Hims: What the FDA Letter Means for What You Pay

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.hims.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide.

1. 1

   “The following claims concerning your compounded semaglutide products appear on your website: "Same active ingredient as Ozempic and Wegovy" "Clinically proven ingredients"”

2. 2

   “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA.”

3. 3

   “Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.”

1. 1

   Letter issued

   September 2025

2. 2

   15-working-day response window

   FDA gives the company 15 working days to respond in writing.

3. 3

   Close-out, if issued

   FDA may post one once it is satisfied the cited issues have been corrected.

Hims & Hers Health, Inc. trades publicly on the NYSE under ticker HIMS and continues to operate hims.com. Our direct check returned a bot-protection response rather than a page, which is expected for a high-traffic consumer site behind bot mitigation and is not evidence of closure.

This letter is about ad copy, not a product recall: FDA objected to Hims comparing its compounded semaglutide to the FDA-approved brands Ozempic and Wegovy in its own marketing. It says nothing about whether the medication is safe or effective — it says the specific comparison Hims made to a branded, FDA-approved product overstated FDA's involvement. Read any "same as Ozempic" language on a provider's pricing page with that distinction in mind.

Doseworth’s review of Hims has the pricing, the states served, and what’s included.

As of August 2026, FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Hims failed to respond.