What happened
On 1 October 2026 the FDA sent warning letters to Amazon CEO Andy Jassy and Walmart's John Furner over unapproved new drugs bought on their sites in July 2026. FDA test purchases of nine products on Amazon — FemiClear, HClear for him, HerpCare Ointment and Spray, Herstat GST, Genital Herpes Ointment, RoyceDerm Herpes Relief Cream, Terragen HG Formula and Genital Herpes Intimate Wash — were 'introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service'.
Walmart's letter covered three of the same products — HClear for him, Herstat GST and Terragen HG Formula — introduced via Walmart Fulfillment Services. All are marketed for genital herpes symptoms; FDA's letters state it has approved no over-the-counter drug for the treatment, cure, mitigation or prevention of any STI, and warn that relying on them can mean skipped medical care, risks of infertility, sepsis, and unknowingly transmitting infections to partners.
The legal framing is the point: by stocking, packing and shipping the products themselves, the platforms weren't passive marketplaces — they were the introducers of unapproved drugs into interstate commerce under sections 301(d) and 505(a) of the FD&C Act, with both letters warning that failure to correct could bring seizure and injunction without further notice. For Amazon it was also the second time in three years a US agency pinned seller-side responsibility on its own logistics: the CPSC had ruled Amazon a distributor in 2024 and ordered recalls of 400,000 faulty products.
What it cost
No fines in the letters, but FDA put seizure and injunction on the table if the violations continue
Why it happened
It extends the platform-liability line: after CPSC ruled Amazon a distributor in 2024, FDA's letter reaches the same conclusion on the drug side — a repeat finding, not a one-off
Both letters name the CEOs and the fulfilment services — the violation attaches to the logistics product, not third-party sellers
The same July sweep already produced letters to the products' makers, so the platforms cannot shift blame upstream
The lesson
Fulfilment-as-a-service makes the platform the shipper of record: when you stock, pack and ship it, the product's paperwork problems are yours.
Aftermath
Both companies were told to promptly address the violations, with seizure and injunction explicitly threatened for continued violations; the letters followed FDA's July 2026 review that produced warning letters to the products' makers, including OrganiCare and the four sellers behind the HerpCare line.
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