Yes. Dietary supplement products are regulated by the U.S. Food and Drug Administration (FDA). This is probably the most commonly misunderstood fact about the dietary supplements industry. Most of the misunderstanding occurs when people confuse dietary supplements with prescription or over-the-counter (OTC) medicines and expect them to be regulated in the same manner.
Dietary supplements are meant to supplement the diet; accordingly, the Dietary Supplement Health and Education Act of 1994 (DSHEA) defines them as a subset of foods, and they are regulated as such. As is the case with foods, FDA regulates the types of ingredients allowed in dietary supplements and the types of claims that can be made about an ingredient and/or a product. FDA also has detailed requirements for the labeling of dietary supplements (e.g., nutrition labeling, allergen labeling, statement of identity, and a net quantity statement, among others).
While dietary supplement manufacturers must ensure that their products are safe prior to marketing, FDA also has several post-marketing responsibilities to ensure the safety of dietary supplements. Among those is enforcement of the final rule on dietary supplement Current Good Manufacturing Practices (cGMPs), released on June 25, 2007. This rule is mandatory for all dietary supplement companies and it became effective for all companies in June 2010 following a three-year, phase-in period. cGMPs establish uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplement products.
FDA also oversees mandatory adverse event reporting by dietary supplement manufacturers. In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, requiring that dietary supplement manufacturers promptly communicate serious adverse events to FDA. This requirement went into effect December 22, 2007. Serious adverse events associated with the use of a dietary supplement should be reported to FDA’s MedWatch Program.
