FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates 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 and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of the Federal Food, Drug, and Cosmetic Act as amended by DSHEA and FDA regulations.
FDA has the authority to take action against any adulterated or misbranded dietary supplement product after it reaches the market.
Links to constituent updates, press releases, and other actions taken on dietary supplements and products marketed as dietary supplements, including warning letters and recalls.
Information on selected dietary supplement products, ingredients, and other substances.
Learn how consumers, health care providers, and others can report a complaint, concern, or problem related to dietary supplements. Includes links to guidance for dietary supplement manufacturers, packers, and distributors.
Includes consumer updates, information from other agencies, and other educational materials for dietary supplement users.
Resources and links for submissions for new dietary ingredient notifications and structure/function claim notifications, applications, guidances and regulations, and other items of interest to industry members.
- New Dietary Ingredients Notification Process
Background information for industry, instructions for submitting premarket notifications, and links to relevant guidance and Federal Register documents.
- Structure/Function Claim Notification for Dietary Supplements
Background information for industry, instructions for submitting notifications, and links to relevant guidance and Federal Register documents.
Office of Dietary Supplement Programs, HFS-810
Food and Drug Administration
5001 Campus Dr
College Park, MD 20740
To contact the Office of Dietary Supplement Programs, email: [email protected]
To reach FDA’s Food and Cosmetics Information Center, call: 1-888-SAFEFOOD (1-888-723-3366)