FDA just sent Amazon and Walmart warning letters. Here is the two-year wave behind them
FDA sent 10 warning letters to online sellers on October 1, 2026, Amazon and Walmart among them. We tracked the telehealth and GLP-1 wave across 1,667 letters: 4 in 2024, 67 in 2025, 68 so far in 2026.
On October 1, 2026, FDA issued ten warning letters on the same day, to the same kind of seller, for the same reason. Eight were small companies selling topical products for genital herpes and other STI symptoms online. The other two were Amazon.com, Inc. and Walmart, Inc., cited for listing those products on their marketplaces. Every one of the ten rests on a single regulation, 21 CFR 201.128, the rule that defines what a drug's "intended use" is.
That batch is not an outlier. It is the latest installment in the largest shift in FDA warning letter activity since the index began: the move from factory floors to websites. Every number below comes from the Botable FDA Warning Letter Explorer, which reads every drug, device and biologics warning letter FDA publishes. Figures are as of October 6, 2026, covering 1,667 letters issued since January 2021.
What did the October 1 letters say?
All ten letters make the same case: the products are drugs because of what their sellers say they do, and no approved application exists for them, so they are unapproved new drugs. Several are marketed as homeopathic. The products named include FemiClear, Hclear for him, HerpCare Ointment and Spray, Herstat GST, RoyceDerm Herpes Relief Cream and Terragen HG Formula. The Amazon letter lists nine of them by name as items available on Amazon.com.
The recipients are spread across ten states, from Rhode Island to California, and each was given 15 business days to respond. None of the ten letters cites a manufacturing rule. There is no Part 211 citation anywhere in the batch, which is typical: across the whole dataset, not one letter that anchors a finding on 201.128 also cites a CGMP section. These are marketing letters, and the evidence is the website.
See the 2026 letters citing 21 CFR 201.128
That filter lists all 72 letters from 2026 that cite the section anywhere in the text. The 27 used in this article are the letters that anchor a numbered finding on it, the count the explorer's trends view shows.
How big is the telehealth and internet-sales wave?
Letters the explorer tags as telehealth or internet sales went from 4 in 2024 to 67 in 2025 and 68 so far in 2026. Before that the category barely existed: 1 letter in 2021, 11 in 2022, 5 in 2023. The 2026 count has already passed the 2025 total with three months to go.
| Year | Telehealth and internet-sales letters | Letters citing 21 CFR 201.128 in a finding | Letters whose findings mention semaglutide, tirzepatide or GLP-1 |
|---|---|---|---|
| 2021 | 1 | 1 | 0 |
| 2022 | 11 | 2 | 0 |
| 2023 | 5 | 0 | 2 |
| 2024 | 4 | 2 | 10 |
| 2025 | 67 | 20 | 66 |
| 2026 through Oct 6 | 68 | 27 | 72 |
The 201.128 column is the sharpest line in the table. Through October 6, 2025, FDA had anchored 9 findings on that section. Through the same date in 2026 it has anchored 27, three times as many.
See telehealth and internet-sales letters by year
Why do these letters arrive in batches?
Because FDA posts them that way. The wave is made of a handful of coordinated releases, not a steady stream. 58 of the 96 warning letters issued in September 2025 were telehealth and internet-sales letters, and 68 letters in that month carry the same issue date, September 9. February 2026 brought 30 more. June 2026 brought 25, all dated June 8. October 1, 2026 brought the ten above.
This matters for anyone reading monthly counts. September 2025 looks like FDA tripled its output; it did not. It released one campaign on one day. The explorer's timeline shows the spikes for what they are, and the trends view compares year to date rather than month to month for the same reason.
Who is getting these letters?
Almost entirely US sellers: 125 of the 156 telehealth and internet-sales letters in the dataset went to US addresses. Florida (19), California (18), New York (10) and Texas (8) lead. The letters are short by warning letter standards, a median of 1,162 words against 1,756 for drug letters overall, and they rarely name an executive. Most are addressed to the company with no title, because the recipient is a website operator rather than a plant with a quality unit.
The products fall into three groups. Compounded or counterfeit GLP-1 drugs sold online, with semaglutide and tirzepatide named in the findings. Ketamine products marketed online for depression. And over-the-counter or homeopathic products with disease claims, which is where the October 1 batch sits. The GLP-1 letters tend to cite the misbranding rules, 21 CFR 201.5 and 201.115, because the drug is a prescription product sold without adequate directions. The disease-claim letters cite 201.128, because the claim itself is what makes the product a drug.
What does 21 CFR 201.128 actually say?
It says a product's intended use is decided by the objective intent of the people responsible for its labeling, and that intent can be shown by labeling claims, advertising, oral or written statements, and the circumstances of its sale. In practice this means the product page, the Amazon listing, the Instagram caption and the customer review the seller chose to pin all count as evidence. If they say the product treats herpes, the product is a drug for herpes, whatever the label says.
FDA revised the rule in 2021 and has leaned on it since. For the five years before 2025 it anchored a finding on 201.128 in a total of 5 letters. In the 21 months since January 2025 it has done so in 47.
What should an online seller or a marketplace check?
Three things, in this order.
Every claim on every channel. Pull the product page, the marketplace listings, paid ads, social posts and email. Any statement that a product diagnoses, treats, cures or prevents a disease is a drug claim under 201.128. Homeopathic labeling does not change that.
Whether the product has a path to market. An OTC drug needs to fit a monograph; a prescription drug needs an approved application; a compounded drug needs to be compounded for a specific patient under a valid prescription. The GLP-1 letters are almost all about the third case.
Whether a competitor or supplier has already been cited. The explorer lists every letter by company, product family and section. The Amazon and Walmart letters name the sellers whose products triggered them; a marketplace that carries those products is on notice.
FDA gives 15 business days to respond, and the letter asks for the steps taken to correct the violations and prevent them from recurring. The response window is the same for a two-person website and for Walmart.
Frequently asked questions
How many FDA warning letters have gone to telehealth and online sellers? 156 since January 2021 in the drug, device and biologics scope: 4 in 2024, 67 in 2025 and 68 through October 6, 2026.
What regulation do FDA GLP-1 warning letters cite? Most cite the misbranding rules, 21 CFR 201.5 and 201.115, because semaglutide and tirzepatide are prescription drugs sold without adequate directions for use. Disease-claim letters for OTC and homeopathic products cite 21 CFR 201.128.
Did Amazon and Walmart get FDA warning letters in 2026? Yes. Both received letters dated October 1, 2026, citing 21 CFR 201.128 for listing unapproved products marketed for herpes and other STI symptoms. Amazon.com, Inc. now has 10 warning letters in the dataset, the most of any recipient, and Walmart has 4.
Why did FDA issue 96 warning letters in September 2025? 68 of them were posted on a single day, September 9, as one internet-sales campaign. 58 of the month's letters are tagged telehealth or internet sales.
Source: FDA warning letter index via the Botable FDA Warning Letter Explorer, as of October 6, 2026. Counts are letters, not findings, unless stated. Scope is drugs, medical devices and biologics; 2026 is a partial year.
