Hers vs Ivim Health

Regulatory noticeRegulatory note (verified August 22, 2026): Hers is a brand of Hims & Hers Health, Inc., and the FDA wrote to that company twice on September 9, 2025, once for each brand. The Hers letter, MARCS-CMS 716825, went to chief executive Andrew Dudum after an August 2025 review of forhers.com. It quotes two claims made for compounded semaglutide: "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." The agency’s position is that compounded products carry no FDA approval, so claims like these imply a sameness with approved medicines that has not been established, making the products misbranded. FDA’s index lists neither a response nor a close-out letter, so the matter stands open. Read the FDA letter

Regulatory noticeRegulatory note (verified August 22, 2026): Ivim Services LLC received FDA warning letter MARCS-CMS 721816 on February 20, 2026, after the agency reviewed ivimhealth.com in December 2025. This letter is narrower than most in the same enforcement round: it quotes no marketing claims at all. The one cited violation concerns labeling. Compounded semaglutide and tirzepatide products pictured on the site show the "Ivim" name, which the FDA said represents Ivim as the compounder when it is not, citing 21 CFR 201.1(h)(2) and the misbranding provisions at FD&C Act 502(a) and 502(bb). We checked FDA’s index for a close-out letter and found none; on the public record the matter remains open. Read the FDA letter

Regulatory noticeRegulatory note (verified August 22, 2026): On February 20, 2026 the FDA issued MEDVi, LLC a warning letter (MARCS-CMS 721455) citing misbranding under sections 502(a) and 502(bb) of the FD&C Act. Reviewing medvi.io in December 2025, the FDA said labels bearing "MEDVi" implied MEDVi compounds the drugs when it does not, and that "Same active ingredient as Wegovy and Ozempic" and "Same active ingredient as Mounjaro and Zepbound" implied an FDA approval compounded drugs do not have. We found no close-out letter, so the matter appears open. MEDVi states medvi.io is affiliate-operated rather than company-operated; we could not verify that, and the letter is addressed to MEDVi, LLC. Read the FDA letter