Dietary supplements-- an FDA primer

The Federal Food, Drug, and Cosmetic Act (Act) defines a dietary supplement as a product intended for ingestion that contains a “dietary ingredient” intended to add further nutritional value to supplement the diet. A dietary ingredient is a vitamin, mineral, herb, or other botanical, amino acid, or a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

Supplements are typically marketed to consumers in forms such as tablets, capsules, soft gels, gel caps, powders, or liquids and do not require a prescription written by a health care practitioner. These products are sold in most pharmacies, grocery stores, and nutritional supplement centers. Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. This means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs that have been approved by the FDA for a particular indication.

Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994 (DSHEA), the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (eg, that the product is unsafe) or misbranded (eg, that the labeling is false or misleading).

FDA regulates both finished dietary supplement products as well as dietary ingredients. It also regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the DSHEA, manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. These firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that requirements are met.

FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. Because dietary supplements are under the “umbrella” of foods, FDA’s Center for Food Safety and Applied Nutrition oversees these products. The DSHEA, which amended the Act, created a new regulatory framework for the safety and labeling of dietary supplements. FDA is not authorized to review dietary supplement products for safety and effectiveness before they are placed on the market.

FDA provides a safety reporting portal for the public.This lets FDA know when consumers, health professionals, or industry members find a problem with a particular dietary supplement. It is an electronic version of the existing MedWatch 3500, 3500A, and 3500B forms used by industry and consumers to report problems with FDA-regulated products. The electronic version is tailored exclusively for dietary supplements.

Stakeholders of the dietary supplement industry, which includes individual consumers and pharmacists, may use the reporting form on the safety reporting portal to meet the reporting requirements established under the Act.   

This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with attorneys familiar with the relevant drug and pharmacy laws.Ned Milenkovich, RPh, is chair of the healthcare law practice at Much Shelist PC and vice chair of the Illinois State Board of Pharmacy. Call him at 312-521-2482 or nmilenkovich@muchshelist.com.