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Amazon Supplement Listing Policy: Banned Claims and Compliant Rewrites

By ProductGuard. Published by M Huzaifa. October 24, 2026.

Practical guidance from Amazon’s published US dietary supplement rules and the FDA and FTC materials they rely on. Not legal advice, and not a promise that Amazon will reinstate a listing. Open the help page and the notice Amazon sent about the listing while you edit. Seller Central requires sign-in.

Amazon’s dietary supplement rules prohibit a disease claim on the label and the detail page. Amazon has deactivated listings it identified as a supplement, consumable, cosmetic, or topical that makes one. Editing one bullet and leaving the claim in a keyword, an image, or the label photo does not finish the job. Below is what the US dietary supplement help page bans, and how to rewrite it.

What the label and the detail page must show

Amazon’s Dietary Supplements help page describes these products as vitamins, minerals, herbs, or other substances, such as amino acids or fatty acids, eaten to supplement the diet, in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids. The disease-claim rule on that page is written for humans. Do not assume the same sentences fit a pet listing.

The English label needs the product name, the amount, a Supplement Facts panel, the ingredient list, and the manufacturer, packer, or distributor name and address. The detail page needs the name, the amount, an image of the ingredient list, and a direct image of the whole label: the facts panel, ingredient list, any certification logos, the identity statement, directions, warnings, the product name, and the brand or manufacturer contact.

Disease claims Amazon bans

The label must not contain a disease claim, or an implied disease claim, unless FDA has approved that statement. Amazon uses the statutory list: diagnose, cure, mitigate, treat, or prevent a disease in humans. It points sellers to FDA’s Small Entity Compliance Guide on Structure/Function Claims, and it says disease claims need prior FDA approval and may only be made by approved drug products.

Amazon says the detail page must not:

Say the product cures, mitigates, treats, or prevents a disease in humans, unless FDA has approved that statement
Include a disease name in the keywords
Claim the same effect as a controlled substance or a prescription drug, claim to be an alternative, or claim to be just as effective
Claim a steroid-like effect, which Amazon illustrates with “Legal Steroids”
Say the supplement is “FDA approved”

Detail-page images must not include the FDA logo. The label has the same ban, and it must not say “tester,” “not for retail sale,” or “not intended for resale.” Amazon’s examples of confusing names are “Viagrex” and “TestosterX.”

Amazon’s inactivation notices tell sellers that an inaccurate or misleading botanical-extract amount per serving does not meet FDA labeling requirements, and they point to 21 CFR 101.36. That regulation says the listed weight is the weight of the dietary ingredient, not the weight of the source it came from. For a dried extract, the weight is the weight of the dried extract. An illustration, not an Amazon example: the panel says 500 mg of extract and a bullet says “10,000 mg of raw herb.” Use the panel’s amount.

A cosmetic or topical listing can be deactivated for the same kind of claim. See cosmetic vs. drug claims.

What can replace the banned sentence

FDA’s guide is the document Amazon tells sellers to use. A sentence can skip the disease name and still be a disease claim if it names a characteristic sign of that disease.

A structure/function claim describes a nutrient’s role in the body’s normal structure or function, such as “calcium builds strong bones,” or how it maintains that structure or function, such as “fiber maintains bowel regularity.” FDA’s page is Structure/Function Claims. You need substantiation that it is truthful and not misleading, the disclaimer, and a notification to FDA no later than 30 days after first marketing. Notification is not approval. See FDA’s notification page and “Is It Really ‘FDA Approved?’”

Use the wording in 21 CFR 101.93: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The labeling guide says you may not modify that wording. The type is boldface and no smaller than one-sixteenth of an inch, next to the claim or in a linked box on the same panel. The FTC’s Health Products Compliance Guidance says the DSHEA disclaimer will not cure a contradictory disease claim. Its example is an unqualified diabetes-treatment claim next to the disclaimer. If the page implies a disease benefit, substantiate that implied claim.

Before and after: claim rewrites

These are fictional illustrations, not a clearance. Keep an “after” line only if you can substantiate it, the rest of the page does not restore the disease meaning, and the label carries the disclaimer.

Cholesterol

Before: “Lowers cholesterol and prevents heart disease.” Keywords: heart disease, cholesterol drug.

After: “Helps maintain cholesterol levels that are already in the normal range.” FDA’s guide treats “reduces cholesterol” as an implied disease claim, and treats that “already in the normal range” wording as a structure/function claim when the label makes clear it is about levels that are already normal. Delete the disease names from the title, bullets, images, and keywords.

