FDA warning letter · #716567
Hims: What the FDA Letter Means for What You Pay
Legal name: Hims & Hers Health, Inc.
Primary source
Read the original letter on fda.gov →
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hims-hers-health-inc-dba-hims-716567-09092025
What FDA cited
Read the full letter →Quoted verbatim from the FDA letter dated
“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.”
“The following claims concerning your compounded semaglutide products appear on your website: "Same active ingredient as Ozempic and Wegovy" "Clinically proven ingredients"”
“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.”
“Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.”
Is Hims still operating?
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.
What this means for what you pay
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.
Has Hims responded?
As of , 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.
Sources
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View the full index →Editorial disclaimer: An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.