Amazon took down my listing over an FDA claim: which words crossed the line

Updated 2026-08-24

Two different enforcers, one set of words

When Amazon removes a listing and cites FDA, two things may be happening at once. Amazon is applying its own catalogue rules. FDA, separately, treats statements on labels and in labeling as claims. A product page is labeling when it is used to present the product.

A dietary supplement may describe the role of a nutrient or ingredient in affecting the structure or function of the body. It may not claim to diagnose, treat, cure or prevent disease, unless that claim has gone through the drug or authorised-health-claim route. That is the line.

What is allowed, in FDA’s own examples

FDA’s own illustrations of structure/function claims include “calcium builds strong bones,” “fiber maintains bowel regularity,” and “antioxidants maintain cell integrity.” Those statements are not pre-approved, but they are the kind of claim DSHEA contemplated.

If you make such a claim on a dietary supplement, three things have to be true. You must have substantiation that the statement is truthful and not misleading. You must print the disclaimer that FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease. You must notify FDA of the text no later than 30 days after you first market the supplement with that claim.

What turns the same product into a drug

A disease claim, express or implied, is a claim to diagnose, cure, mitigate, treat or prevent disease. FDA’s 2000 final rule and 21 CFR 101.93(g) set out how implication works: naming a disease, naming its characteristic signs, presenting the product as a substitute for a therapy, or otherwise suggesting an effect on a disease.

“Supports joint health” and “treats arthritis” are not two tones of the same sentence. The second is a disease claim. So is a before-and-after that is only intelligible as treatment of a disease, and so is a listing that says the product is for diabetes, cancer, COVID, hypertension or infection.

Undeclared drug ingredients are a different problem again. In December 2023 FDA wrote to Amazon after buying, on amazon.com, products labelled as supplements or food that laboratory analysis showed contained sildenafil or tadalafil. Those products were not dietary supplements under the statute. They were unapproved new drugs.

What to do in the first 48 hours

Save the Amazon notice, the listing as it stood, and every image. Do not relist the same copy under a new SKU. Read the words against 21 CFR 101.93, not against a rumour about banned keywords.

If the takedown is about disease language, the fix is to take the disease out of the title, bullets, A-plus, images and insert cards, put a lawful structure/function claim in its place if you can substantiate it, add the disclaimer, and file the 30-day notification if you have not already. If the takedown is about an ingredient FDA treats as a drug, editing adjectives will not help.

What a review costs

Amazon or ecommerce claim review is $249 per listing, returned in three business days. Label review of the physical pack is $349 per SKU. Neither service is a promise that Amazon will restore the catalogue page. It is a reading of the words against the rule FDA actually published.

Common questions

Is an Amazon product page “labeling”?

FDA regulates statements on labels and in labeling. Marketplace copy that presents the product is treated as a claim surface. Do not assume that words you would never print on the bottle are safe on the listing.

Do I need FDA to pre-approve a structure/function claim?

No. You must substantiate it, carry the disclaimer, and notify FDA within 30 days after first marketing. That is not pre-approval.

Can I say “not intended to treat disease” and then describe a disease in the bullets?

The disclaimer is required for a lawful structure/function claim. It does not wash a disease claim clean. If the rest of the page is a treatment claim, the disclaimer does not save it.

Amazon cited FDA but did not quote a regulation. Does that mean they made it up?

Not necessarily. Amazon does not have to write 21 CFR 101.93 in the email. The underlying FDA line still applies to the words you used.

Will changing the title be enough?

Only if the disease claim lived only in the title. Bullets, images, A-plus modules and Q&A are all claim surfaces.

Sources

• FDA, Structure/Function Claims — DSHEA claims, disclaimer, 30-day notification, 21 CFR 101.93 — fda.gov
• FDA, Small Entity Compliance Guide on Structure/Function Claims — disease claims require prior FDA review; structure/function claims do not — fda.gov
• FDA, Dietary Supplement Labeling Guide, Chapter VI — required disclaimer text — fda.gov
• FDA, Warning Letter to Amazon.com, Inc., 20 December 2023 (662503) — products sold on amazon.com containing undeclared sildenafil or tadalafil — fda.gov

This guide is general information about FDA claim rules, not legal advice, and it does not create a client relationship. We cannot promise Amazon will restore a listing. Confirm the words on your own page before you republish them.