of including framing information for FOP nutrition label instructions; however, no individual frame led to significantly different behavior compared to the other frames. While ratings of product healthfulness were influenced by the framing and the label type, purchase intention was not impacted by either of these factors. Copyright © 2018 Elsevier Ltd. All rights reserved.

  2. 9 CFR 381.115 - Containers of inspected and passed poultry products required to be labeled.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... poultry products required to be labeled. 381.115 Section 381.115 Animals and Animal Products FOOD SAFETY... AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and Containers § 381.115 Containers of inspected and passed poultry products required to...

  3. Stable isotope dimethyl labelling for quantitative proteomics and beyond

    PubMed Central

    Hsu, Jue-Liang; Chen, Shu-Hui

    2016-01-01

    Stable-isotope reductive dimethylation, a cost-effective, simple, robust, reliable and easy-to- multiplex labelling method, is widely applied to quantitative proteomics using liquid chromatography-mass spectrometry. This review focuses on biological applications of stable-isotope dimethyl labelling for a large-scale comparative analysis of protein expression and post-translational modifications based on its unique properties of the labelling chemistry. Some other applications of the labelling method for sample preparation and mass spectrometry-based protein identification and characterization are also summarized. This article is part of the themed issue ‘Quantitative mass spectrometry’. PMID:27644970

  4. Polyketide biosynthesis in dinoflagellates: what makes it different?

    PubMed

    Van Wagoner, Ryan M; Satake, Masayuki; Wright, Jeffrey L C

    2014-09-01

    Dinoflagellates produce unique polyketides characterized by their size and complexity. The biosynthesis of a limited number of such metabolites has been reported, with studies largely hampered by the low yield of compounds and the severe scrambling of label in the isotopically-labeled precursors. Nonetheless, of the successful biosynthetic experiments that have been reported, many surprising and unique processes have been discovered. This knowledge has been accessed through a series of biochemical labeling studies, and while limited molecular genetic data has been amassed, it is still in the early stages of development. In an attempt to meet this challenge, this review has compared some of the biosynthetic processes with similar ones identified in other microbes such as bacteria and myxobacteria, with the idea that similar genes and enzymes are employed by dinoflagellates.

  5. Impact of Health Labels on Flavor Perception and Emotional Profiling: A Consumer Study on Cheese

    PubMed Central

    Schouteten, Joachim J.; De Steur, Hans; De Pelsmaeker, Sara; Lagast, Sofie; De Bourdeaudhuij, Ilse; Gellynck, Xavier

    2015-01-01

    The global increase of cardiovascular diseases is linked to the shift towards unbalanced diets with increasing salt and fat intake. This has led to a growing consumers’ interest in more balanced food products, which explains the growing number of health-related claims on food products (e.g., “low in salt” or “light”). Based on a within-subjects design, consumers (n = 129) evaluated the same cheese product with different labels. Participants rated liking, saltiness and fat flavor intensity before and after consuming four labeled cheeses. Even though the cheese products were identical, inclusion of health labels influenced consumer perceptions. Cheese with a “light” label had a lower overall expected and perceived liking compared to regular cheese. Although cheese with a “salt reduced” label had a lower expected liking compared to regular cheese, no lower liking was found when consumers actually consumed the labeled cheese. All labels also influenced the perceived intensities of the attributes related to these labels, e.g., for example salt intensity for reduced salt label. While emotional profiles of the labeled cheeses differed before tasting, little differences were found when actual tasting these cheeses. In conclusion, this study shows that health-related labels might influence the perceived flavor and emotional profiles of cheese products. PMID:26690211

  6. 21 CFR 211.42 - Design and construction features.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...

  7. 21 CFR 211.42 - Design and construction features.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...

  8. 21 CFR 211.42 - Design and construction features.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...

  9. 21 CFR 211.42 - Design and construction features.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and... withholding from use of components, drug product containers, closures, and labeling, pending the appropriate...

  10. 16 CFR 1211.25 - Product certification and labeling by importers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1211.25 Section 1211.25 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.25 Product certification and labeling by importers. (a) General. The importer of any automatic...

  11. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... fixed-pitch propellers, etc.). If the engine is certified as a recreational engine, state: “INSTALLING... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix...

  12. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... fixed-pitch propellers, etc.). If the engine is certified as a recreational engine, state: “INSTALLING... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix...

  13. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... fixed-pitch propellers, etc.). If the engine is certified as a recreational engine, state: “INSTALLING... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix...

  14. 9 CFR 112.2 - Final container label, carton label, and enclosure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...

  15. 9 CFR 112.2 - Final container label, carton label, and enclosure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...

  16. 9 CFR 112.2 - Final container label, carton label, and enclosure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...

  17. 16 CFR 300.15 - Labeling of containers or packaging of wool products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Labeling of containers or packaging of wool products. 300.15 Section 300.15 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.15...

  18. 9 CFR 112.2 - Final container label, carton label, and enclosure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... biological product which name shall be identical with that shown in the product license under which such... container label if complete descriptive terms appear on a carton label and enclosures; (2) If the biological... if the biological product is prepared in a foreign country, the name and address of the permittee and...

  19. Soil Fumigant Labels - Dimethyl Disulfide (DMDS)

    EPA Pesticide Factsheets

    Search by EPA registration number, product name, or company and follow the link to the Pesticide Product Labeling System (PPLS) for label details. Updated labels include new safety requirements for buffer zones and related measures.

  20. E-cigarette nicotine content and labelling practices in a restricted market: Findings from Ontario, Canada.

    PubMed

    Czoli, Christine D; Goniewicz, Maciej L; Palumbo, Mary; White, Christine M; Hammond, David

    2018-05-04

    Although several countries, including Canada, have prohibited the sale of nicotine-containing e-cigarettes, there is little evidence examining the impact of such regulatory measures on nicotine content and labelling. E-cigarettes were systematically purchased at 80 retail outlets across 4 cities in Ontario, Canada in January-February 2015. Products' nicotine content and labelling accuracy were assessed using gas chromatography. A total of 166 e-cigarette products were purchased, including disposable products (33%), refillable products (14%), and e-liquids (53%). Similar proportions of products were labelled as 'without nicotine' (41%), and 'with nicotine' (44%), while 15% of products were unlabelled. Analyses revealed that almost half the products (48%) contained nicotine. With respect to the presence of nicotine, 10 products (6%) were mislabelled. Just over one-quarter (27%) of products labelled as 'with nicotine' (n = 73) fell outside their labelled concentration. All of the mislabelled products were e-liquids (100%) and the vast majority were sold in vape shops (90%). Despite a prohibition, nicotine-containing e-cigarettes are commonly sold in Canada. While many e-cigarettes were correctly labelled, inaccuracies were common, particularly among nicotine-containing products sold in vape shops. The findings reflect limitations regarding the design and enforcement of the current e-cigarette regulatory framework. Copyright © 2018 Elsevier B.V. All rights reserved.

  1. 9 CFR 590.950 - Labeling of containers of eggs or egg products for importation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of containers of eggs or egg... SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.950 Labeling of containers of eggs or egg products for importation...

  2. 9 CFR 590.950 - Labeling of containers of eggs or egg products for importation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labeling of containers of eggs or egg... SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.950 Labeling of containers of eggs or egg products for importation...

  3. 75 FR 32953 - Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products; Availability AGENCY: Food... in the Label, Labeling, or Advertising of Tobacco Products.'' This guidance provides information on... the use of ``light,'' ``mild,'' ``low,'' or similar descriptors in the label, labeling, or advertising...

  4. Voluntary Folic Acid Fortification Levels and Nutrient Composition of Food Products from the Spanish Market: A 2011–2015 Update

    PubMed Central

    Samaniego-Vaesken, María Lourdes; Alonso-Aperte, Elena; Varela-Moreiras, Gregorio

    2017-01-01

    Introduction. Folic acid (FA) is a synthetic compound commonly added for voluntary fortification of food products in many European countries. In our country, food composition databases (FCDB) lack comprehensive data on FA fortification practices and this is considered a priority research need when undergoing nutritional assessment of the population. Methods. A product inventory was collected and updated by visiting retail stores in Madrid Region, conducting online supermarket searches, and by the provision of food label information by manufacturers. Euro-FIR FCDB guidelines for data compilation and harmonization were used. Results. The FCDB, compiled between 2011 and 2015, includes FA as well as macro and micronutrient data from 338 fortified foodstuffs. As compared to previous FCDB updates (May 2010), 37 products have ceased to declare added FA in their labels, mainly yogurt and fermented milk products. The main food subgroup is ‘breakfast cereals’ (n = 95, 34% of total). However, the highest average FA fortification levels per recommended serving were observed in the ‘milk, milk products, and milk substitutes’ group at ≥35% FA Nutrient Reference Values (NRV, 200 µg, EU Regulation 1169 of 2011) (60–76.3 µg FA per 200 mL). Average contribution to the FA NRV per food group and serving ranged between 16%–35%. Conclusion. Our data show a minor decrease in the number of FA fortified products, but vitamin levels added by manufacturers are stable in most food groups and subgroups. This representative product inventory comprises the main FA food source from voluntary fortification in our country. It is therefore a unique compilation tool with valuable data for the assessment of dietary intakes for the vitamin. PMID:28273872

  5. Voluntary Folic Acid Fortification Levels and Nutrient Composition of Food Products from the Spanish Market: A 2011-2015 Update.

    PubMed

    Samaniego-Vaesken, María Lourdes; Alonso-Aperte, Elena; Varela-Moreiras, Gregorio

    2017-03-05

    Folic acid (FA) is a synthetic compound commonly added for voluntary fortification of food products in many European countries. In our country, food composition databases (FCDB) lack comprehensive data on FA fortification practices and this is considered a priority research need when undergoing nutritional assessment of the population. A product inventory was collected and updated by visiting retail stores in Madrid Region, conducting online supermarket searches, and by the provision of food label information by manufacturers. Euro-FIR FCDB guidelines for data compilation and harmonization were used. The FCDB, compiled between 2011 and 2015, includes FA as well as macro and micronutrient data from 338 fortified foodstuffs. As compared to previous FCDB updates (May 2010), 37 products have ceased to declare added FA in their labels, mainly yogurt and fermented milk products. The main food subgroup is 'breakfast cereals' ( n = 95, 34% of total). However, the highest average FA fortification levels per recommended serving were observed in the 'milk, milk products, and milk substitutes' group at ≥35% FA Nutrient Reference Values (NRV, 200 µg, EU Regulation 1169 of 2011) (60-76.3 µg FA per 200 mL). Average contribution to the FA NRV per food group and serving ranged between 16%-35%. Our data show a minor decrease in the number of FA fortified products, but vitamin levels added by manufacturers are stable in most food groups and subgroups. This representative product inventory comprises the main FA food source from voluntary fortification in our country. It is therefore a unique compilation tool with valuable data for the assessment of dietary intakes for the vitamin.

  6. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

  7. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

  8. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

  9. Soil Fumigant Labels - Methyl Bromide

    EPA Pesticide Factsheets

    Search soil fumigant pesticide labels by EPA registration number, product name, or company, and follow the link to The Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

  10. Synthetic techniques of radiopharmaceuticals production labeled with C-11 for PET in cardiology

    NASA Astrophysics Data System (ADS)

    Dyubkov, V. S.; Ekaeva, I. V.; Katunina, T. A.; Rumyantsev, A. S.; Silchenkov, A. V.; Tuflina, T. V.

    2017-01-01

    Positron emission tomography (PET) and PET-Computerised Tomography (CT) are unique, non-invasive diagnostic techniques, in which the local, temporal and quantitative distributions of radioactive labelled substances are measured to investigate physiological processes. It is well known that PET centre of Bakulev Scientific Centre for Cardiovascular Surgery is the oldest one in Moscow. During more than fifteen years a large number of patients have received PET scans. Due to main stream of Scientific Centre, emphasis is placed on examining the heart functioning. For the diagnosis innervation of the heart muscle a number of radiopharmaceuticals are used, including PET radiopharmaceuticals such as 11C-CGP 12177, 11C-meta-hydroxyephedrine as well as its synthetic analogues labelled with other PET radionuclides (18F, 68Ga). 11C-meta-hydroxyephedrine is one of the most perspective radiopharmaceutical for an investigation of cardiac receptors function due to required materials availability for a radio synthesis in Russia. The main advantage of proposed 11C-meta-hydroxyephedrine synthesis technique is the use of a catalyst which allows one decrease reaction time from 5 minutes to 30 seconds. Obtained results allow one decrease reaction time of methylation and increase radiochemical and technological yields.

  11. Consumer product chemical weight fractions from ingredient lists.

    PubMed

    Isaacs, Kristin K; Phillips, Katherine A; Biryol, Derya; Dionisio, Kathie L; Price, Paul S

    2018-05-01

    Assessing human exposures to chemicals in consumer products requires composition information. However, comprehensive composition data for products in commerce are not generally available. Many consumer products have reported ingredient lists that are constructed using specific guidelines. A probabilistic model was developed to estimate quantitative weight fraction (WF) values that are consistent with the rank of an ingredient in the list, the number of reported ingredients, and labeling rules. The model provides the mean, median, and 95% upper and lower confidence limit WFs for ingredients of any rank in lists of any length. WFs predicted by the model compared favorably with those reported on Material Safety Data Sheets. Predictions for chemicals known to provide specific functions in products were also found to reasonably agree with reported WFs. The model was applied to a selection of publicly available ingredient lists, thereby estimating WFs for 1293 unique ingredients in 1123 products in 81 product categories. Predicted WFs, although less precise than reported values, can be estimated for large numbers of product-chemical combinations and thus provide a useful source of data for high-throughput or screening-level exposure assessments.

  12. An application of mass spectrometry for quality control of biologicals: Highly sensitive profiling of plasma residuals in human plasma-derived immunoglobulin.

    PubMed

    Limonier, Franck; Van Steendam, Katleen; Waeterloos, Geneviève; Brusselmans, Koen; Sneyers, Myriam; Deforce, Dieter

    2017-01-30

    Thromboembolic events (TEE) associated to trace amounts of plasmatic activated coagulation factor XI (FXIa) in administrated immunoglobulin (Ig) have recently raised concerns and hence there is a need for highly sensitive profiling of residual plasma source proteins. This study aims to consider LC-ESI-QTOF data-dependent acquisition in combination with sample fractionation for this purpose. Sample fractionation proved mandatory to enable identification of plasma residuals. Two approaches were compared: Ig depletion with protein G - protein A affinity chromatography and low-abundant protein enrichment with a combinatorial peptide ligand library (ProteoMiner™, Bio-Rad). The latter allowed a higher number of identifications. Highly sensitive detection of prothrombotic FXIa was assessed with confident identification of a 1ng/mg spike. Moreover, different residuals compositions were profiled for various commercial Ig products. Using a quantitative label free analysis, a TEE-positive Ig batch was distinguished from other regular Ig products, with increased levels of FXIa but also other unique proteins. This could have prevented the recently observed TEE problems with Ig. The method is a convenient tool to better characterize Ig products after any plasma pool or manufacture process change, gaining insights in the product quality profile without any prior information required. This study characterized residual plasma proteins in Ig products, using bottom-up LC-MS/MS with conventional data-dependent acquisition, preceded by sample fractionation. Without any prior information or target-specific development, >30 proteins were identified in a commercial Ig product. Quality control relevance was demonstrated with the identification of FXIa spiked at 1ng/mg in Ig, which is below the minimal thrombotic dose of 3ng/mg observed in an in vivo model. Relative label-free quantitation highlighted significant differences in normalized abundances of residual proteins between Ig products. A TEE-positive batch was distinguished by unique profile of residual proteins, including FXIa but also various blood stream-regulator proteins (fibrinogen, angiotensinogen, antithrombin-III, complement component C8, …). Those results emphasize that MS screening is a relevant first-line test to prevent any undesired concentration of plasma impurities after a plasma pool or manufacturing process change. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  13. Clinically relevant safety issues associated with St. John's wort product labels.

    PubMed

    Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

    2008-07-17

    St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0-8) for 23.9% completeness. The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements.

  14. Clinically relevant safety issues associated with St. John's wort product labels

    PubMed Central

    Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

    2008-01-01

    Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of counseling by HCPs and health store clerks. HCPs and consumers may benefit if the FDA re-examined labeling requirements for dietary supplements. PMID:18637192

  15. What do we know about the effects of exposure to 'Low alcohol' and equivalent product labelling on the amounts of alcohol, food and tobacco people select and consume? A systematic review.

    PubMed

    Shemilt, Ian; Hendry, Vivien; Marteau, Theresa M

    2017-01-12

    Explicit labelling of lower strength alcohol products could reduce alcohol consumption by attracting more people to buy and drink such products instead of higher strength ones. Alternatively, it may lead to more consumption due to a 'self-licensing' mechanism. Equivalent labelling of food or tobacco (for example "Low fat" or "Low tar") could influence consumption of those products by similar mechanisms. This systematic review examined the effects of 'Low alcohol' and equivalent labelling of alcohol, food and tobacco products on selection, consumption, and perceptions of products among adults. A systematic review was conducted based on Cochrane methods. Electronic and snowball searches identified 26 eligible studies. Evidence from 12 randomised controlled trials (all on food) was assessed for risk of bias, synthesised using random effects meta-analysis, and interpreted in conjunction with evidence from 14 non-randomised studies (one on alcohol, seven on food and six on tobacco). Outcomes assessed were: quantities of the product (i) selected or (ii) consumed (primary outcomes - behaviours), (iii) intentions to select or consume the product, (iv) beliefs associated with it consumption, (v) product appeal, and (vi) understanding of the label (secondary outcomes - cognitions). Evidence for impacts on the primary outcomes (i.e. amounts selected or consumed) was overall of very low quality, showing mixed effects, likely to vary by specific label descriptors, products and population characteristics. Overall very low quality evidence suggested that exposure to 'Low alcohol' and equivalent labelling on alcohol, food and tobacco products can shift consumer perceptions of products, with the potential to 'self-licence' excess consumption. Considerable uncertainty remains about the effects of labels denoting low alcohol, and equivalent labels, on alcohol, food and tobacco selection and consumption. Independent, high-quality studies are urgently needed to inform policies on labelling regulations.

  16. Labelling of household products and prevention of unintentional poisoning.

    PubMed

    de Presgrave, Rosaura Farias; Alves, Eloisa Nunes; Camacho, Luiz Antônio Bastos; Bôas, Maria Helena Simões Villas

    2008-04-01

    Unintentional poisoning occurs mainly in childhood due to ingestion of common household products. A decisive factor is the lack of knowledge concerning the potential toxicity of these products. A random study of 158 labels of cleaning products was conducted at the National Institute of Quality Control in Health--Brazil. Health hazard warnings, first aid in case of poisoning and storage instructions were evaluated to assess the quality of information provided to the consumer regarding the risks inherent in these products. Among these labels, 75% were considered inadequate since they did not provide all cautionary information necessary to avoid the health hazards associated with these products. First aid instructions in the case of inhalation were missing on more than 50% of labels studied and 47% did not recommend taking the label to a health professional in case of accident. Furthermore, the labels did not provide other important warnings such as "read before use" and "keep in original container': The results indicate that the labelling of cleaning products does not provide all safety information recommended for consumers.

  17. 9 CFR 317.343 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. Link to an... nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw meat products, as...

  18. 9 CFR 381.443 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. Link to an... nutrition labeling, FSIS will consider only the major cuts of single-ingredient, raw poultry products, as...

  19. When zero is greater than one: consumer misinterpretations of nutrition labels.

    PubMed

    Graham, Dan J; Mohr, Gina S

    2014-12-01

    Front-of-package (FOP) nutrition labels are increasingly used by food manufacturers. A call to regulate the content and format of these labels resulted in recommendations by the Institute of Medicine (IOM) for standardized FOP labels that clearly communicate packaged foods' healthfulness. It is currently unclear how consumers would interpret and use these proposed labels. This research addresses psychological factors affecting the efficacy of FOP label use. It was hypothesized that IOM's proposed 0- to 3-point rating scale would produce the zero-comparison effect, leading to more favorable evaluations than are warranted for the least healthful products (i.e., those earning zero nutritional points). In two studies (Study 1, n = 68; Study 2, n = 101), participants evaluated products containing FOP labels on the basis of IOM recommendations. Primary outcomes were perceived product healthfulness and purchase intentions. Study 1 demonstrated that less-healthful products were rated by study participants to be equally healthful as more-healthful products. The relationship between FOP rating and purchase intentions was mediated by perceived healthfulness. Biases in product healthfulness ratings were exacerbated for consumers with higher (vs. lower) health concern. Study 2 demonstrated that by changing the rating scale from 0-3 to 1-4, consumers avoid the zero-comparison effect and accurately evaluate products' healthfulness. This research has implications for theory and policy in the domains of nutrition labeling and consumer health. Specifically, FOP labels can help consumers identify healthful options, but products receiving zero nutritional points may be misidentified as healthful; a simple label modification can prevent this confusion.

  20. 9 CFR 317.345 - Nutrition labeling of single-ingredient, raw meat products that are not ground or chopped...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Nutrition....301. (a)(1) Nutrition information on the major cuts of single-ingredient, raw meat products identified...

  1. 9 CFR 317.345 - Nutrition labeling of single-ingredient, raw meat products that are not ground or chopped...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Nutrition....301. (a)(1) Nutrition information on the major cuts of single-ingredient, raw meat products identified...

  2. The impact of front-of-pack nutrition labels on consumer product evaluation and choice: an experimental study.

    PubMed

    Hamlin, Robert P; McNeill, Lisa S; Moore, Vanessa

    2015-08-01

    The present research was an experimental test that aimed to quantify the impact of two dominant front-of-pack (FOP) nutritional label formats on consumer evaluations of food products that carried them. The two FOP label types tested were the traffic light label and the Percentage Daily Intake. A 4×5 partially replicated Latin square design was used that allowed the impact of the FOP labels to be isolated from the effects of the product and the consumers who were performing the evaluations. The experiment was conducted on campus at the University of Otago, New Zealand. The participants were 250 university students selected at random who met qualifying criteria of independent living and regular purchase of the products used in the research. They were not aware of the purpose of the research. The presence of FOP labels led to significant and positive changes in consumer purchase intentions towards the products that carried them. These changes were not affected by the nature of FOP labels used, their size or the product nutritional status (good/bad) that they were reporting. The result is consistent with the participants paying attention to the FOP label and then using it as an adimensional cue indicating product desirability. As such, it represents a complete functional failure of both of these FOP label types in this specific instance. This result supports calls for further research on the performance of these FOP labels before any move to compulsory deployment is made.

  3. 76 FR 69585 - Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... 1107 Testing and Labeling Pertaining to Product Certification Regarding Representative Samples for... [CPSC Docket No. CPSC-2011-0082] Testing and Labeling Pertaining to Product Certification Regarding... to Product Certification.'' The proposed rule was intended to implement what was then known as...

  4. 7 CFR 205.303 - Packaged products labeled “100 percent organic” or “organic.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Information § 205.303 Packaged products labeled “100 percent organic” or “organic.” (a) Agricultural products... product, the following: (1) The term, “100 percent organic” or “organic,” as applicable, to modify the name of the product; (2) For products labeled “organic,” the percentage of organic ingredients in the...

  5. Packaging and labeling of pharmaceutical products obtained from the internet.

    PubMed

    Veronin, Michael

    2011-02-15

    For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

  6. Allergen labelling in meat, dairy and cereal products from the Serbian market

    NASA Astrophysics Data System (ADS)

    Spirić, D.; Nikolić, D.; Ćirić, J.; Janković, S.; Stefanović, S.; Janković, V.; Teodorović, V.

    2017-09-01

    Allergens in food are a great health risk, because of the ratio of severity of problems compared to small amounts of ingested allergen. Since 2014, Serbian producers and importers of food have been obliged to declare allergens from the list of Codex Alimentarius on the product packaging. Surveillance of different meat, diary, and cereal product took place in 2016, with aim of checking if the Serbian regulatory requirements for labelling of allergens in food are being fulfilled. Out of 68 different meat products, 20 were not labelled for allergens. Thirty-six labels of various dairy products were examined revealing that allergen information was included on 27 of them. Only one of eight examined cereal products did not have allergen labelling.

  7. Nicotine Concentrations in Electronic Cigarette Refill and Do-It-Yourself Fluids

    PubMed Central

    Davis, Barbara; Dang, Michael; Kim, Jisoo

    2015-01-01

    Introduction: We evaluated the accuracy of nicotine concentration labeling on electronic cigarette refill products. Methods: The nicotine concentration of 71 electronic cigarette refill fluid products and 1 related do-it-yourself (DIY) product was quantified using high-performance liquid chromatography. Quantified data were compared with manufacturers labeled concentrations. Duplicate refill fluid products purchased at different times were evaluated by visual comparison of fluid coloration and quantified nicotine concentration. Results: Thirty-five of the 54 nicotine-containing fluids had quantified nicotine concentrations that deviated by more than ±10% from the manufacturer labels, with 46 of 50 being in excess of labeled values. Refill fluids labeled as 0 nicotine had no detectable nicotine. Of the 5 products that were unlabeled for nicotine concentration, 3 contained no detectable nicotine, whereas the remaining 2 contained nicotine in excess of 100mg/ml and may have been intended for DIY use. Sixteen of the 18 duplicate bottles of refill fluid varied greatly in their nicotine concentrations. One of the 5 companies showed significant improvement in labeling accuracy among the most recently purchased products. Of the 23 total duplicate pairs, 15 of 23 varied in coloration from their mates. Conclusions: Nicotine concentration labeling on electronic cigarette refill products was often inaccurate but showed improvement recently in products from 1 company. To ensure the safety of refill fluids and DIY products, it is necessary to establish quality control guidelines for the manufacturing and labeling and to monitor products longitudinally. PMID:24862971

  8. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...

  9. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...

  10. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...

  11. Labeling HCFC Products Starting 2015: A More In-depth Look at What You Need to Know & Specific Guidance on Foam Products

    EPA Pesticide Factsheets

    Fact sheet provides information on labeling foam products. Products imported or manufactured after January 1, 2015 that contain or were manufactured with an HCFC must bear a warning label before they can be introduced into interstate commerce.

