FDA Just Did to Amazon What Amazon Does to Us: Write an Appeal in 15 Days. But Sellers Are the Ones Who Need to Be Careful Now.
Officially it's a "written response," due within 15 business days: explain what went wrong, show what you fixed, and prove it won't happen again. Every Amazon seller knows that drill. This time Amazon is the one writing it.
The letter went straight to CEO Andy Jassy, dated October 1, 2026, and FDA posted it this week. According to FDA, 9 herpes symptom-relief products, sold by third-party sellers and shipped through Fulfillment by Amazon, are "unapproved new drugs." Amazon has to come back with the steps it took to fix the violations and keep them from happening again.
It's not the first one this year, either. In June 2026, Amazon got a similar FDA letter (reference 728814) over a different group of creams, also fulfilled by Amazon.
What matters for sellers
FDA didn't only go after words like "cure." Most of the claims it quoted were about symptoms. A few examples straight from the letter:
- "Fast-acting ointment for recurring outbreak symptoms"
- "Soothes and calms genital sores"
- "FIGHTS OUTBREAKS" and "REDUCES RECURRENCE"
- "Soothes irritation, burning & itching quickly"
Because those claims are tied to a disease, FDA treated them as drug claims. And the "homeopathic" label didn't help. The letter says homeopathic products "are subject to the same statutory requirements as other drugs."
Our take
From our experience, not from the letter: when pressure lands on Amazon itself, it tends to roll downhill to sellers fast. Listing removals, Health & Safety flags, hits to Account Health. And not always only on the products named in the letter.
So if you sell supplements, ointments, or anything close to OTC, this is a good week to go through your own listings before someone else does:
- Your title, bullets, images, and A+ content
- Words like treat, cure, and prevent
- Disease names, even next to "relief" or "support"
- Before and after images or claims
Fixing it yourself today is a lot better than Amazon fixing it for you.
And if you've already been hit with a removal or a block, that's exactly the kind of hard case we solve. We bring a decade and a half of solving appeals problems and twenty years of helping clients grow on Amazon.
Send me a message on WhatsApp or book a call, and we'll look at it together.
Source: FDA warning letter to Amazon.com, Inc., 736006, October 1, 2026. Earlier letter: Amazon.com, Inc., 728814, June 17, 2026.