Bring your supplements to the U.S. market
Multivitamins, minerals and every common format: capsules, tablets, gummies, powders and liquids. We cover facility registration, Supplement Facts labeling, 21 CFR 111 cGMP and the product assessment before you ship.
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Supplement formats we support
Multivitamins and minerals are our most frequent case. Pick a format to start an assessment with it selected.
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Multivitamins & minerals
Vitamin and mineral formulas for adults and children.
Assess this product : Multivitamins & minerals
How we can help
Dietary supplements are regulated as a category of food with their own labeling and manufacturing rules.
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Facility registration and U.S. Agent
Supplement facilities register as food facilities; foreign facilities need a U.S. Agent.
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Supplement Facts and label review
Supplement Facts panel, ingredient statement, allergens and required statements.
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Claims review
Structure/function claims with the required disclaimer and FDA notification; no disease claims.
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cGMP under 21 CFR 111
Gap assessment, SOPs, specifications and records for manufacturing, packaging and holding.
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Ingredient and product assessment
Whether an ingredient may need a new dietary ingredient (NDI) notification, and the product classification.
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Prior Notice and import support
Shipment notices and importer requirements.
We do not create therapeutic claims. A supplement cannot claim to diagnose, treat, cure or prevent a disease; we review your claims against that line.
Key FDA regulations for supplements
| Reference | Topic | Why it matters |
|---|---|---|
| 21 CFR 111 | cGMP for dietary supplements | Manufacturing, packaging, labeling and holding operations. |
| 21 CFR 101.36 | Supplement Facts | Format and content of the nutrition panel. |
| 21 CFR 101.93 | Structure/function claims | Required disclaimer and notification to FDA. |
| 21 CFR 190.6 | New dietary ingredients | Premarket notification for ingredients that require it. |
| 21 CFR 1, Subparts H & I | Registration and Prior Notice | Facility registration, U.S. Agent and shipment notices. |
Our process
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Product assessment
Formula, ingredients, format and intended claims.
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Gap analysis
Labeling, claims and cGMP gaps, prioritized.
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Compliance implementation
Registration, label corrections and SOPs.
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U.S. market readiness
Shipment documents and importer requirements.
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Ongoing support
Renewals, label updates and questions within scope.
Dietary supplement FAQs
Does FDA approve dietary supplements?
No. FDA does not approve dietary supplements before they are sold. The company is responsible for safety, labeling and following cGMP.
Can my label say the product treats a condition?
No. Disease claims would make the product an unapproved drug. Structure/function claims are allowed with the required disclaimer and notification to FDA.
Do gummies or powders have different rules?
The same supplement rules apply to every format. What changes is the formulation, the serving size and how the Supplement Facts panel is built.
Does my supplement facility need to register?
Yes. Facilities that manufacture, pack or hold dietary supplements for the U.S. register as food facilities, and foreign facilities need a U.S. Agent.
Talk to us about your formula
Call or WhatsApp us with the product and format. We will tell you where to start.
Ready to bring your supplements to the U.S.?
Start with a product assessment.