Pure Food, Drug and Cosmetic Act

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). 

A wide variety of natural and synthetic dyes are used to color foodstuffs. Florida oranges, often a natural green color when ripe, are sometimes dyed orange with synthetic dyes. Since some synthetic dyes cause illness, their use is restricted, or excluded, even in the coloration of textiles. In the United States, the Pure Food, Drug, and Cosmetic Act enables the Food and Drug Administration (FDA) to control the dyes in foods. This is why these dyes are given names with the prefix FD C or External D C. 

A revision of the Pure Food and Drug Act, the Federal Food Drug and Cosmetic Act, passed in 1938, added several provisions that impacted the food industry. Among those provisions were authorized factory inspections and the authority for court injunction to the previous seizure and prosecution actions (Janssen, 1992). Adulterated food was now defined as Sec. 402, A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food, or if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The importance of the whereby clause is the concept that a food product need not be contaminated physically to be considered adulterated, but has been exposed to conditions that may have resulted in contamination of the food. This situation is vastly different from that which existed at the time the 1906 Food and Drug Act was passed. 

Food, Drug, and Cosmetic Act of 1938 Required that new drugs be safe as well as pure (but did not require proof of efficacy). Enforcement by FDA. 

FDA (Food and Drug Administration)—agency administered under the U.S. Department of Health and Human Services (formerly Health, Education and Welfare) "to enforce the Federal Food, Drug, and Cosmetic Act and thereby carry out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions drugs and therapeutic devices are safe and effective for their intended uses cosmetics are safe and prepared from appropriate ingredients and that all of these products are honestly and informatively labeled and packaged."... 

The first law was the Pure Food Law of 1906. It has been amended several times since then and is now known as the Federal Food, Drug, and Cosmetic Act. Its main purpose is to maintain the purity of our food supply. This was the first federal effort toward protecting the consumer from pesticide-contaminated foods, by providing tolerances for pesticide residues. 

Kay G. Regulating Beauty Cosmetics in American Culture from the 1906 Pure Food and Dmgs Act to the 1938 Food, Drug, and Cosmetic Act. Ph.D. diss., Yale University 1997. 

The FDA was founded in 1927, based on the Pure Food and Drug Act of1906. The 1938 Food, Drug and Cosmetic Act introduced an absolute restriction of all poisonous substances from food. This approach was deemed unpractical and led to the application of the de minimis principle poisonous chemicals are permitted in food if their concentrations are minimal, based on the work of famously misquoted Swiss physician Paracelsus ( the dose makes the poison ). ... 

The formation of nitrosamines in aprotic solvents has applicability to many practical lipophilic systems including foods (particularly bacon), cigarette smoke, cosmetics, and some drugs. The very rapid kinetics of nitrosation reactions in lipid solution indicates that the lipid phase of emulsions or analogous multiphase systems can act as "catalyst" to facilitate nitrosation reactions that may be far slower in purely aqueous media (41, 53, 54). This is apparently true in some cosmetic emulsion systems and may have important applicability to nitrosation reactions in vivo, particularly in the GI tract. In these multiphase systems, the pH of the aqueous phase may be poor for nitrosation in aqueous media (e.g., neutral or alkaline pH) because of the very small concentration of HONO or that can exist at these pH ranges. 

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