New York Times profile of MEDVi came after FDA warning on compounded GLP-1 marketing

The New York Times published a profile of MEDVi on April 2, 2026, presenting the telehealth seller of compounded GLP-1 drugs as an example of how artificial intelligence tooling can let one founder build a billion-dollar company. The article said the firm is on pace for $1.8 billion in 2026 sales, but it did not mention that the FDA had warned the company six weeks earlier about how it marketed compounded semaglutide and tirzepatide ^[1].

The Times said it was given access to MEDVi's financial records to verify revenue and profit. Founder Matthew Gallagher reported $401 million in 2025 revenue and 250,000 customers by the end of that year, and called the growth "insane" and accelerating. He said the company has two full-time employees — himself and his brother Elliot — plus contract engineers, account managers and outside agencies, with CareValidate and OpenLoop Health handling physicians, pharmacies, shipping and compliance. Gallagher said he used ChatGPT, Claude, Grok, MidJourney and Runway while building the business ^[1].

The FDA's letter, dated February 20, 2026, said MEDVi misbranded the compounded drugs that produced that revenue. According to the agency, the site implied that MEDVi itself was the compounder, and claims such as "Same active ingredient as Wegovy® and Ozempic®" and "Same active ingredient as Mounjaro® and Zepbound®" wrongly suggested FDA approval or evaluation. The letter said uncorrected violations could lead to seizure or injunction and that the cited problems were "not intended to be an all-inclusive statement of violations" ^[1].

MEDVi said on April 8 that medvi.io was run by an affiliate marketing agency and that the company had "never received a letter from the FDA." The warning letter is addressed to "MEDVi, LLC dba MEDVi" at a Newark, Delaware address, uses MEDVi's help@medvi.io email, and quotes MEDVi-branded claims from medvi.io ^[1].

Advertising also came under scrutiny. A review of MEDVi's site, Facebook ads and public records on April 3 found more than 5,000 active Meta ads, many running under apparently fabricated physician personas such as "Dr. Robert Whitworth," "Professor Albust Dongledore" and "Dr. Richard Hörzgock." Business Insider reported similar findings the same day; after it asked questions, the count of active MEDVi-related ads fell from over 5,000 to about 2,800. Gallagher told Business Insider that "maybe 30%" of advertising ran through affiliates. MEDVi's site carries a notice that "Individuals appearing in advertisements may be actors or AI portraying doctors and are not licensed medical professionals" ^[1].

Sellers of compounded GLP-1s operate in a narrowing legal space. Federal law generally bars compounders from copying FDA-approved drugs, though sections 503A and 503B of the Food, Drug, and Cosmetic Act allow compounding in some cases, including shortages. The FDA determined the tirzepatide injection shortage was resolved on December 19, 2024, and the semaglutide injection shortage on February 21, 2025. Many sellers then moved to "personalized" formulas that add ingredients such as vitamin B-12. On April 1, 2026, the FDA said such a mix may still be "essentially a copy" unless a prescriber documents a patient-specific "significant difference"; Eli Lilly warned in March 2026 against combining tirzepatide with vitamin B-12 ^[1].

OpenLoop Health, which MEDVi's site names as the source of its clinicians, disclosed a January 7, 2026 cyber breach in which a threat actor claimed to have taken records on about 1.6 million patients. The company confirmed at least 68,160 affected people in Texas to that state's attorney general in March 2026 and faces multiple class actions. In November 2025, a North Carolina consumer sued OpenLoop and compounding pharmacy Triad Rx over compounded oral tirzepatide, describing it in the complaint as "modern-day snake oil." MEDVi is not a defendant, but the complaint says the plaintiff bought the pills through MEDVi ^[1].

Why it matters for patients

Compounded semaglutide and tirzepatide are not FDA-approved products. Saying a compounded drug shares an active ingredient with Ozempic, Wegovy, Mounjaro or Zepbound describes a molecule, not a regulatory review, and the FDA said MEDVi's phrasing implied an approval the company does not hold ^[1]. Who provides the care can also be unclear: MEDVi's site attributes prescribing decisions to OpenLoop clinicians, and the two physicians previously listed there, Dr. Ana Lisa Carr and Dr. Kelly Tenbrink of a Wellington, Florida concierge practice, were removed on April 10 after questions were raised. Florida Department of Health profiles show neither holds certification from specialty boards the state recognizes ^[1]. The OpenLoop breach means personal and medical data connected to that platform may have been exposed ^[1].

What happens next

No further FDA enforcement against MEDVi has been reported since the warning letter, and no outcome has been reported in the OpenLoop class actions ^[1]. The FDA's April 1 statement sets a documentation standard for prescribers who add ingredients such as B-12 ^[1].