FDA issues warning letters to Altru Telehealth, FITISH and others
The FDA sent warning letters dated June 8, 2026 to 25 telehealth and compounding-linked companies over marketing claims that suggested compounded semaglutide and tirzepatide are FDA-approved.
The U.S. Food and Drug Administration issued warning letters dated June 8, 2026 to 25 companies that market compounded GLP-1-style products, saying their websites made false or misleading claims about those drugs [1][2][3]. The letters were published on FDA's website on June 16, 2026, and were based on website reviews the agency conducted in March 2026 [1][2][3].
Two of the letters show what the agency objected to. In the letter to Altru Telehealth, LLC of Oakland, Maryland, FDA cited website statements including "Compounded semaglutide combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12" and "Compounded semaglutide & tirzepatide offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy" [1]. FDA wrote that "Compounded drug products are not FDA-approved" and that such claims represent the products "have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not" [1].
FDA also flagged Altru's claims that "[a]n FDA approved, regulated & sterile compounding pharmacy mixes the formula" and that "[o]ur compounding pharmacies are all FDA approved." The agency said no such designation exists: "The FD&C Act does not establish an 'FDA-approved' or 'FDA-licensed' designation for pharmacies or outsourcing facilities" [1]. Registering as an outsourcing facility under section 503B does not amount to FDA approval or licensure, and neither 503A nor 503B compounders go through premarket review of their products [1].
The letter to FITISH, of Fort Worth, Texas, raised a different issue on top of the approval claims. FDA said the compounded semaglutide and tirzepatide products pictured on the site "identify 'FITISH' on the pictured label, suggesting FITISH is the compounder of those drugs when in fact it is not" [2]. FDA also cited the site's statements that "Semaglutide is the active ingredient in ozempic" and "Tirzepatide is the active ingredient in Mounjaro® and Zepbound®" [2].
Both letters say the claims make the products misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, and that shipping misbranded drugs in interstate commerce is a prohibited act under section 301(a) [1][2]. Each letter warns that failure to fix the problems "may result in legal action without further notice, including, without limitation, seizure and injunction" [1][2]. The letters were signed by Matthew J. Lash, JD, acting director of FDA's Office of Compounding Quality and Compliance [1][2].
According to Telehealth.org's tally, the 25 recipients included Maximus Health, Glow Medispa (Mint Med), Public Health Solution (DrMedHealth), Trinity HealthCare Supply, Momentum Health 360, Medica Weight Loss, Ezra Holdco, Ready Med, FITISH, OrderlyMeds, Roen Health (RoenRx), Joi and Blokes, D&H Medical Services, Clover Meds, NexLife, Amie Health, VivioMD Group, Thrivelab, Nexus Health Solutions (Harper Meds), Nova Vascular (NOVARX), Altru Telehealth, Eden Health International, NativeMed, FitRX (AM RX) and HydraMed IV [3].
Why it matters for patients
Many people found compounded semaglutide and tirzepatide through telehealth sites during the GLP-1 shortages that ran from 2022 to 2025 [3]. FDA's central point in these letters is that the marketing language on some of those sites blurs a real distinction: compounded drugs are not FDA-approved and have not been evaluated by the agency for safety, effectiveness or quality before marketing [1].
That includes claims about the pharmacy itself. If a site says its compounding pharmacy is "FDA approved," that is not a real status [1]. And a company name on a vial label does not necessarily mean that company made the drug, as the FITISH letter shows [2].
FDA notes that compounded drugs can be legal when they meet the conditions in sections 503A or 503B of the law [1][2]. Telehealth.org notes the letters do not bar companies from offering compounded medicines where legally permitted; they target how those products are described [3]. The letters do not allege that any specific patient was harmed, and they do not identify any recalls or quality test results [1][2].
What happens next
Each company was given 15 business days from receipt to send a written response to FDA's Office of Compounding Quality and Compliance, including steps taken to correct the violations, the identity of the entities that actually produce the products, and sample labeling [1][2]. What the companies submitted, and whether FDA considered the responses adequate, is not stated in the available sources.
Sources
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/altru-telehealth-llc-dba-altru-telehealth-728274-06082026
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fitish-728280-06082026
- https://telehealth.org/news/fda-sends-new-round-of-warning-letters-over-compounded-glp-1-marketing-claims/
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