If you take dietary supplements in an effort to stay healthy like millions of Americans do, you may have questions concerning what, if any, regulations ensure their safety and quality. Claims by the media and other outlets may falsely lead you to believe that the dietary supplement industry is largely unregulated and in turn, unsafe. On the contrary, dietary supplements are subject to comprehensive regulations covering virtually all facets of their manufacture, labeling and marketing. The following is a brief overview of the regulations governing dietary supplements:
WHO REGULATES DIETARY SUPPLEMENTS?
- The dietary supplement industry is regulated by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). The FDA has regulatory authority under the Federal Food, Drug and Cosmetic Act as amended in 1994 by the Dietary Supplement Health and Education Act (DSHEA) and in 2006 by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
HOW DO WE KNOW THE PRODUCTS AND INGREDIENTS ARE SAFE?
- The FDA regulates both finished dietary supplement products and dietary ingredients. They also regulate dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers and distributors of dietary supplements are responsible for evaluating the safety and labeling of their products before marketing, to ensure that they meet all the requirements of DSHEA and FDA regulations.
HOW IS QUALITY REGULATED?
- Under FDA regulations, all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control. Good manufacturing practices help ensure that dietary supplements meet specifications for identity, purity, strength, and composition.
WHO ENSURES THE LABEL IS ACCURATE?
- FDA regulates dietary supplement labels and other labeling, such as package inserts and accompanying literature. FDA requires that certain information appear on the dietary supplement label and that all claims and information on the product label and in other labeling be truthful and not misleading.
- The Federal Trade Commission (FTC) regulates dietary supplement advertising.
So, rest assured, the vitamins, minerals, herbs, amino acids, and specialty supplements you are taking ARE regulated. Just because they fall under a different set of regulations from those organizations covering conventional food and drug products, does not mean they are unregulated. Supplements are indeed held to strict requirements, ensuring their safety and efficacy. Nutritional supplements, as their name implies, are intended to be supplements to, not substitutes for, a well-balanced diet and a healthy lifestyle. When used properly, they can help promote overall good health and wellness.
(1) Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling (2014, December 12). Retrieved September 20, 2015 from http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm070597.htm
(2) Dietary Supplements. (2015, September 17). Retrieved September 20, 2015 from http://www.fda.gov/Food/DietarySupplements/default.htm