The short answer
Collagen and probiotics are two of the fastest-growing supplement categories on Amazon US. Collagen raises questions about animal sources and allergens; probiotics about strain identity and CFU counts.
What exporters should watch for
🐄 Collagen sources
Bovine collagen and gelatin must not use prohibited cattle materials (21 CFR 189.5). Marine collagen from fish must declare fish (and the species) as an allergen.
🦠 Probiotic counts
FDA allows live microbials to be declared in colony-forming units (CFU) alongside weight. Counts must still be met at the end of shelf life, so stability testing matters.
🧬 New strains
A probiotic strain not sold in the U.S. before October 15, 1994 may need a New Dietary Ingredient notification at least 75 days before marketing.
🏷️ Claims and CGMP
Claims like “supports skin” or “supports digestion” are structure/function claims and need the FDA disclaimer. Makers follow supplement CGMP (21 CFR Part 111) and register with FDA.
Common reasons shipments are stopped
- Fish not declared in marine collagen
- CFU counts that drop below label claims
- Disease claims such as “treats arthritis” or “cures IBS”
- New strains without NDI notification
- No CGMP records
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Do collagen supplements need FDA approval?
No product approval is needed, but the manufacturer must register with FDA, follow supplement CGMP and label the product correctly, including allergens for marine collagen. Claims must stay within structure/function rules.
Can probiotic labels show CFUs?
Yes. FDA allows companies to declare live microbials in CFUs alongside the weight on the Supplement Facts panel. The count should be guaranteed through the end of shelf life.
Does a new probiotic strain need an NDI?
If the strain was not marketed in the U.S. as a dietary ingredient before October 15, 1994, a New Dietary Ingredient notification is usually needed at least 75 days before sale.
Sources
- eCFR — 21 CFR 189.5, Prohibited cattle materials
- FDA — New dietary ingredient (NDI) notification process
- eCFR — 21 CFR Part 111, CGMP for dietary supplements
- eCFR — 21 CFR 101.36, Nutrition labeling of dietary supplements
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.