  12. 16 CFR 1203.34 - Product certification and labeling by manufacturers (including importers).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by....34 Product certification and labeling by manufacturers (including importers). (a) Form of permanent... the requirements of this subpart has been performed by or for the foreign manufacturer of the product...

  13. Synergistic capture of Clostridium botulinum Type A neurotoxin by scFv antibodies to novel epitopes

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gray, Sean A.; Barr, John R.; Kalb, Suzanne R.

    2011-10-01

    A non-immune library of human single chain fragment variable (scFv) antibodies displayed on Saccharomyces cerevisiae was screened for binding to the Clostridium botulinum neurotoxin serotype A binding domain [BoNT/A (Hc)] with the goal of identifying scFv to novel epitopes. To do this, an antibody-mediated labeling strategy was used in which antigen-binding yeast clones were selected after labeling with previously characterized monoclonal antibodies (MAbs) specific to the Hc. Twenty unique scFv clones were isolated that bound Hc. Of these, three also bound to full-length BoNT/A toxin complex with affinities ranging from 5 nM to 170 nM. Epitope binning showed that themore » three unique clones recognized at least two epitopes that were distinct from one another and from the detection MAbs. After production in E. coli, the scFv were coupled to magnetic particles and tested for their ability to capture BoNT/A holotoxin using an Endopep-MS assay. In this assay, toxin captured by scFv coated magnetic particles was detected by incubation of the complex with a peptide containing a BoNT/A-specific cleavage sequence. Mass spectrometry was used to detect the ratio of intact peptide to cleavage products as evidence for toxin capture. When tested individually, each of the scFv showed a weak positive Endopep-MS result. However, when the particles were coated with all three scFv simultaneously, they exhibited significantly higher Endopep-MS activity, consistent with synergistic binding. These results demonstrate novel approaches toward the isolation and characterization of scFv antibodies specific to unlabeled antigen. They also provide evidence that distinct scFv antibodies can work synergistically to increase the efficiency of antigen capture onto a solid support.« less

  14. 40 CFR 211.104 - Label content.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...

  15. 40 CFR 211.104 - Label content.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...

  16. 40 CFR 211.104 - Label content.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...

  17. 40 CFR 211.104 - Label content.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...

  18. 40 CFR 211.104 - Label content.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Label content. 211.104 Section 211.104 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) NOISE ABATEMENT PROGRAMS PRODUCT NOISE LABELING General Provisions § 211.104 Label content. The following data and information must be on the label of all products for which...

  19. 7 CFR 205.307 - Labeling of nonretail containers used for only shipping or storage of raw or processed...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... shipping or storage of raw or processed agricultural products labeled as â100 percent organic,â âorganic,â... containers used for only shipping or storage of raw or processed agricultural products labeled as “100...) Nonretail containers used only to ship or store raw or processed agricultural product labeled as containing...

  20. 7 CFR 205.307 - Labeling of nonretail containers used for only shipping or storage of raw or processed...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... shipping or storage of raw or processed agricultural products labeled as â100 percent organic,â âorganic,â... containers used for only shipping or storage of raw or processed agricultural products labeled as “100...) Nonretail containers used only to ship or store raw or processed agricultural product labeled as containing...

  1. 40 CFR 1042.135 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Emission Standards and Related Requirements § 1042.135 Labeling. (a) Assign each engine a unique identification number and permanently affix, engrave, or stamp it on the engine in a legible way. (b) At the time of manufacture, affix a permanent and...

  2. Extending the scope of eco-labelling in the food industry to drive change beyond sustainable agriculture practices.

    PubMed

    Miranda-Ackerman, Marco A; Azzaro-Pantel, Catherine

    2017-12-15

    New consumer awareness is shifting industry towards more sustainable practices, creating a virtuous cycle between producers and consumers enabled by eco-labelling. Eco-labelling informs consumers of specific characteristics of products and has been used to market greener products. Eco-labelling in the food industry has yet been mostly focused on promoting organic farming, limiting the scope to the agricultural stage of the supply chain, while carbon labelling informs on the carbon footprint throughout the life cycle of the product. These labelling strategies help value products in the eyes of the consumer. Because of this, decision makers are motivated to adopt more sustainable models. In the food industry, this has led to important environmental impact improvements at the agricultural stage, while most other stages in the Food Supply Chain (FSC) have continued to be designed inefficiently. The objective of this work is to define a framework showing how carbon labelling can be integrated into the design process of the FSC. For this purpose, the concept of Green Supply Chain Network Design (GSCND) focusing on the strategic decision making for location and allocation of resources and production capacity is developed considering operational, financial and environmental (CO 2 emissions) issues along key stages in the product life cycle. A multi-objective optimization strategy implemented by use of a genetic algorithm is applied to a case study on orange juice production. The results show that the consideration of CO 2 emission minimization as an objective function during the GSCND process together with techno-economic criteria produces improved FSC environmental performance compared to both organic and conventional orange juice production. Typical results thus highlight the importance that carbon emissions optimization and labelling may have to improve FSC beyond organic labelling. Finally, CO 2 emission-oriented labelling could be an important tool to improve the effects eco-labelling has on food product environmental impact going forward. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Advanced surface-enhanced Raman gene probe systems and methods thereof

    DOEpatents

    Vo-Dinh, Tuan

    2001-01-01

    The subject invention is a series of methods and systems for using the Surface-Enhanced Raman (SER)-labeled Gene Probe for hybridization, detection and identification of SER-labeled hybridized target oligonucleotide material comprising the steps of immobilizing SER-labeled hybridized target oligonucleotide material on a support means, wherein the SER-labeled hybridized target oligonucleotide material comprise a SER label attached either to a target oligonucleotide of unknown sequence or to a gene probe of known sequence complementary to the target oligonucleotide sequence, the SER label is unique for the target oligonucleotide strands of a particular sequence wherein the SER-labeled oligonucleotide is hybridized to its complementary oligonucleotide strand, then the support means having the SER-labeled hybridized target oligonucleotide material adsorbed thereon is SERS activated with a SERS activating means, then the support means is analyzed.

  4. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

    PubMed Central

    2011-01-01

    Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

  5. Adverse Event extraction from Structured Product Labels using the Event-based Text-mining of Health Electronic Records (ETHER)system.

    PubMed

    Pandey, Abhishek; Kreimeyer, Kory; Foster, Matthew; Botsis, Taxiarchis; Dang, Oanh; Ly, Thomas; Wang, Wei; Forshee, Richard

    2018-01-01

    Structured Product Labels follow an XML-based document markup standard approved by the Health Level Seven organization and adopted by the US Food and Drug Administration as a mechanism for exchanging medical products information. Their current organization makes their secondary use rather challenging. We used the Side Effect Resource database and DailyMed to generate a comparison dataset of 1159 Structured Product Labels. We processed the Adverse Reaction section of these Structured Product Labels with the Event-based Text-mining of Health Electronic Records system and evaluated its ability to extract and encode Adverse Event terms to Medical Dictionary for Regulatory Activities Preferred Terms. A small sample of 100 labels was then selected for further analysis. Of the 100 labels, Event-based Text-mining of Health Electronic Records achieved a precision and recall of 81 percent and 92 percent, respectively. This study demonstrated Event-based Text-mining of Health Electronic Record's ability to extract and encode Adverse Event terms from Structured Product Labels which may potentially support multiple pharmacoepidemiological tasks.

  6. 21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of drug products for the control of... DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic...

  7. 21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of drug products for the control of... DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic...

  8. 21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of drug products for the control of... DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic...

  9. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

  10. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

  11. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  12. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  13. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  14. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  15. 21 CFR 357.850 - Labeling of deodorant drug products for internal use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of deodorant drug products for internal... HUMAN USE Deodorant Drug Products for Internal Use § 357.850 Labeling of deodorant drug products for... drug, if any, and identifies the product as a “deodorant for internal use” or as a “colostomy or...

  16. 78 FR 28856 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... Request; Bar Code Label Requirement for Human Drug and Biological Products AGENCY: Food and Drug... and clearance. Bar Code Label Requirement for Human Drug and Biological Products--(OMB Control Number... that required human drug product and biological product labels to have bar codes. The rule required bar...

  17. 9 CFR 381.445 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Guidelines for voluntary nutrition... INSPECTION REGULATIONS Nutrition Labeling § 381.445 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. (a) Nutrition information on the cuts of single-ingredient, raw poultry products...

  18. 9 CFR 317.345 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Guidelines for voluntary nutrition... DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. (a) Nutrition information on the cuts of single-ingredient, raw meat products...

  19. 40 CFR 763.171 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... placed for sale, shipment, or storage. If the product has more than one layer of external wrapping or packaging, the label must be attached to the innermost layer adjacent to the product. If the innermost layer... product's innermost layer of product wrapping or packaging, or a label must be attached to the next outer...

  20. 21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA Center...

  1. Making sense of the "clean label" trends: A review of consumer food choice behavior and discussion of industry implications.

    PubMed

    Asioli, Daniele; Aschemann-Witzel, Jessica; Caputo, Vincenzina; Vecchio, Riccardo; Annunziata, Azzurra; Næs, Tormod; Varela, Paula

    2017-09-01

    Consumers in industrialized countries are nowadays much more interested in information about the production methods and components of the food products that they eat, than they had been 50years ago. Some production methods are perceived as less "natural" (i.e. conventional agriculture) while some food components are seen as "unhealthy" and "unfamiliar" (i.e. artificial additives). This phenomenon, often referred to as the "clean label" trend, has driven the food industry to communicate whether a certain ingredient or additive is not present or if the food has been produced using a more "natural" production method (i.e. organic agriculture). However, so far there is no common and objective definition of clean label. This review paper aims to fill the gap via three main objectives, which are to a) develop and suggest a definition that integrates various understandings of clean label into one single definition, b) identify the factors that drive consumers' choices through a review of recent studies on consumer perception of various food categories understood as clean label with the focus on organic, natural and 'free from' artificial additives/ingredients food products and c) discuss implications of the consumer demand for clean label food products for food manufacturers as well as policy makers. We suggest to define clean label, both in a broad sense, where consumers evaluate the cleanliness of product by assumption and through inference looking at the front-of-pack label and in a strict sense, where consumers evaluate the cleanliness of product by inspection and through inference looking at the back-of-pack label. Results show that while 'health' is a major consumer motive, a broad diversity of drivers influence the clean label trend with particular relevance of intrinsic or extrinsic product characteristics and socio-cultural factors. However, 'free from' artificial additives/ingredients food products tend to differ from organic and natural products. Food manufacturers should take the diversity of these drivers into account in developing new products and communication about the latter. For policy makers, it is important to work towards a more homogenous understanding and application of the term of clean label and identify a uniform definition or regulation for 'free from' artificial additives/ingredients food products, as well as work towards decreasing consumer misconceptions. Finally, multiple future research avenues are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Systematic Comparison of Label-Free, Metabolic Labeling, and Isobaric Chemical Labeling for Quantitative Proteomics on LTQ Orbitrap Velos

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Li, Zhou; Adams, Rachel M; Chourey, Karuna

    2012-01-01

    A variety of quantitative proteomics methods have been developed, including label-free, metabolic labeling, and isobaric chemical labeling using iTRAQ or TMT. Here, these methods were compared in terms of the depth of proteome coverage, quantification accuracy, precision, and reproducibility using a high-performance hybrid mass spectrometer, LTQ Orbitrap Velos. Our results show that (1) the spectral counting method provides the deepest proteome coverage for identification, but its quantification performance is worse than labeling-based approaches, especially the quantification reproducibility; (2) metabolic labeling and isobaric chemical labeling are capable of accurate, precise, and reproducible quantification and provide deep proteome coverage for quantification. Isobaricmore » chemical labeling surpasses metabolic labeling in terms of quantification precision and reproducibility; (3) iTRAQ and TMT perform similarly in all aspects compared in the current study using a CID-HCD dual scan configuration. Based on the unique advantages of each method, we provide guidance for selection of the appropriate method for a quantitative proteomics study.« less

  3. Effects of alternative label formats on choice of high- and low-sodium products in a New Zealand population sample.

    PubMed

    McLean, Rachael; Hoek, Janet; Hedderley, Duncan

    2012-05-01

    Dietary sodium reduction is a cost-effective public health intervention to reduce chronic disease. In response to calls for further research into front-of-pack labelling systems, we examined how alternative sodium nutrition label formats and nutrition claims influenced consumers' choice behaviour and whether consumers with or without a diagnosis of hypertension differed in their choice patterns. An anonymous online experiment in which participants viewed ten choice sets featuring three fictitious brands of baked beans with varied label formats and nutritional profiles (high and low sodium) and indicated which brand in each set they would purchase if shopping for this product. Participants were recruited from New Zealand's largest online nationwide research panel. Five hundred people with self-reported hypertension and 191 people without hypertension aged 18 to 79 years. The addition of a front-of-pack label increased both groups' ability to discriminate between products with high and low sodium, while the Traffic Light label enabled better identification of the high-sodium product. Both front-of-pack formats enhanced discrimination in the presence of a reduced salt claim, but the Traffic Light label also performed better than the Percentage Daily Intake label in moderating the effect of the claim for the high-sodium product. Front-of-pack labels, particularly those with simple visual cues, enhance consumers' ability to discriminate between high- and low-sodium products, even when those products feature nutrition claims.

  4. Soil Fumigant Labels - Dazomet

    EPA Pesticide Factsheets

    Updated labels include new safety requirements for buffer zones and related measures. Find information from the Pesticide Product Labeling System (PPLS) for products such as Basamid G, manufactured by Amvac.

  5. Agro-food industry growth and obesity in China: what role for regulating food advertising and promotion and nutrition labelling?

    PubMed

    Hawkes, C

    2008-03-01

    Taking a food supply chain approach, this paper examines the regulation of food marketing and nutrition labelling as strategies to help combat obesity in China in an era of rapid agro-food industry growth. China is the largest food producer and consumer in the world. Since the early 1980s, the agro-food industry has undergone phenomenal expansion throughout the food supply chain, from agricultural production to trade, agro-food processing to food retailing, and from food service to advertising and promotion. This industry growth, alongside related socioeconomic changes and government policies, has encouraged a 'nutrition transition'. China's population, especially in urban areas, is now consuming significantly more energy from dietary fat, which is leading to higher rates of obesity. Regulation of food advertising and promotion and nutrition labelling has the potential to help prevent the further growth of obesity in China and encourage the agro-food industry to supplier healthier foods. Government legislation and guidance, as well as self-regulation and voluntary initiatives, are needed to reduce children's exposure to food advertising and promotion, and increase the effectiveness of nutrition labelling. Policies on food marketing and nutrition labelling should be adapted to the China context, and accompanied by further action throughout the food supply chain. Given China's unique characteristics and position in the world today, there is an opportunity for the government and the agro-food industry to lead the world by creating a balanced, health promoting model of complementary legislation and industry action.

  6. 9 CFR 381.128 - Labels in foreign languages.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and Containers § 381.128 Labels in foreign languages. Any label to be affixed to a container of any dressed poultry or other poultry...

  7. List M: Registered Antimicrobial Products with Label Claims for Avian (Bird) Flu Disinfectants

    EPA Pesticide Factsheets

    These EPA disinfectant products are registered and labeled with a claim to inactivate Avian influenza A viruses on hard, non-porous surfaces. The label specifies the use sites (e.g., poultry houses and farm premises) for application of the product.

  8. 9 CFR 381.445 - Nutrition labeling of single-ingredient, raw poultry products that are not ground or chopped...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.445 Nutrition... § 381.401. (a)(1) Nutrition information on the major cuts of single-ingredient, raw poultry products...

  9. 9 CFR 381.445 - Nutrition labeling of single-ingredient, raw poultry products that are not ground or chopped...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition labeling of single... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.445 Nutrition... § 381.401. (a)(1) Nutrition information on the major cuts of single-ingredient, raw poultry products...

  10. 21 CFR 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...

  11. 21 CFR 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...

  12. 19 CFR 11.12b - Labeling textile fiber products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... pursuant to § 141.113 of this chapter shall demand the immediate return of the involved products to customs... 19 Customs Duties 1 2010-04-01 2010-04-01 false Labeling textile fiber products. 11.12b Section 11... THE TREASURY PACKING AND STAMPING; MARKING Marking § 11.12b Labeling textile fiber products. (a...

  13. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  14. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  15. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  16. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  17. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

  18. Comparative analysis of the labelling of nanotechnologies across four stakeholder groups

    NASA Astrophysics Data System (ADS)

    Capon, Adam; Gillespie, James; Rolfe, Margaret; Smith, Wayne

    2015-08-01

    Societies are constantly challenged to develop policies around the introduction of new technologies, which by their very nature contain great uncertainty. This uncertainty gives prominence to varying viewpoints which are value laden and have the ability to drastically shift policy. The issue of nanotechnologies is a prime example. The labelling of products that contain new technologies has been one policy tool governments have used to address concerns around uncertainty. Our study develops evidence regarding opinions on the labelling of products made by nanotechnologies. We undertook a computer-assisted telephone (CATI) survey of the Australian public and those involved in nanotechnologies from the academic, business and government sectors using a standardised questionnaire. Analysis was undertaken using descriptive and logistic regression techniques. We explored reluctance to purchase as a result of labelling products which contained manufactured nanomaterials both generally and across five broad products (food, cosmetics/sunscreens, medicines, pesticides, tennis racquets/computers) which represent the broad categories of products regulated by differing government agencies in Australia. We examined the relationship between reluctance to purchase and risk perception, trust, and familiarity. We found irrespective of stakeholder, most supported the labelling of products which contained manufactured nanomaterials. Perception of risk was the main driver of reluctance to purchase, while trust and familiarity were likely to have an indirect effect through risk perception. Food is likely to be the greatest product impacted by labelling. Risk perception surrounding nanotechnologies and label `framing' on the product are key issues to be addressed in the implementation of a labelling scheme.

  19. Toddler drinks, formulas, and milks: Labeling practices and policy implications.

    PubMed

    Pomeranz, Jennifer L; Romo Palafox, Maria J; Harris, Jennifer L

    2018-04-01

    Toddler drinks are a growing category of drinks marketed for young children 9-36 months old. Medical experts do not recommend them, and public health experts raise concerns about misleading labeling practices. In the U.S., the toddler drink category includes two types of products: transition formulas, marketed for infants and toddlers 9-24 months; and toddler milks, for children 12-36 months old. The objective of this study was to evaluate toddler drink labeling practices in light of U.S. food labeling policy and international labeling recommendations. In January 2017, we conducted legal research on U.S. food label laws and regulations; collected and evaluated toddler drink packages, including nutrition labels and claims; and compared toddler drink labels with the same brand's infant formula labels. We found that the U.S. has a regulatory structure for food labels and distinct policies for infant formula, but no laws specific to toddler drinks. Toddler drink labels utilized various terms and images to identify products and intended users; made multiple health and nutrition claims; and some stated there was scientific or expert support for the product. Compared to the same manufacturer's infant formula labels, most toddler drink labels utilized similar colors, branding, logos, and graphics. Toddler drink labels may confuse consumers about their nutrition and health benefits and the appropriateness of these products for young children. To support healthy toddler diets and well-informed decision-making by caregivers, the FDA can provide guidance or propose regulations clarifying permissible toddler drink labels and manufacturers should end inappropriate labeling practices. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. 76 FR 59504 - Intelligent Mail Package Barcode (IMpb) Implementation for Commercial Parcels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... formats when printing an IMpb. Current standards require a different human-readable service banner text... packages must also ensure sufficient label space exists to print a longer barcode that meets specifications... service) will be used for pre-printed MRS labels (since unique serial numbers cannot be used). Response...

  1. 27 CFR 5.32 - Mandatory label information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Mandatory label information. 5.32 Section 5.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF DISTILLED SPIRITS Labeling Requirements for...

  2. 27 CFR 18.55 - Label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...

  3. 27 CFR 18.55 - Label.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2012-04-01 2012-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...

  4. 27 CFR 18.55 - Label.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY LIQUORS PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...

  5. 27 CFR 18.55 - Label.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Label. 18.55 Section 18.55 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL PRODUCTION OF VOLATILE FRUIT-FLAVOR CONCENTRATE Operations § 18.55 Label. Each container...

  6. The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization.

    PubMed

    Gruber, Marion F

    2015-11-25

    The FDA has responsibility for ensuring that prescription drug and biological products including vaccines are accompanied by labeling that summarizes scientific information concerning their safe and effective use. As part of a broader effort to improve the content and format of prescription drug labeling FDA published a final rule, the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the "Pregnancy and Lactation Labeling Rule (PLLR)." The most significant change to be implemented by this Rule is the removal of the letter risk categories A, B, C, D and X from all labeling, replacing them with a narrative summary of the risks of using a drug or biological product including vaccines during pregnancy. The PLLR requires an evaluation of available information about a product's use in pregnancy and provides an opportunity to update labeling when new information about use of a vaccine in pregnancy becomes available. Implementation of the provisions articulated in the PLLR, as they apply to vaccine product labeling, will require close collaboration between FDA and the vaccine manufacturer for both currently licensed vaccines and those in development. Copyright © 2015 The Author. Published by Elsevier Ltd.. All rights reserved.

  7. Variations in Label Information and Nicotine Levels in Electronic Cigarette Refill Liquids in South Korea: Regulation Challenges

    PubMed Central

    Kim, Sungroul; Goniewicz, Maciej L.; Yu, Sol; Kim, Bokyeong; Gupta, Ribhav

    2015-01-01

    Background: In South Korea, the consumption of liquid nicotine used in electronic cigarettes has dramatically increased from 4310 L in 2012 to 7220 L in 2013. This study aimed to examine the level of heterogeneity of contents of the labels and discrepancy of the nicotine content between that indicated on the label and the actual values for electronic cigarette liquid refill products in South Korea. Methods: We purchased 32 electronic cigarette liquid refill products (17 Korean domestic, 15 imported ones) and one pure nicotine product at six different electronic cigarette retail stores in Seoul between May and June 2014. The actual nicotine concentrations of each product were measured by a blinded analyst at Roswell Park Cancer Institute, Buffalo, NY, USA. Results: Three out of 15 imported liquid refill products provided manufacturing dates, while expiration dates were available on eight products. The range of nicotine concentration was from “not detected” to 17.5 mg/mL. Labeling discrepancies of the concentrations ranged from −32.2% to 3.3% among electronic cigarette liquid refill products. The highest concentration (150.3 ± 7.9 mg/mL) was found in a sample labeled as “pure nicotine”. Conclusions: There is no standardization of labelling among electronic cigarette liquids sampled from retail stores and the labels did not accurately reflect the content. One product labeled “pure nicotine” raises concerns, since it may be poisonous to consumers, especially to children. This study revealed the urgent need for the development of product regulations in South Korea. PMID:25950652

  8. Oligonucleotide labeling methods. 3. Direct labeling of oligonucleotides employing a novel, non-nucleosidic, 2-aminobutyl-1,3-propanediol backbone.

    PubMed Central

    Nelson, P S; Kent, M; Muthini, S

    1992-01-01

    Novel CE-phosphoramidite (7a-e) and CPG (8a, c, d, e) reagents have been prepared from a unique 2-aminobutyl-1,3-propanediol backbone. The reagents have been used to directly label oligonucleotides with fluorescein, acridine, and biotin via automated DNA synthesis. The versatile 2-aminobutyl-1,3-propanediol backbone allows for labeling at any position (5', internal, and 3') during solid phase oligonucleotide synthesis. Multiple labels can be achieved by repetitive coupling cycles. Furthermore, the 3-carbon atom internucleotide phosphate distance is retained when inserted internally. Using this method, individual oligonucleotides possessing two and three different reporter molecules have been prepared. PMID:1475185

  9. Pesticide Labeling Questions & Answers

    EPA Pesticide Factsheets

    Pesticide manufacturers, applicators, state regulatory agencies, and other stakeholders raise questions or issues about pesticide labels. The questions on this page are those that apply to multiple products or address inconsistencies among product labels.

  10. 7 CFR 205.670 - Inspection and testing of agricultural product to be sold or labeled “organic.”

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... agricultural product to be sold or labeled “organic.” (a) All agricultural products that are to be sold... product to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic... 7 Agriculture 3 2011-01-01 2011-01-01 false Inspection and testing of agricultural product to be...

  11. 9 CFR 381.500 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82167, Dec. 29, 2010. (a) The...

  12. 9 CFR 381.500 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Exemption from nutrition labeling. 381... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.500 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82167, Dec. 29, 2010. This amendment...

  13. 27 CFR 4.32 - Mandatory label information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2014-04-01 2014-04-01 false Mandatory label information. 4.32 Section 4.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.32...

  14. 27 CFR 4.32 - Mandatory label information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2013-04-01 2013-04-01 false Mandatory label information. 4.32 Section 4.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF WINE Labeling Requirements for Wine § 4.32...

  15. [Academic production on food labeling in Brazil].

    PubMed

    Câmara, Maria Clara Coelho; Marinho, Carmem Luisa Cabral; Guilam, Maria Cristina; Braga, Ana Maria Cheble Bahia

    2008-01-01

    To review and discuss academic production (theses and dissertations) on the topic of labeling of prepackaged foods in Brazil. A search of the database maintained by the Coordination for the Development of Higher Education Professionals (CAPES), one of the two Brazilian government research funding and support agencies, was conducted on the following keywords: "rotulagem" (labeling), "rotulagem nutricional" (food labeling) and "rótulo de alimentos" (food labels). The search covered the years 1987 (earliest year available) to 2004. We identified 49 studies on this topic. Content analysis identified three major themes: the extent to which food labels meet specific legal requirements (57.2%); the degree to which consumers understand the information on labels (22.4%); and the labeling of transgenic or genetically-modified foods (20.4%). Food labeling is a frequent topic and is adequately covered by the Brazilian academic production. In most of the studies, ineffective law enforcement appears to be the main factor in the lack of compliance with and disrespect for the food labeling rules and regulations in Brazil.

  16. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.

