Can I sell supplements on Amazon, and what do I need?
Yes, but Amazon asks for proof first. That's a cGMP certificate from an accredited third party, which is proof from an audit that the factory follows FDA's rules, plus images of the full English label and $1M of insurance. Weight-loss, sports, sexual-health and joint products also need lab tests.
See the plan for your product →This page covers dietary supplements sold in the US. The free check in the plan confirms the rules for yours, product by product.
What does Amazon ask for before you list supplements?
- A cGMP certificate from an accredited third party (21 CFR 111 or 117). It's proof from an audit that the factory follows FDA's rules. FDA inspections and self-audits aren't accepted.1 Amazon help, “Dietary supplements” ↗
- Images of the full English label, with Supplement Facts and a lot code.1 Amazon help, “Dietary supplements” ↗
- Weight-loss, sports, sexual-health and joint products also need lab tests. The tests look for heavy metals, microbes and hidden drugs.1 Amazon help, “Dietary supplements” ↗
- You need $1M of insurance. If Amazon sends a notice about a listing, a tester Amazon approves checks the documents.2 Amazon help, “Enhanced safety listing requirements” ↗
- Based in mainland China? You have to buy this insurance through Amazon's own program, the Amazon Insurance Accelerator, unless Amazon agrees otherwise in writing.3 Amazon help, “Commercial Liability Insurance Requirements” ↗
Also on Amazon for this product (4)
- Decide whether the product needs a Prop 65 warning. If it does, set the warning type and chemical names on the Compliance tab.4 Amazon help, “California Proposition 65” ↗
- Set it on every child SKU that needs one, not the parent: Amazon rejects a warning sent on the parent SKU, and the upload fails.4 Amazon help, “California Proposition 65” ↗
- Amazon applies this even with fewer than 10 employees.4 Amazon help, “California Proposition 65” ↗
- Don't send Amazon labels or signs.4 Amazon help, “California Proposition 65” ↗
What does the law ask for, whatever the marketplace?
- FDA's rules for making supplements (cGMP) cover you as the importer.1 21 CFR 111.1, who the cGMP rule covers ↗
- The label needs Supplement Facts. It also needs a US address or phone for reports of bad reactions (adverse events).2 21 U.S.C. 343(y) and 21 CFR 101.36 ↗
- If your name is on the label, keep adverse-event records 6 years.3 21 U.S.C. 379aa-1, adverse-event records ↗
- Imported supplements need a program for checking the supplier too (supplier verification). Supplements get a modified version of it.4 21 CFR 1.511(c), FSVP for supplements ↗
- California requires a clear warning before anyone is exposed to a chemical on its list.5 Cal. Health & Safety Code 25249.6 ↗
More the law asks for this product (2)
- Businesses with fewer than 10 employees are outside the law.6 Cal. Health & Safety Code 25249.11(b) ↗
- This plan doesn't yet say how or where to warn: on the label, in a notice to stores, or online. That waits until the official rules are read.
Sources (6) · read 11 Nov 2026
- 121 CFR 111.1, who the cGMP rule covers. eCFR text as of 1 Sep 2026
- 221 U.S.C. 343(y) and 21 CFR 101.36. US Code, 2024 edition (govinfo)
- 321 U.S.C. 379aa-1, adverse-event records. US Code, 2024 edition (govinfo)
- 421 CFR 1.511(c), FSVP for supplements. eCFR text as of 1 Sep 2026
- 5Cal. Health & Safety Code 25249.6. California code
- 6Cal. Health & Safety Code 25249.11(b). California code
What does that look like for one product?
Say you sell a joint supplement on Amazon. You need the cGMP certificate, images of the label with Supplement Facts and a lot code, lab tests for heavy metals, microbes and hidden drugs, and $1M of insurance.
What's the next step?
The plan lists every step for your product in order, with a source for each line. It opens with Amazon and the product type already picked, and you can change either. It's free, with no signup.
See the plan for your product →Not sure which FDA import steps apply? The free certificate check shows them for your product, with the rule cited for each. Check which certificate you need — free →
Related
Checked against Amazon's and the government's own pages on 11 Nov 2026.