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...

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

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.

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

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...

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...

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...

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...

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...

Apparatus for reading two-dimensional electrophoretograms containing. beta. -ray-emitting labeled compounds

DOEpatents

Anderson, H.L.; Kinnison, W.W.; Lillberg, J.W.

1985-04-30

An apparatus and method for electronically reading planar two-dimensional ..beta..-ray emitter-labeled gel electrophoretograms. A single, flat rectangular multiwire proportional chamber is placed in close proximity to the gel and the assembly placed in an intense uniform magnetic field disposed in a perpendicular manner to the rectangular face of the proportional chamber. Beta rays emitted in the direction of the proportional chamber are caused to execute helical motions which substantially preserve knowledge the coordinates of their origin in the gel. Perpendicularly oriented, parallel wire, parallel plane cathodes electronically sense the location of the ..beta..-rays from ionization generated thereby in a detection gas coupled with an electron avalanche effect resulting from the action of a parallel wire anode located therebetween. A scintillator permits the present apparatus to be rendered insensitive when signals are generated from cosmic rays incident on the proportional chamber. Resolution for concentrations of radioactive compounds in the gel exceeds 700-..mu..m. The apparatus and method of the present invention represent a significant improvement over conventional autoradiographic techniques in dynamic range, linearity and sensitivity of data collection. A concentration and position map for gel electrophoretograms having significant concentrations of labeled compounds and/or highly radioactive labeling nuclides can generally be obtained in less than one hour.

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

Copper-catalyzed oxidative desulfurization-oxygenation of thiocarbonyl compounds using molecular oxygen: an efficient method for the preparation of oxygen isotopically labeled carbonyl compounds.

PubMed

Shibahara, Fumitoshi; Suenami, Aiko; Yoshida, Atsunori; Murai, Toshiaki

2007-06-21

A novel copper-catalyzed oxidative desulfurization reaction of thiocarbonyl compounds, using molecular oxygen as an oxidant and leading to formation of carbonyl compounds, has been developed, and the utility of the process is demonstrated by its application to the preparation of a carbonyl-18O labeled sialic acid derivative.

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...

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...

Arylglycerol-γ-Formyl Ester as an Aromatic Ring Cleavage Product of Nonphenolic β-O-4 Lignin Substructure Model Compounds Degraded by Coriolus versicolor†

PubMed Central

Kawai, Shingo; Umezawa, Toshiaki; Higuchi, Takayoshi

1985-01-01

4-Ethoxy-3-methoxyphenylglycerol-γ-formyl ester (compound IV) was identified as a degradation product of both 4-ethoxy-3-methoxyphenylglycerol-β-syringaldehyde ether (compound I) and 4-ethoxy-3-methoxyphenylglycerol-β-2,6-dimethoxyphenyl ether (compound II) by a ligninolytic culture of Coriolus versicolor. An isotopic experiment with a 13C-labeled compound (compound II′) indicated that the formyl group of compound IV was derived from the β-phenoxyl group of β-O-4 dimer as an aromatic ring cleavage fragment. However, compound IV was not formed from 4-ethoxy-3-methoxyphenylglycerol-β-guaiacyl ether (compound III). γ-Formyl arylglycerol (compound IV) could be a precursor of 4-ethoxy-3-methoxyphenylglycerol (compound VI), because 3-(4-ethoxy-3-methoxyphenyl)-1-formyloxy propane (compound VII) was cleaved to give 3-(4-ethoxy-3-methoxyphenyl)-1-propanol (compound VIII) by C. versicolor. 4-Ethoxy-3-methoxyphenylglycerol-β,γ-cyclic carbonate (compound V), previously found as a degradation product of compound III by Phanerochaete chrysosporium (T. Umezawa, and T. Higuchi, FEBS Lett., 25:123-126, 1985), was also identified from the cultures with compound I, II, and III and degraded to give the arylglycerol (compound VI). An isotopic experiment with 13C-labeled compounds II′ and III′ indicated that the carbonate carbon of compound V was derived from the β-phenoxyl groups of β-O-4 substructure. PMID:16346950

Synthesis of labeled compounds using recovered tritium from expired beta light sources

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

Matei, L.; Postolache, C.; Bubueanu, G.

2008-07-15

In this paper, the technological procedures for extracting tritium from beta light source are highlighted. The recovered tritium was used in the synthesis of organically labeled compounds and in the preparation of tritiated water (HTO) with high specific activity. Technological procedures for treatment of beta light sources consist of: envelope breaking into evacuated enclosure, the radioactive gaseous mixture pumping and its storage on metallic sodium. The mixtures of T{sub 2} and {sup 3}He were used in the synthesis of tritium labeled steroid hormones, nucleosides analogues and for the preparation of HTO with high radioactivity concentrations. (authors)

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...

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.

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...

Creating and virtually screening databases of fluorescently-labelled compounds for the discovery of target-specific molecular probes

NASA Astrophysics Data System (ADS)

Kamstra, Rhiannon L.; Dadgar, Saedeh; Wigg, John; Chowdhury, Morshed A.; Phenix, Christopher P.; Floriano, Wely B.

2014-11-01

Our group has recently demonstrated that virtual screening is a useful technique for the identification of target-specific molecular probes. In this paper, we discuss some of our proof-of-concept results involving two biologically relevant target proteins, and report the development of a computational script to generate large databases of fluorescence-labelled compounds for computer-assisted molecular design. The virtual screening of a small library of 1,153 fluorescently-labelled compounds against two targets, and the experimental testing of selected hits reveal that this approach is efficient at identifying molecular probes, and that the screening of a labelled library is preferred over the screening of base compounds followed by conjugation of confirmed hits. The automated script for library generation explores the known reactivity of commercially available dyes, such as NHS-esters, to create large virtual databases of fluorescence-tagged small molecules that can be easily synthesized in a laboratory. A database of 14,862 compounds, each tagged with the ATTO680 fluorophore was generated with the automated script reported here. This library is available for downloading and it is suitable for virtual ligand screening aiming at the identification of target-specific fluorescent molecular probes.

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...

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...

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...

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

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

Extemporaneous compounding in a sample of New Zealand hospitals: a retrospective survey.

PubMed

Kairuz, Therése; Chhim, Srey; Hasan, Fhazeel; Kumar, Karishma; Lal, Aarti; Patel, Roshni; Singh, Ranjani; Dogra, Mridula; Garg, Sanjay

2007-03-23

To determine the extent and nature of extemporaneous compounding of liquid preparations in a sample of New Zealand hospitals. Retrospective data were collected from eight hospitals known to provide compounding services during the period 1 June 2004 to 31 December 2004; including dosage form, volume, and quantity prepared. Data were collected on site from compounding logbooks and batch sheets. Demographic patient data was limited to age and was only collected from pharmacy departments where this information was readily available. Off-label use was analysed where appropriate data were available. 2015 products were compounded over the 7-month period; an average of 251.9 per month. More oral dosage forms were compounded (n=152) compared to topical dosage forms (n=100); 74 drugs required extemporaneous preparation for oral use. There were 16 drugs used in an off-label manner on 144 occasions for paediatric patients. Most off-label drugs were reformulated as suspensions; omeprazole suspension was compounded at all of the hospitals. Off-label use of four drugs (sotalol, labetalol, diazoxide, and clonidine) was analysed for different paediatric age groups. Suspensions are the most frequently compounded dosage form and omeprazole is the drug that is most frequently reformulated. Off-label medicines form a small but integral role in the supply of medicinal products.

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...

Desiderata for product labeling of medical expert systems.

PubMed

Geissbühler, A; Miller, R A

1997-12-01

The proliferation and increasing complexity of medical expert systems raise ethical and legal concerns about the ability of practitioners to protect their patients from defective or misused software. Appropriate product labeling of expert systems can help clinical users to understand software indications and limitations. Mechanisms of action and knowledge representation schema should be explained in layperson's terminology. User qualifications and resources available for acquiring the skills necessary to understand and critique the system output should be listed. The processes used for building and maintaining the system's knowledge base are key determinants of the product's quality, and should be carefully documented. To meet these desiderata, a printed label is insufficient. The authors suggest a new, more active, model of product labeling for medical expert systems that involves embedding 'knowledge of the knowledge base', creating user-specific data, and sharing global information using the Internet.

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.

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...

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...

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...

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...

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...

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...

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...

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.

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...

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...

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...

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...

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...

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...

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...

Apparatus and method for reading two-dimensional electrophoretograms containing .beta.-ray-emitting labeled compounds

DOEpatents

Anderson, Herbert L.; Kinnison, W. Wayne; Lillberg, John W.

1987-01-01

Apparatus and method for electronically reading planar two dimensional .beta.-ray emitter-labeled gel electrophoretograms. A single, flat rectangular multiwire proportional chamber is placed in close proximity to the gel and the assembly placed in an intense uniform magnetic field disposed in a perpendicular manner to the rectangular face of the proportional chamber. Beta rays emitted in the direction of the proportional chamber are caused to execute helical motions which substantially preserve knowledge of the coordinates of their origin in the gel. Perpendicularly oriented, parallel wire, parallel plane cathodes electronically sense the location of the .beta.-rays from ionization generated thereby in a detection gas coupled with an electron avalanche effect resulting from the action of a parallel wire anode located therebetween. A scintillator permits the present apparatus to be rendered insensitive when signals are generated from cosmic rays incident on the proportional chamber. Resolution for concentrations of radioactive compounds in the gel exceeds 700 .mu.m. The apparatus and method of the present invention represent a significant improvement over conventional autoradiographic techniques in dynamic range, linearity and sensitivity of data collection. A concentration and position map for gel electrophoretograms having significant concentrations of labeled compounds and/or highly radioactive labeling nuclides can generally be obtained in less than one hour.

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 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...

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...

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...

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...

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...

Clinical use of indium-111 labeled blood products

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

Loken, M.K.; Clay, M.E.; Carpenter, R.T.

1985-12-01

Following the introduction of In-111 oxine as a label for blood cells by McAffee and Thakur in 1976, these procedures have become increasingly important in the practice of nuclear medicine. Of particular interest are studies involving the use of labeled leukocytes for the detection of focal infection. The clinical utility of labeled platelets is less well developed, although the use of platelets to detect the formation of thrombi in blood vessels and on vascular grafts and prostheses is gaining prominence. This report summarizes the techniques presently employed at the University of Minnesota for the labeling of blood products, and theirmore » clinical use. Consideration also is given to the desired expertise and cost factors involved in the labeling of leukocytes and platelets.43 references.« less

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.

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

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

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

Combining position-specific 13C labeling with compound-specific isotope analysis: first steps towards soil fluxomics

NASA Astrophysics Data System (ADS)

Dippold, Michaela; Kuzyakov, Yakov

2015-04-01

Understanding the soil organic matter (SOM) dynamics is one of the most important challenges in soil science. Transformation of low molecular weight organic substances (LMWOS) is a key step in biogeochemical cycles because 1) all high molecular substances pass this stage during their decomposition and 2) only LMWOS will be taken up by microorganisms. Previous studies on LMWOS were focused on determining net fluxes through the LMWOS pool, but they rarely identified transformations. As LMWOS are the preferred C and energy source for microorganisms, the transformations of LMWOS are dominated by biochemical pathways of the soil microorganisms. Thus, understanding fluxes and transformations in soils requires a detailed knowledge on the biochemical pathways and its controlling factors. Tracing C fate in soil by isotopes became on of the most applied and promising biogeochemistry tools. Up to now, studies on LMWOS were nearly exclusively based on uniformly labeled organic substances i.e. all C atoms in the molecules were labeled with 13C or 14C. However, this classical approach did not allow the differentiation between use of intact initial substances in any process, or whether they were transformed to metabolites. The novel tool of position-specific labeling enables to trace molecule atoms separately and thus to determine the cleavage of molecules - a prerequisite for metabolic tracing. Position-specific labeling of LMWOS and quantification of 13CO2 and 13C in bulk soil enabled following the basic metabolic pathways of soil microorganisms. However, only the combination of position-specific 13C labeling with compound-specific isotope analysis of microbial biomarkers and metabolites allowed 1) tracing specific anabolic pathways in diverse microbial communities in soils and 2) identification of specific pathways of individual functional microbial groups. So, these are the prerequisites for soil fluxomics. Our studies combining position-specific labeled glucose with amino

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...

All Natural and Clean-Label Preservatives and Antimicrobial Agents Used during Poultry Processing and Packaging.

PubMed

Grant, Ar'quette; Parveen, Salina

2017-04-01

The poultry industry is faced with compounding pressures of maintaining product safety and wholesomeness while keeping up with consumer trends of all-natural foods and label accuracy. Consumers are increasingly demanding that their foods be minimally processed and contain compounds that are easily read and recognized, i.e., products must be clean labeled. The purpose of this review is to briefly describe several natural antimicrobial agents that can be incorporated into poultry processing. These compounds and their essential oils were included in this mini-review because they are generally recognized as safe by the U.S. Food and Drug Administration and are considered clean label: thyme extract, rosemary extract, garlic, and oregano. This list of natural antimicrobial agents by no means includes all of the options available to poultry processors. Rather, this review provides a brief glance at the potential these natural antimicrobial agents have in terms of reduced pathogenicity, increased shelf stability, and sensory acceptability through direct product application or as part of the product packaging.

99mTc: Labeling Chemistry and Labeled Compounds

NASA Astrophysics Data System (ADS)

Alberto, R.; Abram, U.

This chapter reviews the radiopharmaceutical chemistry of technetium related to the synthesis of perfusion agents and to the labeling of receptor-binding biomolecules. To understand the limitations of technetium chemistry imposed by future application of the complexes in nuclear medicine, an introductory section analyzes the compulsory requirements to be considered when facing the incentive of introducing a novel radiopharmaceutical into the market. Requirements from chemistry, routine application, and market are discussed. In a subsequent section, commercially available 99mTc-based radiopharmaceuticals are treated. It covers the complexes in use for imaging the most important target organs such as heart, brain, or kidney. The commercially available radiopharmaceuticals fulfill the requirements outlined earlier and are discussed with this background. In a following section, the properties and perspectives of the different generations of radiopharmaceuticals are described in a general way, covering characteristics for perfusion agents and for receptor-specific molecules. Technetium chemistry for the synthesis of perfusion agents and the different labeling approaches for target-specific biomolecules are summarized. The review comprises a general introduction to the common approaches currently in use, employing the N x S4-x , [3+1] and 2-hydrazino-nicotinicacid (HYNIC) method as well as more recent strategies such as the carbonyl and the TcN approach. Direct labeling without the need of a bifunctional chelator is briefly reviewed as well. More particularly, recent developments in the labeling of concrete targeting molecules, the second generation of radiopharmaceuticals, is then discussed and prominent examples with antibodies/peptides, neuroreceptor targeting small molecules, myocardial imaging agents, vitamins, thymidine, and complexes relevant to multidrug resistance are given. In addition, a new approach toward peptide drug development is described. The section

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.

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

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

Separation-oriented derivatization of native fluorescent compounds through fluorous labeling followed by liquid chromatography with fluorous-phase.

PubMed

Sakaguchi, Yohei; Yoshida, Hideyuki; Todoroki, Kenichiro; Nohta, Hitoshi; Yamaguchi, Masatoshi

2009-06-15

We have developed a new and simple method based on "fluorous derivatization" for LC of native fluorescent compounds. This method involves the use of a column with a fluorous stationary phase. Native fluorescent analytes with target functional groups are precolumn derivatized with a nonfluorescent fluorous tag, and the fluorous-labeled analytes are retained in the column, whereas underivatized substances are not. Only the retained fluorescent analytes are detected fluorometrically at appropriate retention times, and retained substrates without fluorophores are not detected. In this study, biologically important carboxylic acids (homovanillic acid, vanillylmandelic acid, and 5-hydroxyindoleacetic acid) and drugs (naproxen, felbinac, flurbiprofen, and etodolac) were used as model native fluorescent compounds. Experimental results indicate that the fluorous-phase column can selectively retain fluorous compounds including fluorous-labeled analytes on the basis of fluorous separation. We believe that separation-oriented derivatization presented here is the first step toward the introduction of fluorous derivatization in quantitative LC analysis.

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.

United States Food and Drug Administration Product Label Changes.

PubMed

Kircik, Leon; Sung, Julie C; Stein-Gold, Linda; Goldenberg, Gary

2017-02-01

Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug.

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...

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...

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...

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

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...

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...

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...

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...

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...

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

United States Food and Drug Administration Product Label Changes

PubMed Central

Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

2017-01-01

Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:28367259

United States Food and Drug Administration Product Label Changes

PubMed Central

Sung, Julie C.; Stein-Gold, Linda; Goldenberg, Gary

2016-01-01

Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug. Diclofenac gel, 5-fluorouracil cream, imiquimod, and ingenol mebutate are examples of actinic keratosis treatments that have all undergone at least one label revision. With the current system of spontaneous reports leading to numerous label changes, each occurrence does not necessarily signify a radical change in the safety of a drug. PMID:26962391

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...

