Dietary Supplements

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.

What's New in Dietary Supplements
Links to constituent updates, press releases, and other actions taken on dietary supplements and products marketed as dietary supplements, including warning letters and recalls.

How to Report a Problem with Dietary Supplements
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.

Information for Consumers on Using Dietary Supplements
Includes consumer updates, information from other agencies, and other educational materials for dietary supplement users.

Information for Industry on Dietary Supplements
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 Ingredient Notification Process
  Background information for industry, instructions for submitting premarket notifications, and links to relevant guidance and Federal Register documents.
• Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling
  Background information for industry, instructions for submitting notifications, and links to relevant guidance and Federal Register documents.

Contact FDA

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: ODSP@fda.hhs.gov

To reach FDA’s Food and Cosmetics Information Center, call: 1-888-SAFEFOOD (1-888-723-3366)