Between the dietary supplement industry, the government, and consumers, there is clear discordance as to how dietary supplements should be regulated. This page notes the major laws and amendments and provides links to more information:
Governmental Institutions:
- The Food & Drug Administration (FDA):
- The FDA’s Mission
- The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA regulates both finished dietary supplement products and dietary ingredients. However, they are not able to regulate supplements before they hit the market.
Cick here for more information on the FDA
Click here for more information on the FDA’s role in regards to dietary supplements
2. Federal Trade Commission (FTC):
- The FTC’s Mission:
- Working to protect consumers by preventing anticompetitive, deceptive, and unfair business practices, enhancing informed consumer choice and public understanding of the competitive process, and accomplishing this without unduly burdening legitimate business activity. The FTC regulates advertising claims for dietary supplements.
Click here for more information on the FTC
Laws and Regulations:
- 1906 Pure Food and Drug Act
- This law prohibited interstate commerce of adulterated and misbranded foods and drugs in an effort to prevent manufacturers from deceiving customers. There was no premarket approval system for in place and the FDA could act only after products were already on the market.
- Click here for more information on the 1906 Pure Food and Drug Act
2. 1938 Federal Food, Drug, and Cosmetic Act
- Its purpose was to address the limitations of the Pure Food and Drug Act, as well as expand federal protection of consumers from unsafe and misleading products. It required premarket approval of products, so that a manufacturer would have to prove to the FDA the product was safe before it could be sold. In addition, three food standards: identity, quality, and fill of container regulations were established.
- Click here for more information on the 1938 Federal Food, Drug and Cosmetic Act
3. The 1967 Fair Packaging and Labeling Act (FPLA)
- The FPLA directs the FTC and the FDA to issue regulations requiring that all “consumer commodities” be labeled to disclose net contents, identity of commodity, and name and place of business of the product’s manufacturer, packer, or distributor. The Act allows for additional regulations when necessary in order to prevent consumer deception.
- Click here for more information on FPLA
4. The Nutrition Labeling and Education Act of 1990 (NLEA)
- NLEA required packaged foods to have nutrition labeling. NLEA declares a food misbranded unless the label bears nutrition information that provides: (1) the serving size or other common household unit of measure customarily used; (2) the number of servings or other units per container; (3) the number of calories per serving and derived from total fat and saturated fat; (4) the amount of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, total protein, and dietary fiber per serving or other unit; and (5) subject to conditions, vitamins, minerals or other nutrients
- Click here for more information on NLEA
5. Dietary Supplement Health and Education Act of 1994 (DSHEA)
- The purpose of DSHEA was to create a balance between providing consumers access to both products and truthful information while retaining authority for the FDA to take action against mislabeled and unsafe products. The FDA’s role in regards to dietary supplement regulation begins after the product enters the marketplace. Federal law does not require dietary supplements to be proven safe or effective to the FDA’s satisfaction before they are marketed. The DSHEA enables manufacturers to market dietary supplement more easily than other products because they can only be removed if the FDA proves that the supplement bears a significant risk or is otherwise adulterated to consumers after it is already on the market.
- Click here for more information of DSHEA
Click here for a brief overview of the laws stated above as well as additional amendments
Click here to hear an interview with Dr. Peter Cohen, a primary care physician at Cambridge Health Alliance in Somerville, Massachusetts, and an assistant professor of medicine at Harvard Medical School on the regulation of dietary supplements. He has written many articles on supplements.