Applications & Submissions
Instructions and links for industry to submit specific notifications and applications for dietary supplements.
- New Dietary Ingredient (NDI) Notification
- Structure/Function Claim Notification for Dietary Supplements
- How to Report a Problem with Dietary Supplements
- Online Applications for Export Certificates for Food (incl. Certificates of Free Sale for Dietary Supplements)
- Food Facility Registration
- Small Business Nutrition Labeling Exemption
- How to Submit Label Claim Petitions & Notifications
Guidance & Regulatory Information
Policies, resources, and links to provide guidance related to dietary supplements.
- Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification
- Draft Guidance for Industry: Policy Regarding N-acetyl-L-cysteine
- Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials
- Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements
- Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
- Dietary Supplement Labeling Guide
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- All Dietary Supplements Guidance Documents & Regulatory Information
Searchable database of warning letters sent by FDA to manufacturers.
Miscellaneous resources for industry.