Sleep

Before: The name “Soothing Sleep,” plus “Treats insomnia.”

After: “For occasional sleeplessness.” FDA says “Soothing Sleep” can be read as an insomnia treatment unless the labeling makes the occasional, non-disease context clear. “Treats insomnia” comes off.

Immunity

Before: “Supports the body’s antiviral capabilities. Kills cold and flu viruses.”

After: “Supports the immune system.” FDA’s guide calls the antiviral line a disease claim and says “supports the immune system,” by itself, is not specific enough to imply disease prevention. “Flu” in the keywords is still a disease name, which Amazon bans there.

Prescriptions, names, and badges

Before: “Natural alternative to a prescription drug. Just as effective, with fewer side effects.” Nearby: the name “TestosterX,” a “Legal Steroids” bullet, the name “CircuCure,” a heart symbol, an EKG trace, and an “FDA approved” badge.

After: Delete the comparison, the “fewer side effects” line, the lookalike name, and the steroid line. FDA treats a substitute for a disease therapy, and a claim of fewer side effects than that therapy, as a disease claim. Amazon’s examples of confusing names are “Viagrex” and “TestosterX,” and its steroid example is “Legal Steroids.” FDA’s guide treats “CircuCure,” a heart symbol, and an EKG trace as implied disease claims. Take “FDA approved” and the FDA logo off the label and the images.

A weight the panel does not show

Before: “10,000 mg raw herb” when the panel lists 500 mg of extract per serving.

After: “500 mg of [the extract name] per serving.”

Put the listing back together

Edit before you ask Amazon to reinstate the ASIN. If the images you attach still show the old claim, that claim is still in the file.

Read the notice Amazon sent about the listing. Note the ASIN and the policy line. The notice says where to send the request and which files it wants.
Copy the title, bullets, description, A+ or other brand content, every image, and the backend search terms.
Photograph the bottle you will ship. If “treats arthritis” is printed on it, the bullets are not the only problem. Amazon’s label rule prohibits that claim unless FDA has approved the statement. Amazon asks for a direct image of the entire label.
Delete disease claims from every field, including keywords. Remove prescription comparisons, steroid language, “FDA approved,” and the FDA logo.
Make every number match the Supplement Facts panel, and name the ingredient.
If a structure/function sentence remains, keep the substantiation, add the disclaimer in FDA’s wording, and notify FDA within 30 days of first marketing that claim.
Replace the images with a direct image of the label, including the full panel and the ingredient list. Submit the reinstatement the way the notice instructs.

If Amazon lets the ASIN sell again, check A+ content, ads, and any review you feature. The FTC says an advertiser should not make a claim through a testimonial that it could not substantiate if it said the claim itself. Sellers who also list on TikTok Shop can use the medical-claim appeal guide.

Questions that come up when the ASIN is inactive

Does the FDA disclaimer let me say the supplement treats a disease?

No. FDA requires that disclaimer on a permitted structure/function claim, and the claim still must not diagnose, mitigate, treat, cure, or prevent a disease. Amazon prohibits disease claims on the label and the detail page unless FDA has approved the statement. The FTC says the DSHEA disclaimer will not cure a deceptive ad, including a diabetes-treatment claim placed next to it.

Can the disease name live only in backend keywords?

No. Amazon’s dietary supplement rules say detail pages must not include disease names in the keywords. A shopper may never see the search term. The policy still treats it as part of the detail page.

Is “supports the immune system” a disease claim?

FDA’s guide says “supports the immune system” is not specific enough, by itself, to imply disease prevention. “Supports the body’s antiviral capabilities” and “supports the body’s ability to resist infection” are disease claims. A picture can put a disease meaning back. FDA says a heart symbol and an EKG trace ordinarily do. Whatever you keep still needs substantiation.

What if the disease claim is printed on the bottle, not just the bullets?

Amazon’s rules apply to the label and the detail page. Editing the bullets while the bottle still says “treats arthritis” leaves the label problem in place. Change the label, then update the images so they show that bottle, including the Supplement Facts panel.

Do I have to notify FDA when I use a structure/function claim?

Yes, after you start marketing it. For a structure/function, general well-being, or classical nutrient-deficiency disease claim, you need substantiation that the statement is truthful and not misleading, the required disclaimer, and a notification to FDA no later than 30 days after first marketing. Notification is not FDA approval, and Amazon prohibits “FDA approved” on a supplement.