Food, drugs, and cosmetics

Impact of the Food, Drug, and Cosmetic Act on Fine Chemicals... 

Federal Food, Drug and Cosmetic Act, Section 601 (e), U.S. Government Printing Office, Washiagton, D.C. Ibid, Section 601 (a). 

Considerable interest has been shown ia poly(ethylene oxide) for diverse appHcations ia food, drug, and cosmetic products. Such uses fall within the scope of the Federal Food, Dmg, and Cosmetic Act. The U.S. FDA has recognized and approved the use of poly(ethylene oxide) for specific food and food packaging uses. USP/NF-grades of Polyox water-soluble resins (Union Carbide Corp.) are available for pharmaceutical appHcations. 

See Colorants for foods, drugs, and cosmetics Dyes, natural. 

T artrazine, 4,5-dihydro-5 -oxo-1 -(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1// -pyrazole-3-carboxylic acid trisodium salt was discovered by Ziegler in 1884 and is used as a dye for wool and silk. It is used as a colour additive in foods, drugs and cosmetics, and is an adsorption-elution indicator for chloride estimations in biochemistry (B-76MI40404). 

The Food and Drug Administration (FDA) regulates foods, drugs, and cosmetics it is housed in tlie Department of Health and Human Services and reports to tlie Assistant Secretary for Health. 

The measurement of filth elements by microanalysis is a valuable adjunct in the enforcement of the Food, Drug, and Cosmetic Act and serves as an efficient means of evaluating conditions of cleanliness, decency, and sanitation in food-producing plants. This, of course, is in addition to the value of microanalytical methods in the determination of the fitness of foods as they reach the consumer. The techniques available, together with proficiency of manipulation, repeated references to authentic materials, and sound judgment in the interpretation of results, provide effective enforcement weapons in the constant war to prevent the production and interstate distribution of products which are unfit for the table of the American consumer. 

Many laws have been enacted over the last century that affect drug distribution and administration. Those included here are the Pure Food and Drug Act Harrison Narcotic Act Pure Food, Drug, and Cosmetic Act and the Comprehensive Drug Abuse Prevention and Control Act. These laws control the use of the three categories of drugs in the United States (prescription, nonprescription, and controlled substances). 

The term FD C color, often seen on ingredients labels, refers to food, drug, and cosmetic colors. These are organic compounds (as opposed to inorganic pigments, such as titanium dioxide) that are so intense in color that it takes only very tiny amounts to color something, and thus they can be used in concentrations so minute that they are safe for consumption. 

J. H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States Business Office, Bureau of Food and Drugs, Austin, Texas, Chap. Dermal Toxicity, Texas State Dept, of Health, 1959, pp. 46-48. 

The Food, Drug and Cosmetic Act is passed. This requires drugs to be shown to be safe before marketing, and authorises inspections of facilities. 

Since national food legislation within the European Union varies and differences also exist with regard to United States, Asian, and South American legislation, coloring of foods, drugs, and cosmetics is indeed a most crucial issue for manufacturers." ... 

Combes, R.D. and Haveland-Smith, R.B., A review of the genotoxicity of food, drug and cosmetic colours and other azo, triphenyhnethane and xanthene dyes, Mutation Res., 98, 101, 1982. 

US legislation on food additives consists of the Federal Food, Drug, and Cosmetic Act (FD C Act), the Fair Packaging and Labeling Act, and other applicable laws including the Public Health Security and Bioterrorism Preparedness and Response Act. The FD C Act states that foods are adulterated if they contain color additives that have not been approved as safe to the satisfaction of the Food Drug Administration (FDA) for a particular use. ... 

Part 81 General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics — This part contains provisional... 

Food legislation in the US was implemented in 1938 and since then has been improved dynamically. The Food, Drug and Cosmetic Act classified specific colorants to be used in food and non-food products (FD C colorants). Each colorant has a color index (Cl) number and Cl name. Colorants are also identified by their Chemical Abstract Service (CAS) registry code numbers. The two groups are Certifiable Colorants and Exempt Colorants. 

Otterstatter, G., Coloring of Food, Drugs and Cosmetics, Marcel Dekker, New York, 1999. 

Marmion, D.M., Handbook of US Colorants For Foods, Drugs and Cosmetics, 3rd ed. John WUey Sons, New York, 1991. 

Hallagan, J.B., Allen, D.C., and Borzelleca, J.F., The safety and regulatory status of food, drug and cosmetic color additives exempt from certification. Food Chem.Tox-icoL, 33, 515, 1995. 

Stem, P.W., Food, drug and cosmetic colors, in Pigment Handbook, Vol. 1., Lewis, P.A., Ed., John Wiley Sons, New York, 1988, 925. 

One major problem caused by Section 409 (c) (3) of the Federal Food, Drug and Cosmetic Act, commonly known as the Delaney Clause , which governed the registration of pesticides was the statement, No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,... . Dr Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, in... 

US Food and Drug Administration, Federal Food, Drug and Cosmetic Act (Amended 1997). Also available on the World Wide Web http //www.fda.gov/opacoiii/laws/fdcact/fdctoc.htm. 

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