    PubMed

    Klara, Kristina; Kim, Jeanie; Ross, Joseph S

    2018-05-01

    Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions. Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.

  17. Nicotine concentrations in electronic cigarette refill and do-it-yourself fluids.

    PubMed

    Davis, Barbara; Dang, Michael; Kim, Jisoo; Talbot, Prue

    2015-02-01

    We evaluated the accuracy of nicotine concentration labeling on electronic cigarette refill products. The nicotine concentration of 71 electronic cigarette refill fluid products and 1 related do-it-yourself (DIY) product was quantified using high-performance liquid chromatography. Quantified data were compared with manufacturers labeled concentrations. Duplicate refill fluid products purchased at different times were evaluated by visual comparison of fluid coloration and quantified nicotine concentration. Thirty-five of the 54 nicotine-containing fluids had quantified nicotine concentrations that deviated by more than ± 10% from the manufacturer labels, with 46 of 50 being in excess of labeled values. Refill fluids labeled as 0 nicotine had no detectable nicotine. Of the 5 products that were unlabeled for nicotine concentration, 3 contained no detectable nicotine, whereas the remaining 2 contained nicotine in excess of 100mg/ml and may have been intended for DIY use. Sixteen of the 18 duplicate bottles of refill fluid varied greatly in their nicotine concentrations. One of the 5 companies showed significant improvement in labeling accuracy among the most recently purchased products. Of the 23 total duplicate pairs, 15 of 23 varied in coloration from their mates. Nicotine concentration labeling on electronic cigarette refill products was often inaccurate but showed improvement recently in products from 1 company. To ensure the safety of refill fluids and DIY products, it is necessary to establish quality control guidelines for the manufacturing and labeling and to monitor products longitudinally. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. 76 FR 9574 - Agency Information Collection Activities; Proposed Collection; Comment Request; Use of Surveys in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... of Surveys in Developing Improved Labeling for Insect Repellent Products AGENCY: Environmental... of Surveys in Developing Improved Labeling for Insect Repellent Products'' and identified by EPA ICR... insect repellent products. Title: Use of Surveys in Developing Improved Labeling for Insect Repellent...

  19. 40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...

  20. 40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...

  1. 16 CFR 305.16 - Labeling and marking for plumbing products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CONGRESS RULE CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Labeling and marking for plumbing products...

  2. 16 CFR 305.16 - Labeling and marking for plumbing products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CONGRESS RULE CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Labeling and marking for plumbing products...

  3. 16 CFR 305.16 - Labeling and marking for plumbing products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CONGRESS RULE CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Labeling and marking for plumbing products...

  4. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  5. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  6. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  7. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  8. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  9. 7 CFR 205.670 - Inspection and testing of agricultural product to be sold or labeled “organic.”

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM... agricultural product to be sold or labeled “organic.” (a) All agricultural products that are to be sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic (specified ingredients...

  10. Impact of front-of-pack 'traffic-light' nutrition labelling on consumer food purchases in the UK.

    PubMed

    Sacks, Gary; Rayner, Mike; Swinburn, Boyd

    2009-12-01

    Front-of-pack 'traffic-light' nutrition labelling has been widely proposed as a tool to improve public health nutrition. This study examined changes to consumer food purchases after the introduction of traffic-light labels with the aim of assessing the impact of the labels on the 'healthiness' of foods purchased. The study examined sales data from a major UK retailer in 2007. We analysed products in two categories ('ready meals' and sandwiches), investigating the percentage change in sales 4 weeks before and after traffic-light labels were introduced, and taking into account seasonality, product promotions and product life-cycle. We investigated whether changes in sales were related to the healthiness of products. All products that were not new and not on promotion immediately before or after the introduction of traffic-light labels were selected for the analysis (n = 6 for ready meals and n = 12 for sandwiches). For the selected ready-meals, sales increased (by 2.4% of category sales) in the 4 weeks after the introduction of traffic-light labels, whereas sales of the selected sandwiches did not change significantly. Critically, there was no association between changes in product sales and the healthiness of the products. This short-term study based on a small number of ready meals and sandwiches found that the introduction of a system of four traffic-light labels had no discernable effect on the relative healthiness of consumer purchases. Further research on the influence of nutrition signposting will be needed before this labelling format can be considered a promising public health intervention.

  11. Warnings as a directive front-of-pack nutrition labelling scheme: comparison with the Guideline Daily Amount and traffic-light systems.

    PubMed

    Arrúa, Alejandra; Machín, Leandro; Curutchet, María Rosa; Martínez, Joseline; Antúnez, Lucía; Alcaire, Florencia; Giménez, Ana; Ares, Gastón

    2017-09-01

    Warnings have recently been proposed as a new type of directive front-of-pack (FOP) nutrition labelling scheme to flag products with high content of key nutrients. In the present work, this system was compared with the two most common FOP nutrition labelling schemes (Guideline Daily Amounts (GDA) and traffic-light system) in terms of goal-directed attention, influence on perceived healthfulness and ability to differentiate between products. Design/Setting/Subjects Goal-directed attention to FOP labels was evaluated using a visual search task in which participants were presented with labels on a computer screen and were asked to indicate whether labels with high sodium content were present or absent. A survey with 387 participants was also carried out, in which the influence of FOP labels on perceived healthfulness and ability to identify the healthful alternative were evaluated. Warnings improved consumers' ability to correctly identify a product with high content of a key nutrient within a set of labels compared with GDA and received the highest goal-directed attention. In addition, products with high energy, saturated fat, sugar and/or sodium content that featured warnings on the label were perceived as less healthful than those featuring the GDA or traffic-light system. Warnings and the traffic-light system performed equally well in the identification of the most healthful product. Results from the present work suggest that warnings have potential as directive FOP nutrition labels to improve consumer ability to identify unhealthful products and highlight advantages compared with the traffic-light system.

  12. Fragrance contact allergens in 5588 cosmetic products identified through a novel smartphone application.

    PubMed

    Bennike, N H; Oturai, N B; Müller, S; Kirkeby, C S; Jørgensen, C; Christensen, A B; Zachariae, C; Johansen, J D

    2018-01-01

    More than 25% of the adult European population suffers from contact allergy, with fragrance substances recognized as one of the main causes. Since 2005, 26 fragrance contact allergens have been mandatory to label in cosmetic products within the EU if present at 10 ppm or above in leave-on and 100 ppm or above in wash-off cosmetics. To examine exposure, based on ingredient labelling, to the 26 fragrances in a sample of 5588 fragranced cosmetic products. The investigated products were identified through a novel, non-profit smartphone application (app), designed to provide information to consumers about chemical substances in cosmetic products. Products registered through the app between December 2015 and October 2016 were label checked according to International Nomenclature of Cosmetic Ingredients (INCI) for the presence of the 26 fragrance substances or the wording 'fragrance/parfum/aroma'. The largest product categories investigated were 'cream, lotion and oil' (n = 1192), 'shampoo and conditioner' (n = 968) and 'deodorants' (n = 632). Among cosmetic products labelled to contain at least one of the 26 fragrances, 85.5% and 73.9% contained at least two and at least three of the 26 fragrances, respectively. Linalool (49.5%) and limonene (48.5%) were labelled most often among all investigated products. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC/Lyral ® ) was found in 13.5% of deodorants. Six of the 26 fragrance substances were labelled on less than one per cent of all products, including the natural extracts Evernia furfuracea (tree moss) and Evernia prunastri (oak moss). A total of 329 (5.9%) products had one or more of the 26 fragrance substances labelled but did not have 'parfum/fragrance/aroma' listed on the label. Consumers are widely exposed to, often multiple, well-established fragrance contact allergens through various cosmetic products intended for daily use. Several fragrance substances that are common causes of contact allergy were rarely labelled in this large sample of cosmetic products. © 2017 European Academy of Dermatology and Venereology.

  13. Succinyl-CoA Synthetase is a Phosphate Target for the Activation of Mitochondrial Metabolism

    PubMed Central

    Phillips, Darci; Aponte, Angel M.; French, Stephanie A.; Chess, David J.; Balaban, Robert S.

    2009-01-01

    Succinyl-CoA synthetase (SCS) is the only mitochondrial enzyme capable of ATP production via substrate level phosphorylation in the absence of oxygen, but it also plays a key role in the citric acid cycle, ketone metabolism and heme synthesis. Inorganic phosphate (Pi) is a signaling molecule capable of activating oxidative phosphorylation at several sites, including NADH generation and as a substrate for ATP formation. In this study it was shown that Pi-binds porcine heart SCS α-subunit (SCSα) in a non-covalent manner and enhances its enzymatic activity, thereby providing a new target for Pi-activation in mitochondria. Coupling 32P-labeling of intact mitochondria with SDS gel electrophoresis revealed that 32P-labeling of SCSα was enhanced in substrate-depleted mitochondria. Using mitochondrial extracts and purified bacterial SCS (BSCS) it was shown that this enhanced 32P-labeling resulted from a simple binding of 32P, not covalent protein phosphorylation. The ability of SCSα to retain its 32P throughout the SDS denaturing gel process was unique over the entire mitochondrial proteome. In vitro studies also revealed a Pi-induced activation of SCS activity by more than 2-fold when mitochondrial extracts and purified BSCS were incubated with mM concentrations of Pi. Since 32P-binding to SCSα was increased in substrate-depleted mitochondria, where matrix Pi concentration is increased, we conclude that SCS activation by Pi-binding represents another mitochondrial target for the Pi-induced activation of oxidative phosphorylation and anaerobic ATP production in energy-limited mitochondria. PMID:19527071

  14. Attention mediates the effect of nutrition label information on consumers' choice. Evidence from a choice experiment involving eye-tracking.

    PubMed

    Bialkova, Svetlana; Grunert, Klaus G; Juhl, Hans Jørn; Wasowicz-Kirylo, Grazyna; Stysko-Kunkowska, Malgorzata; van Trijp, Hans C M

    2014-05-01

    In two eye-tracking studies, we explored whether and how attention to nutrition information mediates consumers' choice. Consumers had to select either the healthiest option or a product of their preference within an assortment. On each product a particular label (Choices logo, monochrome GDA label, or color-coded GDA label) communicated the product's nutrient profile. In study 1, participants had to select from 4 products differentiated, in addition to the nutrition information, by flavor (strawberry, muesli, apple, chocolate; varied within participants) and brand (local vs. global, varied between participants). Study 2 further explored brand effect within-participants, and thus only 2 flavors (strawberry, chocolate) were presented within an assortment. Actual choice made, response time and eye movements were recorded. Respondents fixated longer and more often on products with color-coded GDAs label than on products with monochrome GDAs or Choices logo. A health goal resulted in longer and more frequent fixations in comparison to a preference goal. Products with color-coded and monochrome GDAs had the highest likelihood of being chosen, and this effect was related to the attention-getting property of the label (irrespective of brand and flavor effects). The product fixated most had the highest likelihood of being chosen. These results suggest that attention mediates the effect of nutrition labels on choice. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Single tag for total carbohydrate analysis.

    PubMed

    Anumula, Kalyan Rao

    2014-07-15

    Anthranilic acid (2-aminobenzoic acid, 2-AA) has the remarkable property of reacting rapidly with every type of reducing carbohydrate. Reactivity of 2-AA with carbohydrates in aqueous solutions surpasses all other tags reported to date. This unique capability is attributed to the strategically located -COOH which accelerates Schiff base formation. Monosaccharides, oligosaccharides (N-, O-, and lipid linked and glycans in secretory fluids), glycosaminoglycans, and polysaccharides can be easily labeled with 2-AA. With 2-AA, labeling is simple in aqueous solutions containing proteins, peptides, buffer salts, and other ingredients (e.g., PNGase F, glycosidase, and transferase reaction mixtures). In contrast, other tags require relatively pure glycans for labeling in anhydrous dimethyl sulfoxide-acetic acid medium. Acidic conditions are known to cause desialylation, thus requiring a great deal of attention to sample preparation. Simpler labeling is achieved with 2-AA within 30-60 min in mild acetate-borate buffered solution. 2-AA provides the highest sensitivity and resolution in chromatographic methods for carbohydrate analysis in a simple manner. Additionally, 2-AA is uniquely qualified for quantitative analysis by mass spectrometry in the negative mode. Analyses of 2-AA-labeled carbohydrates by electrophoresis and other techniques have been reported. Examples cited here demonstrate that 2-AA is the universal tag for total carbohydrate analysis. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Soil Fumigant Labels - Metam Sodium/Potassium

    EPA Pesticide Factsheets

    Search by EPA registration number, product name, or company; and follow the link to the Pesticide Product Label System (PPLS) for details. Updated labels include new safety requirements for buffer zones and related measures.

  17. Off-label use of medical products in radiation therapy: Summary of the Report of AAPM Task Group No. 121

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Thomadsen, Bruce R.; Thompson, Heaton H. II; Jani, Shirish K.

    Medical products (devices, drugs, or biologics) contain information in their labeling regarding the manner in which the manufacturer has determined that the products can be used in a safe and effective manner. The Food and Drug Administration (FDA) approves medical products for use for these specific indications which are part of the medical product's labeling. When medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use canmore » be confusing. Although the responsibility and, ultimately, the liability for off-label use often rests with the prescribing physician, medical physicists and others are also responsible for the safe and proper use of the medical products. When these products are used for purposes other than which they were approved, it is important for medical physicists to understand their responsibilities. In the United States, medical products can only be marketed if officially cleared, approved, or licensed by the FDA; they can be used if they are not subject to or specifically exempt from FDA regulations, or if they are being used in research with the appropriate regulatory safeguards. Medical devices are either cleared or approved by FDA's Center for Devices and Radiological Health. Drugs are approved by FDA's Center for Drug Evaluation and Research, and biological products such as vaccines or blood are licensed under a biologics license agreement by FDA's Center for Biologics Evaluation and Research. For the purpose of this report, the process by which the FDA eventually clears, approves, or licenses such products for marketing in the United States will be referred to as approval. This report summarizes the various ways medical products, primarily medical devices, can legally be brought to market in the United States, and includes a discussion of the approval process, along with manufacturers' responsibilities, labeling, marketing and promotion, and off-label use. This is an educational and descriptive report and does not contain prescriptive recommendations. This report addresses the role of the medical physicist in clinical situations involving off-label use. Case studies in radiation therapy are presented. Any mention of commercial products is for identification only; it does not imply recommendations or endorsements of any of the authors or the AAPM. The full report, containing extensive background on off-label use with several appendices, is available on the AAPM website (http://www.aapm.org/pubs/reports/).« less

  18. Effectiveness of Front-Of-Pack Nutrition Labels in French Adults: Results from the NutriNet-Santé Cohort Study.

    PubMed

    Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold; Hercberg, Serge; Péneau, Sandrine

    2015-01-01

    To date, no consensus has emerged on the most appropriate front-of-pack (FOP) nutrition label to help consumers in making informed choices. We aimed to compare the effectiveness of the label formats currently in use: nutrient-specific, graded and simple summary systems, in a large sample of adults. The FOP label effectiveness was assessed by measuring the label acceptability and understanding among 13,578 participants of the NutriNet-Santé cohort study, representative of the French adult population. Participants were exposed to five conditions, including four FOP labels: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), and a "no label" condition. Acceptability was evaluated by several indicators: attractiveness, liking and perceived cognitive workload. Objective understanding was assessed by the percentage of correct answers when ranking three products according to their nutritional quality. Five different product categories were tested: prepared fish dishes, pizzas, dairy products, breakfast cereals, and appetizers. Differences among the label effectiveness were compared with chi-square tests. The 5-CNL was viewed as the easiest label to identify and as the one requiring the lowest amount of effort and time to understand. GDA was considered as the least easy to identify and to understand, despite being the most attractive and liked label. All FOP labels were found to be effective in ranking products according to their nutritional quality compared with the "no label" situation, although they showed differing levels of effectiveness (p<0.0001). Globally, the 5-CNL performed best, followed by MTL, GDA and Tick labels. The graded 5-CNL label was considered as easy to identify, simple and rapid to understand; it performed well when comparing the products' nutritional quality. Therefore, it is likely to present advantages in real shopping situations where choices are usually made quickly.

  19. Tracer-based estimates of protein flux in cases of incomplete product renewal: evidence and implications of heterogeneity in collagen turnover

    PubMed Central

    Zhou, Haihong; Wang, Sheng-Ping; Herath, Kithsiri; Kasumov, Takhar; Sadygov, Rovshan G.; Kelley, David E.

    2015-01-01

    The synthesis of various molecules can be estimated by measuring the incorporation of a labeled precursor into a product of interest. Unfortunately, a central problem in many studies has been an inability to estimate the intracellular dilution of the precursor and therein correctly calculate the synthesis of the product; it is generally assumed that measuring the true product labeling is straightforward. We initiated a study to examine liver collagen synthesis and identified an apparent problem with assumptions regarding measurements of the product labeling. Since it is well known that collagen production is relatively slow, we relied on the use of [2H]H2O labeling (analogous to a primed infusion) and sampled animals over the course of 16 days. Although the water labeling (the precursor) remained stable and we observed the incorporation of labeled amino acids into collagen, the asymptotic protein labeling was considerably lower than what would be expected based on the precursor labeling. Although this observation is not necessarily surprising (i.e., one might expect that a substantial fraction of the collagen pool would appear “inert” or turn over at a very slow rate), its implications are of interest in certain areas. Herein, we discuss a novel situation in which tracers are used to quantify rates of flux under conditions where a product may not undergo complete replacement. We demonstrate how heterogeneity in the product pool can lead one to the wrong conclusions regarding estimates of flux, and we outline an approach that may help to minimize errors surrounding data interpretation. PMID:26015435

  20. --No Title--

    Science.gov Websites

    Column descriptions ID : Unique integer for each control time simulation LABEL : Description unique to each ID (see paper) Z : Redshift TIMEAREA : Observer-frame control time x area at 'Z' (year-arcmin ^2) Z2 : Second redshift TIMEVOL : Total rest-frame control time x volume between 'Z' and 'Z2' (year

  1. Discrimination of clostridium species using a magnetic bead based hybridization assay

    NASA Astrophysics Data System (ADS)

    Pahlow, Susanne; Seise, Barbara; Pollok, Sibyll; Seyboldt, Christian; Weber, Karina; Popp, Jürgen

    2014-05-01

    Clostridium chauvoei is the causative agent of blackleg, which is an endogenous bacterial infection. Mainly cattle and other ruminants are affected. The symptoms of blackleg are very similar to those of malignant edema, an infection caused by Clostridium septicum. [1, 2] Therefore a reliable differentiation of Clostridium chauvoei from other Clostridium species is required. Traditional microbiological detection methods are time consuming and laborious. Additionally, the unique identification is hindered by the overgrowing tendency of swarming Clostridium septicum colonies when both species are present. [1, 3, 4] Thus, there is a crucial need to improve and simplify the specific detection of Clostridium chauvoei and Clostridium septicum. Here we present an easy and fast Clostridium species discrimination method combining magnetic beads and fluorescence spectroscopy. Functionalized magnetic particles exhibit plentiful advantages, like their simple manipulation in combination with a large binding capacity of biomolecules. A specific region of the pathogenic DNA is amplified and labelled with biotin by polymerase chain reaction (PCR). These PCR products were then immobilized on magnetic beads exploiting the strong biotin-streptavidin interaction. The specific detection of different Clostridium species is achieved by using fluorescence dye labeled probe DNA for the hybridization with the immobilized PCR products. Finally, the samples were investigated by fluorescence spectroscopy. [5

  2. Soil Fumigant Labels - Chloropicrin

    EPA Pesticide Factsheets

    Search by EPA registration number, product name, or company name, and follow the link to the Pesticide Product Label System (PPLS) for details on each fumigant. Updated labels include new safety requirements for buffer zones and related measures.

  3. Logos and Graphics on Pesticide Product Labels

    EPA Pesticide Factsheets

    There are several logos that pesticide companies can add to their labels with EPA approval. The requirements and process vary, so review the guidance carefully before applying to add a logo to a product label.

  4. 78 FR 43974 - Energy and Water Use Labeling for Consumer Products Under the Energy Policy and Conservation Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ...The Commission amends the Energy Labeling Rule (``Rule'') by updating comparability ranges and unit energy costs for many EnergyGuide labels. The Commission also issues a conditional exemption and amendments for modified refrigerator and clothes washer labels to help consumers compare the labels for these products after the implementation of upcoming changes to the Department of Energy (``DOE'') test procedures.

  5. 9 CFR 317.345 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Guidelines for voluntary nutrition... DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) Nutrition...

  6. 9 CFR 381.445 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Guidelines for voluntary nutrition... INSPECTION REGULATIONS Nutrition Labeling § 381.445 Guidelines for voluntary nutrition labeling of single-ingredient, raw products. Link to an amendment published at 75 FR 82166, Dec. 29, 2010. (a) Nutrition...

  7. 21 CFR 340.50 - Labeling of stimulant drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of stimulant drug products. 340.50 Section 340.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 340.50...

  8. 21 CFR 331.30 - Labeling of antacid products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...

  9. 21 CFR 331.30 - Labeling of antacid products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...

  10. 77 FR 69393 - Unique Device Identification System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ... submitted to the GUDID data base. Sec. 830.300. Two years after publication of a final rule.... The label... are required to be labeled with a UDI, must be submitted to the GUDID data base. Sec. 830.300. All... a UDI, must be submitted to the GUDID data base. Sec. 830.300. Five years after publication of a...

  11. Probing effects of pressure release on virus capture during virus filtration using confocal microscopy.

    PubMed

    Dishari, Shudipto K; Venkiteshwaran, Adith; Zydney, Andrew L

    2015-10-01

    Virus filtration is used to ensure drug safety in the production of biotherapeutics. Several recent studies have shown a dramatic decrease in virus retention as a result of a process disruption, e.g., a transient pressure release. In this work, a novel two-label fluorescence technique was developed to probe virus capture within virus filtration membranes using confocal microscopy. Experiments were performed with Ultipor® DV20, Viresolve® Pro, and Viresolve® NFP membranes using bacteriophage φx174 as a model virus. The filters were challenged with two batches of fluorescently labeled phage: one labeled with red dye (Cy5) and one with green dye (SYBR Gold) to visualize captured phage from before and after the pressure release. The capture patterns seen in the confocal images were a strong function of the underlying membrane morphology and pore structure. The DV20 and Viresolve® NFP showed migration of previously captured phage further into the filter, consistent with the observed loss of virus retention after the pressure release. In contrast, there was no migration of captured virus in the Viresolve® Pro membranes, and these filters were also the only ones to show stable virus retention after a pressure release. The direct visualization of virus capture using the two-label fluorescence technique provides unique insights into the factors controlling the retention characteristics of virus filters with different pore structure. © 2015 Wiley Periodicals, Inc.

  12. System and method for representing and manipulating three-dimensional objects on massively parallel architectures

    DOEpatents

    Karasick, Michael S.; Strip, David R.

    1996-01-01

    A parallel computing system is described that comprises a plurality of uniquely labeled, parallel processors, each processor capable of modelling a three-dimensional object that includes a plurality of vertices, faces and edges. The system comprises a front-end processor for issuing a modelling command to the parallel processors, relating to a three-dimensional object. Each parallel processor, in response to the command and through the use of its own unique label, creates a directed-edge (d-edge) data structure that uniquely relates an edge of the three-dimensional object to one face of the object. Each d-edge data structure at least includes vertex descriptions of the edge and a description of the one face. As a result, each processor, in response to the modelling command, operates upon a small component of the model and generates results, in parallel with all other processors, without the need for processor-to-processor intercommunication.

  13. Current Over-the-Counter Medicine Label: Take a Look

    MedlinePlus

    ... of OTC medicines sometimes make changes to their products or labeling (new ingredients, dosages, or warnings). Make sure to read the label each time you use the product. Always look for special "flags" or "banners" on ...

  14. Impact of explained v. unexplained front-of-package nutrition labels on parent and child food choices: a randomized trial.

    PubMed

    Graham, Dan J; Lucas-Thompson, Rachel G; Mueller, Megan P; Jaeb, Melanie; Harnack, Lisa

    2017-04-01

    The present study investigated whether parent/child pairs would select more healthful foods when: (i) products were labelled with front-of-package (FOP) nutrition labels relative to packages without labels; (ii) products were labelled with colour-coded Multiple Traffic Light (MTL) FOP labels relative to monochromatic Facts up Front (FuF) FOP labels; and (iii) FOP labels were explained via in-aisle signage v. unexplained. Participants were randomly assigned to one of five conditions: (i) FuF labels with in-aisle signs explaining the labels; (ii) FuF labels, no signage; (iii) MTL labels with in-aisle signage; (iv) MTL labels, no signage; (v) control group, no labels/signage. Saturated fat, sodium, sugar and energy (calorie) content were compared across conditions. The study took place in a laboratory grocery aisle. Parent/child pairs (n 153) completed the study. Results did not support the hypothesis that MTL labels would lead to more healthful choices than FuF labels. The presence of FOP labels did little to improve the healthfulness of selected foods, with few exceptions (participants with v. without access to FOP labels selected lower-calorie cereals, participants with access to both FOP labels and in-aisle explanatory signage selected products with less saturated fat v. participants without explanatory signage). Neither MTL nor FuF FOP labels led to food choices with significantly lower saturated fat, sodium or sugar. In-aisle signs explaining the FOP labels were somewhat helpful to consumers in making more healthful dietary decisions. New FOP labelling programmes could benefit from campaigns to increase consumer awareness and understanding of the labels.

  15. 78 FR 78305 - Energy and Water Use Labeling for Consumer Products Under the Energy Policy and Conservation Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... FEDERAL TRADE COMMISSION 16 CFR Part 305 [3084-AB15] Energy and Water Use Labeling for Consumer Products Under the Energy Policy and Conservation Act (``Energy Labeling Rule'') AGENCY: Federal Trade... to the Energy Labeling Rule (``Rule'') to require a new Department of Energy (DOE) test procedure for...

  16. 9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...

  17. 9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...

  18. 21 CFR 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requirements for human drug products held by the Strategic National Stockpile. 201.26 Section 201.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.26 Exceptions or alternatives to labeling requirements for human...

