Health claims

FDA approved claim rules for Amazon listings

What "FDA approved" actually means, why Amazon treats the phrase as a restricted claim, and the safe language you can use instead.

Most consumer products are not "FDA approved" — the FDA approves drugs, medical devices, and a handful of high-risk categories, not dietary supplements, cosmetics, or wellness devices. Amazon treats the phrase as a restricted health claim: if your listing says "FDA approved" without that agency having reviewed and cleared the product, the listing is at high risk of suppression. Before you publish, drop the phrase or qualify it with the precise approval pathway you actually hold.

What the FDA actually approves

The FDA runs pre-market review for prescription drugs, biologics, 510(k) medical devices, and a small set of animal-drug categories. Everything else — supplements, cosmetics, most wellness electronics, beauty tools — sits outside any approval pathway. If your supplement is FDA "registered" that means you have filed a facility registration, not that the agency has reviewed your formula or your claims.

Amazon Style Guide §Health claims states that "FDA approved" can only appear on a listing when the seller can point to a specific approval number (an NDA, an ANADA, a 510(k) K-number, or a PMA). Otherwise the phrase is treated as misleading and the listing comes down.

Safe substitutes that still build trust

Use the precise approval pathway you hold: "FDA-registered facility", "cleared under 510(k) K######", "NDC listed", or "manufactured in an FDA-inspected facility" when the inspection record is current. These descriptions match what shoppers need to know without making a claim the agency has not authorised, and they keep your bullet copy inside Amazon Style Guide §Medical and health claims.

Pair the qualified language with a citation to the FDA record your bullet references — Amazon compliance reviewers will request it on appeal, so surfacing it on the PDP closes the loop before it opens.

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Frequently asked questions

Is my dietary supplement FDA approved?
No. The FDA does not approve dietary supplements. Your facility may be FDA-registered and your product may follow cGMP, but the product itself is not approved, pre-cleared, or reviewed by the agency.
Can I say my cosmetic is FDA approved?
Generally no. The FDA does not approve cosmetics. You may say the product is "manufactured in an FDA-registered facility" or "follows FDA cosmetic labeling guidelines", but "approved" is reserved for drug and device clearance pathways.

Sources

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