Pure Food and Drug Acts

Pure Food and Drug Acts, general designation for laws designed to ensure the safety, proper labeling, and purity of foods, drugs, vaccines, devices, and cosmetics. The most important such law in the U.S. is the Food, Drug, and Cosmetic Act of 1938, which is administered by the Food and Drug Administration (FDA) of the Department of Health and Human Services.

Foods, drugs, vaccines, medical devices, veterinary drugs, and cosmetics in interstate commerce must comply with the law, which protects both consumers and manufacturers. Factories where these products are prepared receive inspections covering sanitation, raw materials, adequate processing, and finished product. Penalties for violations include seizure of illegal goods, injunctions to restrain violative shipments, and criminal prosecution of those responsible for the violation, with fines up to $500,000, imprisonment up to 10 years, or both, for repeated offenses.

The first pure food and drug law was enacted in 1906 through the efforts of Harvey Washington Wiley and other crusaders who brought to public attention many abuses in the form of poor health practices and excessive prices. This law, as revised in 1938 and strengthened by subsequent amendments, gives consumers the greatest protection they have ever received from dangerous and impure foods and drugs; it requires labeling that will disclose the nature of the contents of the package when the buyer cannot see the product or judge its composition and value. It also provides safeguards against the introduction of untested new drugs.

A 1951 amendment required that drugs that cannot be used safely without medical supervision must be dispensed only upon prescription. The food additives amendment of 1958 required manufacturers to prove to the FDA the safety of additives before their use in foods. Color additive amendments in 1960 tightened requirements on colors used in foods, drugs, and cosmetics. Both banned the use in foods of substances that cause cancer in animals. Drug amendments passed in 1962 required manufacturers, for the first time, to prove to the FDA the effectiveness, as well as the safety, of drugs before they were marketed. Amendments in 1965 imposed strict controls on abused-drugs—depressants, stimulants, and hallucinogens. The Child Protection Act and the Fair Packaging and Labeling Act of 1966 gave additional protection to the consumer. The Medical Devices Act of 1976 amended the law by providing for controls over medical equipment.