30 Seconds SummarySupplement Regulation: Are Dietary Supplements Unregulated?
- Dietary supplements are regulated in the United States, primarily under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
- Supplements are treated as a special sub-category of food products, with the FDA responsible for overseeing safety and the FTC managing marketing claims.
- Though many believe dietary supplements are unregulated, they are actually subject to post-market regulation, meaning they are monitored after they are available for sale.
- Companies must notify the FDA if they make structure/function claims on labels, but these are not pre-approved by the FDA.
- There are exemptions that allow certain ingredients to bypass pre-market FDA approval if they are considered 'generally recognized as safe' (GRAS) or were part of the food supply in a non-altered form before 1994.
- Several incidents of non-compliance have been observed where supplements contained banned or illegal substances or were mislabeled, showing limitations in post-market regulation.
- For products with new dietary ingredients introduced after 1994, companies must file a pre-market notice with FDA, ensuring safety (not efficacy) of the ingredient.
- Consumers are advised to carefully read labels, be wary of bold health claims, and consider third-party certifications when evaluating supplement safety and quality.
- Third-party certifications can indicate that a product has undergone additional testing for compliance with good manufacturing practices and ingredient safety.
- Consumers should remain proactive and informed, as the supplement market continues to evolve with new products and regulations.
Stronger By Science
Eric Trexler