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...

Accuracy of testosterone concentrations in compounded testosterone products.

PubMed

Grober, Ethan D; Garbens, Alaina; Božović, Andrea; Kulasingam, Vathany; Fanipour, Majid; Diamandis, Eleftherios P

2015-06-01

This study aims to evaluate the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies. Ten compounding pharmacies within Toronto area were included. Pharmacies were blinded as to the nature of the study. A standardized prescription for 50 mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded batches were analyzed from each pharmacy 1 month apart. Testosterone concentrations in a 5-g sachet of Androgel® 1% (Abbott) and 5-g tube of Testim®1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Laboratory Medicine Program at the University Health Network. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone. Compounded formulations included seven gels and three creams with a volume/daily dose ranging from 0.2 mL to 1.25 mL. Product cost ranged from $57.32 to $160.71 for a 30-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products. In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within ± 20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone. Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment. © 2015 International Society for Sexual Medicine.

Identification of potential genomic biomarkers of hepatotoxicity caused by reactive metabolites of N-methylformamide: Application of stable isotope labeled compounds in toxicogenomic studies.

PubMed

Mutlib, Abdul; Jiang, Ping; Atherton, Jim; Obert, Leslie; Kostrubsky, Seva; Madore, Steven; Nelson, Sidney

2006-10-01

The inability to predict if a metabolically bioactivated compound will cause toxicity in later stages of drug development or post-marketing is of serious concern. One approach for improving the predictive success of compound toxicity has been to compare the gene expression profile in preclinical models dosed with novel compounds to a gene expression database generated from compounds with known toxicity. While this guilt-by-association approach can be useful, it is often difficult to elucidate gene expression changes that may be related to the generation of reactive metabolites. In an effort to address this issue, we compared the gene expression profiles obtained from animals treated with a soft-electrophile-producing hepatotoxic compound against corresponding deuterium labeled analogues resistant to metabolic processing. Our aim was to identify a subset of potential biomarker genes for hepatotoxicity caused by soft-electrophile-producing compounds. The current study utilized a known hepatotoxic compound N-methylformamide (NMF) and its two analogues labeled with deuterium at different positions to block metabolic oxidation at the formyl (d(1)) and methyl (d(3)) moieties. Groups of mice were dosed with each compound, and their livers were harvested at different time intervals. RNA was prepared and analyzed on Affymetrix GeneChip arrays. RNA transcripts showing statistically significant changes were identified, and selected changes were confirmed using TaqMan RT-PCR. Serum clinical chemistry and histopathologic evaluations were performed on selected samples as well. The data set generated from the different groups of animals enabled us to determine which gene expression changes were attributed to the bioactivating pathway. We were able to selectively modulate the metabolism of NMF by labeling various positions of the molecule with a stable isotope, allowing us to monitor gene changes specifically due to a particular metabolic pathway. Two groups of genes were

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

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.

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.

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...

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.

21 CFR 350.50 - Labeling of antiperspirant drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

21 CFR 350.50 - Labeling of antiperspirant drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

21 CFR 350.50 - Labeling of antiperspirant drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

21 CFR 350.50 - Labeling of antiperspirant drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

21 CFR 350.50 - Labeling of antiperspirant drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... following: “dampness,” “perspiration,” “sweat,” “sweating,” or “wetness”]. (2) The labeling may state “also...: ‘dampness,’ ‘perspiration,’ ‘sweat,’ ‘sweating,’ or ‘wetness’] due to stress”. (3) For products that demonstrate standard effectiveness (20 percent sweat reduction) over a 24-hour period, the labeling may state...

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...

21 CFR 331.30 - Labeling of antacid products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) For products containing more than 5 gm per day lactose in a maximum daily dosage: “Do not use this...

21 CFR 331.30 - Labeling of antacid products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) For products containing more than 5 gm per day lactose in a maximum daily dosage: “Do not use this...

21 CFR 331.30 - Labeling of antacid products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...) For products containing more than 5 gm per day lactose in a maximum daily dosage: “Do not use this...

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...

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...

Compound cast product and method for producing a compound cast product

DOEpatents

Meyer, Thomas N.; Viswanathan, Srinath

2002-09-17

A compound cast product is formed in a casting mold (14) having a mold cavity (16) sized and shaped to form the cast product. A plurality of injectors (24) is supported from a bottom side (26) of the casting mold (14). The injectors (24) are in fluid communication with the mold cavity (16) through the bottom side (26) of the casting mold (14). A molten material holder furnace (12) is located beneath the casting mold (14). The holder furnace (12) defines molten material receiving chambers (36) configured to separately contain supplies of two different molten materials (37, 38). The holder furnace (12) is positioned such that the injectors (24) extend downward into the receiving chamber (36). The receiving chamber (36) is separated into at least two different flow circuits (51, 52). A first molten material (37) is received in a first flow circuit (51), and a second molten material (38) is received into a second flow circuit (52). The first and second molten materials (37, 38) are injected into the mold cavity (16) by the injectors (24) acting against the force of gravity. The injectors (24) are positioned such that the first and second molten materials (37, 38) are injected into different areas of the mold cavity (16). The molten materials (37, 38) are allowed to solidify and the resulting compound cast product is removed from the mold cavity (16).

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 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...

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.

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...

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...

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.

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.

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.

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

Simple, rapid method for the preparation of isotopically labeled formaldehyde

DOEpatents

Hooker, Jacob Matthew [Port Jefferson, NY; Schonberger, Matthias [Mains, DE; Schieferstein, Hanno [Aabergen, DE; Fowler, Joanna S [Bellport, NY

2011-10-04

Isotopically labeled formaldehyde (*C.sup..sctn.H.sub.2O) is prepared from labeled methyl iodide (*C.sup..sctn.H.sub.3I) by reaction with an oxygen nucleophile having a pendant leaving group. The mild and efficient reaction conditions result in good yields of *C.sup..sctn.H.sub.2O with little or no *C isotopic dilution. The simple, efficient production of .sup.11CH.sub.2O is described. The use of the .sup.11CH.sub.2O for the formation of positron emission tomography tracer compounds is described. The reaction can be incorporated into automated equipment available to radiochemistry laboratories. The isotopically labeled formaldehyde can be used in a variety of reactions to provide radiotracer compounds for imaging studies as well as for scintillation counting and autoradiography.

Production of carbon-13-labeled cadaverine by engineered Corynebacterium glutamicum using carbon-13-labeled methanol as co-substrate.

PubMed

Leßmeier, Lennart; Pfeifenschneider, Johannes; Carnicer, Marc; Heux, Stephanie; Portais, Jean-Charles; Wendisch, Volker F

2015-12-01

Methanol, a one-carbon compound, can be utilized by a variety of bacteria and other organisms as carbon and energy source and is regarded as a promising substrate for biotechnological production. In this study, a strain of non-methylotrophic Corynebacterium glutamicum, which was able to produce the polyamide building block cadaverine as non-native product, was engineered for co-utilization of methanol. Expression of the gene encoding NAD+-dependent methanol dehydrogenase (Mdh) from the natural methylotroph Bacillus methanolicus increased methanol oxidation. Deletion of the endogenous aldehyde dehydrogenase genes ald and fadH prevented methanol oxidation to carbon dioxide and formaldehyde detoxification via the linear formaldehyde dissimilation pathway. Heterologous expression of genes for the key enzymes hexulose-6-phosphate synthase and 6-phospho-3-hexuloisomerase of the ribulose monophosphate (RuMP) pathway in this strain restored growth in the presence of methanol or formaldehyde, which suggested efficient formaldehyde detoxification involving RuMP key enzymes. While growth with methanol as sole carbon source was not observed, the fate of 13C-methanol added as co-substrate to sugars was followed and the isotopologue distribution indicated incorporation into central metabolites and in vivo activity of the RuMP pathway. In addition, 13C-label from methanol was traced to the secreted product cadaverine. Thus, this synthetic biology approach led to a C. glutamicum strain that converted the non-natural carbon substrate methanol at least partially to the non-native product cadaverine.

Regioselective and stereospecific deuteration of bioactive aza compounds by the use of ruthenium nanoparticles.

PubMed

Pieters, Grégory; Taglang, Céline; Bonnefille, Eric; Gutmann, Torsten; Puente, Céline; Berthet, Jean-Claude; Dugave, Christophe; Chaudret, Bruno; Rousseau, Bernard

2014-01-03

An efficient H/D exchange method allowing the deuteration of pyridines, quinolines, indoles, and alkyl amines with D2 in the presence of Ru@PVP nanoparticles is described. By a general and simple procedure involving mild reaction conditions and simple filtration to recover the labeled product, the isotopic labeling of 22 compounds proceeded in good yield with high chemo- and regioselectivity. The viability of this procedure was demonstrated by the labeling of eight biologically active compounds. Remarkably, enantiomeric purity was conserved in the labeled compounds, even though labeling took place in the vicinity of the stereogenic center. The level of isotopic enrichment observed is suitable for metabolomic studies in most cases. This approach is also perfectly adapted to tritium labeling because it uses a gas as an isotopic source. Besides these applications to molecules of biological interest, this study reveals a rich and underestimated chemistry on the surface of ruthenium nanoparticles. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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...

76 FR 13550 - Fur Products Labeling Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-14

... products of ``relatively small quantity or values from labeling requirements. 15 U.S.C. 69(d). Exercising... things, the economic impact of, and the continuing need for, the Fur Rule provisions; the benefits of the...) Is there a continuing need for the Rules as currently promulgated? Why or why not? (2) What benefits...

21 CFR 341.78 - Labeling of expectorant 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 expectorant drug products. 341.78 Section 341.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

21 CFR 341.78 - Labeling of expectorant 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 expectorant drug products. 341.78 Section 341.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

21 CFR 341.78 - Labeling of expectorant 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 expectorant drug products. 341.78 Section 341.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

21 CFR 341.78 - Labeling of expectorant 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 expectorant drug products. 341.78 Section 341.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

21 CFR 341.78 - Labeling of expectorant 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 expectorant drug products. 341.78 Section 341.78 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR...

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. ...

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. ...

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. ...

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. ...

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. ...

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...

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...

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.

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...

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...

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...

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...

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.

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...

Testing isotopic labeling with [¹³C₆]glucose as a method of advanced glycation sites identification.

PubMed

Kielmas, Martyna; Kijewska, Monika; Stefanowicz, Piotr; Szewczuk, Zbigniew

2012-12-01

The Maillard reaction occurring between reducing sugars and reactive amino groups of biomolecules leads to the formation of a heterogeneous mixture of compounds: early, intermediate, and advanced glycation end products (AGEs). These compounds could be markers of certain diseases and of the premature aging process. Detection of Amadori products can be performed by various methods, including MS/MS techniques and affinity chromatography on immobilized boronic acid. However, the diversity of the structures of AGEs makes detection of these compounds more difficult. The aim of this study was to test a new method of AGE identification based on isotope (13)C labeling. The model protein (hen egg lysozyme) was modified with an equimolar mixture of [(12)C(6)]glucose and [(13)C(6)]glucose and then subjected to reduction of the disulfide bridges followed by tryptic hydrolysis. The digest obtained was analyzed by LC-MS. The glycation products were identified on the basis of characteristic isotopic patterns resulting from the use of isotopically labeled glucose. This method allowed identification of 38 early Maillard reaction products and five different structures of the end glycation products. This isotopic labeling technique combined with LC-MS is a sensitive method for identification of advanced glycation end products even if their chemical structure is unknown. Copyright © 2012 Elsevier Inc. All rights reserved.

21 CFR 347.52 - Labeling of astringent drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... use only”. (ii) The labeling states “When using this product [bullet] avoid contact with eyes. If... affected area. Dry pencil after use.” (3) For products containing witch hazel identified in § 347.12(c... may be omitted. The second warning in § 347.52(c)(1) may state: “avoid contact with eyes”. The warning...

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...

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...

Monitoring Microbial Mineralization Using Reverse Stable Isotope Labeling Analysis by Mid-Infrared Laser Spectroscopy

PubMed Central

2017-01-01

Assessing the biodegradation of organic compounds is a frequent question in environmental science. Here, we present a sensitive, inexpensive, and simple approach to monitor microbial mineralization using reverse stable isotope labeling analysis (RIL) of dissolved inorganic carbon (DIC). The medium for the biodegradation assay contains regular organic compounds and 13C-labeled DIC with 13C atom fractions (x(13C)DIC) higher than natural abundance (typically 2–50%). The produced CO2 (x(13C) ≈ 1.11%) gradually dilutes the initial x(13C)DIC allowing to quantify microbial mineralization using mass-balance calculations. For 13C-enriched CO2 samples, a newly developed isotope ratio mid-infrared spectrometer was introduced with a precision of x(13C) < 0.006%. As an example for extremely difficult and slowly degradable compounds, CO2 production was close to the theoretical stoichiometry for anaerobic naphthalene degradation by a sulfate-reducing enrichment culture. Furthermore, we could measure the aerobic degradation of dissolved organic carbon (DOC) adsorbed to granular activated carbon in a drinking water production plant, which cannot be labeled with 13C. Thus, the RIL approach can be applied to sensitively monitor biodegradation of various organic compounds under anoxic or oxic conditions. PMID:28903553

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.

Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products

PubMed Central

Nishioka, Marcia; Standley, Laurel J.; Perovich, Laura J.; Brody, Julia Green; Rudel, Ruthann A.

2012-01-01

Background: Laboratory and human studies raise concerns about endocrine disruption and asthma resulting from exposure to chemicals in consumer products. Limited labeling or testing information is available to evaluate products as exposure sources. Objectives: We analytically quantified endocrine disruptors and asthma-related chemicals in a range of cosmetics, personal care products, cleaners, sunscreens, and vinyl products. We also evaluated whether product labels provide information that can be used to select products without these chemicals. Methods: We selected 213 commercial products representing 50 product types. We tested 42 composited samples of high-market-share products, and we tested 43 alternative products identified using criteria expected to minimize target compounds. Analytes included parabens, phthalates, bisphenol A (BPA), triclosan, ethanolamines, alkylphenols, fragrances, glycol ethers, cyclosiloxanes, and ultraviolet (UV) filters. Results: We detected 55 compounds, indicating a wide range of exposures from common products. Vinyl products contained > 10% bis(2-ethylhexyl) phthalate (DEHP) and could be an important source of DEHP in homes. In other products, the highest concentrations and numbers of detects were in the fragranced products (e.g., perfume, air fresheners, and dryer sheets) and in sunscreens. Some products that did not contain the well-known endocrine-disrupting phthalates contained other less-studied phthalates (dicyclohexyl phthalate, diisononyl phthalate, and di-n-propyl phthalate; also endocrine-disrupting compounds), suggesting a substitution. Many detected chemicals were not listed on product labels. Conclusions: Common products contain complex mixtures of EDCs and asthma-related compounds. Toxicological studies of these mixtures are needed to understand their biological activity. Regarding epidemiology, our findings raise concern about potential confounding from co-occurring chemicals and misclassification due to variability in

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.

Labeling of Pesticide Products under the National Organic Program

EPA Pesticide Factsheets

This notice describes how registrants can obtain EPA approval of label language indicating that all ingredients in a pesticide product and all uses of that pesticide meet the criteria defined in the USDA National Organic Program Rule.

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...

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...

Child Nutrition Labeling for Meat and Poultry Products.

ERIC Educational Resources Information Center

Wade, Cheryl; And Others

Prepared for food manufacturers, this publication contains instructions for calculating the contribution that a meat or poultry product makes toward the meal pattern requirements of child nutrition programs. It also contains instructions on how to apply for and obtain the approval for a label containing a child nutrition statement. These…

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.

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.

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...

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...

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...

Utility and importance of animal data in drug product labels.

PubMed

Baldrick, Paul

2014-08-01

Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

Analysis of fluorescently labeled glycosphingolipid-derived oligosaccharides following ceramide glycanase digestion and anthranilic acid labeling.

PubMed

Neville, David C A; Coquard, Virginie; Priestman, David A; te Vruchte, Danielle J M; Sillence, Daniel J; Dwek, Raymond A; Platt, Frances M; Butters, Terry D

2004-08-15

Interest in cellular glycosphingolipid (GSL) function has necessitated the development of a rapid and sensitive method to both analyze and characterize the full complement of structures present in various cells and tissues. An optimized method to characterize oligosaccharides released from glycosphingolipids following ceramide glycanase digestion has been developed. The procedure uses the fluorescent compound anthranilic acid (2-aminobenzoic acid; 2-AA) to label oligosaccharides prior to analysis using normal-phase high-performance liquid chromatography. The labeling procedure is rapid, selective, and easy to perform and is based on the published method of Anumula and Dhume [Glycobiology 8 (1998) 685], originally used to analyze N-linked oligosaccharides. It is less time consuming than a previously published 2-aminobenzamide labeling method [Anal. Biochem. 298 (2001) 207] for analyzing GSL-derived oligosaccharides, as the fluorescent labeling is performed on the enzyme reaction mixture. The purification of 2-AA-labeled products has been improved to ensure recovery of oligosaccharides containing one to four monosaccharide units, which was not previously possible using the Anumula and Dhume post-derivatization purification procedure. This new approach may also be used to analyze both N- and O-linked oligosaccharides.