  19. Menthol Content in U.S. Marketed Cigarettes

    PubMed Central

    Ai, Jiu; Taylor, Kenneth M.; Lisko, Joseph G.; Tran, Hang; Watson, Clifford H.; Holman, Matthew R.

    2015-01-01

    Introduction In 2011 menthol cigarettes accounted for 32 percent of the market in the United States, but there are few literature reports that provide measured menthol data for commercial cigarettes. To assess current menthol application levels in the U.S. cigarette market, menthol levels in cigarettes labeled or not labeled to contain menthol was determined for a variety of contemporary domestic cigarette products. Method We measured the menthol content of 45whole cigarettes using a validated gas chromatography/mass spectrometry method (GC/MS). Results In 23 cigarette brands labeled as menthol products, the menthol levels of the whole cigarette ranged from 2.9 to 19.6 mg/cigarette, with three products having higher levels of menthol relative to the other menthol products. The menthol levels for 22 cigarette products not labeled to contain menthol ranged from 0.002 to 0.07 mg/cigarette. The type of packaging (soft vs. hard pack) for a given cigarette product does not appear to affect menthol levels based on the current limited data. Conclusion Menthol levels in cigarette products labeled as containing menthol are approximately 50 to 5,000-fold higher than those in cigarette products not labeled as containing menthol. In general, menthol content appears to occur within discrete ranges for both mentholated and non-mentholated cigarettes. PMID:26259988

  20. Compliance and Verification of Standards and Labelling Programs in China: Lessons Learned

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Saheb, Yamina; Zhou, Nan; Fridley, David

    2010-06-11

    After implementing several energy efficiency standards and labels (30 products covered by MEPS, 50 products covered by voluntary labels and 19 products by mandatory labels), the China National Institute of Standardization (CNIS) is now implementing verification and compliance mechanism to ensure that the energy information of labeled products comply with the requirements of their labels. CNIS is doing so by organizing check testing on a random basis for room air-conditioners, refrigerators, motors, heaters, computer displays, ovens, and self -ballasted lamps. The purpose of the check testing is to understand the implementation of the Chinese labeling scheme and help local authoritiesmore » establishing effective compliance mechanisms. In addition, to ensure robustness and consistency of testing results, CNIS has coordinated a round robin testing for room air conditioners. Eight laboratories (Chinese (6), Australian (1) and Japanese (1)) have been involved in the round robin testing and tests were performed on four sets of samples selected from manufacturer?s production line. This paper describes the methodology used in undertaking both check and round robin testing, provides analysis of testing results and reports on the findings. The analysis of both check and round robin testing demonstrated the benefits of a regularized verification and monitoring system for both laboratories and products such as (i) identifying the possible deviations between laboratories to correct them, (ii) improving the quality of testing facilities, (iii) ensuring the accuracy and reliability of energy label information in order to strength the social credibility of the labeling program and the enforcement mechanism in place.« less

  1. Compliance and Verification of Standards and Labeling Programs in China: Lessons Learned

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Saheb, Yamina; Zhou, Nan; Fridley, David

    2010-08-01

    After implementing several energy efficiency standards and labels (30 products covered by MEPS, 50 products covered by voluntary labels and 19 products by mandatory labels), the China National Institute of Standardization (CNIS) is now implementing verification and compliance mechanism to ensure that the energy information of labeled products comply with the requirements of their labels. CNIS is doing so by organizing check testing on a random basis for room air-conditioners, refrigerators, motors, heaters, computer displays, ovens, and self -ballasted lamps. The purpose of the check testing is to understand the implementation of the Chinese labeling scheme and help local authoritiesmore » establishing effective compliance mechanisms. In addition, to ensure robustness and consistency of testing results, CNIS has coordinated a round robin testing for room air conditioners. Eight laboratories (Chinese (6), Australian (1) and Japanese (1)) have been involved in the round robin testing and tests were performed on four sets of samples selected from manufacturer's production line. This paper describes the methodology used in undertaking both check and round robin testing, provides analysis of testing results and reports on the findings. The analysis of both check and round robin testing demonstrated the benefits of a regularized verification and monitoring system for both laboratories and products such as (i) identifying the possible deviations between laboratories to correct them, (ii) improving the quality of testing facilities, (iii) ensuring the accuracy and reliability of energy label information in order to strength the social credibility of the labeling program and the enforcement mechanism in place.« less

  2. 21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...

  3. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  4. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  5. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  6. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  7. 21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...

  8. 9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

  9. 9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

  10. What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling.

    PubMed

    Willy, Mary E; Li, Zili

    2004-04-01

    The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States. We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling. Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling. The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling.

  11. Multiplex N-terminome analysis of MMP-2 and MMP-9 substrate degradomes by iTRAQ-TAILS quantitative proteomics.

    PubMed

    Prudova, Anna; auf dem Keller, Ulrich; Butler, Georgina S; Overall, Christopher M

    2010-05-01

    Proteolysis is a major protein posttranslational modification that, by altering protein structure, affects protein function and, by truncating the protein sequence, alters peptide signatures of proteins analyzed by proteomics. To identify such modified and shortened protease-generated neo-N-termini on a proteome-wide basis, we developed a whole protein isobaric tag for relative and absolute quantitation (iTRAQ) labeling method that simultaneously labels and blocks all primary amines including protein N- termini and lysine side chains. Blocking lysines limits trypsin cleavage to arginine, which effectively elongates the proteolytically truncated peptides for improved MS/MS analysis and peptide identification. Incorporating iTRAQ whole protein labeling with terminal amine isotopic labeling of substrates (iTRAQ-TAILS) to enrich the N-terminome by negative selection of the blocked mature original N-termini and neo-N-termini has many advantages. It enables simultaneous characterization of the natural N-termini of proteins, their N-terminal modifications, and proteolysis product and cleavage site identification. Furthermore, iTRAQ-TAILS also enables multiplex N-terminomics analysis of up to eight samples and allows for quantification in MS2 mode, thus preventing an increase in spectral complexity and extending proteome coverage by signal amplification of low abundance proteins. We compared the substrate degradomes of two closely related matrix metalloproteinases, MMP-2 (gelatinase A) and MMP-9 (gelatinase B), in fibroblast secreted proteins. Among 3,152 unique N-terminal peptides identified corresponding to 1,054 proteins, we detected 201 cleavage products for MMP-2 and unexpectedly only 19 for the homologous MMP-9 under identical conditions. Novel substrates identified and biochemically validated include insulin-like growth factor binding protein-4, complement C1r component A, galectin-1, dickkopf-related protein-3, and thrombospondin-2. Hence, N-terminomics analyses using iTRAQ-TAILS links gelatinases with new mechanisms of action in angiogenesis and reveals unpredicted restrictions in substrate repertoires for these two very similar proteases.

  12. Multiplex N-terminome Analysis of MMP-2 and MMP-9 Substrate Degradomes by iTRAQ-TAILS Quantitative Proteomics*

    PubMed Central

    Prudova, Anna; auf dem Keller, Ulrich; Butler, Georgina S.; Overall, Christopher M.

    2010-01-01

    Proteolysis is a major protein posttranslational modification that, by altering protein structure, affects protein function and, by truncating the protein sequence, alters peptide signatures of proteins analyzed by proteomics. To identify such modified and shortened protease-generated neo-N-termini on a proteome-wide basis, we developed a whole protein isobaric tag for relative and absolute quantitation (iTRAQ) labeling method that simultaneously labels and blocks all primary amines including protein N- termini and lysine side chains. Blocking lysines limits trypsin cleavage to arginine, which effectively elongates the proteolytically truncated peptides for improved MS/MS analysis and peptide identification. Incorporating iTRAQ whole protein labeling with terminal amine isotopic labeling of substrates (iTRAQ-TAILS) to enrich the N-terminome by negative selection of the blocked mature original N-termini and neo-N-termini has many advantages. It enables simultaneous characterization of the natural N-termini of proteins, their N-terminal modifications, and proteolysis product and cleavage site identification. Furthermore, iTRAQ-TAILS also enables multiplex N-terminomics analysis of up to eight samples and allows for quantification in MS2 mode, thus preventing an increase in spectral complexity and extending proteome coverage by signal amplification of low abundance proteins. We compared the substrate degradomes of two closely related matrix metalloproteinases, MMP-2 (gelatinase A) and MMP-9 (gelatinase B), in fibroblast secreted proteins. Among 3,152 unique N-terminal peptides identified corresponding to 1,054 proteins, we detected 201 cleavage products for MMP-2 and unexpectedly only 19 for the homologous MMP-9 under identical conditions. Novel substrates identified and biochemically validated include insulin-like growth factor binding protein-4, complement C1r component A, galectin-1, dickkopf-related protein-3, and thrombospondin-2. Hence, N-terminomics analyses using iTRAQ-TAILS links gelatinases with new mechanisms of action in angiogenesis and reveals unpredicted restrictions in substrate repertoires for these two very similar proteases. PMID:20305284

  13. Automated sorting of polymer flakes: fluorescence labeling and development of a measurement system prototype.

    PubMed

    Brunner, S; Fomin, P; Kargel, Ch

    2015-04-01

    The extensive demand and use of plastics in modern life is associated with a significant economical impact and a serious ecological footprint. The production of plastics involves a high energy consumption and CO2 emission as well as the large need for (limited) fossil resources. Due to the high durability of plastics, large amounts of plastic garbage is mounting in overflowing landfills (plus 9.6 million tons in Europe in the year 2012) and plastic debris is floating in the world oceans or waste-to-energy combustion releases even more CO2 plus toxic substances (dioxins, heavy metals) to the atmosphere. The recycling of plastic products after their life cycle can obviously contribute a great deal to the reduction of the environmental and economical impacts. In order to produce high-quality recycling products, mono-fractional compositions of waste polymers are required. However, existing measurement technologies such as near infrared spectroscopy show limitations in the sorting of complex mixtures and different grades of polymers, especially when black plastics are involved. More recently invented technologies based on mid-infrared, Raman spectroscopy or laser-aided spectroscopy are still under development and expected to be rather expensive. A promising approach to put high sorting purities into practice is to label plastic resins with unique combinations of fluorescence markers (tracers). These are incorporated into virgin resins during the manufacturing process at the ppm (or sub ppm) concentration level, just large enough that the fluorescence emissions can be detected with sensitive instrumentation but neither affect the visual appearance nor the mechanical properties of the polymers. In this paper we present the prototype of a measurement and classification system that identifies polymer flakes (mill material of a few millimeters size) located on a conveyor belt in real time based on the emitted fluorescence of incorporated markers. Classification performance and throughput were experimentally quantified using 3 different types of polymers (Polyoxymethylene (POM), Polybutylenterephthalat (PBT) and Acrylonitrile Styrene Acrylate (ASA)) in colored and uncolored form. Overall, 12 classes of plastic flakes were investigated in this study, where 11 classes were labeled with unique binary combinations of 4 fluorescence markers and class 12 includes unlabeled plastic flakes of various colors. From approx. 68,000 investigated flakes it was found that the developed measurement prototype system achieves an average sensitivity (true positive rate) of 99.4% and a precision (positive predictive value) of 99.5%, while being able to handle up to approx. 1800 flakes per second. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. 40 CFR 763.171 - Labeling requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.171 Labeling requirements. (a) After August 27, 1990, manufacturers, importers, and processors of all asbestos-containing products that are...

  15. 16 CFR 1615.5 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE.... (a) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions... accordance with rules and regulations established by the Consumer Product Safety Commission. (b) [Reserved...

  16. Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.

    PubMed

    Momper, Jeremiah D; Mulugeta, Yeruk; Green, Dionna J; Karesh, Alyson; Krudys, Kevin M; Sachs, Hari C; Yao, Lynn P; Burckart, Gilbert J

    2013-10-01

    During pediatric drug development, dedicated pharmacokinetic studies are generally performed in all relevant age groups to support dose selection for subsequent efficacy trials. To our knowledge, no previous assessments regarding the need for an intensive pharmacokinetic study in adolescents have been performed. To compare U.S. Food and Drug Administration (FDA)-approved adult and adolescent drug dosing and to assess the utility of allometric scaling for the prediction of drug clearance in the adolescent population. Adult and adolescent dosing and drug clearance data were obtained from FDA-approved drug labels and publicly available databases containing reviews of pediatric trials submitted to the FDA. Dosing information was compared for products with concordant indications for adolescent and adult patients. Adolescent drug clearance was predicted from adult pharmacokinetic data by using allometric scaling and compared with observed values. Adolescent and adult dosing information and drug clearance. There were 126 unique products with pediatric studies submitted to the FDA since the FDA Amendments Act of 2007, of which 92 had at least 1 adolescent indication concordant with an adult indication. Of these 92 products, 87 (94.5%) have equivalent dosing for adults and adolescent patients. For 18 of these 92 products, a minimum weight or body surface area threshold is recommended for adolescents to receive adult dosing. Allometric scaling predicted adolescent drug clearance with an overall mean absolute percentage error of 17.0%. Approved adult and adolescent drug dosing is equivalent for 94.5% of products with an adolescent indication studied since the FDA Amendments Act of 2007. Allometric scaling may be a useful tool to avoid unnecessary dedicated pharmacokinetic studies in the adolescent population during pediatric drug development, although each development program in adolescents requires a full discussion of drug dosing with the FDA.

  17. Survey of undeclared egg allergen levels in the most frequently recalled food types (including products bearing precautionary labelling).

    PubMed

    Khuda, Sefat E; Sharma, Girdhari M; Gaines, Dennis; Do, Andrew B; Pereira, Marion; Chang, Michael; Ferguson, Martine; Williams, Kristina M

    2016-08-01

    Since the number of recalls involving undeclared allergens is commonly associated with bakery and snack foods, we aimed to determine the frequency of egg allergens in a large number of these products using two commercial enzyme-linked immunosorbent assay (ELISA) methods. Samples were chosen that either had no egg identified on the product label or which had an egg precautionary statement. Among all samples, egg protein was detected in 5% of products using a Morinaga (MO) kit and 1% of products using a R-Biopharm (RB) kit. For bakery samples, egg protein was detected in 6% of 363 samples with no precautionary labelling (6% by MO and 1% by RB kit) and 12% of 80 samples which had precautionary labelling. For snack samples, egg protein was detected in 2% of 371 samples with no precautionary labelling (2% by MO and < 1% by RB kit) and 5% of 21 samples which had precautionary labelling. The disagreement rates between two methods were 5.2% for bakery products and 2.6% for snack products. The sample repeatability was at an acceptable level for bakery (< 12.5%) and snack foods (< 7.5%) for each method. The relative standard deviation between test kits was high (103.1%) for bakery foods. Four bakery products without precautionary labelling had a higher level of egg protein per serving compared with the eliciting dose (ED10 of 3.7 mg protein) for egg allergic patients. These results highlight the fact that detection methodology plays a vital role for accurate labelling control and mitigation of risk for egg allergic consumers.

  18. Penetration of nutrition information on food labels across the EU-27 plus Turkey

    PubMed Central

    Storcksdieck genannt Bonsmann, S; Celemín, L Fernández; Larrañaga, A; Egger, S; Wills, J M; Hodgkins, C; Raats, M M

    2010-01-01

    Objectives: The European Union (EU)-funded project Food Labelling to Advance Better Education for Life (FLABEL) aims to understand how nutrition information on food labels affects consumers' dietary choices and shopping behaviour. The first phase of this study consisted of assessing the penetration of nutrition labelling and related information on various food products in all 27 EU Member States and Turkey. Methods: In each country, food products were audited in three different types of retailers to cover as many different products as possible within five food and beverage categories: sweet biscuits, breakfast cereals, pre-packed chilled ready meals, carbonated soft drinks and yoghurts. Results: More than 37 000 products were audited in a total of 84 retail stores. On average, 85% of the products contained back-of-pack (BOP) nutrition labelling or related information (from 70% in Slovenia to 97% in Ireland), versus 48% for front-of-pack (FOP) information (from 24% in Turkey to 82% in the UK). The most widespread format was the BOP tabular or linear listing of nutrition content. Guideline daily amounts labelling was the most prevalent form of FOP information, showing an average penetration of 25% across all products audited. Among categories, breakfast cereals showed the highest penetration of nutrition-related information, with 94% BOP penetration and 70% FOP penetration. Conclusions: Nutrition labelling and related information was found on a large majority of products audited. These findings provide the basis for subsequent phases of FLABEL involving attention, reading, liking, understanding and use by consumers of different nutrition labelling formats. PMID:20808336

  19. Explicit Versus Implicit "Halal" Information: Influence of the Halal Label and the Country-of-Origin Information on Product Perceptions in Indonesia.

    PubMed

    Maison, Dominika; Marchlewska, Marta; Syarifah, Dewi; Zein, Rizqy A; Purba, Herison P

    2018-01-01

    Halal refers to what is permissible in traditional Islamic law. Food that meets halal requirements is marked by a halal label on the packaging and should be especially attractive to those Muslims who follow the set of dietary laws outlined in the Quran. This research examines the role of the halal label (explicit cue) and the country-of-origin (COO) (implicit cue) in predicting positive product perceptions among Muslim consumers. We hypothesized that when an explicit sign of "halalness" (i.e., halal label) relating to a particular product is accompanied by an implicit sign of anti - "halalness" (i.e., non-Islamic COO information), Muslim consumers who pay attention to the dietary laws of Islam would have negative perceptions of such a product. We tested our assumptions in an experiment conducted among Indonesian participants who declared themselves as Muslims ( n = 444). We manipulated: (a) exposure to the halal label, and (b) the COO information. Religion-based purchase behavior was measured as a moderator variable. Positive product perceptions were measured as a dependent variable. The results showed that the halal label itself had limited influence on product perceptions. However, we found that positive product perceptions significantly decreased among people who were high in religion-based purchase behavior in response to exposure to non-Islamic COO information accompanied by a halal label. In conclusion, people who are high (vs. low) in religion-based purchase behavior do not seem to trust halal-labeled food produced in a country with other than an Islamic tradition.

  20. Explicit Versus Implicit “Halal” Information: Influence of the Halal Label and the Country-of-Origin Information on Product Perceptions in Indonesia

    PubMed Central

    Maison, Dominika; Marchlewska, Marta; Syarifah, Dewi; Zein, Rizqy A.; Purba, Herison P.

    2018-01-01

    Halal refers to what is permissible in traditional Islamic law. Food that meets halal requirements is marked by a halal label on the packaging and should be especially attractive to those Muslims who follow the set of dietary laws outlined in the Quran. This research examines the role of the halal label (explicit cue) and the country-of-origin (COO) (implicit cue) in predicting positive product perceptions among Muslim consumers. We hypothesized that when an explicit sign of “halalness” (i.e., halal label) relating to a particular product is accompanied by an implicit sign of anti-“halalness” (i.e., non-Islamic COO information), Muslim consumers who pay attention to the dietary laws of Islam would have negative perceptions of such a product. We tested our assumptions in an experiment conducted among Indonesian participants who declared themselves as Muslims (n = 444). We manipulated: (a) exposure to the halal label, and (b) the COO information. Religion-based purchase behavior was measured as a moderator variable. Positive product perceptions were measured as a dependent variable. The results showed that the halal label itself had limited influence on product perceptions. However, we found that positive product perceptions significantly decreased among people who were high in religion-based purchase behavior in response to exposure to non-Islamic COO information accompanied by a halal label. In conclusion, people who are high (vs. low) in religion-based purchase behavior do not seem to trust halal-labeled food produced in a country with other than an Islamic tradition. PMID:29623061

  1. News coverage and sales of products with trans fat: effects before and after changes in federal labeling policy.

    PubMed

    Niederdeppe, Jeff; Frosch, Dominick L

    2009-05-01

    The Food and Drug Administration mandated that food products list the amount of trans fat per serving on nutrition facts labels by January 1, 2006. There have been no coordinated efforts to raise awareness about trans fat since the policy went into effect, but news coverage may promote informed decisions about food purchases. This paper assesses whether news coverage influenced sales of products containing trans fat, between December 13, 2004, and June 24, 2007, both before and after the labeling policy went into effect. Sales data for products containing trans fat from a major grocery store chain with stores throughout Los Angeles County were merged with news coverage data from LexisNexis and ProQuest. Cross-sectional time-series regression was conducted in 2008 to assess the effect of news coverage on weekly unit sales volume for seven trans-fat products across 11,997 store-weeks. News coverage effects were apparent for sales of two of the seven trans-fat products in the year before the trans-fat nutrition facts labeling policy went into effect (p<0.05 with Bonferroni correction). News coverage effects were observed for sales of six of the seven trans-fat products in the post-labeling period (p<0.05 with Bonferroni correction). For most products, effects were strongest at concurrent and 1-week lags, and they dissipated over time. News coverage about trans fat, combined with labeling information, appears to influence consumer behavior in the short term. News coverage and product labeling may not be sufficient to promote sustained changes in trans-fat purchases.

  2. PRN 93-8: Labeling Statement Prohibiting Application to Water; Amendment to PR Notice 93-3

    EPA Pesticide Factsheets

    This notice adds one paragraph to P.R. Notice 93-3, which requested registrants to amend product labeling to include a new labeling statement prohibiting application of a pesticide to water for certain products.

  3. Personality Factors in Elementary School Children: Contributions to Academic Performance over and above Executive Functions?

    ERIC Educational Resources Information Center

    Neuenschwander, Regula; Cimeli, Patrizia; Rothlisberger, Marianne; Roebers, Claudia M.

    2013-01-01

    Unique contributions of Big Five personality factors to academic performance in young elementary school children were explored. Extraversion and Openness (labeled "Culture" in our study) uniquely contributed to academic performance, over and above the contribution of executive functions in first and second grade children (N = 446). Well…

  4. Developing a Community of Critically Literate Consumers . . . One Close Label-Reading at a Time

    ERIC Educational Resources Information Center

    Reissman, Rose Cherie

    2012-01-01

    This article focuses on middle school students analyzing product labels. The labels were analyzed in terms of which facts they purported to impart and to what extent these so-called facts tallied with actual data and scientific/health analyses of the products. Students then reworded the labels to include only documented facts. They also shared the…

  5. 7 CFR 70.50 - Approval of official identification and wording on labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... INSPECTION ACT (CONTINUED) VOLUNTARY GRADING OF POULTRY PRODUCTS AND RABBIT PRODUCTS Grading of Poultry Products and Rabbit Products Identifying and Marking Products § 70.50 Approval of official identification... CFR part 381. Poultry Products Inspection Regulations. Labeling requirements for ready-to-cook rabbits...

  6. Calendar Year 2007 Program Benefits for U.S. EPA Energy Star Labeled Products: Expanded Methodology

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sanchez, Marla; Homan, Gregory; Lai, Judy

    2009-09-24

    This report provides a top-level summary of national savings achieved by the Energy Star voluntary product labeling program. To best quantify and analyze savings for all products, we developed a bottom-up product-based model. Each Energy Star product type is characterized by product-specific inputs that result in a product savings estimate. Our results show that through 2007, U.S. EPA Energy Star labeled products saved 5.5 Quads of primary energy and avoided 100 MtC of emissions. Although Energy Star-labeled products encompass over forty product types, only five of those product types accounted for 65percent of all Energy Star carbon reductions achieved tomore » date, including (listed in order of savings magnitude)monitors, printers, residential light fixtures, televisions, and furnaces. The forecast shows that U.S. EPA?s program is expected to save 12.2 Quads of primary energy and avoid 215 MtC of emissions over the period of 2008?2015.« less

  7. Activity-based assay for ricin-like toxins

    DOEpatents

    Keener, William K.; Ward, Thomas E.

    2007-02-06

    A method of detecting N-glycosylase activity in a sample involves incubating an oligodeoxyribonucleotide substrate containing a deoxyadenosine or deoxyuridine residue with the sample to be tested such that the N-glycosylase, if present, hydrolyzes the deoxyadenosine or deoxyuridine residue to result in an N-glycosylase product having an abasic site. A primer is annealed to the N-glycosylase product, and the primer is extended with a DNA polymerase, such as Taq DNA polymerase, that pauses at abasic sites. The resulting extension products are melted from the N-glycosylase product, allowed to form hairpins due to self-complementarity, and further extended in the presence of labeled precursors to result in labeled products. Extension products synthesized from undigested substrate as template do not result in labeled products. Thus, detection of labeled products results in detection of N-glycosylase activity. Oligodeoxyribonucleotide substrates, primer, and positive controls and a kit for N-glycosylase assay are also disclosed.

  8. 78 FR 20604 - Enhanced Document Requirements To Support Use of the Dolphin Safe Label on Tuna Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... Commission Act for including a dolphin-safe label on tuna product in the United States that fails to meet the.... 130221153-3153-01] RIN 0648-BC78 Enhanced Document Requirements To Support Use of the Dolphin Safe Label on Tuna Products AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric...

  9. 78 FR 49412 - Personal Flotation Devices Labeling and Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ...The Coast Guard proposes to remove references to type codes in its regulations on the carriage and labeling of Coast Guard-approved personal flotation devices (PFDs). PFD type codes are unique to Coast Guard approval and are not well understood by the public. Removing these type codes from our regulations would facilitate future incorporation by reference of new industry consensus standards for PFD labeling that will more effectively convey safety information, and is a step toward harmonization of our regulations with PFD requirements in Canada and in other countries.

  10. Evaluation of concordance between labelling and content of 52 hair dye products: overview of the market of oxidative hair dye.

    PubMed

    Antelmi, Annarita; Bruze, Magnus; Zimerson, Erik; Engfeldt, Malin; Young, Ewa; Persson, Lena; Foti, Caterina; Sörensen, Östen; Svedman, Cecilia

    2017-04-01

    Hair dyes contain strong allergens and are widely available. Correct labelling is a necessity in order to provide information about the contents. To compare the labelling and content of hair dyes. In total, 52 hair dyes, from 11 different countries, were bought over the counter. High-pressure liquid chromatography was used for the analysis of p-phenylenediamine (PPD), toluene-2,5-diamine (2,5-TDA), and three oxidation products of PPD. There was good agreement between labelling and content, although seven of the 52 products (13.5%) studied were incorrectly labelled. There were differences in the geographical use of PPD and 2,5-TDA; 2,5-TDA was more common in European products, while PPD was more common in products purchased outside Europe and was present in higher concentrations. All dyes purchased in Europe contained PPD and 2,5-TDA at levels within the limits defined by European legislation, however, levels were higher in some products purchased outside Europe. Only a small group of hair dyes sold in Europe were mislabelled. Further improvement in labelling, by providing the concentration of chemicals, may facilitate products to be purchased both locally and within the global market, when travelling or on the internet.

