History of federal regulation of food and drugs
Food and Drugs Act of 1906 | Established broad authority to protect the public from adulterated or misbranded foods and drugs by requiring demonstrated safety and accurate labeling |
| Federal Food, Drug, and Cosmetic Act of 1938 | Transferred responsibility for proving safety of new drugs to the manufacturer but maintained that the FDA be responsible for determining that a conventional food was adulterated |
| Food Additives Amendment of 1958 | Shifted the burden of proof of safety for new substances added to food away from the FDA and to the manufacturers; afforded the FDA to clarify the regulatory status of food substance in use before 1958, listing them as GRAS |
| Health Research and Health Services Amendment in 1976 “Proxmire Amendments” | Established standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based on potency |
| The Nutrition Labeling and Education Act of 1990 and Health Claims | Provided that health claims describing the relationship of a nutrient to a disease or health-related matter were allowed for both traditional foods and dietary supplements if the claims complied with FDA regulations |
| DSHEA | Established a new regulatory framework for dietary supplements that limited the FDA's authority over these products to that of conventional food, compared with its authority over food additives or new drugs; no requirement needed for a manufacturer to obtain premarket approval (Khatcheressian, 1999) or establish GRAS status |