Photooxidation products of polycyclic aromatic compounds containing sulfur.

PubMed

Bobinger, Stefan; Andersson, Jan T

2009-11-01

Photooxidation of crude oil components is an important process that removes pollutants from the environment. Polycyclic aromatic compounds (PACs) are known to be toxic to many life forms, but little is known about their photooxidation products in the aqueous phase. We here identify a large number of photoproducts from 11 benzothiophenes, a polycyclic aromatic sulfur heterocycle that is a major representative of PACs in crude oil. The investigated compounds contain two to four methyl groups and an ethyl or an n-octyl group. In water, the products arise through oxidation of alkyl side chains to aldehydes and carboxylic acids or through an opening in one of the aromatic rings. The product analysis was performed using gas chromatography with mass spectrometric or atomic emission detection. The main product is always a sulfobenzoic acid, which strongly lowers the pH of the solution. With long alkyl substituents, surfactants are formed, which may possess solubilizing properties in water. The larger the number of alkyl groups, the faster is the photooxidation. Several of the identified acidic compounds were also found when whole crude oil was photooxidized, showing that simulation with individual compounds reflects the situation in whole crude.

Targeting Prostate-Specific Membrane Antigen (PSMA) with F-18-Labeled Compounds: the Influence of Prosthetic Groups on Tumor Uptake and Clearance Profile.

PubMed

Bouvet, Vincent; Wuest, Melinda; Bailey, Justin J; Bergman, Cody; Janzen, Nancy; Valliant, John F; Wuest, Frank

2017-12-01

Prostate-specific membrane antigen (PSMA) is an important biomarker expressed in the majority of prostate cancers. The favorable positron emission tomography (PET) imaging profile of the PSMA imaging agent 2-(3-(1-carboxy-5-[(6-[ 18 F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentane-dioic acid [ 18 F]DCFPyL in preclinical prostate cancer models and in prostate cancer patients stimulated the development and validation of other fluorine-containing PSMA inhibitors to further enhance pharmacokinetics and simplify production methods. Here, we describe the synthesis and radiopharmacological evaluation of various F-18-labeled PSMA inhibitors which were prepared through different prosthetic group chemistry strategies. Prosthetic groups N-succinimidyl-4-[ 18 F]fluorobenzoate ([ 18 F]SFB), 4-[ 18 F]fluorobenzaldehyde, and 2-deoxy-2-[ 18 F]fluoro-D-glucose ([ 18 F]FDG) were used for bioconjugation reactions to PSMA-binding lysine-urea-glutamate scaffold via acylation and oxime formation. All fluorine-containing PSMA inhibitors were tested for their PSMA inhibitory potency in an in vitro competitive binding assay in comparison to an established reference compound [ 125 I]TAAG-PSMA. Tumor uptake and clearance profiles of three F-18-labeled PSMA inhibitors ([ 18 F]4, [ 18 F]7, and [ 18 F]8) were studied with dynamic PET imaging using LNCaP tumor-bearing mice. F-18-labeled PSMA inhibitors were synthesized in 32-69 % radiochemical yields using (1) acylation reaction at the primary amino group of the lysine residue with [ 18 F]SFB and (2) oxime formation with 4-[ 18 F]fluorobenzaldehyde and [ 18 F]FDG using the respective aminooxy-functionalized lysine residue. Compound 7 displayed an IC 50 value of 6 nM reflecting very high affinity for PSMA. Compounds 4 and 8 showed IC 50 values of 13 and 62 nM, respectively. The IC 50 value of reference compound DCFPyL was 13 nM. Dynamic PET imaging revealed the following SUV 60min for radiotracer uptake in PSMA(+) LNCaP tumors: 0

Practices of pharmacies that compound extemporaneous formulations.

PubMed

Treadway, Angela K; Craddock, Deeatra; Leff, Richard

2007-07-01

A survey was conducted to characterize the standard of practice for extemporaneous pharmaceutical compounding within community and institutional pharmacies. Extemporaneous compounding practices vary among pharmacies. Because of this, the survey inquired specifically about a single pharmaceutical product (caffeine citrate 20 mg/mL) to minimize variability among respondents. Survey questions were written to identify compounding practice variations with (1) policies and procedures, (2) process validation, (3) personnel education, training, and evaluation, (4) expiration dating, (5) storage and handling of compounded prescriptions within the pharmacy, (6) labeling, (7) facilities and equipment, (8) end-product evaluation, (9) handling of sterile products outside of the pharmacy, (10) aseptic technique and product preparation, and (11) documentation. A total of 522 surveys were mailed; 117 completed surveys were returned and included in the analyses. Over half of the pharmacies surveyed were large institutional pharmacies with daily prescriptions exceeding 300. Almost 71% of pharmacies reported having policies and procedures for compounding and providing compounding training for staff. Almost one third of the pharmacies that responded did not have compounding policies and procedures and did not provide staff training. For those pharmacies that provided training, the methods used were diverse (e.g., lectures and videotapes, external certificate programs). Formulations used to compound caffeine appeared to be diverse as evidenced by the varied addition of inactive ingredients. A survey of compounding pharmacies found variability in overall compounding practices and training and in practices specifically related to compounding preparations of caffeine citrate.

Shelf Life of Food Products: From Open Labeling to Real-Time Measurements.

PubMed

Corradini, Maria G

2018-03-25

The labels currently used on food and beverage products only provide consumers with a rough guide to their expected shelf lives because they assume that a product only experiences a limited range of predefined handling and storage conditions. These static labels do not take into consideration conditions that might shorten a product's shelf life (such as temperature abuse), which can lead to problems associated with food safety and waste. Advances in shelf-life estimation have the potential to improve the safety, reliability, and sustainability of the food supply. Selection of appropriate kinetic models and data-analysis techniques is essential to predict shelf life, to account for variability in environmental conditions, and to allow real-time monitoring. Novel analytical tools to determine safety and quality attributes in situ coupled with modern tracking technologies and appropriate predictive tools have the potential to provide accurate estimations of the remaining shelf life of a food product in real time. This review summarizes the necessary steps to attain a transition from open labeling to real-time shelf-life measurements.

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.

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 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...

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...

High Throughput, Label-free Screening Small Molecule Compound Libraries for Protein-Ligands using Combination of Small Molecule Microarrays and a Special Ellipsometry-based Optical Scanner.

PubMed

Landry, James P; Fei, Yiyan; Zhu, X D

2011-12-01

Small-molecule compounds remain the major source of therapeutic and preventative drugs. Developing new drugs against a protein target often requires screening large collections of compounds with diverse structures for ligands or ligand fragments that exhibit sufficiently affinity and desirable inhibition effect on the target before further optimization and development. Since the number of small molecule compounds is large, high-throughput screening (HTS) methods are needed. Small-molecule microarrays (SMM) on a solid support in combination with a suitable binding assay form a viable HTS platform. We demonstrate that by combining an oblique-incidence reflectivity difference optical scanner with SMM we can screen 10,000 small-molecule compounds on a single glass slide for protein ligands without fluorescence labeling. Furthermore using such a label-free assay platform we can simultaneously acquire binding curves of a solution-phase protein to over 10,000 immobilized compounds, thus enabling full characterization of protein-ligand interactions over a wide range of affinity constants.

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

Process for removing halogenated aliphatic and aromatic compounds from petroleum products

DOEpatents

Googin, John M.; Napier, John M.; Travaglini, Michael A.

1983-01-01

A process for removing halogenated aliphatic and aromatic compounds, e.g., polychlorinated biphenyls, from petroleum products by solvent extraction. The halogenated aliphatic and aromatic compounds are extracted from a petroleum product into a polar solvent by contacting the petroleum product with the polar solvent. The polar solvent is characterized by a high solubility for the extracted halogenated aliphatic and aromatic compounds, a low solubility for the petroleum product and considerable solvent power for polyhydroxy compound. The preferred polar solvent is dimethylformamide. A miscible compound, such as, water or a polyhydroxy compound, is added to the polar extraction solvent to increase the polarity of the polar extraction solvent. The halogenated aliphatic and aromatic compounds are extracted from the highly-polarized mixture of water or polyhydroxy compound and polar extraction solvent into a low polar or nonpolar solvent by contacting the water or polyhydroxy compound-polar solvent mixture with the low polar or nonpolar solvent. The halogenated aliphatic and aromatic compounds and the low polar or nonpolar solvent are separated by physical means, e.g., vacuum evaporation. The polar and nonpolar solvents are recovered from recycling. The process can easily be designed for continuous operation. Advantages of the process include that the polar solvent and a major portion of the nonpolar solvent can be recycled, the petroleum products are reclaimable and the cost for disposing of waste containing polychlorinated biphenyls is significantly reduced.

Microbial status and product labelling of 58 original tattoo inks.

PubMed

Høgsberg, T; Saunte, D M; Frimodt-Møller, N; Serup, J

2013-01-01

European Council resolutions on tattoo ink introduce sterility and preservation of inks to protect customers. Inks used in Denmark are typically purchased over the internet from international suppliers and manufacturers from the US and the UK. In Denmark tattoo inks are regulated and labelled according to REACH as if they were plain chemicals. The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Physical inspection and culture of bacteria and fungi. Six of 58 unopened stock bottles (10%) were contaminated with bacteria and one of six samples (17%) of previously used stock bottles was contaminated. The bacterial species represented bacteria considered pathogenic in humans as well as non-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled a maximum period of durability of typically 2-3 years. The physical sealing was leaking in 28% of the products. The European Council resolutions regarding safety of tattoo inks are not effective. Stock bottles of tattoo ink may contain bacteria pathogenic to humans and environmental bacteria, and packaging, labelling and preservation of inks are of inadequate quality. Claim of sterility can be erroneous. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Label-free pharmacological profiling based on dynamic mass redistribution for characterization and authentication of hazardous natural products.

PubMed

Song, Hui-Peng; Wang, Hong; Zhao, Xiaoai; He, Ling; Zhong, Huailing; Wu, Si-Qi; Li, Ping; Yang, Hua

2017-07-05

Natural products are becoming increasingly popular in multiple fields involving medicines, foods and beverages. However, due to the frequent occurrence of poisoning incidents, their toxicity and safety have caused a serious concern. Here we report a method of biosensor-based two-phase pharmacological profiling (BTPP) for discovery, monitor and control of receptor-targeted natural products. BTPP uses a resonant waveguide grating biosensor for label-free and non-invasive detection of intracellular dynamic mass redistribution (DMR), a phenomenon caused by protein relocalization after receptors receiving stimulation from toxicants. The method can not only facilitate the identification of hazardous materials but also quantify their bioactivity by EC 50 . As a proof of concept, the method was successfully applied to recognize Daturae Flos (DF), an herb that can antagonize muscarinic acetylcholine M 2 receptor and further cause poisoning, from other easily confused species. BTPP combined with high performance liquid chromatography revealed that scopolamine and hyoscyamine in DF were the key marker compounds. Moreover, the method accurately picked out 2 M 2 receptor antagonists from 25 natural compounds, displaying its potential in high-throughput screening. This study provides a systematic illustration about the establishment, applicability and advantages of BTPP, which contributes to the safety assessment of natural products in related fields. Copyright © 2017 Elsevier B.V. All rights reserved.

Labeling HCFC Products Starting 2015: What You Need to Know

EPA Pesticide Factsheets

Fact sheet explains that 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.

Process for removing halogenated aliphatic and aromatic compounds from petroleum products

DOEpatents

Googin, J.M.; Napier, J.M.; Travaglini, M.A.

1983-09-20

A process is described for removing halogenated aliphatic and aromatic compounds, e.g., polychlorinated biphenyls, from petroleum products by solvent extraction. The halogenated aliphatic and aromatic compounds are extracted from a petroleum product into a polar solvent by contacting the petroleum product with the polar solvent. The polar solvent is characterized by a high solubility for the extracted halogenated aliphatic and aromatic compounds, a low solubility for the petroleum product and considerable solvent power for polyhydroxy compound. The preferred polar solvent is dimethylformamide. A miscible compound, such as, water or a polyhydroxy compound, is added to the polar extraction solvent to increase the polarity of the polar extraction solvent. The halogenated aliphatic and aromatic compounds are extracted from the highly-polarized mixture of water or polyhydroxy compound and polar extraction solvent into a low polar or nonpolar solvent by contacting the water or polyhydroxy compound-polar solvent mixture with the low polar or nonpolar solvent. The halogenated aliphatic and aromatic compounds and the low polar or nonpolar solvent are separated by physical means, e.g., vacuum evaporation. The polar and nonpolar solvents are recovered from recycling. The process can easily be designed for continuous operation. Advantages of the process include that the polar solvent and a major portion of the nonpolar solvent can be recycled, the petroleum products are reclaimable and the cost for disposing of waste containing polychlorinated biphenyls is significantly reduced. 1 fig.

PRN 2001-1: First Aid Statements on Pesticide Product Labels

EPA Pesticide Factsheets

This PR notice is intended to provide guidance for what the Agency believes is the most updated appropriate first aid language for pesticide product labels to ensure that they continue to adequately protect the public.

Nutritional supplement products: Does the label information influence purchasing decisions for the physically active?

PubMed

Gabriels, Gary; Lambert, Mike

2013-10-02

The increase in sales of nutritional supplement globally can be attributed, in part, to aggressive marketing by manufacturers, rather than because the nutritional supplements have become more effective. Furthermore, the accuracy of the labelling often goes unchallenged. Therefore, any effects of the supplement, may be due to contaminants or adulterants in these products not reflected on the label. A self-administered questionnaire was used to determine how consumers of nutritional supplements acquired information to assist their decision-making processes, when purchasing a product. The study was approved by the University of Cape Town, Faculty of Health Sciences Human Research Ethics Committee. The questionnaire consisted of seven, closed and open-ended questions. The participants were asked to respond to the questions according to a defined list of statements. A total of 259 participants completed and returned questionnaires. The data and processing of the returned questionnaires was captured using Windows-based Microsoft® Office Excel 2003 SP 1 (Excel © 1985-2003 Microsoft Corporation). Statistica Version 10 (copyright © Stat Soft, Inc. 1984-2011) was used to calculate the descriptive statistics. The main finding of the study was that nearly 70% of the respondents who purchased supplements were strongly influenced by container label information that stipulated that the nutritional supplement product is free of banned substances. The second finding was that just over 50% of the respondents attached importance to the quality of the nutritional supplement product information on the container label. The third finding was that about 40% of the respondents were strongly influenced by the ingredients on the labels when they purchased nutritional supplements. This study, (i) identifies short-comings in current labelling information practices, (ii) provides opportunities to improve label and non-label information and communication, and, (iii) presents the case for

Nutritional supplement products: does the label information influence purchasing decisions for the physically active?

PubMed Central

2013-01-01

Background The increase in sales of nutritional supplement globally can be attributed, in part, to aggressive marketing by manufacturers, rather than because the nutritional supplements have become more effective. Furthermore, the accuracy of the labelling often goes unchallenged. Therefore, any effects of the supplement, may be due to contaminants or adulterants in these products not reflected on the label. Methods A self-administered questionnaire was used to determine how consumers of nutritional supplements acquired information to assist their decision-making processes, when purchasing a product. The study was approved by the University of Cape Town, Faculty of Health Sciences Human Research Ethics Committee. The questionnaire consisted of seven, closed and open-ended questions. The participants were asked to respond to the questions according to a defined list of statements. A total of 259 participants completed and returned questionnaires. The data and processing of the returned questionnaires was captured using Windows-based Microsoft® Office Excel 2003 SP 1 (Excel © 1985–2003 Microsoft Corporation). Statistica Version 10 (copyright © Stat Soft, Inc. 1984–2011) was used to calculate the descriptive statistics. Results The main finding of the study was that nearly 70% of the respondents who purchased supplements were strongly influenced by container label information that stipulated that the nutritional supplement product is free of banned substances. The second finding was that just over 50% of the respondents attached importance to the quality of the nutritional supplement product information on the container label. The third finding was that about 40% of the respondents were strongly influenced by the ingredients on the labels when they purchased nutritional supplements. Conclusion This study, (i) identifies short-comings in current labelling information practices, (ii) provides opportunities to improve label and non-label information and

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...

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...

21 CFR 346.50 - Labeling of anorectal drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

...., cream, lotion, or ointment).” (b) Indications. The labeling of the product states, under the heading... protective coating over inflamed tissues to help prevent drying of tissues.” (B) “Temporarily protects irritated areas.” (C) “Temporarily relieves burning.” (D) “Provides temporary relief from skin irritations...

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...

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...

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 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...

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...

Toward a sustainability label for food products: an analysis of experts' and consumers' acceptance.

