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Regulatory Knowledge Center
Navigate Supplement Compliance
From FDA registration to international market entry — everything you need to know about manufacturing compliant dietary supplements.
FDA Regulation of Dietary Supplements
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Unlike pharmaceutical drugs, supplements do not require pre-market approval — but they must be manufactured in compliance with Current Good Manufacturing Practices (cGMP) under 21 CFR Part 111.
Manufacturers are responsible for ensuring product safety and that label claims are truthful and not misleading. The FDA can take action against adulterated or misbranded products after they reach the market.
Key Points
- No pre-market approval required (unlike drugs)
- Must comply with cGMP (21 CFR Part 111)
- Facility registration with FDA required
- Serious adverse event reporting mandatory
- Structure/function claims allowed with disclaimer
Frequently Asked Questions
Market Compliance at a Glance
We handle compliance for all major markets so you can sell confidently worldwide.
| Requirement | US (FDA) | EU (EFSA) | Canada | Australia | MENA |
|---|---|---|---|---|---|
| Facility Registration | |||||
| Ingredient Pre-approval | |||||
| Mandatory Label Elements | |||||
| Health Claim Restrictions | |||||
| Third-party Testing | |||||
| Novel Food / NDI Filing | |||||
| Halal / Special Certification |
Our regulatory team manages every filing, label review, and certification process for your target markets.
Our Certifications & Registrations
