Hers: 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.forhers.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: • "Weekly injectable GLP-1 with the 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.”

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 forhers.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.

As with the companion Hims letter, this is about a specific comparison in Hers's own ad copy, not a finding that the medication doesn't work or is unsafe. FDA said pairing "GLP-1" with "same active ingredient as Ozempic and Wegovy" implied an FDA evaluation the compounded product had not received. It doesn't change whether the price is fair — it changes how much weight to put on brand-name comparisons in Hers's own marketing.

Doseworth’s review of Hers 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 Hers failed to respond.