The short answer
Protein powders and sports products can be sold as dietary supplements or as conventional foods. The choice decides the label, the manufacturing rules and which ingredients are allowed, so it must be made before printing.
What exporters should watch for
⚖️ Supplement or food?
As a supplement, a protein powder uses a Supplement Facts panel and follows supplement CGMP (21 CFR Part 111). As a conventional food it uses Nutrition Facts, and every ingredient must be GRAS or approved. Marketing and serving directions must match the choice.
🏷️ Protein claims
A %Daily Value for protein must be corrected for protein quality (PDCAAS). Claims like “high protein” have fixed rules, and label amounts must match testing.
🧪 Pre-workout ingredients
Stimulants and newer ingredients may need a New Dietary Ingredient notification. FDA has warned companies about ingredients such as DMAA, which are not allowed.
🔬 Contaminants and testing
U.S. buyers and Amazon expect testing for heavy metals, microbes and label accuracy for each lot. Plants register with FDA and name a U.S. Agent.
Common reasons shipments are stopped
- Wrong panel: Nutrition Facts on a supplement or the reverse
- Unlawful stimulants or new ingredients without NDI
- Protein %DV without PDCAAS
- Disease claims such as “builds muscle to treat…”
- No CGMP records for supplements
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) 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
Is protein powder a dietary supplement or a food in the U.S.?
It can be either. The company decides, but FDA looks at how the product is labeled and marketed. Supplements use Supplement Facts and supplement CGMP; foods use Nutrition Facts and only GRAS or approved ingredients.
Do protein powder manufacturers need FDA registration?
Yes. Facilities that make, pack or store protein powders for the U.S. must register with FDA, name a U.S. Agent and file Prior Notice. Supplement makers also follow 21 CFR Part 111.
Does a new sports ingredient need FDA approval?
A dietary ingredient not marketed in the U.S. before October 15, 1994 usually needs a New Dietary Ingredient notification at least 75 days before sale.
Sources
- eCFR — 21 CFR Part 111, CGMP for dietary supplements
- eCFR — 21 CFR 101.36, Nutrition labeling of dietary supplements
- FDA — New dietary ingredient (NDI) notification process
- FDA — Guidance: Distinguishing Liquid Dietary Supplements from Beverages
- 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.