  11. 16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...

  12. 16 CFR 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Extremely flammable contact adhesives; labeling. 1500.133 Section 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...

  13. Objective Understanding of Front-of-Package Nutrition Labels among Nutritionally At-Risk Individuals

    PubMed Central

    Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold K.; Hercberg, Serge; Péneau, Sandrine

    2015-01-01

    In the ongoing debate about front-of-package (FOP) nutrition labels, little data exist regarding nutritionally at-risk populations, although they are critical targets of prevention programs. This study aimed to compare the impact of FOP labels on the ability to rank products according to their nutritional quality among French adults potentially at risk of poor dietary quality (N = 14,230). Four labels were evaluated: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), along with a reference without label. Mixed models were used to assess how individual characteristics and FOP labels were associated with the ability to rank products. Older participants and those with a lower educational level, income, nutritional knowledge, and likelihood of reading nutrition facts were less skilled at ranking food products according to nutritional quality. Compared with individual characteristics, nutrition labels had an increased impact on food product ranking ability. Overall, 5-CNL corresponded to the highest rate of correct responses, followed by MTL, GDA, and Tick (p < 0.0001). The strongest impact of 5-CNL was observed among individuals with no nutritional knowledge (odds ratio (OR): 20.24; 95% confidence interval (CI): 13.19–31.06). Therefore, 5-CNL appeared to be effective at informing consumers, including those who are nutritionally at-risk, about the nutritional quality of food products. PMID:26305255

  14. Objective Understanding of Front-of-Package Nutrition Labels among Nutritionally At-Risk Individuals.

    PubMed

    Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold K; Hercberg, Serge; Péneau, Sandrine

    2015-08-24

    In the ongoing debate about front-of-package (FOP) nutrition labels, little data exist regarding nutritionally at-risk populations, although they are critical targets of prevention programs. This study aimed to compare the impact of FOP labels on the ability to rank products according to their nutritional quality among French adults potentially at risk of poor dietary quality (N = 14,230). Four labels were evaluated: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), along with a reference without label. Mixed models were used to assess how individual characteristics and FOP labels were associated with the ability to rank products. Older participants and those with a lower educational level, income, nutritional knowledge, and likelihood of reading nutrition facts were less skilled at ranking food products according to nutritional quality. Compared with individual characteristics, nutrition labels had an increased impact on food product ranking ability. Overall, 5-CNL corresponded to the highest rate of correct responses, followed by MTL, GDA, and Tick (p < 0.0001). The strongest impact of 5-CNL was observed among individuals with no nutritional knowledge (odds ratio (OR): 20.24; 95% confidence interval (CI): 13.19-31.06). Therefore, 5-CNL appeared to be effective at informing consumers, including those who are nutritionally at-risk, about the nutritional quality of food products.

  15. Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products.

    PubMed

    Tassinari, Melissa S; Sahin, Leyla; Yao, Lynne P

    2015-08-01

    Obtaining human pregnancy data to inform product labeling is important for drug and biological products. Collection and analyses of safety data on their use during pregnancy is usually performed after approval. The Centers for Disease Control National Birth Defects Prevention Study has provided important data on the relationship between drug use in pregnancy and birth defects. The Pregnancy and Lactation Labeling Rule will set new and improved standards for the inclusion of information about the use of prescription drugs and biological products during pregnancy; the National Birth Defects Prevention Study, along with other data sources, will be critical for providing safety data to inform product labeling. © 2015 Wiley Periodicals, Inc.

  16. 9 CFR 381.408 - Labeling of poultry products with number of servings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of poultry products with... SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS...

  17. Recognition memory for hue: Prototypical bias and the role of labeling.

    PubMed

    Kelly, Laura Jane; Heit, Evan

    2017-06-01

    How does the concurrent use of language affect perception and memory for exemplars? Labels cue more general category information than a specific exemplar. Applying labels can affect the resulting memory for an exemplar. Here 3 alternative hypotheses are proposed for the role of labeling an exemplar at encoding: (a) labels distort memory toward the label prototype, (b) labels guide the level of specificity needed in the current context, and (c) labels direct attention to the label's referent among all possible features within a visual scene. University students were shown hues on object silhouettes that they either labeled with basic color categories, made preference judgments about, or indicated the animacy of its category. Experiments 1 and 2 established that there are response shifts toward the category prototype regardless of labeling, showing a pervasive influence of category knowledge on response bias. They also established an effect of labeling whereby labeling decreases the magnitude of shifts. Experiments 3 and 4 investigated the uniqueness and necessity of language in causing the decreased shift-neither of which proved to be the case. Overall, category-relative bias was pervasive and labeling appears to direct attention to the feature resulting in less biased memory. The results highlight that the context at encoding affects how memory is formed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  18. Readability of product ingredient labels can be improved by simple means: an experimental study.

    PubMed

    Yazar, Kerem; Seimyr, Gustaf Ö; Novak, Jiri A; White, Ian R; Lidén, Carola

    2014-10-01

    Ingredient labels on products used by consumers and workers every day, such as food, cosmetics, and detergents, can be difficult to read and understand. To assess whether typographical design and ordering of ingredients can improve the readability of product ingredient labels. The study subjects (n = 16) had to search for two target ingredients in 30 cosmetic product labels and three alternative formats of each. Outcome measures were completion time (reading speed), recognition rate, eye movements, task load and subjective rating when the reading of ingredient labels was assessed by video recording, an eye tracking device, and questionnaires. The completion time was significantly lower (p < 0.001) when subjects were reading all alternative formats than when they were reading the original. The recognition rate was generally high, and improved slightly with the alternative formats. The eye movement measures confirmed that the alternative formats were easier to read than the original product labels. Mental and physical demand and effort were significantly lower (p < 0.036) and experience rating was higher (p < 0.042) for the alternative formats. There were also differences between the alternative formats. Simple adjustments in the design of product ingredient labels would significantly improve their readability, benefiting the many allergic individuals and others in their daily struggle to avoid harmful or unwanted exposure. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. A study of the nonprescription drug consumer's understanding of the ranitidine product label and actual product usage patterns in the treatment of episodic heartburn.

    PubMed

    Ciociola, A A; Sirgo, M A; Pappa, K A; McGuire, J A; Fung, K

    2001-01-01

    A study of the consumer's understanding of the product label instructions and the resulting product use were conducted to support the switch of a product from prescription to nonprescription status. H2 receptor antagonists have recently been approved for nonprescription use. This study evaluated the consumer's understanding of the product label for ranitidine hydrochloride (Zantac 75) and the product usage pattern in the treatment of episodic heartburn. Our objectives were to evaluate each aspect of the communication of labeled indications, contraindications, and directions for use of two label formats (old and new) for a new nonprescription preparation of ranitidine (Zantac) and to evaluate nonprescription consumers' use of ranitidine 75-mg tablets (as Zantac 75) in a medically unsupervised, at-home setting to observe whether these consumers used the product appropriately and followed directions as written on the package label. Adult male and female consumers (n = 1405) in a shopping mall environment who were attracted to a poster asking, "Do you have stomach problems?" were recruited for the label comprehension phase (two different label formats) and the 3-week usage phase if after reading the Zantac 75 package label they decided the product was appropriate for them. No instructions regarding the use of Zantac 75 were provided beyond what was printed on the package label. Subjects recorded use in a diary and tablet counts were performed at the end of the study period. A medical history was also taken at this time and an assessment of product use was performed by a physician. In at least 84% of all subjects, both formats were effective in the communication of label objectives for the contraindication against concurrent prescription stomach ulcer medication, maximum daily dose, and maximum duration of dosing at maximum daily doses. The direction to take one tablet per dose was adhered to by 90% of consumers, and 90% of consumers followed the instructions to take no more than two tablets in 24 hours. Ninety-six percent of consumers complied with the direction not to take the maximum daily dose for more than 14 consecutive days. Notably, the maximum daily dose was taken for < or =3 consecutive days by 79% of consumers. The most frequently reported adverse events were headache, acute nasopharyngitis, upper respiratory tract infection, diarrhea, nausea, and menstrual cramps. The study demonstrated that the vast majority of a large sample of unsupervised consumers understood the package label and fully complied with the package directions by not exceeding the maximum daily dosage and length of use. Nonprescription consumers safely used Zantac 75 without medical supervision.

  20. 9 CFR 590.410 - Shell eggs and egg products required to be labeled.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Shell eggs and egg products required..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Identifying and Marking Product § 590.410 Shell eggs and egg products required to be labeled...

  1. 9 CFR 590.410 - Shell eggs and egg products required to be labeled.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Shell eggs and egg products required..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Identifying and Marking Product § 590.410 Shell eggs and egg products required to be labeled...

  2. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

  3. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

  4. 7 CFR 60.300 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...

  5. 7 CFR 60.300 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...

  6. 7 CFR 60.300 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...

  7. 7 CFR 60.300 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AGRICULTURAL MARKETING ACT OF 1946 AND THE EGG PRODUCTS INSPECTION ACT (CONTINUED) COUNTRY OF ORIGIN LABELING FOR FISH AND SHELLFISH General Provisions Country of Origin Notification § 60.300 Labeling. (a) Country of origin declarations and method of production (wild and/or farm-raised) designations can either...

  8. Associations of Proposed Relative-Risk Warning Labels for Snus With Perceptions and Behavioral Intentions Among Tobacco Users and Nonusers.

    PubMed

    Rodu, Brad; Plurphanswat, Nantaporn; Hughes, John R; Fagerström, Karl

    2016-05-01

    The US Food and Drug Administration can require changes in warning statements for modified risk tobacco products. We report an independent analysis of a consumer perception survey sponsored by Swedish Match as part of a Modified Risk Tobacco Product application to change warning labels for Swedish snus products. The survey exposed each of 4324 daily exclusive cigarette smokers, 1033 daily smokeless tobacco users, 1205 daily other tobacco users, 726 former users, and 5915 triers/never users to one of four current warnings and two proposed relative-risk labels (No tobacco product is safe, but this product presents lower risks to health than cigarettes, or No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes) for snus. Descriptive and logistic regression analyses examined four outcomes: believability, harmfulness, motivation to use, and intention to buy snus. Compared with the current not-safe-alternative warning, adult tobacco users who viewed the proposed labels perceived them as less believable, perceived snus as less harmful and were more likely to use and buy snus. The proposed labels had no impact on former smokers' likelihood to use and buy snus; triers/never users viewing the substantially lower risk label were more likely to buy snus. Tobacco users viewing the proposed labels perceived snus as less harmful than cigarettes and may be more likely to use and buy snus. If labeling changes lead to increased snus use and cigarette reduction or abstinence, public health may benefit. If the opposite occurs, public health could suffer. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  9. Compliance status of product labels to the international code on marketing of breast milk substitutes.

    PubMed

    Ergin, Ahmet; Hatipoğlu, Celile; Bozkurt, Ali Ihsan; Erdoğan, Aslı; Güler, Serdar; Ince, Gülberat; Kavurgacı, Nuran; Oz, Ahmet; Yeniay, Mustafa K

    2013-01-01

    The aim of this study was to determine the compliance status of product labels regarding Article 9 of the International Code on Marketing of Breast-milk Substitutes (the Code) in Denizli province, Turkey. A cross-sectional study design was employed to determine the compliance status. The product labels were obtained from a convenience sample of five supermarkets, one store and 5 pharmacies in the City centre and district of Honaz. Using a data collection form prepared by previously published studies, data were collected between July 26, 2010 and August 06, 2010. Data collection form included 13 criteria. In addition, we checked the boxes for the availability of a Turkish written label. Forty product labels of 7 companies were reached and evaluated. These products consisted of 83.0% of the products marketed by these companies in Turkey. Thirty seven (92.5%) of the labels violated Article 9 of the Code in terms of one or more criteria. Thirty four (85.0%) of the labels had photos or pictures idealizing the use of infant formula. Nine (22.5%) had a photo, a picture or any representation of an infant, and five (12.5%) had text which idealize the use of infant formula or discouraging breastfeeding. Eight (20%) did not state that breastfeeding is the best. Four (10%) had a term such as 'similar to breast milk or human milk'. In conclusion, the majority of the product labels of breast milk substitutes marketed in our country violate the Code. It is appropriate that the Turkish Ministry of Health, medical organizations, companies, and NGOs work more actively to increase awareness of this issue.

  10. Single-larger-portion-size and dual-column nutrition labeling may help consumers make more healthful food choices.

    PubMed

    Lando, Amy M; Lo, Serena C

    2013-02-01

    The Food and Drug Administration is considering changes to the Nutrition Facts label to help consumers make more healthful choices. To examine the effects of modifications to the Nutrition Facts label on foods that can be listed as having 1 or 2 servings per container, but are reasonably consumed at a single eating occasion. Participants were randomly assigned to study conditions that varied on label format, product, and nutrition profile. Data were collected via an online consumer panel. Adults aged 18 years and older were recruited from Synovate's online household panel. Data were collected during August 2011. A total of 32,897 invitations were sent for a final sample of 9,493 interviews. Participants were randomly assigned to one of 10 label formats classified into three groups: listing 2 servings per container with a single column, listing 2 servings per container with a dual column, and listing a single serving per container. Within these groups there were versions that enlarged the font size for "calories," removed "calories from fat," and changed the wording for serving size declaration. The single product task measured product healthfulness, the amount of calories and various nutrients per serving and per container, and label perceptions. The product comparison task measured ability to identify the healthier product and the product with fewer calories per container and per serving. Analysis of covariance models with Tukey-Kramer tests were used. Covariates included general label use, age, sex, level of education, and race/ethnicity. Single-serving and dual-column formats performed better and scored higher on most outcome measures. For products that contain 2 servings but are customarily consumed at a single eating occasion, using a single-serving or dual-column labeling approach may help consumers make healthier food choices. Published by Elsevier Inc.

  11. Dietary Supplements for Musculoskeletal Pain: Science Versus Claims.

    PubMed

    Crawford, Cindy; Saldanha, Leila; Costello, Rebecca; Deuster, Patricia A

    2018-01-01

    Special Operations Forces (SOF) face unique challenges that manifest themselves both mentally and physically. The extremes of training and combat can affect the readiness to perform at peak levels, especially when confronted with musculoskeletal pain. Many SOF Operators turn to dietary supplements in hopes of gaining an edge. Although some supplements are now being marketed for pain, decisions to use these products need to be driven by information that is evidence based. We describe SOF-specific evidence-based recommendations for the use of dietary ingredients for pain that emerged from a rigorous scientific evaluation. These recommendations are compared with the label claims made in the commercial market by companies selling products to combat musculoskeletal pain. This information can be used by the SOF medical community to assist Operators in making informed decisions when considering or selecting dietary supplements for maintaining and optimizing performance. 2018.

  12. TRITIUM-LABELED COMPOUNDS VII. ISOTOPE EFFECTS IN THE OXIDATION OF d- MANNITOLS-C$sup 14$ AND d-MANNITOLS-t TO d-FRUCTOSES

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sniegoski, L.T.; Frush, H.L.; Isbell, H.S.

    1961-09-01

    D-Mannitols, labeled either with carbon-14 at C1, C2, or C3, or with tritium attached to C1, C2, or C3, were prepared. After oxidation by Acetobacter suboxydans, the distribution of radioactivity in each of the resulting labeled D- fructoses was determined. Labeled D-mannitol is unique among the hexitols in that it may be oxidized by A. suboxydans in either the labeled or the unlabeled part of the molecule. Except in the oxidation of D-mannitol-2-t, the competing reactions result in the formation of a mixture of D-fructoses, each having radioactivity in one of two different positions. Hence, the isotope effect, k*/ k,more » (where k* and k are, respectively, the rate constants for oxidation in the labeled and in the unlabeled part of the labeled emannitol molecule) is the ratio of the activities at the two positions of the product, D-fructose. The following isotope effects were found for the bacterial oxidation of labeled D-mannitols: for D-mannitol-2-C/sup 14/, k*/k = 0.93; for Dmannitol-2-t, k*/k = 0.23; and for D-mannitol-3-t, k*/k = 0.70. For D-mannitols labeled at other positions, no isotope effect was detected, since k*/k was unity. The large isotope effect for D-mannitol-2-t is indicative of rupture of the C2-H bond in the rate determining process. It is suggested that the secondary isotope effect for tritium at C3 indicates hyperconjugation of the C3 hydrogen atom in the activated enzyme-- substrate complex; the lack of such effect for tritium at C1 may be due to unfavorable steric conditions for hyperconjugation of the C1 hydrogen atoms in the complex. The following substances were prepared and their isotopic distributions determined: D-fructose1,6-C/sup 14/ and D-fructose-1,6-t (from 1- labeled D-mannitols); D-fructose-2,5-C/sup 14/ and D-fructose-5-t (from 2-labeled e-mannitols); and D-fructose-3,4-C/sup 14/ and D-fructose-3,4-t (from 3-labeled D- mannitols). A procedure, employing D-fructose-1,6-C/sup 14/ as an internal standard, was devised for the analysis of D-fructose-3,4-t. (auth)« less

  13. 9 CFR 317.9 - Labeling of equine products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of equine products. 317.9 Section 317.9 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY...

  14. Quantitative risk assessment of foods containing peanut advisory labeling.

    PubMed

    Remington, Benjamin C; Baumert, Joseph L; Marx, David B; Taylor, Steve L

    2013-12-01

    Foods with advisory labeling (i.e. "may contain") continue to be prevalent and the warning may be increasingly ignored by allergic consumers. We sought to determine the residual levels of peanut in various packaged foods bearing advisory labeling, compare similar data from 2005 and 2009, and determine any potential risk for peanut-allergic consumers. Of food products bearing advisory statements regarding peanut or products that had peanut listed as a minor ingredient, 8.6% and 37.5% contained detectable levels of peanut (>2.5 ppm whole peanut), respectively. Peanut-allergic individuals should be advised to avoid such products regardless of the wording of the advisory statement. Peanut was detected at similar rates and levels in products tested in both 2005 and 2009. Advisory labeled nutrition bars contained the highest levels of peanut and an additional market survey of 399 products was conducted. Probabilistic risk assessment showed the risk of a reaction to peanut-allergic consumers from advisory labeled nutrition bars was significant but brand-dependent. Peanut advisory labeling may be overused on some nutrition bars but prudently used on others. The probabilistic approach could provide the food industry with a quantitative method to assist with determining when advisory labeling is most appropriate. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. An Overview of Advanced SILAC-Labeling Strategies for Quantitative Proteomics.

    PubMed

    Terzi, F; Cambridge, S

    2017-01-01

    Comparative, quantitative mass spectrometry of proteins provides great insight to protein abundance and function, but some molecular characteristics related to protein dynamics are not so easily obtained. Because the metabolic incorporation of stable amino acid isotopes allows the extraction of distinct temporal and spatial aspects of protein dynamics, the SILAC methodology is uniquely suited to be adapted for advanced labeling strategies. New SILAC strategies have emerged that allow deeper foraging into the complexity of cellular proteomes. Here, we review a few advanced SILAC-labeling strategies that have been published during last the years. Among them, different subsaturating-labeling as well as dual-labeling schemes are most prominent for a range of analyses including those of neuronal proteomes, secretion, or cell-cell-induced stimulations. These recent developments suggest that much more information can be gained from proteomic analyses if the labeling strategies are specifically tailored toward the experimental design. © 2017 Elsevier Inc. All rights reserved.

  16. Use of phenyl/tetrazolyl-functionalized magnetic microspheres and stable isotope labeled internal standards for significant reduction of matrix effect in determination of nine fluoroquinolones by liquid chromatography-quadrupole linear ion trap mass spectrometry.

    PubMed

    Xu, Fei; Liu, Feng; Wang, Chaozhan; Wei, Yinmao

    2018-02-01

    In this study, the strategy of unique adsorbent combined with isotope labeled internal standards was used to significantly reduce the matrix effect for the enrichment and analysis of nine fluoroquinolones in a complex sample by liquid chromatography coupled to quadrupole linear ion trap mass spectrometry (LC-QqQ LIT -MS/MS). The adsorbent was prepared conveniently by functionalizing Fe 3 O 4 @SiO 2 microspheres with phenyl and tetrazolyl groups, which could adsorb fluoroquinolones selectively via hydrophobic, electrostatic, and π-π interactions. The established magnetic solid-phase extraction (MSPE) method as well as using stable isotope labeled internal standards in the next MS/MS detection was able to reduce the matrix effect significantly. In the process of LC-QqQ LIT -MS/MS analysis, the precursor and product ions of the analytes were monitored quantitatively and qualitatively on a QTrap system equipped simultaneously with the multiple reaction monitoring (MRM) and enhanced product ion (EPI) scan. Subsequently, the enrichment method combined with LC-QqQ LIT -MS/MS demonstrated good analytical features in terms of linearity (7.5-100.0 ng mL -1 , r > 0.9960), satisfactory recoveries (88.6%-118.3%) with RSDs < 12.0%, LODs = 0.5 μg kg -1 and LOQs = 1.5 μg kg -1 for all tested analytes. Finally, the developed MSPE-LC-QqQ LIT -MS/MS method had been successfully applied to real pork samples for food-safety risk monitoring in Ningxia Province, China. Graphical abstract Mechanism of reducing matrix effect through the as-prepared adsorbent.

  17. Measurement of gross photosynthesis, respiration in the light and mesophyll conductance in leaves using H218O labeling and high precision isotope ratio mass spectrometry

    NASA Astrophysics Data System (ADS)

    Griffin, K. L.; Gauthier, P. P.; Battle, M. O.; Bender, M. L.

    2016-12-01

    A fundamental challenge in plant physiology is independently determining the rates of gross O2 production by photosynthesis and O2 consumption by respiration, photorespiration, and other processes. Previous studies on isolated chloroplasts or leaves have separately constrained net and gross O2 production (NOP and GOP, respectively) by labeling ambient O2 with 18O while leaf water was unlabeled. Here, we introduce a new method to accurately measure GOP and NOP of whole detached leaves in a cuvette as a routine gas exchange measurement. The petiole is immersed in water enriched to a δ18O of 10,000‰, and the leaf is labeled through the transpiration stream. GOP is calculated from the increase in δ18O of O2 as air passes through the cuvette. NOP is determined from the increase in O2/N2. Both terms are measured by isotope ratio mass spectrometry. CO2 assimilation and other standard gas exchange parameters are also measured. Reproducible measurements are made on a single leaf for up to 15 hours. By investigating the light response curve of NOP and GOP in Phaseolus vulgaris, we found that respiration is inhibited in the light (Kok effect) when [O2]=21% but not when [O2]=2%. The ratio of NOP to net CO2 assimilation was 1.03 ± 0.01 for all leaves studied. Additionally, using GOP as a constraint, we determined chloroplastic [CO2], and we found that mesophyll conductance increases with light intensity. An extensive list of gas exchange properties is measured with this O2 method, making it a unique tool to study and understand leaf physiological traits and the biogeochemistry of carbon cycling.

  18. Impact of food labelling systems on food choices and eating behaviours: a systematic review and meta-analysis of randomized studies.

    PubMed

    Cecchini, M; Warin, L

    2016-03-01

    Food labels are considered a crucial component of strategies tackling unhealthy diets and obesity. This study aims at assessing the effectiveness of food labelling in increasing the selection of healthier products and in reducing calorie intake. In addition, this study compares the relative effectiveness of traffic light schemes, Guideline Daily Amount and other food labelling schemes. A comprehensive set of databases were searched to identify randomized studies. Studies reporting homogeneous outcomes were pooled together and analysed through meta-analyses. Publication bias was evaluated with a funnel plot. Food labelling would increase the amount of people selecting a healthier food product by about 17.95% (confidence interval: +11.24% to +24.66%). Food labelling would also decrease calorie intake/choice by about 3.59% (confidence interval: -8.90% to +1.72%), but results are not statistically significant. Traffic light schemes are marginally more effective in increasing the selection of healthier options. Other food labels and Guideline Daily Amount follow. The available evidence did not allow studying the effects of single labelling schemes on calorie intake/choice. Findings of this study suggest that nutrition labelling may be an effective approach to empowering consumers in choosing healthier products. Interpretive labels, as traffic light labels, may be more effective. © 2015 World Obesity.

  19. The role of appeals to tradition in origin food marketing. A survey among Polish consumers.

    PubMed

    Bryła, Paweł

    2015-08-01

    The frequency of the use of tradition in marketing is growing. Appealing to tradition reflects the need to have reference points, trust and stability. The perceived authenticity of a product is strongly connected with its origin, which is expressed by the factors of time (history), place (area), socialisation (local community) and naturalness (raw materials). The paper aims to examine consumer attitudes, preferences and behaviours regarding origin food in Poland. We carried out a survey in a representative sample of 1000 Polish consumers. According to our respondents, the characteristics differentiating origin food from conventional food include links with tradition as well as sensory and health properties. Referring to the typology proposed by van der Meulen, traditionality and territoriality are the most important characteristics of origin food. The perceived authenticity of origin products depends to the largest extent on such factors as: natural taste, product quality, sale in the region of origin and labelling. The most important determinants of origin food selection include: traditional recipe, taste, and product uniqueness. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. 9 CFR 590.955 - Labeling of shipping containers of eggs or egg products for importation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... eggs or egg products for importation. 590.955 Section 590.955 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.955 Labeling of shipping containers of eggs or egg...

  1. 9 CFR 381.205 - Labeling of immediate containers of poultry products offered for entry.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of immediate containers of poultry products offered for entry. 381.205 Section 381.205 Animals and Animal Products FOOD SAFETY AND...

