The Food, Drug, and Cosmetic Act of 1938 is the most important of the pure food and drug acts passed and administered by the 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, enacted in 1906, which brought attention to many abuses in the form of poor health practices and excessive pricing. The 1938 revised law and subsequent amendments, give consumers greater protection from dangerous and impure foods and drugs; they require labeling that discloses the nature of the contents of the package when the buyer cannot see the product or judge its composition and value. They also provide safeguards against the introduction of untested new drugs (Versaware Technologies, 1999).

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, to set legally enforceable food standards, and to establish affirmative labeling requirements (Hardy, 1990). 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 sugarwater 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 manufacturer misbranding of food: The food is not adulterated, but the consumer is deceived. In 1993, the FDA seized 2400 cases of Procter & Gamble's Citrus Hill orange juice because the label used the word "fresh" when the product was, in fact, produced from concentrate. (Colford, 1991).

Since the passing of the first food and drug law, food laws and regulations have evolved from (1) concerns centering around food fraud, (2) to concerns about food safety, (3) to protection of the nutritional integrity of food, (4) to truth in labeling, (5) to, most recently, concern about the relationship between health and food. Many amendments to the Food, Drug, and Cosmetics 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, with fines up to $500,000, imprisonment up to ten years, or both, for repeated offenses.