Does my supplement need FDA approval before I can sell it?

No. Under DSHEA, dietary supplements do not require pre-market approval. However, you must comply with cGMP, labeling requirements, and can only use permissible ingredients.

What is a structure/function claim vs. a drug claim?

A structure/function claim describes the role of a nutrient (e.g., 'Calcium supports bone health'). A drug claim states that a product treats, cures, or prevents a disease. Drug claims are not permitted on supplements.

Do I need third-party testing?

While not legally required, third-party testing is strongly recommended. Major retailers, Amazon, and platforms like iHerb require it. It also protects against liability and builds consumer trust.

Can I sell the same formula in the US and EU?

Not always. The EU has different maximum dosage levels, approved ingredient lists, and health claim regulations. Formulations often need adjustment, and labels must be translated and reformatted for each market.

Regulatory Knowledge Center

Navigate Supplement Compliance

From FDA registration to international market entry - everything you need to know about manufacturing compliant dietary supplements.

Research and development laboratory for regulatory compliance testing

Compliance documentation and laboratory testing equipment for supplement quality assurance

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 supply the manufacturing documentation and regulatory support behind each of these markets. The brand owner or importer remains the responsible party on the label.

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 handles the filings, label reviews, and certification work agreed in your quote for your target markets. Registrations, product classification, marketing claims, translations, and post-market obligations stay with the brand owner or importer of record unless we have agreed in writing to take a specific task on.

Our Certifications & Registrations