Amazon Supplements: Requirements, Banned Claims & How to Avoid Delisting
[UPDATE: Amazon has since updated their requirements since this original blog was posted. While the points below still apply, check out the link here for the updated requirements.]
Thinking about selling your supplements on Amazon? Smart move—but it’s not as simple as uploading a label and turning ads on. Amazon actively removes non-compliant listings, has begun mandating third-party product testing in high-risk categories, and now asks for specific documentation (from real labs and real GMP programs). Below is a clear, founder-friendly guide to what’s changing, what Amazon will ask you for, and the build process I use with clients so they don’t get flagged, delisted, or banned.
Key takeaways
Amazon is a compliance gatekeeper now. Expect mandatory third-party testing in certain categories (e.g., weight loss, sexual enhancement) and tighter label/claims reviews.
Your label and PDP (product detail page) are “legal documents.” “FDA approved,” Rx comparisons, and similar high-risk claims are fast-track routes to takedowns.
Documentation is not optional. Amazon typically asks for a GMP certificate (21 CFR 111 compliance) and a COA that meets their format requirements.
Design “compliance-first.” Build your label + Amazon PDP draft up front, then run a structured compliance review before R&D spend.
Plan for testing budget. Depending on category and claims, you may need potency, heavy metals, micro, and category-specific adulterant screens.
Who this is for
Founders and teams who:
Are formulating a new supplement with plans to sell on Amazon.
Have an existing catalog and need to harden listings against flags/delistings.
Want a practical, step-by-step way to bake compliance into product and PDP design.
1) Amazon’s shift: from “list anything” to “prove it”
Amazon has increased enforcement on supplements, especially in weight loss and sexual enhancement, where third-party testing is now required to screen for known adulterants. Practically, that means:
Testing at an ISO-accredited lab (Amazon checks accreditation).
Submitting results that tie to your specific batch/lot.
Founder tip: If your roadmap includes either category (or related keywords/benefits), build the extra test cost and lead time into your P&L and launch plan from day one.
2) Labeling & claims Amazon routinely flags
Amazon explicitly prohibits several framing tactics—on your label and your listing:
No FDA logos and no “FDA approved” statements for supplements (FDA does not “approve” dietary supplements).
No Rx-style comparisons: “as effective as [drug],” “alternative to [drug],” or drug-implied positioning.
No disease claims on PDP bullets, A+ content, images, or Q&A (if you imply treat/cure/mitigate, expect a takedown).
Consistency matters: the claims on your bottle, images, bullets, brand store, and ad creatives must align.
Founder tip: Treat your PDP images like labels. If it appears in an image tile, Amazon considers it part of the claim set.
3) The documents Amazon expects
Most supplement brands are asked for two core items:
A) GMP evidence (21 CFR 111)
A current certificate showing your co-man’s compliance with dietary supplement GMPs.
Ensure it’s issued by a credible body and reflects the physical site making your product.
B) Certificate of Analysis (COA)
Amazon wants a COA that includes:
Brand + product name, lot/batch number, serving size tested.
Test methods (not just “passes”—methods or references should be listed).
Lab details + accreditation (ISO/IEC 17025 or equivalent).
Results vs. specification for each tested parameter (not only “meets label claim”).
Founder tip: Ask your co-man for a sample COA before you sign anything. If it’s missing lot numbers, methods, or lab accreditation, assume you’ll have rework later.
4) A build process that keeps you Amazon-safe
This is the exact sequence I use with clients so we don’t waste R&D dollars or fight listing takedowns:
Label-first + PDP-first
Draft your full label (Supplement Facts, ingredients, warnings, storage, company address) and your Amazon PDP (title, bullets, image copy, A+ headlines).
Add every callout you think you want (non-GMO, vegan, gluten-free, etc.).
Compliance review (pre-R&D)
Check FDA/FTC positioning, Amazon claim rules, and category-specific risks.
Identify which claims require testing (e.g., gluten-free), which need reformulation/dose changes, and which should be removed.
Confirm documentation path with the co-man
Validate GMP certificate availability and recency.
Align on COA contents, test panels, and lab accreditation before PO.
If you’re in a gated category, schedule adulterant testing early.
Budget your testing
Minimum baseline for most formulas: potency/identity, micro (Salmonella/E. coli/Listeria as applicable), heavy metals, and any claim-critical tests (e.g., gluten).
Add adulterant screens where Amazon mandates them.
Lock the spec and SOPs
Finalize your finished product specification (identity, purity, strength, composition).
Ensure your co-man can deliver COAs against that spec (not vague “pass” statements).
5) Common pitfalls that trigger flags
Using the FDA logo or “FDA approved” language anywhere (label, images, A+).
Drug-adjacent phrasing (“as effective as,” “RX-strength,” “[disease] relief”).
COAs without methods/lot numbers or from non-accredited labs.
Mismatched claims across bottle, bullets, and images.
Skipping category-specific tests (then scrambling when Amazon asks).
Quick checklist (save this)
Drafted label + Amazon PDP before R&D spend
Claims reviewed for FDA/FTC/Amazon risk
Co-man’s current GMP certificate on file
COA template reviewed (lot #, methods, accredited lab)
Test plan set: potency, micro, heavy metals, category adulterants
Any “free-from” claims tied to actual test results
Image tiles audited like labels (no risky language or logos)
Summary
Amazon isn’t just a sales channel—it’s a compliance channel. If you design your label and PDP first, run a targeted compliance review, align your co-man documentation, and budget testing by category, you’ll avoid the painful (and expensive) delist → relist cycle.
Next steps (work with us)
Book a Signature Consultation
Bring your draft label and Amazon PDP. In one focused session, we’ll flag high-risk claims, map your document/test requirements, and outline a practical Amazon-readiness plan you can execute with your co-man.Join SSET (Supplement Startup Essentials Training)
Our self-paced training helps founders understand what regs apply, complete a market/product brief, and learn how to find and vet a co-manufacturer—so you can launch with fewer surprises.