PubMed

Engels, Stéphanie V; Hansmann, Ralf; Scholz, Roland W

2010-01-01

The recent proliferation of standards and labels for organic, fair-trade, locally produced, and healthy food products risks creating confusion among consumers. This study presents a standardized approach to developing a comprehensive sustainability label that incorporates ecological, economic, and social values. The methodology is based on an extension of modular life-cycle assessment to non-environmental sustainability criteria. Interviews with a wide range of experts (n=65) and a consumer survey (n=233) were conducted to analyze the feasibility and potential effectiveness of the approach. Responses indicated that a comprehensive sustainability label could considerably influence consumption patterns and facilitate cross-product comparisons. Copyright © Taylor & Francis Group, LLC

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...

[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.

16 CFR 1304.4 - Consumer patching compounds as banned hazardous products.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Consumer patching compounds as banned hazardous products. 1304.4 Section 1304.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS BAN OF CONSUMER PATCHING COMPOUNDS CONTAINING RESPIRABLE FREE-FORM ASBESTOS...

16 CFR 1304.4 - Consumer patching compounds as banned hazardous products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Consumer patching compounds as banned hazardous products. 1304.4 Section 1304.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS BAN OF CONSUMER PATCHING COMPOUNDS CONTAINING RESPIRABLE FREE-FORM ASBESTOS...

76 FR 3789 - Voluntary Labeling Program for Biobased Products

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... manufacturer or vendor has provided relevant information on the product for the USDA BioPreferred Program Web... labeling component of the BioPreferred Program. The final rule also applies to other entities (e.g., trade... Procurement Program (one part of the BioPreferred\\SM\\ Program) is available on the Internet at http://www...

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

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...

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...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

21 CFR 349.50 - Labeling of ophthalmic drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., discard.” (3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury...

Tetrazolium salts and formazan products in Cell Biology: Viability assessment, fluorescence imaging, and labeling perspectives.

PubMed

Stockert, Juan C; Horobin, Richard W; Colombo, Lucas L; Blázquez-Castro, Alfonso

2018-04-01

For many years various tetrazolium salts and their formazan products have been employed in histochemistry and for assessing cell viability. For the latter application, the most widely used are 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium bromide (MTT), and 5-cyano-2,3-di-(p-tolyl)-tetrazolium chloride (CTC) for viability assays of eukaryotic cells and bacteria, respectively. In these cases, the nicotinamide-adenine-dinucleotide (NAD(P)H) coenzyme and dehydrogenases from metabolically active cells reduce tetrazolium salts to strongly colored and lipophilic formazan products, which are then quantified by absorbance (MTT) or fluorescence (CTC). More recently, certain sulfonated tetrazolium, which give rise to water-soluble formazans, have also proved useful for cytotoxicity assays. We describe several aspects of the application of tetrazolium salts and formazans in biomedical cell biology research, mainly regarding formazan-based colorimetric assays, cellular reduction of MTT, and localization and fluorescence of the MTT formazan in lipidic cell structures. In addition, some pharmacological and labeling perspectives of these compounds are also described. Copyright © 2018 Elsevier GmbH. All rights reserved.

21 CFR 341.74 - Labeling of antitussive 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 antitussive drug products. 341.74 Section 341.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... years of age. Drug interaction precaution. “Do not use in a child who is taking a prescription monoamine...

21 CFR 341.74 - Labeling of antitussive 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 antitussive drug products. 341.74 Section 341.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... years of age. Drug interaction precaution. “Do not use in a child who is taking a prescription monoamine...

21 CFR 341.76 - Labeling of bronchodilator 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 bronchodilator drug products. 341.76 Section 341.76 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... prescription drug for asthma unless directed by a doctor.” (4) Drug interaction precaution. “Do not use if you...

21 CFR 341.76 - Labeling of bronchodilator 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 bronchodilator drug products. 341.76 Section 341.76 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... prescription drug for asthma unless directed by a doctor.” (4) Drug interaction precaution. “Do not use if you...

Nitrogenous compounds stimulate glucose-derived acid production by oral Streptococcus and Actinomyces.

PubMed

Norimatsu, Yuka; Kawashima, Junko; Takano-Yamamoto, Teruko; Takahashi, Nobuhiro

2015-09-01

Both Streptococcus and Actinomyces can produce acids from dietary sugars and are frequently found in caries lesions. In the oral cavity, nitrogenous compounds, such as peptides and amino acids, are provided continuously by saliva and crevicular gingival fluid. Given that these bacteria can also utilize nitrogen compounds for their growth, it was hypothesized that nitrogenous compounds may influence their acid production; however, no previous studies have examined this topic. Therefore, the present study aimed to assess the effects of nitrogenous compounds (tryptone and glutamate) on glucose-derived acid production by Streptococcus and Actinomyces. Acid production was evaluated using a pH-stat method under anaerobic conditions, whereas the amounts of metabolic end-products were quantified using high performance liquid chromatography. Tryptone enhanced glucose-derived acid production by up to 2.68-fold, whereas glutamate enhanced Streptococcus species only. However, neither tryptone nor glutamate altered the end-product profiles, indicating that the nitrogenous compounds stimulate the whole metabolic pathways involving in acid production from glucose, but are not actively metabolized, nor do they alter metabolic pathways. These results suggest that nitrogenous compounds in the oral cavity promote acid production by Streptococcus and Actinomyces in vivo. © 2015 The Societies and Wiley Publishing Asia Pty Ltd.

19 CFR 11.12 - Labeling of wool products to indicate fiber content.

Code of Federal Regulations, 2010 CFR

2010-04-01

... an importation of wool products, and pursuant to § 141.113 of this chapter shall demand the immediate.... (e) If the products covered by a notice and demand given pursuant to paragraph (d) of this section... 19 Customs Duties 1 2010-04-01 2010-04-01 false Labeling of wool products to indicate fiber...

Analyzing volatile compounds in dairy products

USDA-ARS?s Scientific Manuscript database

Volatile compounds give the first indication of the flavor in a dairy product. Volatiles are isolated from the sample matrix and then analyzed by chromatography, sensory methods, or an electronic nose. Isolation may be performed by solvent extraction or headspace analysis, and gas chromatography i...

Fragranced consumer products: Chemicals emitted, ingredients unlisted

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

Steinemann, Anne C., E-mail: acstein@u.washington.ed; MacGregor, Ian C.; Gordon, Sydney M.

2011-04-15

Fragranced consumer products are pervasive in society. Relatively little is known about the composition of these products, due to lack of prior study, complexity of formulations, and limitations and protections on ingredient disclosure in the U.S. We investigated volatile organic compounds (VOCs) emitted from 25 common fragranced consumer products-laundry products, personal care products, cleaning supplies, and air fresheners-using headspace analysis with gas chromatography/mass spectrometry (GC/MS). Our analysis found 133 different VOCs emitted from the 25 products, with an average of 17 VOCs per product. Of these 133 VOCs, 24 are classified as toxic or hazardous under U.S. federal laws, andmore » each product emitted at least one of these compounds. For 'green' products, emissions of these compounds were not significantly different from the other products. Of all VOCs identified across the products, only 1 was listed on any product label, and only 2 were listed on any material safety data sheet (MSDS). While virtually none of the chemicals identified were listed, this nonetheless accords with U.S. regulations, which do not require disclosure of all ingredients in a consumer product, or of any ingredients in a mixture called 'fragrance.' Because the analysis focused on compounds emitted and listed, rather than exposures and effects, it makes no claims regarding possible risks from product use. Results of this study contribute to understanding emissions from common products, and their links with labeling and legislation.« less

An overview of methods using (13)C for improved compound identification in metabolomics and natural products.

PubMed

Clendinen, Chaevien S; Stupp, Gregory S; Ajredini, Ramadan; Lee-McMullen, Brittany; Beecher, Chris; Edison, Arthur S

2015-01-01

Compound identification is a major bottleneck in metabolomics studies. In nuclear magnetic resonance (NMR) investigations, resonance overlap often hinders unambiguous database matching or de novo compound identification. In liquid chromatography-mass spectrometry (LC-MS), discriminating between biological signals and background artifacts and reliable determination of molecular formulae are not always straightforward. We have designed and implemented several NMR and LC-MS approaches that utilize (13)C, either enriched or at natural abundance, in metabolomics applications. For LC-MS applications, we describe a technique called isotopic ratio outlier analysis (IROA), which utilizes samples that are isotopically labeled with 5% (test) and 95% (control) (13)C. This labeling strategy leads to characteristic isotopic patterns that allow the differentiation of biological signals from artifacts and yield the exact number of carbons, significantly reducing possible molecular formulae. The relative abundance between the test and control samples for every IROA feature can be determined simply by integrating the peaks that arise from the 5 and 95% channels. For NMR applications, we describe two (13)C-based approaches. For samples at natural abundance, we have developed a workflow to obtain (13)C-(13)C and (13)C-(1)H statistical correlations using 1D (13)C and (1)H NMR spectra. For samples that can be isotopically labeled, we describe another NMR approach to obtain direct (13)C-(13)C spectroscopic correlations. These methods both provide extensive information about the carbon framework of compounds in the mixture for either database matching or de novo compound identification. We also discuss strategies in which (13)C NMR can be used to identify unknown compounds from IROA experiments. By combining technologies with the same samples, we can identify important biomarkers and corresponding metabolites of interest.

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.

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...

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...

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.

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.

21 CFR 344.52 - Labeling of ear drying aid drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Indications. The labeling of the product states, under the heading “Use,” the following: “dries water in the...] washing the hair”). Other truthful and nonmisleading statements, describing only the indications for use...

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

Bioactive Compounds in Functional Meat Products.

PubMed

Pogorzelska-Nowicka, Ewelina; Atanasov, Atanas G; Horbańczuk, Jarosław; Wierzbicka, Agnieszka

2018-01-31

Meat and meat products are a good source of bioactive compounds with positive effect on human health such as vitamins, minerals, peptides or fatty acids. Growing food consumer awareness and intensified global meat producers competition puts pressure on creating new healthier meat products. In order to meet these expectations, producers use supplements with functional properties for animal diet and as direct additives for meat products. In the presented work seven groups of key functional constituents were chosen: (i) fatty acids; (ii) minerals; (iii) vitamins; (iv) plant antioxidants; (v) dietary fibers; (vi) probiotics and (vii) bioactive peptides. Each of them is discussed in term of their impact on human health as well as some quality attributes of the final products.

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...

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...

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.

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 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...

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.

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...

21 CFR 333.250 - Labeling of antifungal drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) “For external use only.” (iii) “Avoid contact with the eyes.” (2) For products labeled according to... of the following: “Clean” or “Wash”] “the affected area and dry thoroughly. Apply” (the word “spray... of the following: “clean” or “wash”) “the feet and dry thoroughly. Apply” (the word “spray” may be...

21 CFR 333.350 - Labeling of acne drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... allows skin to heal.” (ii) “Penetrates pores to” (select one of the following: “eliminate most,” “control... pimples,” “blackheads,” or “whiteheads”). (iii) “Helps keep skin clear of new” (select one or more of the... labeling states “When using this product [bullet] skin irritation and dryness is more likely to occur if...

21 CFR 333.350 - Labeling of acne drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... allows skin to heal.” (ii) “Penetrates pores to” (select one of the following: “eliminate most,” “control... pimples,” “blackheads,” or “whiteheads”). (iii) “Helps keep skin clear of new” (select one or more of the... labeling states “When using this product [bullet] skin irritation and dryness is more likely to occur if...

21 CFR 333.350 - Labeling of acne drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... allows skin to heal.” (ii) “Penetrates pores to” (select one of the following: “eliminate most,” “control... pimples,” “blackheads,” or “whiteheads”). (iii) “Helps keep skin clear of new” (select one or more of the... labeling states “When using this product [bullet] skin irritation and dryness is more likely to occur if...

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...

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...

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...

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...

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...

Unintended allergens in precautionary labelled and unlabelled products pose significant risks to UK allergic consumers.

PubMed

Remington, B C; Baumert, J L; Blom, W M; Houben, G F; Taylor, S L; Kruizinga, A G

2015-07-01

Allergens in food may pose a risk to allergic consumers. While there is EU regulation for allergens present as an ingredient, this is not the case for unintended allergen presence (UAP). Food companies use precautionary allergen labels to inform allergic individuals of a potential risk from UAPs. This study investigates the risk of an allergic reaction within the milk-, wheat-, hazelnut- and peanut-allergic populations when ingesting UK foods across multiple product categories with and without precautionary allergen labelling. Allergen risk assessment using probabilistic techniques enables the estimation of the residual risk after the consumption of a product that unintentionally contains an allergen. Within this selection of UK products, the majority that tested positive for an allergen contained a concentration of allergen predicted to cause a reaction in >1% of the allergic population. The concentrations of allergens measured were greater than the VITAL(®) 2.0 action levels and would trigger precautionary allergen labelling. This was found for products both with and without precautionary allergen labelling. The results highlight the need for the food industry and regulators to adopt a transparent, risk-based approach for the communication of the risk associated with potential cross-contact that could occur in the processing facility or production chain. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Sampling of atmospheric carbonyl compounds for determination by liquid chromatography after 2,4-dinitrophenylhydrazine labelling

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

Vairavamurthy, A.; Roberts, J.M.; Newman, L.

1991-02-01

Determination of carbonyl compounds in the ambient atmosphere is receiving increasing attention because of the critical role these compounds play as pollutants and as key participants in tropospheric photochemistry. Carbonyls are involved in photochemical reactions as products of the oxidation of hydrocarbons, precursors of oxidants including ozone and peroxycarboxylic nitric anhydrides (PANs), and as sources of free radicals and organic aerosols. A correct understanding and assessment of the role of carbonyls in tropospheric chemistry requires the accurate and precise measurement of these compounds along with their parent and product compounds. Here we discuss some of these important issues along withmore » the different techniques used for time-integrated collection of carbonyls in the DNPH based liquid chromatographic methods because of their complexity, variability and as well their importance; we emphasize the principles, advantages, and limitations of these techniques. 58 refs., 9 figs., 3 tabs.« less

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...

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...

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...

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...

Process for production of a borohydride compound

DOEpatents

Allen, Nathan Tait; Butterick, III, Robert; Chin, Arthur Achhing; Millar, Dean Michael; Molzahn, David Craig

2014-08-19

A process for production of a borohydride compound M(BH.sub.4).sub.y. The process has three steps. The first step combines a compound of formula (R.sup.1O).sub.yM with aluminum, hydrogen and a metallic catalyst containing at least one metal selected from the group consisting of titanium, zirconium, hafnium, niobium, vanadium, tantalum and iron to produce a compound of formula M(AlH.sub.3OR.sup.1).sub.y, wherein R.sup.1 is phenyl or phenyl substituted by at least one alkyl or alkoxy group; M is an alkali metal, Be or Mg; and y is one or two; wherein the catalyst is present at a level of at least 200 ppm based on weight of aluminum. The second step combines the compound of formula M(AlH.sub.3OR.sup.1).sub.y with a borate, boroxine or borazine compound to produce M(BH.sub.4).sub.y and a byproduct mixture containing alkali metal and aluminum aryloxides. The third step separates M(BH.sub.4).sub.y from the byproduct mixture.

Single step signal group-imidazole labeling of organic phosphate groups under aqueous conditions

DOEpatents

Giese, Roger W.; Wang, Poguang

1996-01-01

Compounds and methods for single step, covalent labeling of the phosphate group of an organic substance under aqueous conditions are described. The labeling compound includes any kind of detectable signal group covalently bound to an imidazole moiety, which can be imidazole or a substituted imidazole. A preferred labeling compound has the formula ##STR1##

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

Survey of peanut levels in selected Irish food products bearing peanut allergen advisory labels.

PubMed

Robertson, Orla N; Hourihane, Jonathan O'B; Remington, Benjamin C; Baumert, Joseph L; Taylor, Steve L

2013-01-01

Peanut allergy affects up to 2% of consumers and is responsible for the majority of fatalities caused by food-induced anaphylaxis. Peanut-containing products must be clearly labelled. Manufacturers are not legally required to label peanut if its inclusion resulted from unintentional cross contact with foods manufactured in the same facility. However, the use of allergen advisory statements alerting consumers of the potential presence of peanut allergen has increased in recent years. In previous studies, the vast majority of foods with precautionary allergen statements did not contain detectable levels of peanut, but no data are available on Irish food products. Thirty-eight food products bearing peanut/nut allergen-related statements were purchased from multiple locations in the Republic of Ireland and analysed for the presence of peanut. Peanut was detected in at least one lot in 5.3% (2 of 38) of the products tested. The doses of peanut detected ranged from 0.14 mg to 0.52 mg per suggested serving size (0.035-0.13 mg peanut protein). No detectable levels of peanut were found in the products that indicated peanut/nuts as a minor ingredient. Quantitative risk assessment, based on the known distribution of individual threshold doses for peanut, indicates that only a very small percentage of the peanut-allergic population would be likely to experience an allergic reaction to those products while the majority of products with advisory labels appear safe for the peanut-allergic population. Food manufacturers should be encouraged to analyse products manufactured in shared facilities and even on shared equipment with peanuts for peanut residues to determine whether sufficient risk exists to warrant the use of advisory labelling. Although it appears that the majority of food products bearing advisory nut statements are in fact free of peanut contamination, advice to peanut allergy sufferers to avoid said foods should continue in Ireland and therefore in the wider European

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...