  2. 9 CFR 381.206 - Labeling of shipping containers of poultry products offered for entry.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Labeling of shipping containers of poultry products offered for entry. 381.206 Section 381.206 Animals and Animal Products FOOD SAFETY AND...

  3. 9 CFR 590.955 - Labeling of shipping containers of eggs or egg products for importation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... eggs or egg products for importation. 590.955 Section 590.955 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Imports § 590.955 Labeling of shipping containers of eggs or egg...

  4. 5-a-day fruit and vegetable food product labels: reduced fruit and vegetable consumption following an exaggerated compared to a modest label.

    PubMed

    Appleton, K M; Pidgeon, H J

    2018-05-15

    Food product labels based on the WHO 5-a-day fruit and vegetable (FV) message are becoming increasingly common, but these labels may impact negatively on complementary or subsequent FV consumption. This study aimed to investigate the impact of a '3 of your 5-a-day' versus a '1 of your 5-a-day' smoothie product label on subsequent FV consumption. Using an acute experimental design, 194 participants (90 males, 104 females) were randomised to consume a smoothie labelled as either '3 of your 5-a-day' (N = 97) or '1 of your 5-a-day' (N = 97) in full, following a usual breakfast. Subsequent FV consumption was measured for the rest of the day using 24-h recall. Usual FV consumption was also assessed via 24-h recall for the day before the study. Regression analyses revealed a significantly lower subsequent FV consumption following smoothies displaying the '3 of your 5-a-day' label compared to the '1 of your 5-a-day' label (Beta = - 0.15, p = 0.04). Secondary analyses revealed these effects to be driven mainly by changes to consumption in usual high FV consumers, in females and in vegetable as opposed to fruit consumption. These findings demonstrate a role for label information in food intake, and the potential negative impacts of an exaggerated food product label on healthy food consumption and healthy dietary profiles.

  5. Comparison of Test Procedures and Energy Efficiency Criteria in Selected International Standards and Labeling Programs for Clothes Washers, Water Dispensers, Vending Machines and CFLs

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Fridley, David; Zheng, Nina; Zhou, Nan

    Since the late 1970s, energy labeling programs and mandatory energy performance standards have been used in many different countries to improve the efficiency levels of major residential and commercial equipment. As more countries and regions launch programs covering a greater range of products that are traded worldwide, greater attention has been given to harmonizing the specific efficiency criteria in these programs and the test methods for measurements. For example, an international compact fluorescent light (CFL) harmonization initiative was launched in 2006 to focus on collaboration between Australia, China, Europe and North America. Given the long history of standards and labelingmore » programs, most major energy-consuming residential appliances and commercial equipment are already covered under minimum energy performance standards (MEPS) and/or energy labels. For these products, such as clothes washers and CFLs, harmonization may still be possible when national MEPS or labeling thresholds are revised. Greater opportunity for harmonization exists in newer energy-consuming products that are not commonly regulated but are under consideration for new standards and labeling programs. This may include commercial products such as water dispensers and vending machines, which are only covered by MEPS or energy labels in a few countries or regions. As China continues to expand its appliance standards and labeling programs and revise existing standards and labels, it is important to learn from recent international experiences with efficiency criteria and test procedures for the same products. Specifically, various types of standards and labeling programs already exist in North America, Europe and throughout Asia for products in China's 2010 standards and labeling programs, namely clothes washers, water dispensers, vending machines and CFLs. This report thus examines similarities and critical differences in energy efficiency values, test procedure specifications and other technical performance requirements in existing international programs in order to shed light on where Chinese programs currently stands and considerations for their 2010 programs.« less

  6. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

  7. 9 CFR 381.409 - Nutrition label content.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

  8. 75 FR 82011 - Web-Distributed Labeling of Pesticides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ... with pesticide labeling, thereby improving protection of human health and the environment from risks... pesticide products will not pose unreasonable adverse effects to human health or the environment. EPA..., when EPA amends the labeling of a pesticide product to incorporate new protections for human health or...

  9. 16 CFR 305.13 - Labeling for ceiling fans.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ) Required Disclosures § 305.13 Labeling for ceiling fans. (a) Ceiling fans—(1) Content. Any covered product that is a...

  10. 16 CFR 305.13 - Labeling for ceiling fans.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ) Required Disclosures § 305.13 Labeling for ceiling fans. (a) Ceiling fans—(1) Content. Any covered product that is a...

  11. 16 CFR 305.13 - Labeling for ceiling fans.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ) Required Disclosures § 305.13 Labeling for ceiling fans. (a) Ceiling fans—(1) Content. Any covered product that is a...

  12. 16 CFR 305.13 - Labeling for ceiling fans.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CONCERNING DISCLOSURES REGARDING ENERGY CONSUMPTION AND WATER USE OF CERTAIN HOME APPLIANCES AND OTHER PRODUCTS REQUIRED UNDER THE ENERGY POLICY AND CONSERVATION ACT (âAPPLIANCE LABELING RULEâ) Required Disclosures § 305.13 Labeling for ceiling fans. (a) Ceiling fans—(1) Content. Any covered product that is a...

  13. 9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

  14. 9 CFR 590.680 - Approval of labeling for egg products processed in exempted egg products processing plants.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Approval of labeling for egg products processed in exempted egg products processing plants. 590.680 Section 590.680 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF...

  15. 16 CFR 1205.35 - Product certification and labeling by manufacturers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1205.35 Section 1205.35 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.35 Product...

  16. 16 CFR 1205.36 - Product certification and labeling by importers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by importers. 1205.36 Section 1205.36 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR WALK-BEHIND POWER LAWN MOWERS Certification § 1205.36 Product...

  17. An investigative model evaluating how consumers process pictorial information on nonprescription medication labels.

    PubMed

    Sansgiry, S S; Cady, P S

    1997-01-01

    Currently, marketed over-the-counter (OTC) medication labels were simulated and tested in a controlled environment to understand consumer evaluation of OTC label information. Two factors, consumers' age (younger and older adults) and label designs (picture-only, verbal-only, congruent picture-verbal, and noncongruent picture-verbal) were controlled and tested to evaluate consumer information processing. The effects exerted by the independent variables, namely, comprehension of label information (understanding) and product evaluations (satisfaction, certainty, and perceived confusion) were evaluated on the dependent variable purchase intention. Intention measured as purchase recommendation was significantly related to product evaluations and affected by the factor label design. Participants' level of perceived confusion was more important than actual understanding of information on OTC medication labels. A Label Evaluation Process Model was developed which could be used for future testing of OTC medication labels.

  18. Read the Label First: Protect Your Pets

    EPA Pesticide Factsheets

    Learn about the importance of reading pet products labels before purchasing and using any product to insure the safety of your pets. Find tips for ways to reduce the changes of pets accessing potentially dangerous products.

  19. Dietary Supplement Label Database (DSLD)

    MedlinePlus

    ... be an educational and research tool for students, academics, and other professionals. Disclaimer: All information contained in the Dietary Supplement Label Database (DSLD) comes from product labels. Label information has ...

  20. Tuning a Protein-Labeling Reaction to Achieve Highly Site Selective Lysine Conjugation.

    PubMed

    Pham, Grace H; Ou, Weijia; Bursulaya, Badry; DiDonato, Michael; Herath, Ananda; Jin, Yunho; Hao, Xueshi; Loren, Jon; Spraggon, Glen; Brock, Ansgar; Uno, Tetsuo; Geierstanger, Bernhard H; Cellitti, Susan E

    2018-04-16

    Activated esters are widely used to label proteins at lysine side chains and N termini. These reagents are useful for labeling virtually any protein, but robust reactivity toward primary amines generally precludes site-selective modification. In a unique case, fluorophenyl esters are shown to preferentially label human kappa antibodies at a single lysine (Lys188) within the light-chain constant domain. Neighboring residues His189 and Asp151 contribute to the accelerated rate of labeling at Lys188 relative to the ≈40 other lysine sites. Enriched Lys188 labeling can be enhanced from 50-70 % to >95 % by any of these approaches: lowering reaction temperature, applying flow chemistry, or mutagenesis of specific residues in the surrounding protein environment. Our results demonstrated that activated esters with fluoro-substituted aromatic leaving groups, including a fluoronaphthyl ester, can be generally useful reagents for site-selective lysine labeling of antibodies and other immunoglobulin-type proteins. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

  1. Evidence of the photosynthetic origin of monoterpenes emitted by quercus ilex L. leaves by {sup 13}C labeling

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Loreto, F.; Ciccioli, P.; Cecinato, A.

    1996-04-01

    The carbon of the four main monoterpenes emitted by Quercus ilex L. leaves was completely labeled with {sup 13}C after a 20-min feeding with 99% {sup 13}CO{sub 2}. This labeling time course is comparable with the labeling time course of isoprene, the terpenoid emitted by other Quercus species and synthesized in leaf chloroplasts. It is also comparable with that of phosphoglyceric acid. Our experiment therefore provides evidence that monoterpenes emitted by Q. ilex are formed photosynthesis intermediates and may share the same synthetic pathway with isoprene. By analyzing the rate and the distribution of labeling in the different fragments, wemore » looked for evidence of differential carbon labeling in the {alpha}-pinene emitted. However, the labeling pattern was quite uniform in the different fragments, suggesting that the carbon skeleton of the emitted monoterpenes comes from a unique carbon source. 16 refs., 3 figs., 1 tab.« less

  2. The efficacy of sugar labeling formats: Implications for labeling policy.

    PubMed

    Vanderlee, Lana; White, Christine M; Bordes, Isabelle; Hobin, Erin P; Hammond, David

    2015-12-01

    To examine knowledge of sugar recommendations and test the efficacy of formats for labeling total and added sugar on pre-packaged foods. Online surveys were conducted among 2008 Canadians aged 16-24. Participants were asked to identify recommended limits for total and added sugar consumption. In Experiment 1, participants were randomized to one of six labeling conditions with varying information for total sugar for a high- or low-sugar product and were asked to identify the relative amount of total sugar in the product. In Experiment 2, participants were randomized to one of three labels with different added sugar formats and were asked if the product contained added sugar and the relative amount of added sugar. Few young people correctly identified recommendations for total sugar (5%) or added sugar (7%). In Experiment 1, those who were shown percent daily value information were more likely to correctly identify the relative amount of total sugar (P < 0.05). In Experiment 2, those shown added sugar information were more likely to correctly identify that the product contained added sugar and the relative amount of added sugar in the product (P < 0.05). Improved labeling may improve consumer understanding of the amount of sugars in food products. © 2015 The Obesity Society.

  3. Use of DNA barcoding to reveal species composition of convenience seafood.

    PubMed

    Huxley-Jones, Elizabeth; Shaw, Jennifer L A; Fletcher, Carly; Parnell, Juliette; Watts, Phillip C

    2012-04-01

    Increased education of consumers can be an effective tool for conservation of commercially harvested marine species when product labeling is accurate and allows an informed choice. However, generic labeling (e.g., as white fish or surimi) and mislabeling of seafood prevents this and may erode consumer confidence in seafood product labels in general. We used DNA barcoding to identify the species composition of two types of convenience seafood (i.e., products processed for ease of consumption): fish fingers (long pieces of fish covered with bread crumbs or batter, n = 241) and seafood sticks (long pieces of cooked fish, n = 30). In products labeled as either white fish or surimi, four teleost species were present. Less than 1.5% of fish fingers with species-specific information were mislabeled. Results of other studies show substantially more mislabeling (e.g., >25%) of teleost products, which likely reflects the lower economic gains associated with mislabeling of convenience seafood compared with whole fillets. In addition to species identification, seafood product labels should be required to contain information about, for example, harvesting practices, and our data indicate that consumers can have reasonable confidence in the accuracy of the labels of convenience seafood and thus select brands on the basis of information about current fisheries practice. ©2012 Society for Conservation Biology.

  4. 16 CFR 305.16 - Labeling and marking for plumbing products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CONGRESS ENERGY AND WATER USE LABELING FOR CONSUMER PRODUCTS UNDER THE ENERGY POLICY AND CONSERVATION ACT... estimated annual operating costs of covered showerheads, faucets, water closets, and urinals or ranges of...) Showerheads and faucets. Showerheads and faucets shall be marked and labeled as follows: (1) Each showerhead...

  5. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

  6. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

  7. 21 CFR 610.67 - Bar code label requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

  8. 16 CFR § 1500.133 - Extremely flammable contact adhesives; labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Extremely flammable contact adhesives; labeling. § 1500.133 Section § 1500.133 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL...

  9. 27 CFR 19.493 - Caution label for completely denatured alcohol.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Caution label for completely denatured alcohol. 19.493 Section 19.493 Alcohol, Tobacco Products and Firearms ALCOHOL AND... Marks Marking Requirements for Spirits § 19.493 Caution label for completely denatured alcohol. A...

  10. 16 CFR 300.7 - English language requirement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false English language requirement. 300.7 Section... AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.7 English language..., shall appear in the English language. If the product bears any stamp, tag, label, or mark of...

  11. 16 CFR 300.7 - English language requirement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false English language requirement. 300.7 Section... AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.7 English language..., shall appear in the English language. If the product bears any stamp, tag, label, or mark of...

  12. 7 CFR 58.58 - Debarment of service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... any application for any inspection or grading service, appeal reinspection, or regrading service; (ii... “Government graded,” or terms of similar import in the labeling or advertising of any product without stating... aforesaid terms or an official stamp, label, or identification in the labeling or advertising of any product...

  13. Rapid kinetic characterization of glycosyl hydrolases based on oxime derivatization and nanostructure-initiator mass spectrometry (NIMS).

    PubMed

    Deng, Kai; Takasuka, Taichi E; Heins, Richard; Cheng, Xiaoliang; Bergeman, Lai F; Shi, Jian; Aschenbrener, Ryan; Deutsch, Sam; Singh, Seema; Sale, Kenneth L; Simmons, Blake A; Adams, Paul D; Singh, Anup K; Fox, Brian G; Northen, Trent R

    2014-07-18

    Glycoside hydrolases (GHs) are critical to cycling of plant biomass in the environment, digestion of complex polysaccharides by the human gut microbiome, and industrial activities such as deployment of cellulosic biofuels. High-throughput sequencing methods show tremendous sequence diversity among GHs, yet relatively few examples from the over 150,000 unique domain arrangements containing GHs have been functionally characterized. Here, we show how cell-free expression, bioconjugate chemistry, and surface-based mass spectrometry can be used to study glycoside hydrolase reactions with plant biomass. Detection of soluble products is achieved by coupling a unique chemical probe to the reducing end of oligosaccharides in a stable oxime linkage, while the use of (13)C-labeled monosaccharide standards (xylose and glucose) allows quantitation of the derivatized glycans. We apply this oxime-based nanostructure-initiator mass spectrometry (NIMS) method to characterize the functional diversity of GHs secreted by Clostridium thermocellum, a model cellulolytic organism. New reaction specificities are identified, and differences in rates and yields of individual enzymes are demonstrated in reactions with biomass substrates. Numerical analyses of time series data suggests that synergistic combinations of mono- and multifunctional GHs can decrease the complexity of enzymes needed for the hydrolysis of plant biomass during the production of biofuels.

  14. Electron Transfer Dissociation of iTRAQ Labeled Peptide Ions

    PubMed Central

    Han, Hongling; Pappin, Darryl J.; Ross, Philip L; McLuckey, Scott A.

    2009-01-01

    Triply and doubly charged iTRAQ (isobaric tagging for relative and absolute quantitation) labeled peptide cations from a tryptic peptide mixture of bovine carbonic anhydrase II were subjected to electron transfer ion/ion reactions to investigate the effect of charge bearing modifications associated with iTRAQ on the fragmentation pattern. It was noted that electron transfer dissociation (ETD) of triply charged or activated ETD (ETD + supplemental collisional activation of intact electron transfer species) of doubly charged iTRAQ tagged peptide ions yielded extensive sequence information, in analogy with ETD of unmodified peptide ions. That is, addition of the fixed charge iTRAQ tag showed relatively little deleterious effect on the ETD performance of the modified peptides. ETD of the triply charged iTRAQ labeled peptide ions followed by collision-induced dissociation (CID) of the product ion at m/z 162 yielded the reporter ion at m/z 116, which is the reporter ion used for quantitation via CID of the same precursor ions. The reporter ion formed via the two-step activation process is expected to provide quantitative information similar to that directly produced from CID. A 103 Da neutral loss species observed in the ETD spectra of all the triply and doubly charged iTRAQ labeled peptide ions is unique to the 116 Da iTRAQ reagent, which implies that this process also has potential for quantitation of peptides/proteins. Therefore, ETD with or without supplemental collisional activation, depending on the precursor ion charge state, has the potential to directly identify and quantify the peptides/proteins simultaneously using existing iTRAQ reagents. PMID:18646790

  15. Efficient Thread Labeling for Monitoring Programs with Nested Parallelism

    NASA Astrophysics Data System (ADS)

    Ha, Ok-Kyoon; Kim, Sun-Sook; Jun, Yong-Kee

    It is difficult and cumbersome to detect data races occurred in an execution of parallel programs. Any on-the-fly race detection techniques using Lamport's happened-before relation needs a thread labeling scheme for generating unique identifiers which maintain logical concurrency information for the parallel threads. NR labeling is an efficient thread labeling scheme for the fork-join program model with nested parallelism, because its efficiency depends only on the nesting depth for every fork and join operation. This paper presents an improved NR labeling, called e-NR labeling, in which every thread generates its label by inheriting the pointer to its ancestor list from the parent threads or by updating the pointer in a constant amount of time and space. This labeling is more efficient than the NR labeling, because its efficiency does not depend on the nesting depth for every fork and join operation. Some experiments were performed with OpenMP programs having nesting depths of three or four and maximum parallelisms varying from 10,000 to 1,000,000. The results show that e-NR is 5 times faster than NR labeling and 4.3 times faster than OS labeling in the average time for creating and maintaining the thread labels. In average space required for labeling, it is 3.5 times smaller than NR labeling and 3 times smaller than OS labeling.

  16. Trends in added sugars from packaged beverages available and purchased by US households, 2007-2012.

    PubMed

    Ng, Shu Wen; Ostrowski, Jessica D; Li, Kuo-Ping

    2017-07-01

    Background: The US Food and Drug Administration's updated nutrition labeling requirements will include added sugars starting in July 2018, but no measure currently exists to identify the added sugar content of products and what it represents among purchases. Beverages are one of the first targets for reducing added sugar consumption, and hence are the focus here. Objective: Our goal was to estimate trends in added sugars in nonalcoholic packaged beverage products available in the United States and to estimate amounts of added sugars obtained from these beverages given the purchases of US households overall and by subpopulations. Design: On the basis of nutrition label data from multiple sources, we used a stepwise approach to derive the added sugar content of 160,713 beverage products recorded as purchased by US households in 2007-2012 (345,193 observations from 110,539 unique households). We estimated the amounts of added sugars obtained from packaged beverages US households reported buying in 2007-2008, 2009-2010, and 2011-2012, overall and by subpopulations based on household composition, race/ethnicity, and income. The key outcomes are added sugars in terms of per capita grams per day and the percentage of calories from packaged beverages. Results: Packaged beverages alone account for per capita consumption of 12 g/d of added sugars purchased by US households in 2007-2012, representing 32-48% of calories from packaged beverages. Whereas the absolute amount of added sugars from beverages has not changed meaningfully over time, the relative contribution of added sugars to calories from beverages has increased. Non-Hispanic black households and low-income households obtain both higher absolute and relative amounts of added sugars from beverages than non-Hispanic white households and high-income households (all P < 0.01). Conclusions: These results provide measures of added sugars from packaged beverages at both the product level and the population level in the United States and can be used for comparisons after the revised nutrition labels are implemented and for future monitoring. © 2017 American Society for Nutrition.

  17. Mobile Application for Pesticide Label Matching

    EPA Pesticide Factsheets

    The label matching application will give inspectors the ability to instantly compare pesticide product labels against state and federal label databases via their cell phone, tablet or other mobile device.

  18. Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet.

    PubMed

    Van Wagoner, Ryan M; Eichner, Amy; Bhasin, Shalender; Deuster, Patricia A; Eichner, Daniel

    2017-11-28

    Recent reports have described the increasing use of nonsteroidal selective androgen receptor modulators, which have not been approved by the US Food and Drug Administration (FDA), to enhance appearance and performance. The composition and purity of such products is not known. To determine the chemical identity and the amounts of ingredients in dietary supplements and products marketed and sold through the internet as selective androgen receptor modulators and compare the analyzed contents with product labels. Web-based searches were performed from February 18, 2016, to March 25, 2016, using the Google search engine on the Chrome and Internet Explorer web browsers to identify suppliers selling selective androgen receptor modulators. The products were purchased and the identities of the compounds and their amounts were determined from April to August 2016 using chain-of-custody and World Anti-Doping Association-approved analytical procedures. Analytical findings were compared against the label information. Products marketed and sold as selective androgen receptor modulators. Chemical identities and the amount of ingredients in each product marketed and sold as selective androgen receptor modulators. Among 44 products marketed and sold as selective androgen receptor modulators, only 23 (52%) contained 1 or more selective androgen receptor modulators (Ostarine, LGD-4033, or Andarine). An additional 17 products (39%) contained another unapproved drug, including the growth hormone secretagogue ibutamoren, the peroxisome proliferator-activated receptor-δ agonist GW501516, and the Rev-ErbA agonist SR9009. Of the 44 tested products, no active compound was detected in 4 (9%) and substances not listed on the label were contained in 11 (25%). In only 18 of the 44 products (41%), the amount of active compound in the product matched that listed on the label. The amount of the compounds listed on the label differed substantially from that found by analysis in 26 of 44 products (59%). In this limited investigation involving chemical analyses of 44 products marketed as selective androgen receptor modulators and sold via the internet, most products contained unapproved drugs and substances. Only 52% contained selective androgen receptor modulators and many were inaccurately labeled.

  19. Read the Label First! Protect Your Household

    MedlinePlus

    ... as directed on the label. ✔ Keep Products in Original Containers • It is very dangerous to put products ... about the product. • If you throw away the original container, you throw away important information needed in ...

  20. Enhancement of the MODIS Snow and Ice Product Suite Utilizing Image Segmentation

    NASA Technical Reports Server (NTRS)

    Tilton, James C.; Hall, Dorothy K.; Riggs, George A.

    2006-01-01

    A problem has been noticed with the current NODIS Snow and Ice Product in that fringes of certain snow fields are labeled as "cloud" whereas close inspection of the data indicates that the correct labeling is a non-cloud category such as snow or land. This occurs because the current MODIS Snow and Ice Product generation algorithm relies solely on the MODIS Cloud Mask Product for the labeling of image pixels as cloud. It is proposed here that information obtained from image segmentation can be used to determine when it is appropriate to override the cloud indication from the cloud mask product. Initial tests show that this approach can significantly reduce the cloud "fringing" in modified snow cover labeling. More comprehensive testing is required to determine whether or not this approach consistently improves the accuracy of the snow and ice product.

  1. System and method for representing and manipulating three-dimensional objects on massively parallel architectures

    DOEpatents

    Karasick, M.S.; Strip, D.R.

    1996-01-30

    A parallel computing system is described that comprises a plurality of uniquely labeled, parallel processors, each processor capable of modeling a three-dimensional object that includes a plurality of vertices, faces and edges. The system comprises a front-end processor for issuing a modeling command to the parallel processors, relating to a three-dimensional object. Each parallel processor, in response to the command and through the use of its own unique label, creates a directed-edge (d-edge) data structure that uniquely relates an edge of the three-dimensional object to one face of the object. Each d-edge data structure at least includes vertex descriptions of the edge and a description of the one face. As a result, each processor, in response to the modeling command, operates upon a small component of the model and generates results, in parallel with all other processors, without the need for processor-to-processor intercommunication. 8 figs.

  2. 21 CFR 201.72 - Potassium labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Potassium labeling. 201.72 Section 201.72 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.72 Potassium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content...

  3. 21 CFR 201.72 - Potassium labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Potassium labeling. 201.72 Section 201.72 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.72 Potassium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content...

  4. 21 CFR 201.72 - Potassium labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Potassium labeling. 201.72 Section 201.72 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.72 Potassium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content...

  5. "Warning: This image has been digitally altered": The effect of disclaimer labels added to fashion magazine shoots on women's body dissatisfaction.

    PubMed

    Tiggemann, Marika; Brown, Zoe; Zaccardo, Mia; Thomas, Nicole

    2017-06-01

    The present experiment aimed to investigate the impact of the addition of disclaimer labels to fashion magazine shoots on women's body dissatisfaction. Participants were 320 female undergraduate students who viewed fashion shoots containing a thin and attractive model with no disclaimer label, or a small, large, or very large disclaimer label, or product images. Although thin-ideal fashion shoot images resulted in greater body dissatisfaction than product images, there was no significant effect of disclaimer label. Internalisation of the thin ideal was found to moderate the effect of disclaimer label, such that internalisation predicted increased body dissatisfaction in the no label and small label conditions, but not in the larger label conditions. Overall, the results showed no benefit for any size of disclaimer label in ameliorating the negative effect of viewing thin-ideal media images. It was concluded that more extensive research is required before the effective implementation of disclaimer labels. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. High-level production of C-11-carboxyl-labeled amino acids. [For use in tumor and pancreatic imaging

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Washburn, L. C.; Sun, T. T.; Byrd, B. L.

    Carbon-11-labeled amino acids have significant potential as agents for positron tomographic functional imaging. We have developed a rapid, high-temperature, high-pressure modification of the Buecherer--Strecker amino acid synthesis and found it to be quite general for the production of C-11-carboxyl-labeled neutral amino acids. Production of C-11-carboxyl-labeled DL-tryptophan requires certain modifications in the procedure. Twelve different amino acids have been produced to date by this technique. Synthesis and chromatographic purification require approximately 40 min, and C-11-carboxyl-labeled amino acids have been produced in yields of up to 425 mCi. Two C-11-carboxyl-labeled amino acids are being investigated clinically for tumor scanning and two othersmore » for pancreatic imaging. Over 120 batches of the various agents have been produced for clinical use over a three-year period.« less

  7. 16 CFR 300.26 - Pile fabrics and products composed thereof.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Pile fabrics and products composed thereof... CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.26 Pile fabrics and products composed thereof. The fiber content of pile fabrics or products made thereof may be...

