general designation for laws designed to ensure the safety, proper labeling, and purity of foods, drugs, vaccines, medical devices, and cosmetics. In the U.S., federal legislation of this type is administered by several agencies, most notably the U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services, although many categories of food fall within the purview of the Department of Agriculture. Factories where regulated products are prepared typically 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 the guilty subject to fine and/or imprisonment.

The basic food and drug law in the U.S., the Food, Drug, and Cosmetic Act of 1938, is a revision of the Pure Food and Drugs Act of 1906, which was enacted 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. Also passed in 1906 was the original Meat Inspection Act. The 1938 law, as revised and strengthened by subsequent amendments, gives consumers considerable protection 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. Some of the more significant amendments and related laws enacted after 1938 are listed below.

Biological and Medical Devices.

A 1951 amendment required that drugs that cannot be used safely without medical supervision must be dispensed only upon prescription. Drug amendments passed in 1962 forced 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—such as depressants, stimulants, and hallucinogens. The Childhood Vaccine Act of 1986 gave the FDA new authority to recall biologics. The Prescription Drug Marketing Act, passed in 1988, enhanced restrictions on the commercial distribution, resale, and importation of prescription drugs.

Medical device amendments enacted in 1976 provided for controls over medical equipment. The Safe Medical Devices Act of 1990 tightened monitoring of medical devices and empowered the FDA to order recalls of such products.

Food Products.

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. In what was known as the Delaney proviso, both the 1958 and 1960 legislation banned the use in foods of substances that cause cancer in animals. A 1977 measure barred the FDA from prohibiting the use of saccharin but mandated a warning label stating that the artificial sweetener had been found to cause cancer in laboratory animals. Legislation in 1980 provided for FDA control of the safety and nutritional content of infant formula. The Organic Food Protection Act of 1990 required the Department of Agriculture to develop national standards for food products labeled as “organic.” The warning requirement for saccharin was repealed in 1996, as was the application of the Delaney proviso to pesticides.

Packing and Labeling.

The Fair Packaging and Labeling Act of 1966 gave additional protection to the consumer. A 1983 measure made it a crime to tamper with packaged consumer products. The Nutrition Labeling and Education Act of 1990 required nutrition labeling on packaged foods and mandated the standardization of certain terms. The Dietary Supplement Health and Education Act of 1994 specified labeling requirements for “dietary supplements” and “dietary ingredients,” which were classified as food.

General Legislation.

The wide-ranging FDA Modernization Act of 1997 introduced new provisions on the regulation of health and nutrient-content claims made for food products, simplified certain FDA approval processes, provided for increased patient access to experimental drugs and medical devices, expanded the amount of clinical trial information available to patients, and gave the FDA increased authority to act against potentially harmful medical device.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, enacted in a period of heightened concern over terrorism, was aimed, among other things, at upgrading agricultural security and protecting the safety and adequacy of supplies of food, drinking water, and drugs and other medical products.