FDA Warning Letters: The Industry-Wide Picture
Since September 2025, FDA has sent roughly 135 warning letters to telehealth companies over how they market compounded semaglutide and tirzepatide — mostly for claims implying a compounded product is equivalent to an FDA-approved brand-name drug. We checked all 36clinics we rank against FDA's public warning-letter database. Here's exactly what we found, and — just as important — where we couldn't get a confident answer.
Same query, two verticals
We run the identical FDA warning-letter methodology on our sister site, trt-picks.com (TRT/HRT clinics). As of 2026-08-30: MyGLP1 Guides has 7 of 36 providers (19%) holding at least one open letter; trt-picks.com has 3 of 20 providers (15%) holding at least one open letter. (A provider can hold more than one letter — Hims & Hers received two — so this counts affected providers, not raw letter count.) Same enforcement wave, same underlying FDA theory (misbranded compounded-drug marketing), different exposure by vertical — GLP-1 weight-loss clinics deal in the exact medication class these letters target, so more of them get swept in than the adjacent TRT/HRT vertical. As far as we know, no one else has run this query across both categories to compare. Read directly from trt-picks' own data/fda-warning-letters.json on 2026-08-30 (3 of its 20 providers hold an open letter: hims-trt, maximus-tribe, blokes). Not live-computed at build time — the two sites are separate deployments — so this figure is only as current as the date above; re-check the sister site directly for anything more recent.
The three waves so far
- September 2025 (industry-wide, ~80 letters) — 4 of our 36 clinics hit: Direct Meds, Hims & Hers, Ageless, Zealthy. The first and largest wave, industry-wide. Which of our own providers were hit in each wave is computed below from each letter's own date, not hand-maintained — so this note doesn't need updating as the roster grows.
- February 2026 (industry-wide, ~30 letters) — 3 of our 36 clinics hit: Ivim Health, Strut Health, SkinnyRx. Two more letters found in this wave while researching new clinics on 2026-08-29: Ivim Health (added as a provider, see above) and MedVi (not added — see industryOnly below).
- June 2026 (industry-wide, ~25 letters) — no confirmed hit among our 36 clinics. As of the last check, no confirmed hit among our own providers in this wave — see trt-picks.com/fda-warning-letters for the sister site's hits (Maximus, Blokes).
All letters cite the same core issue: FDA states compounded drugs are not FDA-approved, so marketing that implies otherwise (“same active ingredient as [brand]”, labeling that implies the seller is the compounder, etc.) makes the product misbranded under FDCA sections 502(a) and 502(bb). Every letter below is FDA's opening enforcement communication — an allegation, not a court finding or admission of wrongdoing.
This DOES affect scores here
Unlike a purely disclosure-only policy, an open FDA warning letter caps a provider's Transparency & Trust score at 4.0 — one cap per provider regardless of letter count, applied identically to every clinic including affiliate partners, and lifting automatically the moment FDA posts a closeout. See the rule on /editorial-policy.
Confirmed: 8 letters across 7 of 36 clinics we rank (0 closed out)
Hims & Hers' parent company received two letters — one per brand (Hims and Hers) — so the letter count is higher than the affected-clinic count.
- directmeds.com, Inc. dba DirectMeds — MARCS-CMS 716822, 2025-09-09
- Ivim Services LLC dba Ivim — MARCS-CMS 721816, 2026-02-20
- Strut Health, LLC dba Strut — MARCS-CMS 721448, 2026-02-20
- Hims & Hers Health, Inc. dba Hims — MARCS-CMS 716567, 2025-09-09
- Hims & Hers Health, Inc. dba Hers — MARCS-CMS 716825, 2025-09-09
- Lean Rx, Inc. dba SkinnyRx — MARCS-CMS 717989, 2026-02-20
- Lovely Meds, Inc. dba Lovely Meds — MARCS-CMS 716829, 2025-09-09
- FitRX, LLC dba Zealthy — MARCS-CMS 716501, 2025-09-09
“No letter found” is not “confirmed clean”
For the other 29clinics, we found no matching entry in FDA's public warning-letter database at the time we checked (2026-08-28). That is a real, meaningful result — but it is not the same claim as “FDA has cleared this clinic.” A few limits worth being upfront about:
- Letters arrive in waves and a clinic could be named in the next one — see the automated weekly check below.
- FDA addresses letters to a company's legal/operating entity, not always its consumer-facing brand name. For most of our 36clinics we identified the actual operating entity (from each site's own terms of service) and searched under that name too — but for the following 10, we could not confidently pin down the operating entity beyond the brand name, so treat “no letter found” for these specifically as lower-confidence than the rest:
Same wave, clinics we don't list
This page tracks the industry-wide picture, not just our own 36 providers. These are clinics we researched as candidates and decided not to add — for reasons unrelated to the letter itself in every case so far — but that carry a confirmed letter from the same enforcement waves above.
MedVi
MEDVi, LLC dba MEDVi — MARCS-CMS 721455, issued 2026-02-20 (Center for Drug Evaluation and Research (CDER)).
FDA states it reviewed medvi.io in December 2025 and found compounded semaglutide/tirzepatide products with labels displaying the "MEDVi" name, which FDA alleges falsely suggests MEDVi itself compounds the drugs (it does not) — same template and same FDCA sections (502(a), 502(bb)) as the SkinnyRx and Ivim Health letters above, part of the same February 2026 wave.
Why it's not on our list: Researched as a candidate provider 2026-08-29 (Trustpilot-volume-ordered list, 11,000+ reviews). Not added: medvi.io (the domain FDA itself reviewed) returned HTTP 522 (origin down); no app-store listing found; press coverage exists (NYT-adjacent) but carries no pricing; at least 6 other domain variants found, one built on a marketing-template tool (Mobirise), with conflicting third-party pricing figures. See reports/new-partners-2026-08-29.md section 5.
Related, but not FDA
Separately from FDA warning letters, we also track state-level pharmacy-board actions against clinics' fulfillment pharmacies — a different kind of enforcement, against a different entity, and we keep the two clearly apart.
Washington State Department of Health — action against Aequita Pharmacy, Mochi Health's compounding pharmacy fulfillment partner: Temporarily restricted Aequita's compounding license after reporting showed cold-chain shipping shortcuts for temperature-sensitive compounded medication (e.g. non-validated cold packs in place of proper cold-chain packaging).
See Mochi Health's full review →How we keep this current
Letters arrive in waves, so a one-time check goes stale. An automated weekly check queries FDA's public warning-letter database for each of our 36clinics and their known operating entities — and separately re-checks every letter we already hold against FDA's closeout column — opening an issue for human review whenever a new possible match or closeout appears. Nothing gets added to or changed on this page automatically; a hit (or a closeout) is only reflected here once a human has read the actual letter on fda.gov and confirmed it.
Last checked: 2026-08-28. Closeout status last verified: 2026-08-30.
This page reports regulatory facts; it is not legal advice and does not allege wrongdoing beyond what FDA itself states in each letter. An open letter caps the affected clinic's transparency score — see Editorial policy → for the exact rule.