Sodium content and labelling of processed and ultra-processed food products marketed in Brazil.

PubMed

Martins, Carla Adriano; de Sousa, Anete Araújo; Veiros, Marcela Boro; González-Chica, David Alejandro; Proença, Rossana Pacheco da Costa

2015-05-01

To analyse the Na content and labelling of processed and ultra-processed food products marketed in Brazil. Cross-sectional study. A large supermarket in Florianopolis, southern Brazil. Ingredient lists and Na information on nutrition labels of all processed and ultra-processed pre-prepared meals and prepared ingredients, used in lunch or dinner, available for sale in the supermarket. The study analysed 1416 products, distributed into seven groups and forty-one subgroups. Five products did not have Na information. Most products (58.8 %; 95 % CI 55.4, 62.2 %) had high Na content (>600 mg/100 g). In 78.0 % of the subgroups, variation in Na content was at least twofold between similar products with high and low Na levels, reaching 634-fold difference in the 'garnishes and others' subgroup. More than half of the products (52.0 %; 95 % CI 48.2, 55.6 %) had at least one Na-containing food additive. There was no relationship between the appearance of salt on the ingredients list (first to third position on the list) and a product's Na content (high, medium or low; P=0.08). Most food products had high Na content, with great variation between similar products, which presents new evidence for reformulation opportunities. There were inconsistencies in Na labelling, such as lack of nutritional information and incomplete ingredient descriptions. The position of salt on the ingredients list did not facilitate the identification of high-Na foods. We therefore recommend a reduction in Na in these products and a review of Brazilian legislation.

Fragrance ingredient labelling in products on sale in the U.K.

PubMed

Buckley, D A

2007-08-01

The seventh amendment of the European Union (EU) Cosmetics Directive (March 2005) and the Detergents Regulations of the EU (October 2005) are now legal requirements in Europe. Cosmetic products and detergents must be labelled for 26 individual named fragrances, when present at concentrations of > 10 parts per million (p.p.m.) in leave-on products and > 100 p.p.m. in rinse-off products. To make an assessment of the exposure pattern to fragrance of the U.K. consumer and to determine the frequency with which the constituent fragrances of fragrance mix I (FM I) and fragrance mix II (FM II) are included in products currently sold in the U.K. A study of perfumed cosmetic and household products available on the shelves of U.K. retailers was carried out in January 2006. Products were included if 'parfum' or 'aroma' was listed among the ingredients. Three hundred products were surveyed and any of the 26 listed fragrances named on the label were recorded. The top six most frequently labelled fragrances were linalool (190; 63%), limonene (189; 63%), citronellol (145; 48%), geraniol (126; 42%), butyl phenyl methyl propional (Lilial(trade mark)) (126; 42%) and hexyl cinnamal (125; (42%). One of these, geraniol, is present in FM I and two others, citronellol and hexyl cinnamal, in FM II, thus tested as part of the British Standard patch test series. The frequencies of other constituents of FM I were as follows: eugenol, 80 (27%); hydroxycitronellal, 52 (17%); isoeugenol, 27 (9%); cinnamic alcohol, 25 (8%); amyl cinnamal, 22 (7%); cinnamal, 17 (6%); Evernia prunastri (oak moss absolute), 13 (4%). The other constituents of FM II occurred as follows: coumarin, 90 (30%); hydroxyisohexyl-3-cyclohexene carboxaldehyde (Lyral(trade mark)), 88 (29%); citral, 74 (25%); farnesol, 23 (8%). Linalool (n = 46; 66%) was the most frequently found fragrance in 70 personal care products (soap, shampoo, shower gel). Linalool (n = 47; 80%) and limonene (n = 45; 76%) were the most frequent in 59

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.

Single step signal group-imidazole labeling of organic phosphate groups under aqueous conditions

DOEpatents

Giese, R.W.; Wang, P.

1996-04-30

Compounds and methods for single step, covalent labeling of the phosphate group of an organic substance under aqueous conditions are described. The labeling compound includes any kind of detectable signal group covalently bound to an imidazole moiety, which can be imidazole or a substituted imidazole. A preferred labeling compound has the formula shown in the accompanying diagram. 4 figs.

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 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...

Made with Renewable Energy: How and Why Companies are Labeling Consumer Products

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

Baker Brannan, D.; Heeter, J.; Bird, L.

Green marketing--a marketing strategy highlighting the environmental attributes of a product, often through the use of labels or logos--dates back to the 1970s. It did not proliferate until the 1990s, however, when extensive market research identified a rapidly growing group of consumers with a heightened concern for the environment. This group expressed not only a preference for green products but also a willingness to pay a premium for such products. The response was a surge in green marketing that lasted through the early 1990s. This report discusses the experience of companies that communicate to consumers that their products are 'mademore » with renewable energy.' For this report, representatives from 20 companies were interviewed and asked to discuss their experiences marketing products produced using renewable energy. The first half of this report provides an overview of the type of companies that have labeled products or advertised them as being made with renewable energy. It also highlights the avenues companies use to describe their use of renewable energy. The second half of the report focuses on the motivations for making on-product claims about the use of renewable energy and the challenges in doing so.« less

Consumer choice: Linking consumer intentions to actual purchase of GM labeled food products.

PubMed

Sleenhoff, Susanne; Osseweijer, Patricia

2013-01-01

With a mandatory labeling scheme for GM food in Europe since 2004 measuring actual consumer choice in practice has become possible. Anticipating Europeans negative attitude toward GM food, the labeling was enforced to allow consumers to make an informed choice. We studied consumers actual purchase behavior of GM food products and compared this with their attitude and behavioral intention for buying GM food. We found that despite a majority of consumers voicing a negative attitude toward GM food over 50% of our European respondents stated that they did not actively avoid the purchase of GM food and 6% actually purchased one of the few available GM labeled food products in the period between September 2006 and October 2007. Our results imply that a voiced negative attitude of consumers in responses to questionnaires about their intentions is not a reliable guide for what they actually do in supermarkets. We conclude that the assumption of a negative attitude with regard to GM food is at least in part construed.

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...

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...

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...

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...

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...

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...

Organic Phase Change Nanoparticles for in-Product Labeling of Agrochemicals.

PubMed

Wang, Miao; Duong, Binh; Su, Ming

2015-10-28

There is an urgent need to develop in-product covert barcodes for anti-counterfeiting of agrochemicals. This paper reports a new organic nanoparticle-based in-product barcode system, in which a panel of organic phase change nanoparticles is added as a barcode into in a variety of chemicals (herein agrochemicals). The barcode is readout by detecting melting peaks of organic nanoparticles using differential scanning calorimetry. This method has high labeling capacity due to small sizes of nanoparticles, sharp melting peaks, and large scan range of thermal analysis. The in-product barcode can be effectively used to protect agrochemical products from being counterfeited due to its large coding capacity, technical readiness, covertness, and robustness.

21 CFR 341.80 - Labeling of nasal decongestant 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 nasal decongestant drug products. 341.80 Section 341.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to...

21 CFR 341.80 - Labeling of nasal decongestant 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 nasal decongestant drug products. 341.80 Section 341.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN..., subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to...

21 CFR 333.350 - Labeling of acne drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... following: “Clears,” “Clears up,” “Clears up most,” “Dries,” “Dries up,” “Dries and clears,” “Helps clear...) For products containing sulfur identified in §§ 333.310 (d) and (e). “Do not get into eyes. If...] rinse right away with water if it gets in eyes.” (ii) The labeling states “Stop use and ask a doctor...

21 CFR 344.52 - Labeling of ear drying aid drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Indications. The labeling of the product states, under the heading “Use,” the following: “dries water in the...]: Keep away from fire or flame.” (2) “Do not use [in bold type] in the eyes.” (3) “Ask a doctor before...

In vitro plant tissue culture: means for production of biological active compounds.

PubMed

Espinosa-Leal, Claudia A; Puente-Garza, César A; García-Lara, Silverio

2018-05-07

Plant tissue culture as an important tool for the continuous production of active compounds including secondary metabolites and engineered molecules. Novel methods (gene editing, abiotic stress) can improve the technique. Humans have a long history of reliance on plants for a supply of food, shelter and, most importantly, medicine. Current-day pharmaceuticals are typically based on plant-derived metabolites, with new products being discovered constantly. Nevertheless, the consistent and uniform supply of plant pharmaceuticals has often been compromised. One alternative for the production of important plant active compounds is in vitro plant tissue culture, as it assures independence from geographical conditions by eliminating the need to rely on wild plants. Plant transformation also allows the further use of plants for the production of engineered compounds, such as vaccines and multiple pharmaceuticals. This review summarizes the important bioactive compounds currently produced by plant tissue culture and the fundamental methods and plants employed for their production.

The use of compound topical anesthetics: a review.

PubMed

Kravitz, Neal D

2007-10-01

The author reviewed the history of, federal regulations regarding, risks of and adverse drug reactions of five compound topical anesthetics: tetracaine, adrenaline/epinephrine and cocaine (TAC); lidocaine, adrenaline/epinephrine and tetracaine (LET); lidocaine, tetracaine and phenylephrine (TAC 20 percent Alternate); lidocaine, prilocaine and tetracaine (Profound); and lidocaine, prilocaine, tetracaine and phenylephrine with thickeners (Profound PET). The author reviewed clinical trials, case reports, descriptive articles, and U.S. Food and Drug Administration (FDA) regulations and recent public advisory warnings regarding the federal approval of and risks associated with the use of compound topical anesthetics. Compound topical anesthetics are neither FDA-regulated nor -unregulated. Some compounding pharmacies bypass the new FDA drug approval process, which is based on reliable scientific data and ensures that a marketed drug is safe, effective, properly manufactured and accurately labeled. Two deaths have been attributed to the lay use of compound topical anesthetics. In response, the FDA has announced the strengthening of its efforts against unapproved drug products. Compound topical anesthetics may be an effective alternative to local infiltration for some minimally invasive dental procedures; however, legitimate concerns exist in regard to their safety. Until they become federally regulated, compound topical anesthetics remain unapproved drug products whose benefits may not outweigh their risks for dental patients.

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...

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...

76 FR 35619 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

...The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

National Meat Case Study 2004: Product labeling information, branding, and packaging trends.

PubMed

Reicks, A L; Brooks, J C; Kelly, J M; Kuecker, W G; Boillot, K; Irion, R; Miller, M F

2008-12-01

Fresh meat retail cases in 104 supermarkets across 5 regions of the United States were audited for the use of packaging types and materials, branding, and cooking/nutritional information. Frequency means were separated for species of beef, ground beef, pork, chicken, turkey, lamb, and veal. Traditional polyvinyl chloride overwrap was used on 47.0% of packages in the fresh meat case nationwide and was the most frequent packaging type for beef, ground beef, pork, lamb, and veal. The use of modified atmosphere packaging was greatest (P < 0.001) in ground beef (33.2%) and turkey (45.1%) products. The 3 most common tray colors in the fresh meat retail case on a national level were white (39.6%), yellow (22.4%), and black (11.5%). Foam trays were used in 72.6% of all packages in the retail meat case. In 2004, 60.2% of all packages were case-ready. Chicken (94.8%) and turkey (95.6%) products utilized case-ready packaging systems more (P < 0.001) than any other species. On a national level, 50.1% of all products carried a national brand, 12.2% carried a store brand, and the remaining 37.7% of products in the fresh meat case in 2004 were not branded. Chicken was most (P < 0.001) likely to carry a natural brand label. Labels with cooking instructions were found most (P < 0.001) on pork (37.3%) and turkey products (48.1%). Chicken (20.4%) and turkey products (20.7%) were most (P < 0.001) likely to have the cooking instructions printed on the packaging material compared with all other species. Labels with nutritional information were most (P < 0.001) likely to be found on turkey products (55.7%) in the fresh meat case compared with any other species. On the national level, 6.1% of all packages reported in the fresh meat case in 2004 were value-added.

Reductive methods for isotopic labeling of antibiotics

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

Champney, W.S.

1989-08-15

Methods for the reductive methylation of the amino groups of eight different antibiotics using {sup 3}HCOH or H{sup 14}COH are presented. The reductive labeling of an additional seven antibiotics by NaB{sub 3}H{sub 4} is also described. The specific activity of the methyl-labeled drugs was determined by a phosphocellulose paper binding assay. Two quantitative assays for these compounds based on the reactivity of the antibiotic amino groups with fluorescamine and of the aldehyde and ketone groups with 2,4-dinitrophenylhydrazine are also presented. Data on the cellular uptake and ribosome binding of these labeled compounds are also presented.

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

Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study

PubMed Central

Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

2016-01-01

Background Because vital details of potential pharmacokinetic drug-drug interactions are often described in free-text structured product labels, manual curation is a necessary but expensive step in the development of electronic drug-drug interaction information resources. The use of nonexperts to annotate potential drug-drug interaction (PDDI) mentions in drug product label annotation may be a means of lessening the burden of manual curation. Objective Our goal was to explore the practicality of using nonexpert participants to annotate drug-drug interaction descriptions from structured product labels. By presenting annotation tasks to both pharmacy experts and relatively naïve participants, we hoped to demonstrate the feasibility of using nonexpert annotators for drug-drug information annotation. We were also interested in exploring whether and to what extent natural language processing (NLP) preannotation helped improve task completion time, accuracy, and subjective satisfaction. Methods Two experts and 4 nonexperts were asked to annotate 208 structured product label sections under 4 conditions completed sequentially: (1) no NLP assistance, (2) preannotation of drug mentions, (3) preannotation of drug mentions and PDDIs, and (4) a repeat of the no-annotation condition. Results were evaluated within the 2 groups and relative to an existing gold standard. Participants were asked to provide reports on the time required to complete tasks and their perceptions of task difficulty. Results One of the experts and 3 of the nonexperts completed all tasks. Annotation results from the nonexpert group were relatively strong in every scenario and better than the performance of the NLP pipeline. The expert and 2 of the nonexperts were able to complete most tasks in less than 3 hours. Usability perceptions were generally positive (3.67 for expert, mean of 3.33 for nonexperts). Conclusions The results suggest that nonexpert annotation might be a feasible option for comprehensive

Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study.

PubMed

Hochheiser, Harry; Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

2016-04-11

Because vital details of potential pharmacokinetic drug-drug interactions are often described in free-text structured product labels, manual curation is a necessary but expensive step in the development of electronic drug-drug interaction information resources. The use of nonexperts to annotate potential drug-drug interaction (PDDI) mentions in drug product label annotation may be a means of lessening the burden of manual curation. Our goal was to explore the practicality of using nonexpert participants to annotate drug-drug interaction descriptions from structured product labels. By presenting annotation tasks to both pharmacy experts and relatively naïve participants, we hoped to demonstrate the feasibility of using nonexpert annotators for drug-drug information annotation. We were also interested in exploring whether and to what extent natural language processing (NLP) preannotation helped improve task completion time, accuracy, and subjective satisfaction. Two experts and 4 nonexperts were asked to annotate 208 structured product label sections under 4 conditions completed sequentially: (1) no NLP assistance, (2) preannotation of drug mentions, (3) preannotation of drug mentions and PDDIs, and (4) a repeat of the no-annotation condition. Results were evaluated within the 2 groups and relative to an existing gold standard. Participants were asked to provide reports on the time required to complete tasks and their perceptions of task difficulty. One of the experts and 3 of the nonexperts completed all tasks. Annotation results from the nonexpert group were relatively strong in every scenario and better than the performance of the NLP pipeline. The expert and 2 of the nonexperts were able to complete most tasks in less than 3 hours. Usability perceptions were generally positive (3.67 for expert, mean of 3.33 for nonexperts). The results suggest that nonexpert annotation might be a feasible option for comprehensive labeling of annotated PDDIs across a broader

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...

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...

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...

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...

Improved labelling of DTPA- and DOTA-conjugated peptides and antibodies with 111In in HEPES and MES buffer.

