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Telehealth and compounded drugs: what the FTC and FDA have actually said

By Peptide Policy Watch editorial team · Published October 25, 2026

Published October 25, 2026. Status is "as of" this date. Sources and retrieval dates are at the bottom. This is not medical advice. The site owner is not a medical professional. Nothing here is a recommendation for or against any company or product.

Telehealth companies that market compounded drugs draw attention from two federal agencies, and online posts often blur what each one has said. This article sticks to four public documents we read in full, plus a court-docket update from secondary sources that we label as such, and it says what each one covers and does not cover.

What the FTC has said

On July 29, 2026, the FTC, with Utah and California (through Los Angeles County Counsel), sued Hims & Hers Health, Inc. in the U.S. District Court for the Northern District of California (FTC press release). According to the press release, the complaint alleges that Hims:

• Charged consumers and enrolled them in subscriptions shortly after they submitted an intake form, without most consumers having a consultation with a provider first.
• Made cancellation difficult, including by hiding the cancellation button, which the FTC says appeared only after several steps.
• Shared consumers' health information with advertising platforms such as Meta and Snap, despite promising to protect privacy.

The FTC alleges violations of the FTC Act and the Restore Online Shoppers' Confidence Act. Utah and California allege violations of their own state laws. The press release says the Commission vote to file was 2-0, and includes this note: the FTC files a complaint when it has "reason to believe" a defendant is violating the law, and "the case will be decided by the court."

The FTC's case page lists the case as "Pending" and shows two complaint documents, dated July 29 and August 31, 2026 (FTC case page). We have not opened either complaint document or the August 31 filing, so we do not describe what changed between them.

Update on the court docket (as of October 22, 2026). A court-docket aggregator shows that Hims & Hers filed a motion to dismiss the case on October 22, 2026, with a hearing set for January 7, 2027, responses due November 25 and replies due December 17 (PacerMonitor docket, last updated 10/23/2026). We did not open the motion itself. StockTwits, in a report syndicated on Yahoo Finance, said Hims argued that its privacy policy disclosed possible sharing with advertising partners and that the FTC misapplied federal subscription law (Yahoo Finance/StockTwits, Oct. 22, 2026). That description of Hims's arguments is reported by a secondary outlet, not confirmed in the filing. A motion to dismiss is a request that the court end the case. It is not a ruling, and the FTC's page still lists the case as "Pending."

What the FDA has said

A warning letter, September 9, 2025. FDA's Center for Drug Evaluation and Research wrote to Hims & Hers about statements on its website concerning compounded semaglutide. FDA identified two claims, "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." FDA wrote that "compounded drug products are not FDA-approved" and that the claims "imply that your products are the same as an FDA-approved product when they are not," and called the products misbranded under the FD&C Act. The letter asked for a written response within 15 working days (FDA warning letter). We have not located Hims & Hers's response in an FDA document, so we do not describe one.

A statement, February 6, 2026. Then-FDA Commissioner Martin Makary (FDA's page lists his term as April 2025 to May 2026) said FDA intends to restrict GLP-1 active ingredients used in non-FDA-approved compounded drugs that are being mass-marketed, naming Hims & Hers and "other compounding pharmacies." He also said FDA is taking steps against misleading direct-to-consumer advertising following warning letters sent in the fall of 2025, and that companies "cannot claim" compounded products are generic versions or the same as approved drugs (FDA statement). This states an intention, not a completed action.

A Q&A page on compounding. FDA's "Compounding and the FDA: Questions and Answers" page says (FDA Q&A):

• "Compounded drugs are not FDA-approved," so FDA does not verify their safety, effectiveness or quality before marketing.
• A generic drug is approved by FDA and a compounded drug is not, so they are not the same.
• Prescription drug promotion, including by compounders, "must be truthful, non-misleading and accurate." If FDA has concerns, it "may seek voluntary compliance."
• People who buy compounded drugs through online pharmacies or telehealth platforms "may not know the identity of the compounder" that produced the drug.
• Outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements, while drugs compounded under section 503A by pharmacists in state-licensed pharmacies or by physicians are not.
• Biological products cannot be compounded under the section 503A and 503B exemptions.

Sources (all retrieved October 25, 2026)

1. FTC press release, July 29, 2026 — https://www.ftc.gov/news-events/news/press-releases/2026/07/ftc-states-act-against-hims-hers-deceptive-unlawful-privacy-practices
2. FTC case page, Hims & Hers (read for status and document list only) — https://www.ftc.gov/legal-library/browse/cases-proceedings/hims-hers
3. FDA warning letter to Hims & Hers Health, Inc., Sept. 9, 2025 (MARCS-CMS 716567) — https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hims-hers-health-inc-dba-hims-716567-09092025
4. FDA, statement from Commissioner Makary, Feb. 6, 2026 — https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
5. FDA, "Compounding and the FDA: Questions and Answers" — https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
6. PacerMonitor (secondary; mirrors the court docket), N.D. Cal. 3:26-cv-07871, docket last updated 10/23/2026 — https://www.pacermonitor.com/public/case/65961048/Federal_Trade_Commission_et_al_v_Hims__Hers_Health,_Inc
7. Yahoo Finance / StockTwits (secondary), Oct. 22, 2026 — https://finance.yahoo.com/healthcare/articles/telehealth-firm-hims-hers-seeks-215202841.html

Reading this for health reasons? This site reports on regulation; it is not medical advice. See our disclaimer, how we source and corrections policy.