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 53clinics 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 10 of 53 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.com's own FDA warning-letter records 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). 5 of our 53 clinics hit: Direct Meds, Hims & Hers, Remedy Meds, 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). 4 of our 53 clinics hit: MEDVi, Strut Health, Ivím Health, SkinnyRx. Two more letters found in this wave while researching new clinics on 2026-08-29: Ivim Health and MEDVi. MEDVi was first recorded here as industry-only (its medvi.io domain was down); since 2026-10-04 it is a listed clinic on medvi.org, at the same Newark, DE address the letter names, so its letter now sits under letters.
- June 2026 (industry-wide, ~25 letters). 1 of our 53 clinics hit: Maximus. 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: 11 letters across 10 of 53 clinics we rank (0 closed out)
One parent company can receive more than one letter, one per brand it operates, so the letter count runs higher than the affected-clinic count.
- directmeds.com, Inc. dba DirectMeds. MARCS-CMS 716822, 2025-09-09
- MEDVi, LLC dba MEDVi. MARCS-CMS 721455, 2026-02-20
- Maximus Health, Inc. dba Maximus. MARCS-CMS 730095, 2026-06-08
- Strut Health, LLC dba Strut. MARCS-CMS 721448, 2026-02-20
- Ivim Services LLC dba Ivim. MARCS-CMS 721816, 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
- Remedy Meds. MARCS-CMS 716830, 2025-09-09
- 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 43clinics, we found no matching entry in FDA's public warning-letter database at the time we checked (). 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 53clinics 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:
FDA letters against a clinic's pharmacy, not the clinic
A telehealth clinic does not compound its own medication. Where a clinic names its partner pharmacies, most do not, we check those pharmacies against the same FDA database, and record what we find here. These letters are addressed to the pharmacy, so they are disclosed to you and never applied to the clinic's score. The counts in the section above do not include them.
Willow. 3 letters at a named partner pharmacy
Empower Clinic Services, LLC dba Empower Pharmacy. MARCS-CMS 738238, issued 2026-09-18 (no closeout posted)
one of the five compounding pharmacies Willow names in its own Terms of Service, at the same facility address Willow publishes (7601 North Sam Houston Parkway West Suite 100, Houston, TX 77064). This is the facility FDA inspected.
Read the letter on fda.gov →Empower Clinic Services, LLC dba Empower Pharmacy. MARCS-CMS 700964, issued 2025-04-02 (no closeout posted)
one of the five compounding pharmacies Willow names in its own Terms of Service (7601 North Sam Houston Parkway West Suite 100, Houston, TX 77064. The same facility address FDA inspected).
Read the letter on fda.gov →Empower Clinic Services, LLC dba Empower Pharmacy. MARCS-CMS 613792, issued 2021-10-15 (no closeout posted)
same pharmacy, earlier letter; this one cites a different facility (5980 West Sam Houston Parkway North, Houston) than the address Willow publishes.
Read the letter on fda.gov →Pomegranate Health. 3 letters at a named partner pharmacy
Empower Clinic Services, LLC dba Empower Pharmacy. MARCS-CMS 738238, issued 2026-09-18 (no closeout posted)
One of six pharmacies Pomegranate names by brand ("Empower") on its own pricing page, where the patient can pick a pharmacy; Pomegranate publishes no address or facility for it, and its Subscription Terms say it cannot guarantee which pharmacy fills an order. Empower's 503A facility at 7601 N. Sam Houston Pkwy W., Houston is the one FDA inspected.
Read the letter on fda.gov →Empower Clinic Services, LLC dba Empower Pharmacy. MARCS-CMS 700964, issued 2025-04-02 (no closeout posted)
One of six pharmacies Pomegranate names by brand ("Empower") on its own pricing page, where the patient can pick a pharmacy; Pomegranate publishes no address or facility for it, and its Subscription Terms say it cannot guarantee which pharmacy fills an order. Empower's 503A facility at 7601 N. Sam Houston Pkwy W., Houston is the one FDA inspected.
Read the letter on fda.gov →Empower Clinic Services, LLC dba Empower Pharmacy. MARCS-CMS 613792, issued 2021-10-15 (no closeout posted)
Same pharmacy, earlier letter, citing a different Houston facility (5980 West Sam Houston Parkway North). Recorded so the count is complete.
Read the letter on fda.gov →Zevay. 1 letter at a named partner pharmacy
Boothwyn Pharmacy, LLC. MARCS-CMS 717525, issued 2026-01-16 (no closeout posted)
one of the two pharmacy partners Zevay names in its own Terms of Use, at the address Zevay publishes (221 Gale Lane, Kennett Square, PA 19348). This is the facility FDA inspected.
Read the letter on fda.gov →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 Pharmacy Quality Assurance Commission (Department of Health). Action against Aequita Pharmacy LLC, 12825 NE 126th Place, Kirkland, WA (PHAR.CF.61458335), Mochi Health's former compounding pharmacy partner (NBC Bay Area, 2026-06-04: 'Mochi worked with Aequita to create GLP-1 compounded medication'; Aequita closed in April 2026; Mochi 'working with other pharmacies nationwide'): Limited Stop Service issued March 13, 2025 (release 25-034): alleged failure to implement a plan of correction; deficient practices 'include allowing untrained and unqualified staff to perform sterile compounding, not properly supervising staff, and not adhering to sterile compounding procedures'. Aequita could not compound or distribute compounded products in Washington until resolved.
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 53clinics 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: . Closeout status last verified: .
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. For a quick sourced answer to which clinics currently hold open letters, see Quick Answers →.