The FDA oversees both finished dietary supplement products and dietary components. The FDA regulates dietary supplements differently than it does “conventional” foods and drugs. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- Manufacturers and distributors of dietary supplements and ingredients are forbidden from promoting adulterated or misbranded products. This means that these companies are responsible for examining their goods’ safety and labelling before marketing to ensure that they meet all of the standards of the Federal Food, Drug, and Cosmetic Act, as revised by DSHEA and FDA rules.
- The FDA has the jurisdiction to take action against any adulterated or misbranded dietary supplement product that reaches the market.
What’s new in dietary supplements?
Links to constituent updates, press announcements, and other dietary supplement and product-related actions, such as warning letters and recalls.
How to report a problem with dietary supplements. Learn how consumers, health care practitioners, and others can file a complaint, concern, or problem about dietary supplements. Includes links to guidelines for dietary
supplement makers, packers, and distributors.
Details on Dietary Supplements for Industry
Applications, guidelines, rules, and other items of interest to industry participants are available, along with resources and links for submissions for notifications of new dietary ingredients and structure/function claims.
Guideline for Dietary supplements:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-new-dietary-ingredient-notification-master-files-dietary-supplements
