Our History

1938The Federal Food, Drug and Cosmetic Act (FD&C Act) acknowledges vitamin, mineral and other dietary properties of foods. The FDA uses the drug provisions of the law to stake its claim to reclassify dietary supplements as drugs based on their label claims.

1941The first recommended daily allowances (RDAs) are published, establishing the basis for the FDA’s regulation of vitamins and minerals, despite opposing opinions claiming the RDA was not reflective of current scientific advances on the benefits of nutrients in maintaining health.

1966-1973 – The FDA publishes proposed new guidelines for labeling and content of dietary supplements. However, public opposition forces further hearings. Finally, in 1973, the FDA publishes final regulations classifying any supplements stronger than 150 percent of the RDA as drugs.

1976The Proxmire Amendment to the FD&C ACT, passed by Congress after years of debate over nutritional supplements, prohibited the FDA from establishing standards to limit the potency of vitamins and minerals in food supplements or regulating them as drugs based solely on their potency. The bill represents a major defeat for the opposing FDA.

1990The Nutrition Labeling and Education Act (NLEA), is intended to improve nutritional information regarding health claims made for products. The FDA is given the job of implementing the law, but because of its broad wording, the agency capitalizes on the opportunity to over-regulate safe and beneficial nutritional products.

1992The Health Freedom Act is introduced to protect the rights of citizens to choose safe dietary supplements.

An NLEA Moratorium is enacted in late 1992 to allow for further study of nutritional labeling of dietary supplements, postponing implementation of the act.

1994The Dietary Supplement Health and Education Act. DSHEA creates a new framework for regulation of dietary supplements by the FDA, established structure/function claims, authorized regulation of Good Manufacturing Practices and ‘grandfathered’ in existing ingredients.

1996 – The White House Commission on Dietary Supplement labels issues its report.

1997 – The FDA publishes regulations for structure/function claim notification under DSHEA.

Congress includes in the Food and Drug Modernization Act a provision allowing dietary supplements to make health claims.

1999 – FDA regulations require that a “Supplement Facts” panel appear on dietary supplements labels.

2002The Public Health Security and Bioterrorism Preparedness and Response Act requires food manufacturers, including dietary supplement manufacturers, to be registered with the government and give advance notification of raw materials imports.

2003FDA provides for Qualified Health Claims.

2004Ephedra Ban. In a controversial move, the FDA bans ephedra and ephedrine alkaloids that the agency determined could cause serious side effects.

The Anabolic Steroid Control Act: 26 substances were added to the 1990 list of steroids classified as Schedule III controlled substances.

The Food Allergen Labeling and Consumer Protection Act required label disclosure of the 8 major allergens that cause 90% of all food allergies.

2006The Dietary Supplement and Nonprescription Drug Consumer Protection Act required that the manufacturer or distributor listed on the supplement label report all serious adverse events linked to the dietary supplement to the FDA. (Also included over-the-counter medications.)

2007Good Manufacturing Practices are released by the FDA for dietary supplement manufacturers. The GMPs outline requirements for the Manufacturing, Packing, Labeling or Holding Operations for dietary supplements.

2010The FDA Food Safety Modernization Act includes enhanced mandatory recall authority and safety rules for all foods, including dietary supplements.

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