FDA registration is not required for dietary supplements. However, facilities involved in the production of dietary supplements must register with the FDA. Key points:
- Manufacturers, packers, and distributors of dietary supplements must register their facilities with the FDA. This is part of the Food Facility Registration process, which is required under the Bioterrorism Act of 2002.
- The registration helps the FDA monitor the supply chain and trace products if there’s a safety concern.
- The registration must be updated if any information in registration changes
- The registration must be renewed every even numbered year,
- Product registration is not required. Dietary supplement manufacturers do not need to register each product with the FDA before selling it, unlike drugs or medical devices. Instead, it’s the responsibility of the manufacturer to ensure the product is safe and labeled according to FDA guidelines.
- If a dietary supplement contains a new dietary ingredient (an ingredient not marketed in the U.S. before 1994), the manufacturer must notify the FDA about the ingredient before it is marketed.
Liberty Management Group Ltd. can help you with FDA registration.
Namrata
Regulatory Consultant
support@libertymanagement.us