FDA Has Sent Amazon Nine Warning Letters Since 2022. The Newest One Names Fulfillment by Amazon.
FDA has issued nine warning letters to Amazon.com since August 2022, every one alleging the same violation: unapproved new drugs introduced into interstate commerce. The June 2026 letter changes the theory — it ties the violation to Fulfillment by Amazon. Here is what that means for third-party sellers.
FDA Has Sent Amazon Nine Warning Letters Since 2022. The Newest One Names Fulfillment by Amazon.
On June 17, 2026, FDA sent Andy Jassy a warning letter about three creams sold on amazon.com. It posted publicly on June 23. It is the ninth warning letter FDA has issued to Amazon.com, Inc. since August 2022, and every one of the nine alleges the same core violation: unapproved new drugs, introduced into interstate commerce, by Amazon.
The individual letter is unremarkable. The sequence is the story — and one sentence in the 2026 letter marks a real change in how FDA frames Amazon's responsibility.
The nine letters
| Posted | MARCS-CMS | Products at issue |
|---|---|---|
| Aug 2022 | 629452 | Mole and skin tag removers (Deisana, Skincell) |
| Nov 2022 | 631751 | Artri Ajo King and related joint products |
| Aug 2023 | 649056 | Molluscum contagiosum treatments (Naturasil, Conzerol, ZymaDerm, HealthyDerm) |
| Nov 2023 | 665460 | Eye drops (Similasan Pink Eye Relief, Can-C, OcluMed, and four others) |
| Dec 2023 | 662503 | Energy supplements containing undeclared active pharmaceutical ingredients |
| Jul 2024 | 679523 | Chemical peels (MÔOYAM TCA 50%, Skin Beauty Solutions lactic acid 90%) |
| Mar 2025 | 695821 | Injectable lipolytics (LemonBottle, L-Carnitine Body Serum, Matrigen PPC) |
| Apr 2025 | 689355 | Tattoo numbing creams (Painless Tattoo, Ink Scribd, Nupharmisto, QWP, Kaisasa) |
| Jun 2026 | 728814 | Phimosis and balanitis creams (Vajraang, Penile Heal, Beilloso) |
Every letter came from CDER. Every one was addressed to the CEO. The legal theory has been constant since 2022: the products are drugs under section 201(g)(1) because their labeling makes disease treatment claims; they are new drugs under 201(p) because they are not generally recognized as safe and effective; no approved application exists; therefore introducing them into interstate commerce violates sections 301(d) and 505(a).
The categories rotate. Skin tags, then eye drops, then peels, then injectables, then numbing cream, then intimate-health cream. What does not rotate is the mechanism: a small third-party seller lists a product with a treatment claim, FDA buys it, and the letter goes to Amazon.
What changed in 2026
Earlier letters located the violation on the website. The August 2023 letter concerns "products intended to treat molluscum contagiosum and sold on your website, www.amazon.com." The March 2025 letter concerns products "purchased on your website."
The June 2026 letter is more specific:
"FDA purchased 'Vajraang Phimosis Mini Combo,' 'Penile Heal Cream,' and 'Beilloso Balanitis Relief Cream,' through your website and these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service."
That clause is new, and it matters. FDA is no longer resting the argument on Amazon hosting a listing. It is resting on Amazon physically holding and shipping the goods. FBA is the act of introduction.
Our reading — and this is interpretation, not established law — is that this is a deliberately narrower and stronger theory. "You ran the marketplace" invites an argument about intermediary status. "You warehoused it and you shipped it" does not. It puts Amazon in roughly the position of any other distributor.
The tone also hardened. The 2026 letter opens with an instruction absent from the earlier ones:
"Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence."
That is language for a repeat recipient. It closes with the standard escalation warning — regulatory or legal action without further notice, "including, without limitation, seizure and injunction."
The claims that triggered it
The three products were caught on labeling review alone. FDA quoted the claims:
- Vajraang Phimosis Mini Combo — "FOR PHIMOSIS," "Phimosis & Paraphimosis cream," "Coconut Oil for Phimosis"
- Penile Heal Cream — "Daily Phimosis Cream"
- Beilloso Balanitis Relief Cream — "Helps relieve redness, itching & irritation from balanitis," "Balanitis Relief Cream"
Phimosis and balanitis are named medical conditions. Putting either word on a cream makes it a drug under 201(g)(1). There is no ambiguity here and no clever argument available — the product name alone establishes intended use.
What this means if you sell on Amazon
This is the part most readers should act on, because Amazon's exposure becomes your delisting.
Nine letters in four years is not a company FDA considers responsive. Each round produces a compliance sweep on Amazon's side, and those sweeps are automated, broad, and not especially careful about edge cases. Sellers in adjacent categories get caught.
- Audit your listing copy for condition names. Any named disease or medical condition in a title, bullet, or A+ content section makes your product a drug. "Supports skin comfort" is a structure/function claim. "Relieves balanitis" is a drug claim. The line is the condition name.
- Review your back-end search terms. Keywords you bid on or hide in search fields are evidence of intended use under 21 CFR 201.128. FDA has cited marketing context beyond the label before.
- If you use FBA, understand what the 2026 letter did. FDA has now expressly tied introduction into interstate commerce to the fulfillment service. Amazon has a documented incentive to remove inventory first and adjudicate later.
- Do not treat "it's still listed" as clearance. Every product in all nine letters was live on Amazon when FDA bought it.
If you sell only FDA-approved drugs or make no treatment claims: no action required. The exposure here is entirely about claims language.
The unresolved question
Nine letters, four years, same violation. Amazon has responded to each and, based on the products cited, the underlying listings keep reappearing in new categories.
We do not know what FDA does next. The June 2026 letter's seizure-and-injunction language is boilerplate that appears in most warning letters, and reading it as an imminent threat would be over-reading. But the combination of a hardened tone, a narrower liability theory built on FBA, and an explicit instruction to allocate resources is a reasonable signal that FDA regards the current pace of remediation as insufficient.
What we would watch: whether the next letter names FBA again, and whether FDA begins issuing letters to the third-party sellers alongside Amazon rather than to Amazon alone.
Sources
- FDA Warning Letters to Amazon.com, Inc., MARCS-CMS 629452, 631751, 649056, 665460, 662503, 679523, 695821, 689355, 728814 — FDA Warning Letters database
- Most recent: Amazon.com, Inc., MARCS-CMS 728814, June 17, 2026
- FD&C Act sections 201(g)(1), 201(p), 301(d), 505(a); 21 CFR 201.128
Policy Canary tracks FDA enforcement and matches it against your specific products. We are an intelligence service, not a law firm — this is analysis, not legal advice.
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