PubMed

Brom, Maarten; Joosten, Lieke; Oyen, Wim Jg; Gotthardt, Martin; Boerman, Otto C

2012-01-27

In single photon emission computed tomography [SPECT], high specific activity of 111In-labelled tracers will allow administration of low amounts of tracer to prevent receptor saturation and/or side effects. To increase the specific activity, we studied the effect of the buffer used during the labelling procedure: NaAc, NH4Ac, HEPES and MES buffer. The effect of the ageing of the 111InCl3 stock and cadmium contamination, the decay product of 111In, was also examined in these buffers. Escalating amounts of 111InCl3 were added to 1 μg of the diethylene triamine pentaacetic acid [DTPA]- and 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid [DOTA]-conjugated compounds (exendin-3, octreotide and anti-carbonic anhydrase IX [CAIX] antibody). Five volumes of 2-(N-morpholino)ethanesulfonic acid [MES], 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid [HEPES], NH4Ac or NaAc (0.1 M, pH 5.5) were added. After 20 min at 20°C (DTPA-conjugated compounds), at 95°C (DOTA-exendin-3 and DOTA-octreotide) or at 45°C (DOTA-anti-CAIX antibody), the labelling efficiency was determined by instant thin layer chromatography. The effect of the ageing of the 111InCl3 stock on the labelling efficiency of DTPA-exendin-3 as well as the effect of increasing concentrations of Cd2+ (the decay product of 111In) were also examined. Specific activities obtained for DTPA-octreotide and DOTA-anti-CAIX antibody were five times higher in MES and HEPES buffer. Radiolabelling of DTPA-exendin-3, DOTA-exendin-3 and DTPA-anti-CAIX antibody in MES and HEPES buffer resulted in twofold higher specific activities than that in NaAc and NH4Ac. Labelling of DTPA-exendin-3 decreased with 66% and 73% for NaAc and NH4Ac, respectively, at day 11 after the production date of 111InCl3, while for MES and HEPES, the maximal decrease in the specific activity was 10% and 4% at day 11, respectively. The presence of 1 pM Cd2+ in the labelling mixture of DTPA-exendin-3 in NaAc and NH4Ac markedly reduced the labelling

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.

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...

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.

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.

PRN 2003-1: Labeling of Pesticide Products under the National Organic Program

EPA Pesticide Factsheets

This notice describes how registrants can obtain EPA approval of label language indicating that all ingredients (active and inert) in a pesticide product and all uses of that pesticide meet the criteria defined in the USDA's National Organic Program Rule.

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...

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...

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...

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...

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...

Patterns of free amino acids in German convenience food products: marked mismatch between label information and composition.

PubMed

Hermanussen, M; Gonder, U; Jakobs, C; Stegemann, D; Hoffmann, G

2010-01-01

Free amino acids affect food palatability. As information on amino acids in frequently purchased pre-packaged food is virtually absent, we analyzed free amino acid patterns of 17 frequently purchased ready-to-serve convenience food products, and compared them with the information obtained from the respective food labels. Quantitative amino acid analysis was performed using ion-exchange chromatography. gamma-Aminobutyric acid (GABA) concentrations were verified using a stable isotope dilution gas chromatography/mass spectrometry (GC-MS) method. The patterns of free amino acids were compared with information obtained from food labels. An obvious mismatch between free amino acid patterns and food label information was detected. Even on considering that tomatoes and cereal proteins are naturally rich in glutamate, the concentrations of free glutamate outranged the natural concentration of this amino acid in several products, and strongly suggested artificial enrichment. Free glutamate was found to be elevated even in dishes that explicitly state 'no glutamate added'. Arginine was markedly elevated in lentils. Free cysteine was generally low, possibly reflecting thermal destruction of this amino acid during food processing. The meat and brain-specific dipeptide carnosine (CARN) was present in most meat-containing products. Some products did not contain detectable amounts of CARN in spite of meat content being claimed on the food labels. We detected GABA at concentrations that contribute significantly to the taste sensation. This investigation highlights a marked mismatch between food label information and food composition.

15N-labeled glycine synthesis.

PubMed

Tavares, Claudinéia R O; Bendassolli, José A; Coelho, Fernando; Sant'ana Filho, Carlos R; Prestes, Clelber V

2006-09-01

This work describes a method for 15N-isotope-labeled glycine synthesis, as well as details about a recovery line for nitrogen residues. To that effect, amination of alpha-haloacids was performed, using carboxylic chloroacetic acid and labeled aqueous ammonia (15NH3). Special care was taken to avoid possible 15NH3 losses, since its production cost is high. In that respect, although the purchase cost of the 13N-labeled compound (radioactive) is lower, the stable tracer produced constitutes an important tool for N cycling studies in living organisms, also minimizing labor and environmental hazards, as well as time limitation problems in field studies. The tests were carried out with three replications, and variable 15NH3aq volumes in the reaction were used (50, 100, and 150 mL), in order to calibrate the best operational condition; glycine masses obtained were 1.7, 2, and 3.2 g, respectively. With the development of a system for 15NH3 recovery, it was possible to recover 71, 83, and 87% of the ammonia initially used in the synthesis. With the required adaptations, the same system was used to recover methanol, and 75% of the methanol initially used in the amino acid purification process were recovered.

16 CFR 303.29 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2012 CFR

2012-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other textile fiber products are marketed or handled in pairs or ensembles of the same fiber content...

16 CFR 300.12 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2014 CFR

2014-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other wool products are marketed or handled in pairs or ensembles of the same fiber content, only one...

16 CFR 303.29 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2010 CFR

2010-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other textile fiber products are marketed or handled in pairs or ensembles of the same fiber content...

16 CFR 300.12 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2013 CFR

2013-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other wool products are marketed or handled in pairs or ensembles of the same fiber content, only one...

16 CFR 303.29 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2013 CFR

2013-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other textile fiber products are marketed or handled in pairs or ensembles of the same fiber content...

16 CFR 300.12 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2012 CFR

2012-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other wool products are marketed or handled in pairs or ensembles of the same fiber content, only one...

16 CFR 300.12 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2011 CFR

2011-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other wool products are marketed or handled in pairs or ensembles of the same fiber content, only one...

16 CFR 303.29 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2014 CFR

2014-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other textile fiber products are marketed or handled in pairs or ensembles of the same fiber content...

16 CFR 300.12 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2010 CFR

2010-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other wool products are marketed or handled in pairs or ensembles of the same fiber content, only one...

16 CFR 303.29 - Labeling of pairs or products containing two or more units.

Code of Federal Regulations, 2011 CFR

2011-01-01

... handled as a single product or ensemble and are sold and delivered to the ultimate consumer as a single product or ensemble, the required information may be set out on a single label in such a manner as to... other textile fiber products are marketed or handled in pairs or ensembles of the same fiber content...

78 FR 72057 - Rules and Regulations Under the Wool Products Labeling Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-02

... FEDERAL TRADE COMMISSION 16 CFR Part 300 Rules and Regulations Under the Wool Products Labeling Act AGENCY: Federal Trade Commission (``FTC'' or ``Commission''). ACTION: Extension of the deadline..., mail or deliver your comment to the following address: Federal Trade Commission, Office of the...

Data on volatile compounds in fermented materials used for salmon fish sauce production.

PubMed

Nakano, Mitsutoshi; Sagane, Yoshimasa; Koizumi, Ryosuke; Nakazawa, Yozo; Yamazaki, Masao; Watanabe, Toshihiro; Takano, Katsumi; Sato, Hiroaki

2018-02-01

This article describes the analysis of volatile compounds in fermented materials used for salmon fish sauce production via gas chromatography/mass spectrometry (GC/MS). Ten types of fish sauces were produced from raw salmon materials, including various proportions of flesh, viscera, inedible portion (heads, fins, and backbones), and soft roe, by mixing them with salt and allowing them to ferment for up to three months. The volatile compounds were captured by a solid-phase microextraction method and then applied to GC/MS for separation and identification of the compounds in the fish sauce products. The number of volatile compounds identified in the starting materials varied from 15 to 29 depending on the ingredients. The number of compounds in the final fish sauce products was reduced by 3.4-94.7% of that in the original material. The retention times and names of the identified compounds, as well as their relative peak areas, are provided in a Microsoft Excel Worksheet.

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.

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.

Efforts to slacken antibiotic resistance: Labeling meat products from animals raised without antibiotics in the United States.

PubMed

Centner, Terence J

2016-09-01

As bacteria and diseases spread due to climatic change, greater amounts of antibiotics will be used thereby exacerbating the problem of antibiotic resistance. To help slacken the development of resistant bacteria, the medical community is attempting to reduce unnecessary and excessive usage of antibiotics. One of the targets is the use of antibiotics for enhancing animal growth and promoting feed efficiency in the production of food animals. While governments can adopt regulations prohibiting nontherapeutic uses of antibiotics in food animals and strategies to reduce antibiotic usage, another idea is to publicize when antibiotics are used in food animal production by allowing labeled meat products. This paper builds upon existing labeling and marketing efforts in the United States to show how a government can develop a verified antibiotic-free labeling program that would allow consumers to purchase meat products from animals that had never received antibiotics. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

Development of functional agricultural products utilizing the new health claim labeling system in Japan.

PubMed

Maeda-Yamamoto, Mari; Ohtani, Toshio

2018-04-01

In April 2015, Consumer Affairs Agency of Japan launched a new food labeling system known as "Foods with Function Claims (FFC)." Under this system, the food industry independently evaluates scientific evidence on foods and describes their functional properties. As of May 23, 2017, 1023 FFC containing 8 fresh foods have been launched. Meanwhile, to clarify the health-promoting effects of agricultural products, National Agriculture and Food Research Organization (NARO) implemented the "Research Project on Development of Agricultural Products" and demonstrated the risk reduction of osteoporosis of β-cryptoxanthin rich Satsuma mandarins and the anti-allergic effect of the O-methylated catechin rich tea cultivar Benifuuki. These foods were subsequently released as FFC. Moreover, NARO elucidated the health-promoting effects of various functional agricultural products (β-glucan rich barley, β-conglycinin rich soybean, quercetin rich onion, etc.) and a healthy boxed lunch. This review focuses on new food labeling system or research examining functional aspects of agricultural products.

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.

Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

PubMed

Sanders, M E; Huis in't Veld, J

1999-01-01

Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

Photoaffinity-labeled Cytokinins

PubMed Central

Theiler, Jane B.; Leonard, Nelson J.; Schmitz, Ruth Y.; Skoog, Folke

1976-01-01

Two new azidopurine derivatives, 2-azido-N6-(Δ2-isopentenyl)adenine and 2-azido-N6-benzyladenine, have been synthesized as potential photoaffinity labels for probing cytokinin-binding sites. The preparation and the biological activity of these compounds are described. PMID:16659772

Effect of zinc compounds on Fusarium verticillioides growth, hyphae alterations, conidia, and fumonisin production.

PubMed

Savi, Geovana D; Vitorino, Vinícius; Bortoluzzi, Adailton J; Scussel, Vildes M

2013-10-01

Several strategies are used to eliminate toxigenic fungi that produce fumonisins in grains. Fusarium verticillioides can be controlled by the application of synthetic fungicides in the field or during storage. However, there may also be residuals, which may remain in the foods. Inorganic compounds such as zinc are cheap, stable and could present strong antifungal activity. Some Zn compounds can be utilized as dietary supplements and are authorized for the fortification of foods. Knowing the advantages and that low concentrations of Zn can have antimicrobial activity, our objective was to evaluate the effects of Zn compounds on the growth of F. verticillioides and the production of fumonisin and conidia. In addition, we aimed to verify that Zn compounds cause morphological alterations of the hyphae, mortality and production of reactive oxygen species. Zn compounds efficiently reduced fungal growth and fumonisin production. Treatment using zinc perchlorate gave the best results. All treatments inhibited conidia production and caused morphological alterations of the hyphae. It was possible to observe cell death and production of reactive oxygen species. Zn compounds have advantages compared to other antifungal compounds. In particular, they are non-toxic for the organism in appropriate amounts. They could be studied further as potential fungicides in agriculture. © 2013 Society of Chemical Industry.

Photosynthetic carbon metabolism in seagrasses C-labeling evidence for the c(3) pathway.

PubMed

Andrews, T J; Abel, K M

1979-04-01

The delta(13)C values of several seagrasses were considerably less negative than those of terrestrial C(3) plants and tended toward those of terrestrial C(4) plants. However, for Thalassia hemprichii (Ehrenb.) Aschers and Halophila spinulosa (R. Br.) Aschers, phosphoglycerate and other C(3) cycle intermediates predominated among the early labeled products of photosynthesis in (14)C-labeled seawater (more than 90% at the earliest times) and the labeling pattern at longer times was brought about by the operation of the C(3) pathway. Malate and aspartate together accounted for only a minor fraction of the total fixed label at all times and the kinetic data of this labeling were not at all consistent with these compounds being early intermediates in seagrass photosynthesis. Pulse-chase (14)C-labeling studies further substantiated these conclusions. Significant labeling of photorespiratory intermediates was observed in all experiments. The kinetics of total fixation of label during some steady-state and pulse-chase experiments suggested that there may be an intermediate pool of inorganic carbon of variable size closely associated with the leaves, either externally or internally. Such a pool may be one cause for the C(4)-like carbon isotope ratios of seagrasses.

Label Review Training: Module 1: Label Basics, Page 7

EPA Pesticide Factsheets

Page 7, Label Training, Pesticide labels translate results of our extensive evaluations of pesticide products into conditions, directions and precautions that define parameters for use of a pesticide with the goal of ensuring protection of human he

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.

Effects of nutrition label format and product assortment on the healthfulness of food choice.

PubMed

Aschemann-Witzel, Jessica; Grunert, Klaus G; van Trijp, Hans C M; Bialkova, Svetlana; Raats, Monique M; Hodgkins, Charo; Wasowicz-Kirylo, Grazyna; Koenigstorfer, Joerg

2013-12-01

This study aims to find out whether front-of-pack nutrition label formats influence the healthfulness of consumers' food choices and important predictors of healthful choices, depending on the size of the choice set that is made available to consumers. The predictors explored were health motivation and perceived capability of making healthful choices. One thousand German and Polish consumers participated in the study that manipulated the format of nutrition labels. All labels referred to the content of calories and four negative nutrients and were presented on savoury and sweet snacks. The different formats included the percentage of guideline daily amount, colour coding schemes, and text describing low, medium and high content of each nutrient. Participants first chose from a set of 10 products and then from a set of 20 products, which was, on average, more healthful than the first choice set. The results showed that food choices were more healthful in the extended 20-product (vs. 10-product) choice set and that this effect is stronger than a random choice would produce. The formats colour coding and texts, particularly colour coding in Germany, increased the healthfulness of product choices when consumers were asked to choose a healthful product, but not when they were asked to choose according to their preferences. The formats did not influence consumers' motivation to choose healthful foods. Colour coding, however, increased consumers' perceived capability of making healthful choices. While the results revealed no consistent differences in the effects between the formats, they indicate that manipulating choice sets by including healthier options is an effective strategy to increase the healthfulness of food choices. Copyright © 2013 Elsevier Ltd. All rights reserved.

An Isotopic Labelling Strategy to Study Cytochrome P450 Oxidations of Terpenes.

PubMed

Rinkel, Jan; Litzenburger, Martin; Bernhardt, Rita; Dickschat, Jeroen Sidney

2018-04-26

The cytochrome P450 monooxygenase CYP267B1 from Sorangium cellulosum was applied for enzymatic oxidation of the sesquiterpene alcohols T-muurolol and isodauc-8-en-11-ol. Various isotopically labelled geranyl and farnesyl diphosphates were used for product identification from micro-scale reactions, for determination of the absolute configurations of unknown compounds, to follow the stereochemical course of a cytochrome P450-catalysed hydroxylation step, and to investigate kinetic isotope effects. Overall, this study demonstrates that isotopically labelled terpene precursors are highly useful to follow cytochrome P450 dependent oxidations of terpenes. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Assessment of Inhibition of Ebola Virus Progeny Production by Antiviral Compounds.

PubMed

Falzarano, Darryl

2017-01-01

Assessment of small molecule compounds against filoviruses, such as Ebola virus, has identified numerous compounds that appear to have antiviral activity and should presumably be further investigated in animal efficacy trials. However, despite the many compounds that are purported to have good antiviral activity in in vitro studies, there are few instances where any efficacy has been reported in nonhuman primate models. Many of the high-throughput screening assays use reporter systems that only recapitulate a portion of the virus life cycle, while other assays only assess antiviral activity at relatively early time points. Moreover, many assays do not assess virus progeny production. A more in-depth evaluation of small numbers of test compounds is useful to economize resources and to generate higher quality antiviral hits. Assessing virus progeny production as late as 5 days post-infection allows for the elimination of compounds that have initial antiviral effects that are not sustained or where the virus rapidly develops resistance. While this eliminates many potential lead compounds that may be worthy of further structure-activity relationship (SAR) development, it also quickly excludes compounds that in their current form are unlikely to be effective in animal models. In addition, the inclusion of multiple assays that assess both cell viability and cell cytotoxicity, via different mechanisms, provides a more thorough assessment to exclude compounds that are not direct-acting antivirals.

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.

Updating the procedure for metaiodobenzylguanidine labelling with iodine radioisotopes employed in industrial production.