  8. Direct fluorescent-dye labeling of α-tubulin in mammalian cells for live cell and superresolution imaging

    PubMed Central

    Schvartz, Tomer; Aloush, Noa; Goliand, Inna; Segal, Inbar; Nachmias, Dikla; Arbely, Eyal; Elia, Natalie

    2017-01-01

    Genetic code expansion and bioorthogonal labeling provide for the first time a way for direct, site-specific labeling of proteins with fluorescent-dyes in live cells. Although the small size and superb photophysical parameters of fluorescent-dyes offer unique advantages for high-resolution microscopy, this approach has yet to be embraced as a tool in live cell imaging. Here we evaluated the feasibility of this approach by applying it for α-tubulin labeling. After a series of calibrations, we site-specifically labeled α-tubulin with silicon rhodamine (SiR) in live mammalian cells in an efficient and robust manner. SiR-labeled tubulin successfully incorporated into endogenous microtubules at high density, enabling video recording of microtubule dynamics in interphase and mitotic cells. Applying this labeling approach to structured illumination microscopy resulted in an increase in resolution, highlighting the advantages in using a smaller, brighter tag. Therefore, using our optimized assay, genetic code expansion provides an attractive tool for labeling proteins with a minimal, bright tag in quantitative high-resolution imaging. PMID:28835375

  9. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule.

    PubMed

    2014-12-04

    The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.

  10. An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making

    PubMed Central

    Abedtash, Hamed; Duke, Jon D.

    2015-01-01

    FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the ‘signal-to-noise ratio’ and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label. PMID:26958158

  11. An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making.

    PubMed

    Abedtash, Hamed; Duke, Jon D

    FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the 'signal-to-noise ratio' and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label.

  12. Influence of label information on dark chocolate acceptability.

    PubMed

    Torres-Moreno, M; Tarrega, A; Torrescasana, E; Blanch, C

    2012-04-01

    The aim of the present work was to study how the information on product labels influences consumer expectations and their acceptance and purchase intention of dark chocolate. Six samples of dark chocolate, varying in brand (premium and store brand) and in type of product (regular dark chocolate, single cocoa origin dark chocolate and high percentage of cocoa dark chocolate), were evaluated by 109 consumers who scored their liking and purchase intention under three conditions: blind (only tasting the products), expected (observing product label information) and informed (tasting the products together with provision of the label information). In the expected condition, consumer liking was mainly affected by the brand. In the blind condition, differences in liking were due to the type of product; the samples with a high percentage of cocoa were those less preferred by consumers. Under the informed condition, liking of dark chocolates varied depending on both brand and type of product. Premium brand chocolates generated high consumer expectations of chocolate acceptability, which were fulfilled by the sensory characteristics of the products. Store brand chocolates created lower expectations, but when they were tasted they were as acceptable as premium chocolates. Claims of a high percentage of cocoa and single cocoa origin on labels did not generate higher expectations than regular dark chocolates. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Evaluation of Consumer Understanding of Different Front-of-Package Nutrition Labels, 2010–2011

    PubMed Central

    Bragg, Marie A.; Seamans, Marissa J.; Mechulan, Regine L.; Novak, Nicole; Brownell, Kelly D.

    2012-01-01

    Introduction Governments throughout the world are using or considering various front-of-package (FOP) food labeling systems to provide nutrition information to consumers. Our web-based study tested consumer understanding of different FOP labeling systems. Methods Adult participants (N = 480) were randomized to 1 of 5 groups to evaluate FOP labels: 1) no label; 2) multiple traffic light (MTL); 3) MTL plus daily caloric requirement icon (MTL+caloric intake); 4) traffic light with specific nutrients to limit based on food category (TL+SNL); or 5) the Choices logo. Total percentage correct quiz scores were created reflecting participants’ ability to select the healthier of 2 foods and estimate amounts of saturated fat, sugar, and sodium in foods. Participants also rated products on taste, healthfulness, and how likely they were to purchase the product. Quiz scores and product perceptions were compared with 1-way analysis of variance followed by post-hoc Tukey tests. Results The MTL+caloric intake group (mean [standard deviation], 73.3% [6.9%]) and Choices group (72.5% [13.2%]) significantly outperformed the no label group (67.8% [10.3%]) and the TL+SNL group (65.8% [7.3%]) in selecting the more healthful product on the healthier product quiz. The MTL and MTL+caloric intake groups achieved average scores of more than 90% on the saturated fat, sugar, and sodium quizzes, which were significantly better than the no label and Choices group average scores, which were between 34% and 47%. Conclusion An MTL+caloric intake label and the Choices symbol hold promise as FOP labeling systems and require further testing in different environments and population subgroups. PMID:22995103

  14. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  15. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  16. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  17. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  18. 78 FR 4153 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-18

    ...; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION... dietary supplements to notify us that they are marketing a dietary supplement product that bears on its... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a...

  19. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  20. 27 CFR 20.147 - Labels on consumer-size containers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Labels on consumer-size containers. 20.147 Section 20.147 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... of Completely Denatured Alcohol § 20.147 Labels on consumer-size containers. (a) Each consumer-size...

  1. School Foodservice Personnel's Struggle with Using Labels to Identify Whole-Grain Foods

    ERIC Educational Resources Information Center

    Chu, Yen Li; Orsted, Mary; Marquart, Len; Reicks, Marla

    2012-01-01

    Objective: To describe how school foodservice personnel use current labeling methods to identify whole-grain products and the influence on purchasing for school meals. Methods: Focus groups explored labeling methods to identify whole-grain products and barriers to incorporating whole-grain foods in school meals. Qualitative analysis procedures and…

  2. 27 CFR 4.23 - Varietal (grape type) labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Varietal (grape type) labeling. 4.23 Section 4.23 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU... Varietal (grape type) labeling. (a) General. The names of one or more grape varieties may be used as the...

  3. 9 CFR 381.128 - Labels in foreign languages.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labels in foreign languages. 381.128... in foreign languages. Any label to be affixed to a container of any dressed poultry or other poultry product for foreign commerce may be printed in a foreign language. However, the official inspection legend...

  4. 27 CFR 20.147 - Labels on consumer-size containers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2011-04-01 2011-04-01 false Labels on consumer-size containers. 20.147 Section 20.147 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE... of Completely Denatured Alcohol § 20.147 Labels on consumer-size containers. (a) Each consumer-size...

  5. Discrepancy between the composition of some commercial cat foods and their package labelling and suitability for meeting nutritional requirements.

    PubMed

    Gosper, E C; Raubenheimer, D; Machovsky-Capuska, G E; Chaves, A V

    2016-01-01

    To investigate if the label information and nutrient composition of commercial cat foods are accurate and compliant with the Australian Standard (AS 5812-2011) and if they meet the nutritional requirements of an adult cat. A chemical analysis of 10 wet and 10 dry commercial cat foods labelled as 'nutritionally complete' for the adult cat was performed. The results were compared with the package composition values, the Australian Standard and the unique dietary requirements of the cat. In addition, the results of the chemical analysis were compared with the nutrient requirements published by the Association of the American Feed Control Officials and the National Research Council. When compared with the Australian Standard, 9 of the 20 cat foods did not adhere to their 'guaranteed analysis' and 8 did not adhere to the standards for nutrient composition. Also, various deficiencies and excesses of crude protein, crude fat, fatty acid and amino acid were observed in the majority of the cat foods. The results of this study highlight a need for an improved method of ensuring that label information and nutrient composition are accurate and comply with the Australian Standard (AS 5812-2011) to ensure the adult cat's unique dietary requirements are being met by commercial adult cat food. © 2016 Australian Veterinary Association.

  6. [Research on the marketing status of antimicrobial products and the use of antimicrobial agents indicated on product labels from 1991 through 2005].

    PubMed

    Nakashima, Harunobu; Miyano, Naoko; Matsunaga, Ichiro; Nakashima, Naomi; Kaniwa, Masa-aki

    2007-05-01

    To clarify the marketing status of antimicrobial products, descriptions on the labels of commercially available antimicrobial products were investigated from 1991 through 2005, and the results were analyzed using a database system on antimicrobial deodorant agents. A classification table of household antimicrobial products was prepared and revised, based on which target products were reviewed for any changes in the product type. The number of antimicrobial products markedly increased over 3 years starting from 1996, among which there were many products apparently not requiring antimicrobial processing. More recently, in the 2002 and 2004 surveys, while sales of kitchenware and daily necessities decreased, chemical products, baby articles, and articles for pets increased; this poses new problems. To clarify the use of antimicrobial agents in the target products, a 3-step (large, intermediate, small) classification table of antimicrobial agents was also prepared, based on which antimicrobial agents indicated on the product labels were checked. The rate of identifying the agents increased. However, this is because of the increase of chemical products and baby articles, both of which more frequently indicated the ingredient agents on the labels, and the decrease of kitchenware and daily necessities, which less frequently indicated them on the labels. Therefore there has been little change in the actual identification rate. The agents used are characterized by product types: quaternary ammonium salts, metal salts, and organic antimicrobials are commonly used in textiles, plastics, and chemical products, respectively. Since the use of natural organic agents has recently increased, the safety of these agents should be evaluated.

  7. Effectiveness of Front-Of-Pack Nutrition Labels in French Adults: Results from the NutriNet-Santé Cohort Study

    PubMed Central

    Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold; Hercberg, Serge; Péneau, Sandrine

    2015-01-01

    Background To date, no consensus has emerged on the most appropriate front-of-pack (FOP) nutrition label to help consumers in making informed choices. We aimed to compare the effectiveness of the label formats currently in use: nutrient-specific, graded and simple summary systems, in a large sample of adults. Methods The FOP label effectiveness was assessed by measuring the label acceptability and understanding among 13,578 participants of the NutriNet-Santé cohort study, representative of the French adult population. Participants were exposed to five conditions, including four FOP labels: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), and a “no label” condition. Acceptability was evaluated by several indicators: attractiveness, liking and perceived cognitive workload. Objective understanding was assessed by the percentage of correct answers when ranking three products according to their nutritional quality. Five different product categories were tested: prepared fish dishes, pizzas, dairy products, breakfast cereals, and appetizers. Differences among the label effectiveness were compared with chi-square tests. Results The 5-CNL was viewed as the easiest label to identify and as the one requiring the lowest amount of effort and time to understand. GDA was considered as the least easy to identify and to understand, despite being the most attractive and liked label. All FOP labels were found to be effective in ranking products according to their nutritional quality compared with the “no label” situation, although they showed differing levels of effectiveness (p<0.0001). Globally, the 5-CNL performed best, followed by MTL, GDA and Tick labels. Conclusions The graded 5-CNL label was considered as easy to identify, simple and rapid to understand; it performed well when comparing the products’ nutritional quality. Therefore, it is likely to present advantages in real shopping situations where choices are usually made quickly. PMID:26509679

  8. Labels, Gender-Role Conflict, Stigma, and Attitudes Toward Seeking Psychological Help in Men.

    PubMed

    Wahto, Rachel; Swift, Joshua K

    2016-05-01

    Despite a comparable need, research has indicated that on average men hold more negative attitudes toward psychological help seeking than women. Several researchers have suggested that the gender gap in service use and attitudes could be addressed through efforts to better market psychological services to men; however, a limited number of studies have tested this hypothesis. This study examined whether altering the labels for mental health providers (psychologist or counselor), settings (mental health clinic or counseling center), and treatments (problem or feeling focused) could result in less perceived stigma (social and self) by men. Participants, 165 male college students, were asked to read one of eight randomly assigned vignettes that described a man who was experiencing symptoms of depression and was considering seeking help. The vignettes differed in the labels that were used to describe the help that was being considered. Participants then completed measures assessing the stigma (self and social) associated with the treatment, and their preexisting experience of gender-role conflict and attitudes toward psychological help seeking. In summary, perceived stigma did not depend on the type of label that was used; however, 59% of the variance in attitudes was predicted by self-stigma (uniquely explaining 11%), gender-role conflict (uniquely explaining 10%), and social stigma (uniquely explaining 5%). Specifically, higher levels of gender-role conflict, social stigma, and self-stigma were associated with more negative attitudes toward psychological help seeking. Based on the demographics of the sample, these findings primarily have implications for Caucasian college-educated young adult men. Further limitations with the study and recommendations for future research are discussed. © The Author(s) 2014.

  9. Using the Structured Product Labeling format to index versatile chemical data (ACS Spring meeting)

    EPA Science Inventory

    Structured Product Labeling (SPL) is a document markup standard approved by the Health Level Seven (HL7) standards organization and adopted by the FDA as a mechanism for exchanging product and facility information. Product information provided by companies in SPL format may be ac...

  10. 9 CFR 381.132 - Labeling approval.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Labeling approval. 381.132 Section 381.132 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION...

  11. 9 CFR 381.133 - Generically approved labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Generically approved labeling. 381.133 Section 381.133 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCT...

  12. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and...

  13. Inferring glacial flow pathways with DNA-labelled microparticle tracers at the Wolverine Glacier in Alaska

    NASA Astrophysics Data System (ADS)

    McNew, Coy; Dahlke, Helen; O'Neel, Shad; McLaughlin, Seanna

    2017-04-01

    Though recent advances have been made in the understanding of glacial hydrologic pathways, accurate predictions and descriptions of glacial hydrologic processes remain a challenge. The most common method to investigate subglacial pathways tends to be dye tracing. Due to the limited number of unique dye tracers, the photodegradability of some, and the typically long breakthrough times associated with such pathways, dye tracing experiments tend to be restricted to only a few injections, and therefore the contribution of only a few pathways can be investigated at a time. Five uniquely DNA-labelled microparticle tracers were injected in five different locations throughout the Wolverine Glacier ablation zone, one of two "benchmark glaciers" in Alaska and the subject of long term study by the United States Geological Survey. Stream water was sampled several hundred meters downstream at regular intervals and later analyzed for the presence of each tracer. Since each tracer was tagged with a unique sequence of DNA, the contribution of each to the total outflow can be quantified independently. Preliminary results indicate relatively short transit times, suggesting that the ablation zone is characterized by a high-volume (low pressure) subglacial hydrologic network (i.e. conduits). Here we present the results of the study, the challenges faced, and a discussion on the potential of the DNA-labelled microtracer technology.

  14. Status of China's Energy Efficiency Standards and Labels for Appliances and International Collaboration

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Zhou, Nan

    2008-03-01

    China first adopted minimum energy performance standards (MEPS) in 1989. Today, there are standards for a wide range of domestic, commercial and selected industrial equipment. In 1999, China launched a voluntary endorsement label, which has grown to cover over 40 products including water-saving products (See Figure 1). Further, in 2005, China started a mandatory energy information label (also referred to as the 'Energy Label'). Today, the Energy Label is applied to four products including: air conditioners; household refrigerators; clothes washers; and unitary air conditioners (See Figure 2). MEPS and the voluntary endorsement labeling specifications have been updated and revised inmore » order to reflect technology improvements to those products in the market. These programs have had an important impact in reducing energy consumption of appliances in China. Indeed, China has built up a strong infrastructure to develop and implement product standards. Historically, however, the government's primary focus has been on the technical requirements for efficiency performance. Less attention has been paid to monitoring and enforcement with a minimal commitment of resources and little expansion of administrative capacity in this area. Thus, market compliance with both mandatory standards and labeling programs has been questionable and actual energy savings may have been undermined as a result. The establishment of a regularized monitoring system for tracking compliance with the mandatory standard and energy information label in China is a major area for program improvement. Over the years, the Collaborative Labeling and Appliance Standards Program (CLASP) has partnered with several Chinese institutions to promote energy-efficient products in China. CLASP, together with its implementing partner Lawrence Berkeley National Laboratory (LBNL), has assisted China in developing and updating the above-mentioned standards and labeling programs. Because of the increasing need for the development of a monitoring system to track compliance with standards and labeling, CLASP, with support from Japan's Ministry of Economy, Trade and Industry (METI), has expanded its ongoing collaboration with the China National Institute of Standards (CNIS) to include enforcement and monitoring. CNIS has already begun working on the issue of compliance. CNIS has conducted modest sample testing in 2006 for refrigerators, freezers and room air-conditioners, and repeated the same task in 2007 with a similar sample size for three products (refrigerators, freezers, air-conditioners and clothes washers). And, CNIS, with technical support from LBNL, has analyzed the data collected through testing. At the same time, parallel effort has also been paid to look at the potential impact of the label to 2020. In conjunction with CNIS, CLASP technical experts reviewed the standards development timeline of the four products currently subject to the mandatory energy information label. CLASP, with the support of METI/IEEJ, collaborated with CNIS to develop the efficiency grades, providing: technical input to the process; comment and advice on particular technical issues; as well as evaluation of the results. In addition, in order to effectively evaluate the impact of the label on China's market, CLASP further provided assistance to CNIS to collect data on both the efficiency distribution and product volume distribution of refrigerators on the market. This short report summarizes the status of Standards and Labeling program, current enforcement and monitoring mechanism in China, and states the importance of international collaborations.« less

  15. 21 CFR 500.51 - Labeling of animal drugs; misbranding.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Labeling of animal drugs; misbranding. 500.51... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Animal Drug Labeling Requirements § 500.51 Labeling of animal drugs; misbranding. (a) Among the representations on the label or labeling of an animal...

  16. 21 CFR 500.51 - Labeling of animal drugs; misbranding.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Labeling of animal drugs; misbranding. 500.51... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Animal Drug Labeling Requirements § 500.51 Labeling of animal drugs; misbranding. (a) Among the representations on the label or labeling of an animal...

  17. 21 CFR 500.51 - Labeling of animal drugs; misbranding.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Labeling of animal drugs; misbranding. 500.51... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Animal Drug Labeling Requirements § 500.51 Labeling of animal drugs; misbranding. (a) Among the representations on the label or labeling of an animal...

  18. 21 CFR 500.51 - Labeling of animal drugs; misbranding.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Labeling of animal drugs; misbranding. 500.51... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Animal Drug Labeling Requirements § 500.51 Labeling of animal drugs; misbranding. (a) Among the representations on the label or labeling of an animal...

  19. 21 CFR 500.51 - Labeling of animal drugs; misbranding.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Labeling of animal drugs; misbranding. 500.51... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS GENERAL Animal Drug Labeling Requirements § 500.51 Labeling of animal drugs; misbranding. (a) Among the representations on the label or labeling of an animal...

  20. 21 CFR 201.64 - Sodium labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

  1. 21 CFR 201.64 - Sodium labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

  2. 21 CFR 201.64 - Sodium labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

  3. 21 CFR 201.64 - Sodium labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

  4. 21 CFR 201.64 - Sodium labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sodium labeling. 201.64 Section 201.64 Food and... LABELING Labeling Requirements for Over-the-Counter Drugs § 201.64 Sodium labeling. (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per...

  5. PRN 95-1: Effluent Discharge Labeling Statements

    EPA Pesticide Factsheets

    This notice exempts certain pesticide products from bearing effluent discharge labeling statements specified by P.R. Notice 93-10 for manufacturing use products and end use products that may be discharged to waters of the U.S. or municipal sewer systems.

  6. Effect of Vegan Fecal Microbiota Transplantation on Carnitine- and Choline-Derived Trimethylamine-N-Oxide Production and Vascular Inflammation in Patients With Metabolic Syndrome.

    PubMed

    Smits, Loek P; Kootte, Ruud S; Levin, Evgeni; Prodan, Andrei; Fuentes, Susana; Zoetendal, Erwin G; Wang, Zeneng; Levison, Bruce S; Cleophas, Maartje C P; Kemper, E Marleen; Dallinga-Thie, Geesje M; Groen, Albert K; Joosten, Leo A B; Netea, Mihai G; Stroes, Erik S G; de Vos, Willem M; Hazen, Stanley L; Nieuwdorp, Max

    2018-03-26

    Intestinal microbiota have been found to be linked to cardiovascular disease via conversion of the dietary compounds choline and carnitine to the atherogenic metabolite TMAO (trimethylamine-N-oxide). Specifically, a vegan diet was associated with decreased plasma TMAO levels and nearly absent TMAO production on carnitine challenge. We performed a double-blind randomized controlled pilot study in which 20 male metabolic syndrome patients were randomized to single lean vegan-donor or autologous fecal microbiota transplantation. At baseline and 2 weeks thereafter, we determined the ability to produce TMAO from d 6 -choline and d 3 -carnitine (eg, labeled and unlabeled TMAO in plasma and 24-hour urine after oral ingestion of 250 mg of both isotope-labeled precursor nutrients), and fecal samples were collected for analysis of microbiota composition. 18 F-fluorodeoxyglucose positron emission tomography/computed tomography scans of the abdominal aorta, as well as ex vivo peripheral blood mononuclear cell cytokine production assays, were performed. At baseline, fecal microbiota composition differed significantly between vegans and metabolic syndrome patients. With vegan-donor fecal microbiota transplantation, intestinal microbiota composition in metabolic syndrome patients, as monitored by global fecal microbial community structure, changed toward a vegan profile in some of the patients; however, no functional effects from vegan-donor fecal microbiota transplantation were seen on TMAO production, abdominal aortic 18 F-fluorodeoxyglucose uptake, or ex vivo cytokine production from peripheral blood mononuclear cells. Single lean vegan-donor fecal microbiota transplantation in metabolic syndrome patients resulted in detectable changes in intestinal microbiota composition but failed to elicit changes in TMAO production capacity or parameters related to vascular inflammation. URL: http://www.trialregister.nl. Unique identifier: NTR 4338. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  7. 27 CFR 41.83 - Penalties and forfeiture for products labeled or shipped for export.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Tobacco Products and Cigarette Papers... Products and Cigarette Papers and Tubes Without Payment of Tax Or Certain Duty § 41.83 Penalties and... jurisdiction of the United States any tobacco products or cigarette papers or tubes which have been labeled or...

  8. 27 CFR 41.83 - Penalties and forfeiture for products labeled or shipped for export.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Tobacco Products and Cigarette Papers... Products and Cigarette Papers and Tubes Without Payment of Tax Or Certain Duty § 41.83 Penalties and... jurisdiction of the United States any tobacco products or cigarette papers or tubes which have been labeled or...

  9. 27 CFR 41.83 - Penalties and forfeiture for products labeled or shipped for export.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Tobacco Products and Cigarette Papers... Products and Cigarette Papers and Tubes Without Payment of Tax Or Certain Duty § 41.83 Penalties and... jurisdiction of the United States any tobacco products or cigarette papers or tubes which have been labeled or...

  10. 27 CFR 41.83 - Penalties and forfeiture for products labeled or shipped for export.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Tobacco Products and Cigarette Papers... Products and Cigarette Papers and Tubes Without Payment of Tax Or Certain Duty § 41.83 Penalties and... jurisdiction of the United States any tobacco products or cigarette papers or tubes which have been labeled or...

  11. 27 CFR 41.83 - Penalties and forfeiture for products labeled or shipped for export.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... TOBACCO PRODUCTS, CIGARETTE PAPERS AND TUBES, AND PROCESSED TOBACCO Tobacco Products and Cigarette Papers... Products and Cigarette Papers and Tubes Without Payment of Tax Or Certain Duty § 41.83 Penalties and... jurisdiction of the United States any tobacco products or cigarette papers or tubes which have been labeled or...

  12. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  13. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  14. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  15. 9 CFR 592.330 - Unauthorized use or disposition of approved labels.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Unauthorized use or disposition of approved labels. 592.330 Section 592.330 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS Identifying and Marking Products § 592.330 Unauthorized use...

  16. 21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

  17. 21 CFR 607.35 - Notification of registrant; blood product establishment registration number and NDC Labeler Code.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Notification of registrant; blood product establishment registration number and NDC Labeler Code. 607.35 Section 607.35 Food and Drugs FOOD AND DRUG... PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS Procedures for Domestic Blood Product...

  18. Investigating factors influencing consumer willingness to buy GM food and nano-food

    NASA Astrophysics Data System (ADS)

    Yue, Chengyan; Zhao, Shuoli; Cummings, Christopher; Kuzma, Jennifer

    2015-07-01

    Emerging technologies applied to food products often evoke controversy about their safety and whether to label foods resulting from their use. As such, it is important to understand the factors that influence consumer desires for labeling and their willingness-to-buy (WTB) these food products. Using data from a national survey with US consumers, this study employs structural equation modeling to explore relationships between potential influences such as trust in government to manage technologies, views on restrictive government policies, perceptions about risks and benefits, and preferences for labeling on consumer's WTB genetically modified (GM) and nano-food products. Some interesting similarities and differences between GM- and nano-food emerged. For both technologies, trust in governing agencies to manage technologies did not influence labeling preferences, but it did influence attitudes about the food technologies themselves. Attitudes toward the two technologies, as measured by risk-benefit comparisons and comfort with consumption, also greatly influenced views of government restrictive policies, labeling preferences, and WTB GM or nano-food products. For differences, labeling preferences were found to influence WTB nano-foods, but not WTB GM foods. Gender and religiosity also had varying effects on WTB and labeling preferences: while gender and religiosity influenced labeling preferences and WTB for GM foods, they did not have a significant influence for nano-foods. We propose some reasons for these differences, such as greater media attention and other heuristics such as value-based concerns about "modifying life" with GM foods. The results of this study can help to inform policies and communication about the application of these new technologies in food products.

  19. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications.

