FOOD, DRUG, AND COSMETIC ACT OF 1938

The Food, Drug, and Cosmetic Act of 1938 is the most important of the pure food and drug acts passed and administered by the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. Food and drug laws were enacted to ensure the safety, proper labeling, and purity of foods, drugs, vaccines, devices, and cosmetics. The 1938 act is a revision of the first food and drug law, passed in 1906, which brought attention to many abuses in the form of poor health practices and excessive pricing. The revised law of 1938 and subsequent amendments give consumers greater protection from dangerous and impure foods and drugs; these laws require labeling that discloses the nature of the contents of the package, informing the buyer as to the product's composition and giving the buyer some insight as to the value of the product. These laws also provide safeguards against the introduction of untested new drugs.

The Food, Drug, and Cosmetic Act of 1938 addressed the wholesomeness of the food supply by giving the FDA powers to engage in economic regulation, set legally enforceable food standards, and establish affirmative labeling requirements. Consequently, the FDA examines food products' adulteration from the perspectives of both wholesomeness and safety. For example, the FDA has investigated several cases involving the alteration of fruit juices by dilution with sugar water or less expensive juices that represent both reductions in wholesomeness and economic fraud.

Another condition of economic fraud covered by the Food, Drug, and Cosmetic Act is misbranding of food by manufacturers: The food is not adulterated, but the consumer is deceived. In 1993 the FDA seized 2,400 cases of Procter & Gamble's Citrus Hill orange juice because the label used the word fresh when the product was produced from concentrate.

Since the passing of the first food and drug law, food laws and regulations have evolved from:

1. concern about food fraud, to
2. concerns about food safety, to
3. protection of the nutritional integrity of food, to
4. truth in labeling, to, most recently,
5. concern about the relationship between health and food.

Many amendments to the Food, Drug, and Cosmetic Act of 1938 and other food-related laws and acts have been passed by Congress and will continue to be enacted in response to future technological changes and developments. Manufacturers of food, drugs, cosmetics, and their related products must comply with the law. Penalties for violations include seizure of illegal goods, injunctions, restraint of shipments that violate the law, and criminal prosecution of those responsible for the violation.

see also Consumer Advocacy and Protection

bibliography

Food, Drug and Cosmetic Act of 1938. Essential Documents in American History; Essential Documents, 1492–Present. 1–24. EBSCO Publishing.

Meier, Kenneth J., Garman, E. Thomas, and Keiser, Lael R. (2003). Regulation and consumer protection: Politics, bureaucracy and economics (4th ed.). Mason, OH: Custom Thomson.

U.S. Food and Drug Administration. (n.d.). The 1938 Food, Drug, and Cosmetic Act. Retrieved February 20, 2006, from http://www.fda.gov/oc/history/historyoffda/section2.html

Phyllis Bunn

Laurie Barfitt