PubMed

Franceschini, R; Mosca, R; Bonino, C

1991-01-01

The classical procedure used for the preparation of [125I]- and [131I]metaiodobenzylguanidine (MIBG) is the solid-phase isotopic exchange between MIBG and radioiodide. This reaction requires 1.5 hours at 160 degrees C to obtain maximum total labelling yields of 75-80%. Recently, the importance of rapid procedures for the preparation of 123I-MIBG has been highlighted. A highly efficient procedure for the industrial production of 123I-MIBG using ascorbic acid, tin sulfate and copper sulfate pentahydrate in 0.01 M sulfuric acid is reported. Sequential radio-TLC analysis of the labelling mixture shows that the labelling yield reaches 98% within 45 min at 100 degrees C. The specific activity of the 123I-MIBG produced in this manner is on the order of 100 Ci/mmol.

Bioactive compounds and antioxidant activities of some cereal milling by-products.

PubMed

Smuda, Sayed Saad; Mohsen, Sobhy Mohamed; Olsen, Karsten; Aly, Mohamed Hassan

2018-03-01

The present study was performed to evaluate the phytochemicals profiles of some cereal milling by-products such as wheat (bran, germ and shorts), rice (bran, germ and husk) and corn (bran, germ and germ meal) to assess their potentiality as bioactive compounds sources. Distilled water, ethanol, methanol, and acetone separately were used as solvents for the extraction of phytochemicals compounds. The antioxidant activity (AOA), total phenolics content (TPC), and total flavonoids content (TFC) of the extracts were investigated using various in vitro assays. The results showed that tannins content was ranged from 113.4 to 389.5 (mg/100 g sample).The study revealed that TPC and TFC of cereal by-products extracts were significantly different for various solvents. TPC content varied from 366.1 to 1924.9 mg/100 g and TFC content varied from 139.3 to 681.6 mg/100 g. High carotenoids content was observed for corn germ meal and minimum for wheat bran. Distilled water, ethanol and methanol extracts showed significantly different antioxidant activity. Significant variations were observed with regard to AOA of different cereal by-products by using various solvents. The ethanol and methanol were observed to be the best solvents to extract phenolic compounds and antioxidant activity, while acetone extract showed less efficiency. Also, the cereal milling by-products were rich in bioactive compounds and could be used as a value added products.

16 CFR 305.15 - Labeling for lighting products.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Package labeling. For purposes of labeling under this section, packaging for such fluorescent lamp... individually or in small numbers. The encircled capital letter “E” on packages containing fluorescent lamp... ink, on the surface of the package on which printing or a label normally appears. If the package...

Characterization of volatile sulfur compound production by Solobacterium moorei.

PubMed

Tanabe, Shin-ichi; Grenier, Daniel

2012-12-01

Solobacterium moorei is a Gram positive bacterium that has been specifically associated with halitosis. The aim of this study was to characterize volatile sulfur compound (VSC) production by S. moorei. S. moorei was either grown or incubated in the presence of various supplements prior to determining VSC production with a Halimeter sulfide monitor. The effect of exogenous proteases or glycosidase inhibitors on VSC production by S. moorei was examined. We first showed that S. moorei can convert cysteine into hydrogen sulfide. The capacity of S. moorei to produce VSCs from serum, saliva, and mucin was dependent on the presence of an exogenous source of proteases such as pancreatic trypsin or Porphyromonas gingivalis gingipains. VSC production from mucin was inhibited by the presence of a β-galactosidase inhibitor, thus suggesting that deglycosylation of mucin by S. moorei is critical for VSC production. Our study suggests that S. moorei can be a major source of malodorous compounds in halitosis by producing VSCs through a process involving the β-galactosidase activity of the bacterium and an exogenous source of proteases. Copyright © 2012 Elsevier Ltd. All rights reserved.

Notification: Preliminary Research on EPA's Design for the Environment Product Labeling Program OIG

EPA Pesticide Factsheets

Project #OPE-FY14-4012, November 06, 2013. The Office of Inspector General (OIG) is starting preliminary research on the U.S. Environmental Protection Agency’s (EPA’s) Design for the Environment (DfE) Product Labeling Program.

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.

Natural products as an inspiration in the diversity-oriented synthesis of bioactive compound libraries

PubMed Central

Cordier, Christopher; Morton, Daniel; Murrison, Sarah; O'Leary-Steele, Catherine

2008-01-01

The purpose of diversity-oriented synthesis is to drive the discovery of small molecules with previously unknown biological functions. Natural products necessarily populate biologically relevant chemical space, since they bind both their biosynthetic enzymes and their target macromolecules. Natural product families are, therefore, libraries of pre-validated, functionally diverse structures in which individual compounds selectively modulate unrelated macromolecular targets. This review describes examples of diversity-oriented syntheses which have, to some extent, been inspired by the structures of natural products. Particular emphasis is placed on innovations that allow the synthesis of compound libraries that, like natural products, are skeletally diverse. Mimicking the broad structural features of natural products may allow the discovery of compounds that modulate the functions of macromolecules for which ligands are not known. The ability of innovations in diversity-oriented synthesis to deliver such compounds is critically assessed. PMID:18663392

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

21 CFR 358.350 - Labeling of ingrown toenail relief drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter...) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”: (1) “For external use only” in accord with § 201.66(c)(5)(i) of this chapter. (2) “Do not use [bullet] 1 on...

Characterization of Volatile Nylon 6.6 Thermal-Oxidative Degradation Products by Selective Isotopic Labeling and Cryo-GC/MS

NASA Astrophysics Data System (ADS)

Smith, Jonell N.; V. White, Gregory; White, Michael I.; Bernstein, Robert; Hochrein, James M.

2012-09-01

Aged materials, such as polymers, can exhibit modifications to their chemical structure and physical properties, which may render the material ineffective for its intended purpose. Isotopic labeling was used to characterize low-molecular weight volatile thermal-oxidative degradation products of nylon 6.6 in an effort to better understand and predict changes in the aged polymer. Headspace gas from aged (up to 243 d at 138 °C) nylon 6.6 monomers (adipic acid and 1,6-hexanediamine) and polymer were preconcentrated, separated, and detected using cryofocusing gas chromatography mass spectrometry (cryo-GC/MS). Observations regarding the relative concentrations observed in each chromatographic peak with respect to aging time were used in conjunction with mass spectra for samples aged under ambient air to determine the presence and identity of 18 degradation products. A comparison of the National Institute of Standards and Technology (NIST) library, unlabeled, and isotopically labeled mass spectra (C-13 or N-15) and expected fragmentation pathways of each degradation product were used to identify the location of isotopically labeled atoms within the product's chemical structure, which can later be used to determine the exact origin of the species. In addition, observations for unlabeled nylon 6.6 aged in an O-18 enriched atmosphere were used to determine if the source of oxygen in the applicable degradation products was from the gaseous environment or the polymer. Approximations for relative isotopic ratios of unlabeled to labeled products are reported, where appropriate.

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...

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...

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...

Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized.

PubMed

Nichols, Peter D; Dogan, Lalen; Sinclair, Andrew

2016-11-05

We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n -3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%-136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%-119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized.

Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized

PubMed Central

Nichols, Peter D.; Dogan, Lalen; Sinclair, Andrew

2016-01-01

We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n-3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%–136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%–119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized. PMID:27827947

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

Labeling strategies to overcome the problem of niche markets for sustainable milk products: The example of pasture-raised milk.

PubMed

Kühl, S; Gassler, B; Spiller, A

2017-06-01

Pasture-raised milk is gaining in importance in some European countries and in the United States. The production of pasture-raised milk is linked to higher costs, as the milk is normally collected and processed separately from conventional barn milk. This could hinder the production of sustainable milk products. We discuss alternative labeling strategies that allow the mixing of pasture-raised (sustainable) and conventional milk to reduce costs and break free from the current niche market. The lower price would allow for more pasture-raised milk to be produced and enter the mainstream market. The aim of this study was to analyze consumers' willingness to pay for alternative labeling types using a discrete choice experiment with 1,065 German milk buyers. The 2 alternative labels, besides the classical labeling approach, are based on the mass balance approach (at least 50% pasture-raised milk in a package) and cause-related marketing (support of farmers who keep their cows on pasture). The discrete choice experiment was combined with a cluster analysis to get a deeper understanding of the buying behavior of the diverse consumer segments for milk. We found that all consumer groups prefer the classical label where products are segregated but also understand the benefits of cause-related marketing. The average consumer was willing to pay €0.50 more for pasture-raised milk certified with the classical label and €0.38 more for pasture-raised milk labeled with a cause-related marketing claim. However, differences between the clusters are strong: The smallest cluster of ethically involved consumers (15%) is willing to pay the highest premiums, especially for the classical label. Cause-related marketing is an interesting alternative for involved buyers under price pressure (41%), whereas the mass balance approach is little understood and thus less valued by consumers. From our results we concluded that cause-related marketing (in our case, the support of pasturing of

Biogenic volatile organic compounds (BVOCs) emission of Scots pine under drought stress - a 13CO2 labeling study to determine de novo and pool emissions under different treatments

NASA Astrophysics Data System (ADS)

Lüpke, M.

2015-12-01

Plants emit biogenic volatile organic compounds (BVOCs) to e.g. communicate and to defend herbivores. Yet BVOCs also impact atmospheric chemistry processes, and lead to e.g. the built up of secondary organic aerosols. Abiotic stresses, such as drought, however highly influence plant physiology and subsequently BVOCs emission rates. In this study, we investigated the effect of drought stress on BVOCs emission rates of Scots pine trees, a de novo and pool emitter, under controlled climate chamber conditions within a dynamic enclosure system consisting of four plant chambers. Isotopic labeling with 13CO2 was used to detect which ratio of emissions of BVOCs derives from actual synthesis and from storage organs under different treatments. Additionally, the synthesis rate of the BVOCs synthesis can be determined. The experiment consisted of two campaigns (July 2015 and August 2015) of two control and two treated trees respectively in four controlled dynamic chambers simultaneously. Each campaign lasted for around 21 days and can be split into five phases: adaptation, control, dry-out, drought- and re-watering phase. The actual drought phase lasted around five days. During the campaigns two samples of BVOCs emissions were sampled per day and night on thermal desorption tubes and analyzed by a gas chromatograph coupled with a mass spectrometer and a flame ionization detector. Additionally, gas exchange of water and CO2, soil moisture, as well as leaf and chamber temperature was monitored continuously. 13CO2 labeling was performed simultaneously in all chambers during the phases control, drought and re-watering for five hours respectively. During the 13CO2 labeling four BVOCs emission samples per chamber were taken to identify the labeling rate on emitted BVOCs. First results show a decrease of BVOCs emissions during the drought phase and a recovery of emission after re-watering, as well as different strength of reduction of single compounds. The degree of labeling with 13

Spirolactones: Recent Advances in Natural Products, Bioactive Compounds and Synthetic Strategies.

PubMed

Quintavalla, Arianna

2018-01-01

The spirocyclic compounds have always aroused a great interest because this motif is present as structural core in a number of natural products and bioactive compounds. In particular, the spirolactone moiety has been recognized in a wide array of natural and non-natural scaffolds showing a variety of useful pharmacological properties. Extensive literature search using SciFinder (Databases: CA Plus, CAS Registry, CAS React, Chemlist, Chemcat and Medline) and Web of Science (Database: Web of Science Core Collection) was conducted. Nowadays, many efforts are being devoted to the discovery of new natural products containing the promising spirolactone framework and to the disclosure of the potential bioactivities of these chemical entities. Moreover, the medicinal relevance of many spirolactones makes these scaffolds attractive targets for the design and development of innovative and efficient synthetic strategies, enabling the construction of complex and variably substituted products. This review gives an overview on the recent advances in the spirolactones field, in terms of new compounds isolated from natural sources, recently determined bioactivity profiles and innovative synthetic approaches. The collected data demonstrate the key role played by spirolactones in medicinal chemistry and the great attention still devoted by the scientific community to these compounds. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Microfluidic 68Ga-labeling: a proof of principle study.

PubMed

Pfaff, Sarah; Philippe, Cecile; Pichler, Verena; Hacker, Marcus; Mitterhauser, Markus; Wadsak, Wolfgang

2018-05-01

Positron emission tomography (PET) as a tool for molecular imaging of cancer has gained huge interest in the last few years. Gallium-68 is a popular PET nuclide due to its favorable characteristics, like advantageous half-life (68 min) and independency of a cyclotron on-site for its production. Accordingly, several 68Ga-complexes for cancer imaging via PET have been made available during the last few years. In this work, 68Ga-labeled compounds were synthesized applying a commercially available microfluidic device for the first time. Therefore, a proof of principle study using three important radiotracers, [68Ga]Ga-PSMA-11, [68Ga]Ga-NODAGA-RGDyk and [68Ga]Ga-DOTA-NOC, was designed. For all three radioligands, various synthesis parameters were evaluated and the feasibility of using a continuous flow reactor was assessed. All of the precursors were successfully radiolabeled with a radiochemical yield higher than 80%, proving the principle that a microfluidic set-up is a suitable approach for the production of 68Ga-labeled tracers.

76 FR 78929 - Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

... labeling; (2) supply chain issues; and, (3) other issues. FDA may use the information received to develop...? B. Supply Chain Issues 3. What are the supply chain factors (including storage, shipping, and... the optimal point in the supply chain (e.g., newly manufactured product, newly shipped product) and...

Utilization of coffee by-products obtained from semi-washed process for production of value-added compounds.

PubMed

Bonilla-Hermosa, Verónica Alejandra; Duarte, Whasley Ferreira; Schwan, Rosane Freitas

2014-08-01

The semi-dry processing of coffee generates significant amounts of coffee pulp and wastewater. This study evaluated the production of bioethanol and volatile compounds of eight yeast strains cultivated in a mixture of these residues. Hanseniaspora uvarum UFLA CAF76 showed the best fermentation performance; hence it was selected to evaluate different culture medium compositions and inoculum size. The best results were obtained with 12% w/v of coffee pulp, 1 g/L of yeast extract and 0.3 g/L of inoculum. Using these conditions, fermentation in 1 L of medium was carried out, achieving higher ethanol yield, productivity and efficiency with values of 0.48 g/g, 0.55 g/L h and 94.11% respectively. Twenty-one volatile compounds corresponding to higher alcohols, acetates, terpenes, aldehydes and volatile acids were identified by GC-FID. Such results indicate that coffee residues show an excellent potential as substrates for production of value-added compounds. H. uvarum demonstrated high fermentative capacity using these residues. Copyright © 2014 Elsevier Ltd. All rights reserved.

A matrix-assisted laser desorption/ionization mass spectroscopy method for the analysis of small molecules by integrating chemical labeling with the supramolecular chemistry of cucurbituril.

PubMed

Ding, Jun; Xiao, Hua-Ming; Liu, Simin; Wang, Chang; Liu, Xin; Feng, Yu-Qi

2018-10-05

Although several methods have realized the analysis of low molecular weight (LMW) compounds using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) by overcoming the problem of interference with MS signals in the low mass region derived from conventional organic matrices, this emerging field still requires strategies to address the issue of analyzing complex samples containing LMW components in addition to the LMW compounds of interest, and solve the problem of lack of universality. The present study proposes an integrated strategy that combines chemical labeling with the supramolecular chemistry of cucurbit [n]uril (CB [n]) for the MALDI MS analysis of LMW compounds in complex samples. In this strategy, the target LMW compounds are first labeled by introducing a series of bifunctional reagents that selectively react with the target analytes and also form stable inclusion complexes with CB [n]. Then, the labeled products act as guest molecules that readily and selectively form stable inclusion complexes with CB [n]. This strategy relocates the MS signals of the LMW compounds of interest from the low mass region suffering high interference to the high mass region where interference with low mass components is absent. Experimental results demonstrate that a wide range of LMW compounds, including carboxylic acids, aldehydes, amines, thiol, and cis-diols, can be successfully detected using the proposed strategy, and the limits of detection were in the range of 0.01-1.76 nmol/mL. In addition, the high selectivity of the labeling reagents for the target analytes in conjunction with the high selectivity of the binding between the labeled products and CB [n] ensures an absence of signal interference with the non-targeted LMW components of complex samples. Finally, the feasibility of the proposed strategy for complex sample analysis is demonstrated by the accurate and rapid quantitative analysis of aldehydes in saliva and herbal

Synthesis and preliminary biological evaluations of fluorescent or 149Promethium labeled Trastuzumab-polyethylenimine

DOE PAGES

Fitzsimmons, Jonathan; Nayak, Tapan; Cutler, Cathy; ...

2015-12-30

Radioimmunotherapy utilize a targeting antibody coupled to a therapeutic isotope to target and treat a tumor or disease. In this study we examine the synthesis and cell binding of a polymer scaffold containing a radiotherapeutic isotope and a targeting antibody. Methods: The multistep synthesis of a fluorescent or 149Promethium-labeled Trastuzumab-polyethyleneimine (PEI), Trastuzumab, or PEI is described. In vitro uptake, internalization and/or the binding affinity to the Her2/neu expressing human breast adenocarcinoma SKBr3 cells was investigated with the labeled compounds. Fluorescent-labeled Trastuzumab-PEI was internalized more into cells at 2 and 18 h than fluorescent-labeled Trastuzumab or PEI. The fluorescent-labeled Trastuzumab wasmore » concentrated on the cell surface at 2 and 18 h and the labeled PEI had minimal uptake. DOTA-PEI was prepared and contained an average of 16 chelates per PEI; the compound was radio-labeled with 149Promethium and conjugated to Trastuzumab. The purified 149Pm-DOTA-PEI-Trastuzumab had a radiochemical purity of 96.7% and a specific activity of 0.118 TBq/g. The compound demonstrated a dissociation constant for the Her2/neu receptor of 20.30 ± 6.91 nM. In conclusion, the results indicate the DOTA-PEI-Trastuzumab compound has potential as a targeted therapeutic carrier, and future in vivo studies should be performed.« less

A spin labelling study of immunomodulating peptidoglycan monomer and adamantyltripeptides entrapped into liposomes.