    PubMed

    Citrome, Leslie

    2009-09-01

    Pharmaceutical product labeling as approved by regulatory agencies include statements of adverse event risk. Product labels include descriptive statements such as whether events are uncommon or rare, as well as percentage occurrence for more common events. In addition tables are provided with the frequencies of the latter events for both product and placebo as observed in clinical trials. Competing products are not mentioned in a specific drug's product labeling but indirect comparisons can be made using the corresponding label information for the alternate product. Two types of tools are easily used for this purpose: absolute measures such as number needed to harm (NNH), and relative measures such as relative risk increase (RRI). The calculations for both of these types of quantitative measures are presented using as examples the oral first-line second-generation antipsychotic medications. Among three sample outcomes selected a priori, akathisia, weight gain, and discontinuation from a clinical trial because of an adverse reaction, there appears to be differences among the different antipsychotics versus placebo. Aripiprazole was associated with the highest risk for akathisia, particularly when used as adjunctive treatment of major depressive disorder (NNH 5, 95% CI 4-7; RRI 525%, 95% CI 267%-964%). Although insufficient information was available in product labeling to calculate the CI, olanzapine was associated with the highest risk for weight gain of at least 7% from baseline (NNH 6, RRI 640% for adults; NNH 4, RRI 314% for adolescents), and quetiapine for the indication of bipolar depression was associated with the highest risk of discontinuation from a clinical trial because of an adverse reaction (NNH 8, RRI 265% for 600 mg/d; NNH 15, RRI 137% for 300 mg/d). In conclusion, with certain limitations, it is possible for the clinician to extract information from medication product labeling regarding the frequency with which certain adverse reactions can be expected. This supplements, but does not replace, information reported directly in clinical trial reports.

  20. Bacterial discrimination by means of a universal array approach mediated by LDR (ligase detection reaction)

    PubMed Central

    Busti, Elena; Bordoni, Roberta; Castiglioni, Bianca; Monciardini, Paolo; Sosio, Margherita; Donadio, Stefano; Consolandi, Clarissa; Rossi Bernardi, Luigi; Battaglia, Cristina; De Bellis, Gianluca

    2002-01-01

    Background PCR amplification of bacterial 16S rRNA genes provides the most comprehensive and flexible means of sampling bacterial communities. Sequence analysis of these cloned fragments can provide a qualitative and quantitative insight of the microbial population under scrutiny although this approach is not suited to large-scale screenings. Other methods, such as denaturing gradient gel electrophoresis, heteroduplex or terminal restriction fragment analysis are rapid and therefore amenable to field-scale experiments. A very recent addition to these analytical tools is represented by microarray technology. Results Here we present our results using a Universal DNA Microarray approach as an analytical tool for bacterial discrimination. The proposed procedure is based on the properties of the DNA ligation reaction and requires the design of two probes specific for each target sequence. One oligo carries a fluorescent label and the other a unique sequence (cZipCode or complementary ZipCode) which identifies a ligation product. Ligated fragments, obtained in presence of a proper template (a PCR amplified fragment of the 16s rRNA gene) contain either the fluorescent label or the unique sequence and therefore are addressed to the location on the microarray where the ZipCode sequence has been spotted. Such an array is therefore "Universal" being unrelated to a specific molecular analysis. Here we present the design of probes specific for some groups of bacteria and their application to bacterial diagnostics. Conclusions The combined use of selective probes, ligation reaction and the Universal Array approach yielded an analytical procedure with a good power of discrimination among bacteria. PMID:12243651

  1. Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling.

    PubMed

    Wang, Yefeng; Gunashekar, Divya R; Adam, Terrence J; Zhang, Rui

    2017-01-01

    The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Data-base (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements.

  2. Mining Adverse Events of Dietary Supplements from Product Labels by Topic Modeling

    PubMed Central

    Wang, Yefeng; Gunashekar, Divya R.; Adam, Terrence J.; Zhang, Rui

    2018-01-01

    The adverse events of the dietary supplements should be subject to scrutiny due to their growing clinical application and consumption among U.S. adults. An effective method for mining and grouping the adverse events of the dietary supplements is to evaluate product labeling for the rapidly increasing number of new products available in the market. In this study, the adverse events information was extracted from the product labels stored in the Dietary Supplement Label Database (DSLD) and analyzed by topic modeling techniques, specifically Latent Dirichlet Allocation (LDA). Among the 50 topics generated by LDA, eight topics were manually evaluated, with topic relatedness ranging from 58.8% to 100% on the product level, and 57.1% to 100% on the ingredient level. Five out of these eight topics were coherent groupings of the dietary supplements based on their adverse events. The results demonstrated that LDA is able to group supplements with similar adverse events based on the dietary supplement labels. Such information can be potentially used by consumers to more safely use dietary supplements. PMID:29295169

  3. Assessing the Role of Shape and Label in the Misleading Packaging of Food Imitating Products: From Empirical Evidence to Policy Recommendation

    PubMed Central

    Basso, Frédéric; Bouillé, Julien; Le Goff, Kévin; Robert-Demontrond, Philippe; Oullier, Olivier

    2016-01-01

    Food imitating products are chemical consumer items used frequently in the household for cleaning and personal hygiene (e.g., bleach, soap, and shampoo), which resemble food products. Their containers replicate elements of food package design such as possessing a shape close in style to drinking product containers or bearing labels that depict colorful fruits. In marketing, these incongruent forms are designed to increase the appeal of functional products, leading to chemical consumer product embellishment. However, due to the resulting visual ambiguity, food imitating products may expose consumers to the risk of being poisoned from ingestion. Thus, from a public health perspective, food imitating products are considered dangerous chemical products that should not be sold, and may merit being recalled for the safety of consumers. To help policymakers address the hazardous presence of food imitating products, the purpose of this article is to identify the specific design features that generate most ambiguity for the consumer, and therefore increase the likelihood of confusion with foodstuffs. Among the visual elements of food packaging, the two most important features (shape and label) are manipulated in a series of three lab studies combining six Implicit Association Tests (IATs) and two explicit measures on products' drinkability and safety. IATs were administered to assess consumers' implicit association of liquid products with tastiness in a within-subject design in which the participants (N = 122) were presented with two kinds of food imitating products with a drink shape or drink label compared with drinks (experiential products with congruent form) and classic chemical products (hygiene products) (functional products with congruent form). Results show that chemical consumer products with incongruent drink shapes (but not drink labels) as an element of food package design are both implicitly associated with tastiness and explicitly judged as safe and drinkable. These results require confirmation in other studies involving different shapes and labels. Notwithstanding, due to the misleading effect of this ambiguity, public health authorities are thus well advised to focus their market surveillance on chemical products emulating a food or drink shape. PMID:27065919

  4. 9 CFR 381.445 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Guidelines for voluntary nutrition... INSPECTION REGULATIONS Nutrition Labeling § 381.445 Guidelines for voluntary nutrition labeling of single... delayed until Mar. 1, 2012, at 76 FR 76890, Dec. 9, 2011. (a) Nutrition information on the cuts of single...

  5. 9 CFR 317.345 - Guidelines for voluntary nutrition labeling of single-ingredient, raw products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Guidelines for voluntary nutrition... DEVICES, AND CONTAINERS Nutrition Labeling § 317.345 Guidelines for voluntary nutrition labeling of single... delayed until Mar. 1, 2012, at 76 FR 76890, Dec. 9, 2011. (a) Nutrition information on the cuts of single...

  6. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  7. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  8. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  9. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  10. 50 CFR 216.91 - Dolphin-safe labeling standards.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... MAMMALS Dolphin Safe Tuna Labeling § 216.91 Dolphin-safe labeling standards. (a) It is a violation of..., distributor, or seller of any tuna products that are exported from or offered for sale in the United States to... suggests that the tuna contained in the products were harvested using a method of fishing that is not...

  11. 78 FR 18351 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a... manufacturer, packer, or distributor of the dietary supplement product; (2) the text of the statement that is...

  12. 21 CFR 501.17 - Animal food labeling warning statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...

  13. 21 CFR 501.17 - Animal food labeling warning statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...

  14. 21 CFR 501.17 - Animal food labeling warning statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...

  15. Labels, cognomes, and cyclic computation: an ethological perspective.

    PubMed

    Murphy, Elliot

    2015-01-01

    For the past two decades, it has widely been assumed by linguists that there is a single computational operation, Merge, which is unique to language, distinguishing it from other cognitive domains. The intention of this paper is to progress the discussion of language evolution in two ways: (i) survey what the ethological record reveals about the uniqueness of the human computational system, and (ii) explore how syntactic theories account for what ethology may determine to be human-specific. It is shown that the operation Label, not Merge, constitutes the evolutionary novelty which distinguishes human language from non-human computational systems; a proposal lending weight to a Weak Continuity Hypothesis and leading to the formation of what is termed Computational Ethology. Some directions for future ethological research are suggested.

  16. Labels, cognomes, and cyclic computation: an ethological perspective

    PubMed Central

    Murphy, Elliot

    2015-01-01

    For the past two decades, it has widely been assumed by linguists that there is a single computational operation, Merge, which is unique to language, distinguishing it from other cognitive domains. The intention of this paper is to progress the discussion of language evolution in two ways: (i) survey what the ethological record reveals about the uniqueness of the human computational system, and (ii) explore how syntactic theories account for what ethology may determine to be human-specific. It is shown that the operation Label, not Merge, constitutes the evolutionary novelty which distinguishes human language from non-human computational systems; a proposal lending weight to a Weak Continuity Hypothesis and leading to the formation of what is termed Computational Ethology. Some directions for future ethological research are suggested. PMID:26089809

  17. Estimating bacterial production in marine waters from the simultaneous incorporation of thymidine and leucine.

    PubMed

    Chin-Leo, G; Kirchman, D L

    1988-08-01

    We examined the simultaneous incorporation of [H]thymidine and [C]leucine to obtain two independent indices of bacterial production (DNA and protein syntheses) in a single incubation. Incorporation rates of leucine estimated by the dual-label method were generally higher than those obtained by the single-label method, but the differences were small (dual/single = 1.1 +/- 0.2 [mean +/- standard deviation]) and were probably due to the presence of labeled leucyl-tRNA in the cold trichloroacetic acid-insoluble fraction. There were no significant differences in thymidine incorporation between dual- and single-label incubations (dual/ single = 1.03 +/- 0.13). Addition of the two substrates in relatively large amounts (25 nM) did not apparently increase bacterial activity during short incubations (<5 h). With the dual-label method we found that thymidine and leucine incorporation rates covaried over depth profiles of the Chesapeake Bay. Estimates of bacterial production based on thymidine and leucine differed by less than 25%. Although the need for appropriate conversion factors has not been eliminated, the dual-label approach can be used to examine the variation in bacterial production while ensuring that the observed variation in incorporation rates is due to real changes in bacterial production rather than changes in conversion factors or introduction of other artifacts.

  18. 9 CFR 355.36 - Obsolete labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Obsolete labels. 355.36 Section 355.36 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION, CERTIFICATION, AND...

  19. 9 CFR 355.36 - Obsolete labels.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Obsolete labels. 355.36 Section 355.36 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... CERTIFICATION CERTIFIED PRODUCTS FOR DOGS, CATS, AND OTHER CARNIVORA; INSPECTION, CERTIFICATION, AND...

  20. 7 CFR 205.310 - Agricultural products produced on an exempt or excluded operation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (Continued) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Labels, Labeling, and...

  1. 40 CFR 152.166 - Labeling of restricted use products.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...

  2. 40 CFR 152.166 - Labeling of restricted use products.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...

  3. 40 CFR 152.166 - Labeling of restricted use products.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...

  4. 40 CFR 152.166 - Labeling of restricted use products.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...

  5. 40 CFR 152.166 - Labeling of restricted use products.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...

  6. 9 CFR 381.443 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS will consider only the major cuts of single...

  7. 9 CFR 381.443 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... voluntary nutrition labeling. 381.443 Section 381.443 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 381.443 Significant participation for voluntary nutrition labeling. Link to an... 76890, Dec. 9, 2011. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS...

  8. 9 CFR 317.343 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. Link to an... 76890, Dec. 9, 2011. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS...

  9. 9 CFR 317.343 - Significant participation for voluntary nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... voluntary nutrition labeling. 317.343 Section 317.343 Animals and Animal Products FOOD SAFETY AND INSPECTION... Nutrition Labeling § 317.343 Significant participation for voluntary nutrition labeling. (a) In evaluating significant participation for voluntary nutrition labeling, FSIS will consider only the major cuts of single...

  10. 16 CFR 300.14 - Substitute label requirement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Substitute label requirement. 300.14 Section 300.14 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.14 Substitute label...

  11. 16 CFR 300.3 - Required label information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Required label information. 300.3 Section 300.3 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.3 Required label...

  12. Fluorescence lifetime as a new parameter in analytical cytology measurements

    NASA Astrophysics Data System (ADS)

    Steinkamp, John A.; Deka, Chiranjit; Lehnert, Bruce E.; Crissman, Harry A.

    1996-05-01

    A phase-sensitive flow cytometer has been developed to quantify fluorescence decay lifetimes on fluorochrome-labeled cells/particles. This instrument combines flow cytometry (FCM) and frequency-domain fluorescence spectroscopy measurement principles to provide unique capabilities for making phase-resolved lifetime measurements, while preserving conventional FCM capabilities. Cells are analyzed as they intersect a high-frequency, intensity-modulated (sine wave) laser excitation beam. Fluorescence signals are processed by conventional and phase-sensitive signal detection electronics and displayed as frequency distribution histograms. In this study we describe results of fluorescence intensity and lifetime measurements on fluorescently labeled particles, cells, and chromosomes. Examples of measurements on intrinsic cellular autofluorescence, cells labeled with immunofluorescence markers for cell- surface antigens, mitochondria stains, and on cellular DNA and protein binding fluorochromes will be presented to illustrate unique differences in measured lifetimes and changes caused by fluorescence quenching. This innovative technology will be used to probe fluorochrome/molecular interactions in the microenvironment of cells/chromosomes as a new parameter and thus expand the researchers' understanding of biochemical processes and structural features at the cellular and molecular level.

  13. Comparing five front-of-pack nutrition labels' influence on consumers' perceptions and purchase intentions.

    PubMed

    Gorski Findling, Mary T; Werth, Paul M; Musicus, Aviva A; Bragg, Marie A; Graham, Dan J; Elbel, Brian; Roberto, Christina A

    2018-01-01

    In 2011, a National Academy of Medicine report recommended that packaged food in the U.S. display a uniform front-of-package nutrition label, using a system such as a 0-3 star ranking. Few studies have directly compared this to other labels to determine which best informs consumers and encourages healthier purchases. In 2013, we randomized adult participants (N=1247) in an Internet-based survey to one of six conditions: no label control; single traffic light; multiple traffic light; Facts Up Front; NuVal; or 0-3 star ranking. We compared groups on purchase intentions and accuracy of participants' interpretation of food labels. There were no differences in the nutritional quality of hypothetical shopping baskets across conditions (p=0.845). All labels improved consumers' abilities to judge the nutritional quality of foods relative to no label, but the best designs varied by outcomes. NuVal and multiple traffic light labels led to the greatest accuracy identifying the healthier of two products (p<0.001), while the multiple traffic light also led to the most accurate estimates of saturated fat, sugar, and sodium (p<0.001). The single traffic light outperformed other labels when participants compared nutrient levels between similar products (p<0.03). Single/multiple traffic light and Facts Up Front labels led to the most accurate calories per serving estimations (p<0.001). Although front-of-package labels helped participants more accurately assess products' nutrition information relative to no label, no conditions shifted adults' purchase intentions. Results did not point to a clearly superior label design, but they suggest that a 3-star label might not be best for educating consumers. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Safety warnings and first aid instructions on consumer and pharmaceutical products in Nigeria: has there been an improvement?

    PubMed

    Nonyelum, Stanley Catherine; Nkem, Nwachukwu; Ifeyinwa, Chijoke-Nwauche; Orisakwe, Orish Ebere

    2010-10-01

    To investigate the adequacy of safety warnings and first aid instructions on the labels of pharmaceutical and consumer products in Nigeria. A market basket method (total collection of all available samples) was used to investigate the adequacy of safety warnings and first aid instructions on the labels of 600 pharmaceutical and consumer products in Nigeria. The results showed that 69.8% of the products had adequate warnings whereas 385 (64.1%) of the products screened had legible product warnings. Only 52 (8.7%) of the total number of products had appropriate first aid instructions while only 25 (4.12%) of the products described symptoms and full treatment of poisoning by the product and 319 (53.2%) products surveyed recommended calling a health professional. A total of 31 (5.2%) products had labels that were considered too technical (non English). Of the 600 products, 386 (64.3%) had dosage instructions that were considered adequate while 538 (89.6%) had adequate storage instructions. About 68% of the products had partially correct warnings while 44 or 7.3% had partially correct first aid instructions. Some products had neither warnings nor first aid instructions. This study suggests a not too impressive improvement in the correctness and appropriateness of label information.

  15. 78 FR 19718 - Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...] Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use AGENCY: Food...-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing... over-the- counter nicotine replacement therapy products for their approved intended use as aids to...

  16. Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries.

    PubMed

    Hallersten, Anna; Fürst, Walter; Mezzasalma, Riccardo

    2016-06-01

    In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  17. Searching for flavor labels in food products: the influence of color-flavor congruence and association strength.

    PubMed

    Velasco, Carlos; Wan, Xiaoang; Knoeferle, Klemens; Zhou, Xi; Salgado-Montejo, Alejandro; Spence, Charles

    2015-01-01

    Prior research provides robust support for the existence of a number of associations between colors and flavors. In the present study, we examined whether congruent (vs. incongruent) combinations of product packaging colors and flavor labels would facilitate visual search for products labeled with specific flavors. The two experiments reported here document a Stroop-like effect between flavor words and packaging colors. The participants were able to search for packaging flavor labels more rapidly when the color of the packaging was congruent with the flavor label (e.g., red/tomato) than when it was incongruent (e.g., yellow/tomato). In addition, when the packaging color was incongruent, those flavor labels that were more strongly associated with a specific color yielded slower reaction times and more errors (Stroop interference) than those that were less strongly tied to a specific color. Importantly, search efficiency was affected both by color/flavor congruence and association strength. Taken together, these results therefore highlight the role of color congruence and color-word association strength when it comes to searching for specific flavor labels.

  18. Profiling structured product labeling with NDF-RT and RxNorm

    PubMed Central

    2012-01-01

    Background Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich information about FDA approved clinical drugs. However, the lack of linkage to standard drug ontologies hinders their meaningful use. NDF-RT (National Drug File Reference Terminology) and NLM RxNorm as standard drug ontology were used to standardize and profile the product labels. Methods In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies: NDF-RT and RxNorm. We also applied existing categorical annotations from the drug ontologies to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following three approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints. Meanwhile, we imported RxNorm data into MySQL relational database. Results In total, 96.0% SPL drug labels were mapped with NDF-RT categories whereas 97.0% SPL drug labels are linked to RxNorm codes. We found that the majority of SPL drug labels are mapped to chemical ingredient concepts in both drug ontologies whereas a relatively small portion of SPL drug labels are mapped to clinical drug concepts. Conclusions The profiling outcomes produced by this study would provide useful insights on meaningful use of FDA SPL drug labels in clinical applications through standard drug ontologies such as NDF-RT and RxNorm. PMID:23256517

  19. Profiling structured product labeling with NDF-RT and RxNorm.

    PubMed

    Zhu, Qian; Jiang, Guoqian; Chute, Christopher G

    2012-12-20

    Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by United States Food and Drug Administration (FDA) as a mechanism for exchanging drug product information. The SPL drug labels contain rich information about FDA approved clinical drugs. However, the lack of linkage to standard drug ontologies hinders their meaningful use. NDF-RT (National Drug File Reference Terminology) and NLM RxNorm as standard drug ontology were used to standardize and profile the product labels. In this paper, we present a framework that intends to map SPL drug labels with existing drug ontologies: NDF-RT and RxNorm. We also applied existing categorical annotations from the drug ontologies to classify SPL drug labels into corresponding classes. We established the classification and relevant linkage for SPL drug labels using the following three approaches. First, we retrieved NDF-RT categorical information from the External Pharmacologic Class (EPC) indexing SPLs. Second, we used the RxNorm and NDF-RT mappings to classify and link SPLs with NDF-RT categories. Third, we profiled SPLs using RxNorm term type information. In the implementation process, we employed a Semantic Web technology framework, in which we stored the data sets from NDF-RT and SPLs into a RDF triple store, and executed SPARQL queries to retrieve data from customized SPARQL endpoints. Meanwhile, we imported RxNorm data into MySQL relational database. In total, 96.0% SPL drug labels were mapped with NDF-RT categories whereas 97.0% SPL drug labels are linked to RxNorm codes. We found that the majority of SPL drug labels are mapped to chemical ingredient concepts in both drug ontologies whereas a relatively small portion of SPL drug labels are mapped to clinical drug concepts. The profiling outcomes produced by this study would provide useful insights on meaningful use of FDA SPL drug labels in clinical applications through standard drug ontologies such as NDF-RT and RxNorm.

  20. Memory for product sounds: the effect of sound and label type.

    PubMed

    Ozcan, Elif; van Egmond, René

    2007-11-01

    The (mnemonic) interactions between auditory, visual, and the semantic systems have been investigated using structurally complex auditory stimuli (i.e., product sounds). Six types of product sounds (air, alarm, cyclic, impact, liquid, mechanical) that vary in spectral-temporal structure were presented in four label type conditions: self-generated text, text, image, and pictogram. A memory paradigm that incorporated free recall, recognition, and matching tasks was employed. The results for the sound type suggest that the amount of spectral-temporal structure in a sound can be indicative for memory performance. Findings related to label type suggest that 'self' creates a strong bias for the retrieval and the recognition of sounds that were self-labeled; the density and the complexity of the visual information (i.e., pictograms) hinders the memory performance ('visual' overshadowing effect); and image labeling has an additive effect on the recall and matching tasks (dual coding). Thus, the findings suggest that the memory performances for product sounds are task-dependent.

  1. The science on front-of-package food labels.

    PubMed

    Hawley, Kristy L; Roberto, Christina A; Bragg, Marie A; Liu, Peggy J; Schwartz, Marlene B; Brownell, Kelly D

    2013-03-01

    The U.S. Food and Drug Administration and Institute of Medicine are currently investigating front-of-package (FOP) food labelling systems to provide science-based guidance to the food industry. The present paper reviews the literature on FOP labelling and supermarket shelf-labelling systems published or under review by February 2011 to inform current investigations and identify areas of future research. A structured search was undertaken of research studies on consumer use, understanding of, preference for, perception of and behaviours relating to FOP/shelf labelling published between January 2004 and February 2011. Twenty-eight studies from a structured search met inclusion criteria. Reviewed studies examined consumer preferences, understanding and use of different labelling systems as well as label impact on purchasing patterns and industry product reformulation. The findings indicate that the Multiple Traffic Light system has most consistently helped consumers identify healthier products; however, additional research on different labelling systems' abilities to influence consumer behaviour is needed.

  2. A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

    PubMed

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse event data for various audiences. Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of the manufacturer. Attention to the basic principles is essential and, as illustrated, may be sufficient to resolve some problems.

  3. Unique Proteins Expressed by Blood Vessels in Skeletal Sites Colonized by Breast Cancer Cells

    DTIC Science & Technology

    2006-08-01

    fluorescent labeled acetylated LDL at an accelerated rate (3). After one week in culture BVECs and MVECs were harvested. Total RNA was extracted from...both cell types using the Qiagen RNeasy kit (Valencia, CA). Microarray labeling, hybridization and analysis was conducted on the RNA by the Penn...State University DNA Microarray Facility under the direction of Dr. Craig Praul. Briefly, RNA obtained from three separate isolations of BVECs and

  4. Matching by linear programming and successive convexification.

    PubMed

    Jiang, Hao; Drew, Mark S; Li, Ze-Nian

    2007-06-01

    We present a novel convex programming scheme to solve matching problems, focusing on the challenging problem of matching in a large search range and with cluttered background. Matching is formulated as metric labeling with L1 regularization terms, for which we propose a novel linear programming relaxation method and an efficient successive convexification implementation. The unique feature of the proposed relaxation scheme is that a much smaller set of basis labels is used to represent the original label space. This greatly reduces the size of the searching space. A successive convexification scheme solves the labeling problem in a coarse to fine manner. Importantly, the original cost function is reconvexified at each stage, in the new focus region only, and the focus region is updated so as to refine the searching result. This makes the method well-suited for large label set matching. Experiments demonstrate successful applications of the proposed matching scheme in object detection, motion estimation, and tracking.

  5. Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.

    PubMed

    Schuck, Robert N; Grillo, Joseph A

    2016-05-01

    Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.

  6. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ... Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural... Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex...

  7. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  8. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  9. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  10. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  11. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) The...

  12. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. This amendment...

  13. 16 CFR 300.30 - Deceptive labeling in general.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Deceptive labeling in general. 300.30 Section 300.30 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.30 Deceptive labeling...

  14. 21 CFR 501.100 - Animal food; exemptions from labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Animal food; exemptions from labeling. 501.100... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING Exemptions From Animal Food Labeling Requirements § 501.100 Animal food; exemptions from labeling. (a) The following foods are exempt...

  15. 21 CFR 501.100 - Animal food; exemptions from labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Animal food; exemptions from labeling. 501.100... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING Exemptions From Animal Food Labeling Requirements § 501.100 Animal food; exemptions from labeling. (a) The following foods are exempt...

  16. 21 CFR 501.100 - Animal food; exemptions from labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food; exemptions from labeling. 501.100... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING Exemptions From Animal Food Labeling Requirements § 501.100 Animal food; exemptions from labeling. (a) The following foods are exempt...

  17. Maternal Label and Gesture Use Affects Acquisition of Specific Object Names

    ERIC Educational Resources Information Center

    Zammit, Maria; Schafer, Graham

    2011-01-01

    Ten mothers were observed prospectively, interacting with their infants aged 0 ; 10 in two contexts (picture description and noun description). Maternal communicative behaviours were coded for volubility, gestural production and labelling style. Verbal labelling events were categorized into three exclusive categories: label only; label plus…

  18. 9 CFR 101.4 - Labeling terminology.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Labeling terminology. 101.4 Section 101.4 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.4...

  19. 9 CFR 101.4 - Labeling terminology.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Labeling terminology. 101.4 Section 101.4 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.4...

  20. 9 CFR 101.4 - Labeling terminology.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Labeling terminology. 101.4 Section 101.4 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS § 101.4...

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