Dietary supplements are regulated under DSHEA (Dietary Supplement Health and Education Act) and FSMA. Foreign and domestic manufacturers must meet specific FDA registration, labeling, and notification requirements. We guide you through every step.
Facility Registration (FSMA)
Dietary supplement manufacturers are food facilities under FSMA and must register with the FDA. We handle new registrations and biennial renewals.
- Food facility registration for supplements
- Biennial renewal management
- Foreign facility U.S. Agent required
- DUNS number coordination
New Dietary Ingredient (NDI) Notifications
Manufacturers introducing a new dietary ingredient must submit a pre-market notification to the FDA at least 75 days before marketing the product.
- NDI notification preparation
- Safety data compilation
- FDA submission coordination
- Response & follow-up support
Supplement Label Review
Supplement labels have unique requirements including Supplement Facts panels, structure/function claims, and mandatory disclaimer statements.
- Supplement Facts panel review
- Structure/function claim compliance
- FDA disclaimer statement required
- Ingredient disclosure review
GMP Compliance Support
Dietary supplement manufacturers must follow Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 111. We help you prepare and stay compliant.
- cGMP gap analysis
- Documentation review
- Inspection readiness preparation
- Corrective action planning
Bringing a supplement to the U.S. market? Register Now:
From facility registration to NDI notifications and label review, we handle every FDA requirement so you can launch with confidence.
Dietary Supplements FAQs
The Dietary Supplement Health and Education Act sets the framework for how supplements are regulated, including labeling, ingredient safety, and claims, separate from conventional food and drug rules.
Yes, if it’s a New Dietary Ingredient (NDI) not already marketed before October 1994. Notification must reach the FDA at least 75 days before the product goes to market.
Any label making a structure/function claim must include the FDA-mandated disclaimer stating the claim hasn’t been evaluated by the FDA and the product isn’t intended to diagnose, treat, cure, or prevent disease.
Current Good Manufacturing Practice (cGMP) under 21 CFR Part 111, a separate standard from the preventive controls rule that applies to most other food categories.