PubMed

Frkanec, Ruza; Noethig-Laslo, Vesna; Vranesić, Branka; Mirosavljević, Krunoslav; Tomasić, Jelka

2003-04-01

The interaction of immunostimulating compounds, the peptidoglycan monomer (PGM) and structurally related adamantyltripeptides (AdTP1 and AdTP2), respectively, with phospholipids in liposomal bilayers were investigated by electron paramagnetic resonance spectroscopy. (1). The fatty acids bearing the nitroxide spin label at different positions along the acyl chain were used to investigate the interaction of tested compounds with negatively charged multilamellar liposomes. Electron spin resonance (ESR) spectra were studied at 290 and 310 K. The entrapment of the adamantyltripeptides affected the motional properties of all spin labelled lipids, while the entrapment of PGM had no effect. (2). Spin labelled PGM was prepared and the novel compound bearing the spin label attached via the amino group of diaminopimelic acid was chromatographically purified and chemically characterized. The rotational correlation time of the spin labelled molecule dissolved in buffer at pH 7.4 was studied as a function of temperature. The conformational change was observed above 300 K. The same effect was observed with the spin labelled PGM incorporated into liposomes. Such effect was not observed when the spin labelled PGM was studied at alkaline pH, probably due to the hydrolysis of PGM molecule. The study of possible interaction with liposomal membrane is relevant to the use of tested compounds incorporated into liposomes, as adjuvants in vivo.

Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

PubMed

Gnanasakthy, Ari; DeMuro, Carla; Clark, Marci; Haydysch, Emily; Ma, Esprit; Bonthapally, Vijayveer

2016-06-01

To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. FDA Drug Approval Reports by Month were reviewed to obtain the number of new molecular entities and biologic license applications approved from 2010 to 2014. Drugs approved by the FDA OHOP during this period were selected for further review, focusing on brand and generic name; approval date; applicant; indication; PRO labeling describing treatment benefit, measures, end point status, and significant results; FDA reviewer feedback on PRO end points; and study design of registration trials. First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieved for selected oncology drugs from 2011 to 2014. Descriptive analyses were performed by using Microsoft Excel 2010. Of 160 drugs approved by the FDA (2010-2014), 40 were approved by OHOP. Three (7.5%) of the 40 received PRO-related labeling (abiraterone acetate, ruxolitinib phosphate, and crizotinib). Compared with nononcology drugs (2011-2014), oncology drugs were more likely to be orphan and first in class. The majority of oncology drug reviews by FDA were fast track, priority, or accelerated. Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging. © 2016 by American Society of Clinical Oncology.

Herbal products containing Hibiscus sabdariffa L., Crataegus spp., and Panax spp.: Labeling and safety concerns.

PubMed

Nunes, Maria Antónia; Rodrigues, Francisca; Alves, Rita C; Oliveira, Maria Beatriz P P

2017-10-01

Herbs have been used from ancient times for infusion preparation based on their potential health effects. In particular, the consumption of Hibiscus sabdariffa L., Crataegus spp. and Panax spp. has been largely associated to cardiovascular benefits. In this work, the label information of 52 herbal products for infusion preparation containing the referred herbs was analyzed and discussed, taking into consideration the European Union regulation for herbal products, which intends to protect public health and harmonize the legal framework in Member States. Details about the cardiovascular-related statements and warning notifications about consumption were considered. Also, regulatory issues and possible herb-drug interactions were explored and discussed. A total of 14 of the 52 herbal products selected presented health claims/statements on the label. Hibiscus was present in the majority of the products and, in some cases, it was mentioned only in the ingredients list and not on the product front-of-pack. Despite the promising outcomes of these plants to modulate cardiovascular risk markers, consumers with some sort of cardiovascular dysfunction and/or under medication treatments should be aware to carefully analyze the labels and consult additional information related to these herbal products. Manufacturers have also a huge responsibility to inform consumers by presenting awareness statements. Lastly, health professionals must advise and alert their patients about possible interactions that could occur between the concomitant consumption of drugs and herbs. Overall, there is still a real need of additional studies and clinical trials to better understand herbs effects and establish a science-based guidance to assess their safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

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 ...

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

FDA Expands List of "Do Not Compound" Drug Products.

PubMed

2017-03-01

EDITOR'S ABSTRACT On October 3, 2016, the U.S. Food and Drug Administration published in the Federal Register an expanded list of drug products that are not to be used in compounding extemporaneous dosage forms. This list contains numerous analgesic or anti-inflammatory agents and other chemicals sometimes used to manage pain and related symptoms. Because pharmacies are licensed by the states and other jurisdictions (districts, territories) as opposed to the federal government, regulation of extemporaneous compounding is inconsistent across the nation and minimal to nonexistent is some jurisdictions. Clinicians are urged to assure that pharmacies they and their patients use adhere to this list and compound only dosage forms for which there is good evidence of both safety and efficacy.

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...

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...

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...

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...

HL7 Structured Product Labeling - electronic prescribing information for provider order entry decision support.

PubMed

Schadow, Gunther

2005-01-01

Prescribing errors are an important cause of adverse events, and lack of knowledge of the drug is a root cause for prescribing errors. The FDA is issuing new regulations that will make the drug labels much more useful not only to physicians, but also to computerized order entry systems that support physicians to practice safe prescribing. For this purpose, FDA works with HL7 to create the Structured Product Label (SPL) standard that includes a document format as well as a drug knowledge representation, this poster introduces the basic concepts of SPL.

77 FR 5696 - Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... products in the SNS that are approved, licensed, or cleared for marketing.\\2\\ Labels on investigational... the implementation of this rule, when investigational products were ultimately approved for marketing... that any statements concerning preemption can be justified under legal principles governing preemption...

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...

Emerging role of phenolic compounds as natural food additives in fish and fish products.

PubMed

Maqsood, Sajid; Benjakul, Soottawat; Shahidi, Fereidoon

2013-01-01

Chemical and microbiological deteriorations are principal causes of quality loss of fish and fish products during handling, processing, and storage. Development of rancid odor and unpleasant flavor, changes of color and texture as well as lowering nutritional value in fish can be prevented by appropriate use of additives. Due to the potential health hazards of synthetic additives, natural products, especially antioxidants and antimicrobial agents, have been intensively examined as safe alternatives to synthetic compounds. Polyphenols (PP) are the natural antioxidants prevalent in fruits, vegetables, beverages (tea, wine, juices), plants, seaweeds, and some herbs and show antioxidative and antimicrobial activities in different fish and fish products. The use of phenolic compounds also appears to be a good alternative for sulphiting agent for retarding melanosis in crustaceans. Phenolic compounds have also been successfully employed as the processing aid for texture modification of fish mince and surimi. Thus, plant polyphenolic compounds can serve as potential additives for preventing quality deterioration or to retain the quality of fish and fish products.

Biotechnological production of aromatic compounds of the extended shikimate pathway from renewable biomass.

PubMed

Lee, Jin-Ho; Wendisch, Volker F

2017-09-10

Aromatic chemicals that contain an unsaturated ring with alternating double and single bonds find numerous applications in a wide range of industries, e.g. paper and dye manufacture, as fuel additives, electrical insulation, resins, pharmaceuticals, agrochemicals, in food, feed and cosmetics. Their chemical production is based on petroleum (BTX; benzene, toluene, and xylene), but they can also be obtained from plants by extraction. Due to petroleum depletion, health compliance, or environmental issues such as global warming, the biotechnological production of aromatics from renewable biomass came more and more into focus. Lignin, a complex polymeric aromatic molecule itself, is a natural source of aromatic compounds. Many microorganisms are able to catabolize a plethora of aromatic compounds and interception of these pathways may lead to the biotechnological production of value-added aromatic compounds which will be discussed for Corynebacterium glutamicum. Biosynthesis of aromatic amino acids not only gives rise to l-tryptophan, L-tyrosine and l-phenylalanine, but also to aromatic intermediates such as dehydroshikimate or chorismate from which value-added aromatic compounds can be derived. In this review, we will summarize recent strategies for the biotechnological production of aromatic and related compounds from renewable biomass by Escherichia coli, Pseudomonas putida, C. glutamicum and Saccharomyces cerevisiae. In particular, we will focus on metabolic engineering of the extended shikimate pathway. Copyright © 2016 Elsevier B.V. All rights reserved.

Rapid production of positron emitting labeled compounds for use in cardiology PET studies

NASA Astrophysics Data System (ADS)

Bolomey, Leonard

1985-05-01

Large scale clinical application of positron emission tomography requires a variety of short-lived positron emitting radionuclides to be produced in Curie quantities up to 20 times per day. Rapid routine production of these radiopharmaceuticals requires the collaboration of engineers and chemists to achieve production targetry compatible with high beam current (up to 100 μA) and radionuclide production in a chemical form compatible with the rapid radiochemical synthesis. Chemical processing is further complicated by the need to repeat the procedures several times per day and maintain sterility within the shielded area. At our cyclotron facility primary production targets for 11C, 13N, 15O, and 18F (half lives from 2 min to 2 h) are mounted on a vertical gantr that indexes to position the required target on the beam line. Target changes are handled under microprocessor control remotely from the control room such that all valves, cooling, evacuation of target manifold, and testing of interlocks are handled automatically. This system enables us to change targets, energy and particles in less than five minutes. Since the installation of the cyclotron up to fifteen batches of routine radiopharmaceuticals have been produced per day with very low radiation doses to all personnel involved. These radiopharmaceuticals will be used to measure perfusion, metabolism and other biochemical functions in man non invasively with PET.

Compound Nouns and Category Structure in Young Children.

ERIC Educational Resources Information Center

Clark, Eve V.; And Others

1985-01-01

In two experiments 96 children and eight adults were tested for comprehension of the modifier-head relation in compounds such as apple-knife or were asked to label objects with compounds. Results show that by age three children reliably interpret novel compounds and made use of novel compounds to subcategorize. (RH)

Quality and Labelling Information Moringa Oleifera Products Marketed for HIV-infected People in Zimbabwe

PubMed Central

Jani, Zvinji Tella; Maponga, Charles Chiedza; Mudzengi, Josephine; Morse, Gene D.; Nhachi, Charles Fungai Brian

2016-01-01

Labeling information and quality of marketed Moringa oleifera products were assessed. Personnel in 60 pharmacies and 11 herbal shops were interviewed about the sources, dosages, indications and counseling information of Moringa oleifera products. Content analysis of written information provided on Moringa oleifera products was also done. Three samples of Moringa from popular sources were acquired to determine heavy metal content and microbial contamination. The results were compared to specified limits in the European and Chinese pharmacopeia, World Health Organization guidelines and Bureau of Indian Standards. Moringa was available as capsules or powder in 73% of the premises. Moringa was recommended for seven different disease conditions. Four different dosage regimens were prescribed. The main references cited for the counseling information were unscientific literature (62%). The selected Moringa samples were contaminated with bacteria and fungi above the European Pharmacopeia specified limits. Escherichia coli and Salmonella species were present in all three samples. All three samples contained arsenic, nickel and cadmium above the permissible limits. Moringa oleifera with variable labeling information and poor microbial and heavy metal quality is widely available in Zimbabwe. PMID:28239441

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

Great interspecies and intraspecies diversity of dairy propionibacteria in the production of cheese aroma compounds.

PubMed

Yee, Alyson L; Maillard, Marie-Bernadette; Roland, Nathalie; Chuat, Victoria; Leclerc, Aurélie; Pogačić, Tomislav; Valence, Florence; Thierry, Anne

2014-11-17

Flavor is an important sensory property of fermented food products, including cheese, and largely results from the production of aroma compounds by microorganisms. Propionibacterium freudenreichii is the most widely used species of dairy propionibacteria; it has been implicated in the production of a wide variety of aroma compounds through multiple metabolic pathways and is associated with the flavor of Swiss cheese. However, the ability of other dairy propionibacteria to produce aroma compounds has not been characterized. This study sought to elucidate the effect of interspecies and intraspecies diversity of dairy propionibacteria on the production of aroma compounds in a cheese context. A total of 76 strains of Propionibacterium freudenreichii, Propionibacterium jensenii, Propionibacterium thoenii, and Propionibacterium acidipropionici were grown for 15 days in pure culture in a rich medium derived from cheese curd. In addition, one strain each of two phylogenetically related non-dairy propionibacteria, Propionibacterium cyclohexanicum and Propionibacterium microaerophilum were included. Aroma compounds were analyzed using headspace trap-gas chromatography-mass spectrometry (GC-MS). An analysis of variance performed on GC-MS data showed that the abundance of 36 out of the 45 aroma compounds detected showed significant differences between the cultures. A principal component analysis (PCA) was performed for these 36 compounds. The first two axes of the PCA, accounting for 60% of the variability between cultures, separated P. freudenreichii strains from P. acidipropionici strains and also differentiated P. freudenreichii strains from each other. P. freudenreichii strains were associated with greater concentrations of a variety of compounds, including free fatty acids from lipolysis, ethyl esters derived from these acids, and branched-chain acids and alcohols from amino acid catabolism. P. acidipropionici strains produced less of these compounds but more sulfur

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...

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...

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...

An extensive review of commercial product labels the good, bad and ugly.

PubMed

Mrvos, R; Dean, B S; Krenzelok, E P

1986-02-01

Cautions and warnings on consumer products play an important role in the prevention and treatment of poison exposures. Frequently those exposed will follow the directions before calling the poison center, physician or emergency room. An extensive label review of 200 commercial products was conducted to determine if medical treatment advice was correct, if the general public was able to comprehend warning statements, and if warnings were adequate. We conclude there are products available that provide precise, correct information. However, there are many that contain incorrect, misleading, and often dangerous information to an unsuspecting public. Various examples of both types are given to make the poison information specialist aware of what information is presented.

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...

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...

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...

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 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...

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...

Tritium labeling of antisense oligonucleotides by exchange with tritiated water.

PubMed Central

Graham, M J; Freier, S M; Crooke, R M; Ecker, D J; Maslova, R N; Lesnik, E A

1993-01-01

We describe a simple, efficient, procedure for labeling oligonucleotides to high specific activity (< 1 x 10(8) cpm/mumol) by hydrogen exchange with tritiated water at the C8 positions of purines in the presence of beta-mercaptoethanol, an effective radical scavenger. Approximately 90% of the starting material is recovered as intact, labeled oligonucleotide. The radiolabeled compounds are stable in biological systems; greater than 90% of the specific activity is retained after 72 hr incubation at 37 degrees C in serum-containing media. Data obtained from in vitro cellular uptake experiments using oligonucleotides labeled by this method are similar to those obtained using 35S or 14C-labeled compounds. Because this protocol is solely dependent upon the existence of purine residues, it should be useful for radiolabeling modified as well as unmodified phosphodiester oligonucleotides. Images PMID:8367289

Consequences of plant phenolic compounds for productivity and health of ruminants.

PubMed

Waghorn, Garry C; McNabb, Warren C

2003-05-01

Plant phenolic compounds are diverse in structure but are characterised by hydroxylated aromatic rings (e.g. flavan-3-ols). They are categorised as secondary metabolites, and their function in plants is often poorly understood. Many plant phenolic compounds are polymerised into larger molecules such as the proanthocyanidins (PA; condensed tannins) and lignins. Only the lignins, PA, oestrogenic compounds and hydrolysable tannins will be considered here. Lignins slow the physical and microbial degradation of ingested feed, because of resilient covalent bonding with hemicellulose and cellulose, rather than any direct effects on the rumen per se. The PA are prevalent in browse and are expressed in the foliage of some legumes (e.g. Lotus spp.), but rarely in grasses. They reduce the nutritive value of poor-quality diets, but can also have substantial benefits for ruminant productivity and health when improved temperate forages are fed. Beneficial effects are dependent on the chemical and physical structure, and concentration of the PA in the diet, but they have been shown to improve live-weight gain, milk yield and protein concentration, and ovulation rate. They prevent bloat in cattle, reduce gastrointestinal nematode numbers, flystrike and CH4 production. Some phenolic compounds (e.g. coumestans) cause temporary infertility, whilst those produced by Fusarium fungi found in pasture, silage or stored grains can cause permanent infertility. The HT may be toxic because products of their metabolism can cause liver damage and other metabolic disorders.

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.

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...

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...