Hims & Hers, the FTC and the FDA: who has actually said what about telehealth and compounded drugs
Picture a headline: a federal agency has sued a telehealth company that offers compounded drugs. In the comments, one person says it's about what's in the drugs. Another says it's about the ads. A third says the FDA settled all this months ago.
They can't all be right, and here's the twist: they're mostly talking about different documents, from different agencies, about different things. So here's who said what.
Facts are as of October 25, 2026. Sources, with retrieval dates, are at the bottom.
In a sentence: as the FTC's press release describes its lawsuit, it's about privacy, billing and cancellation. The FDA's documents are about how compounded drugs may be described and marketed. We read four public documents in full and add one court-docket update from secondary sources, which we label as such.
Who said what, and when
- September 9, 2025
FDA warning letter to Hims & Hers about website statements on compounded semaglutide. FDA called the products misbranded.
FDA document - February 6, 2026
FDA statement. It states an intent to restrict GLP-1 active ingredients in mass-marketed compounded drugs.
FDA document - July 29, 2026
The FTC, with Utah and California, sues Hims & Hers. The press release describes privacy, billing and cancellation allegations.
Allegation in a court complaint - October 22, 2026
Hims & Hers files a motion to dismiss, per a court-docket aggregator. We did not open the motion. A hearing is set for January 7, 2027.
Reported, not confirmed
The lawsuit: privacy, billing and cancellation
On July 29, 2026, the FTC, together 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). Notice the verb in everything that follows: alleges. These are claims in a complaint. Nobody has proved them.
According to the press release, the complaint alleges that the company charged people and enrolled them in subscriptions soon after they filled out an intake form, before most of them had talked with a provider. It also alleges that cancelling was hard, partly because the cancel button was hidden and, the FTC says, appeared only after several steps. And it alleges that the company shared customers' health information with ad platforms including Meta and Snap, despite promising to keep that data private.
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 Commission voted 2-0 to file, per the release.
The case will be decided by the court. [V]
That sentence is the FTC's own reminder. The release says the agency files a complaint when it has "reason to believe" a defendant is violating the law, and that "the case will be decided by the court." The FTC's case page lists the matter as "Pending" and shows two complaint documents, dated July 29 and August 31, 2026 (FTC case page). We haven't opened either one, or the August 31 filing, so we won't describe what changed between them.
Where the case stands (as of October 22, 2026)
A court-docket aggregator shows that Hims & Hers filed a motion to dismiss on October 22, 2026. It lists a hearing 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. And a motion to dismiss is only a request that the court end the case. It isn't a ruling, and the FTC's page still says "Pending."
The FDA's side: ads, labels and what "compounded" means
The FDA hasn't been silent. It has just been talking about something else, in three separate places.
A warning letter (September 9, 2025). FDA's drug center wrote to Hims & Hers about statements on its website concerning compounded semaglutide. It picked out two claims: "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." FDA wrote that "compounded drug products are not FDA-approved," said 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 reply within 15 working days (FDA warning letter). We haven't found Hims & Hers's response in an FDA document, so we won't 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 the agency plans to limit GLP-1 active ingredients in compounded drugs that lack FDA approval and are marketed at scale. He named Hims & Hers and "other compounding pharmacies." He also said FDA is acting on misleading direct-to-consumer advertising after warning letters sent in the fall of 2025, and that companies "cannot claim" their compounded products are generics of, or equivalent to, approved drugs (FDA statement). That's a stated intention, not a finished action.
A Q&A page on compounding. In plain terms, FDA's "Compounding and the FDA: Questions and Answers" page says "Compounded drugs are not FDA-approved," so FDA doesn't check their safety, effectiveness or quality before they're marketed. A generic is FDA-approved and a compounded drug isn't, so the two aren't the same thing. Promotion of prescription drugs, compounders included, "must be truthful, non-misleading and accurate," and when FDA has concerns it "may seek voluntary compliance." The page also notes that people who get compounded drugs through online pharmacies or telehealth platforms "may not know the identity of the compounder" behind them (FDA Q&A). Two more rules from the page: outsourcing facilities must follow current good manufacturing practice (CGMP) rules, while drugs compounded under section 503A by pharmacists in state-licensed pharmacies or by physicians don't have to. And biological products can't be compounded under the 503A and 503B exemptions.
- 2-0the FTC commission vote to file, per its press release [V]
- 15 working daysthe reply window in FDA's warning letter [V]
- No rulingin the case, as far as we found on October 25, 2026
Why the two stories get blended
It's easy to see why. Same company, same year, same general topic: telehealth and compounded drugs. But the documents differ in kind. One is a court complaint, which holds allegations. The others are an FDA warning letter, a statement and a Q&A page, which describe the agency's view of drug law. The lawsuit, as described, doesn't turn on what's in a compounded drug. The FDA material doesn't turn on privacy or billing.
Part of why the topic draws so much attention is that telehealth is now a mainstream route to these drugs. In a KFF poll fielded from late October to early November 2025, 17% of adults who had taken a GLP-1 drug named an online provider or website, and 76% named one of their doctors (KFF poll, Nov. 14, 2025). [V] That poll is separate from the case and the FDA documents above.
What people get wrong
"The FTC lawsuit proves something about the drugs." The press release doesn't describe claims about drug quality, and a complaint isn't a finding of anything.
"The FDA's letter settled it." A warning letter is about specific website statements. It isn't the FTC case, and we haven't found a published response.
"The February statement already changed the rules." The statement describes what FDA intends to do. We're not treating it as a completed action.
Why this matters to you
If you've ever read a telehealth ad and thought "is this the same as the drug my doctor mentioned?", FDA's Q&A page says a compounded drug isn't FDA-approved and a generic is, so the two aren't the same thing. The word "same" is exactly what FDA objected to in that warning letter. Knowing which agency said what makes the next headline easier to read.
Questions to bring to a clinician or pharmacist
- Is this an FDA-approved medicine, or a compounded drug?
- Who prepares it, and how would I find out?
- If an approved version exists, why is this version being suggested?
- What does the company's privacy policy say about sharing health information with other businesses?
Not confirmed
What we didn't cover
We haven't covered the status of specific peptides sold through telehealth, such as sermorelin, because we haven't confirmed their status in an FDA primary document. We'll write about them once we can cite the source.
What to watch next
The next step in the case is the court's handling of the motion to dismiss. The docket aggregator lists a January 7, 2027 hearing, but that's a secondary source, and dates can move. For the compounding rules themselves, see how a compounded drug differs from an approved one in our comparison of approved and wellness peptides, what FDA's categories mean in our Category 1 and 2 explainer, and the latest status in our regulation timeline. For the history behind the demand, see our timeline of peptide medicines from insulin to GLP-1 drugs.
Sources (all retrieved October 25, 2026)
- 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
- FTC case page, Hims & Hers (read for status and document list only) — https://www.ftc.gov/legal-library/browse/cases-proceedings/hims-hers
- 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
- 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
- FDA, "Compounding and the FDA: Questions and Answers" — https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
- 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
- Yahoo Finance / StockTwits (secondary), Oct. 22, 2026 — https://finance.yahoo.com/healthcare/articles/telehealth-firm-hims-hers-seeks-215202841.html
- KFF, Health Tracking Poll on GLP-1 drug use, Nov. 14, 2025 (fielded Oct. 27–Nov. 2, 2025; used for the share of adults naming an online provider) — https://www.kff.org/public-opinion/poll-1-in-8-adults-say-they-are-currently-taking-a-glp-1-drug-for-weight-loss-diabetes-or-another-condition-even-as-half-say-the-drugs-are-difficult-to-afford/
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