Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 716567 to Hims & Hers Health, Inc. dba Hims
Issued September 9, 2025. The letter alleges that claims on hims.com that compounded semaglutide has the same active ingredient as Ozempic and Wegovy, and clinically proven ingredients, are false or misleading. It asks for a written response and it did not halt the business. The ledger record for Hims & Hers passes S8.
The letter, as filed
Every line below is copied from the letter itself. The addressee and the address are the ones the agency prints in the header, which is the pair an attribution rests on.
| Number | MARCS-CMS 716567 |
|---|---|
| Issued | September 9, 2025 |
| Addressee | Hims & Hers Health, Inc. dba Hims |
| Address | 2269 Chestnut St., # 523, San Francisco, CA 94123 |
| Recipient | Andrew Dudum, Chief Executive Officer |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) |
| Website reviewed | https://www.hims.com, reviewed in August 2025 |
| Sections cited | 502(a), 502(bb), 301(a) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when the close-out column was last read. |
What it alleges
Claims on hims.com that compounded semaglutide has the same active ingredient as Ozempic and Wegovy, and clinically proven ingredients, are false or misleading.
The letter quotes 2 claims from the website it reviewed, reproduced here exactly as the letter prints them, including the agency's own elisions.
“Same active ingredient as Ozempic and Wegovy”
“Clinically proven ingredients”
A quoted claim is evidence of what a page said when the agency read it. It is not evidence of what the page says today, and this site records the seller's current pages separately, on the seller record, with their own date.
The sections cited are 502(a), 502(bb), 301(a). Section 502(a) makes a drug misbranded where its labeling is false or misleading, and section 502(bb) extends that to the advertising or promotion of a compounded drug. Both are labeling and advertising provisions.
How it was attributed
The entity and the street address in the letter match the address the seller prints in its own terms. A letter is filed under an operating entity, and a company may trade under names that appear nowhere in it, so the screen is run against the entity and the address rather than against the brand on the storefront. A name resemblance is never the test, because attaching one company's enforcement record to another is a worse error than missing a disclosure.
The same company holds 1 other letter in this ledger: 716825, to Hims & Hers Health, Inc. dba Hers. Two letters to one company under two trading names are two documents and one company, and the ledger holds one record for it.
What the ledger records since
Hims & Hers is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 716567 and FDA warning letter 716825, both September 2025, name Hims & Hers Health, Inc. doing business as Hims and as Hers at 2269 Chestnut St., #523, San Francisco, California, the address its own terms print. Each alleges that claims for its compounded semaglutide products, among them the same active ingredient as Ozempic and Wegovy, are false or misleading. No close-out letter appears in the index. No FDA action has halted the business, and the company continues to operate. The storefront was reachable and trading when the record was last read.
The index carries no close-out letter for it. When the index was read in September 2026 it held 3,677 letters and 417 of them carried a close-out letter, so the column is populated and an empty cell is a reading rather than a gap. A letter that has been neither closed out nor followed by an action is the ordinary state of a warning letter.
Why this is not a disqualification
A warning letter identifies a concern, requests a response, and states that failure to address the violations may result in legal action, including seizure and injunction. Those actions are what criterion S8 fails on. The letter is the notice that precedes them and it is not one of them, so this ledger records it in full, dates it, links it, and leaves the seller listed and linked exactly as a seller with no letter.
This letter belongs to a wave of 69 letters carrying one issue date on the index. That wave includes letters to Eli Lilly and Company and Novo Nordisk Inc., the manufacturers of the approved brand drugs the compounded products are compared against. A document that names the two largest manufacturers of a drug class on the same day as a telehealth seller cannot mean, on its own, that a company is disreputable.
4 other letters in this ledger carry the same issue date: 716501, to FitRX, LLC dba Zealthy, 716822, to directmeds.com, Inc. dba DirectMeds, 716825, to Hims & Hers Health, Inc. dba Hers, 716830, to Remedy Meds.
Sources
- FDA warning letter 716567 to Hims & Hers Health, Inc. dba Hims, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
- The seller record this letter is disclosed on
The letter was fetched from fda.gov and read in full on the date in the meta line above, in a run where every letter this ledger discloses returned a document and a fabricated letter address returned nothing, by the same method. This page ranks nothing, recommends nothing, and carries no partner link.