FDA Warns Maximus Over "Proven to Lose Weight Effectively" and "FDA Approved Pharmacies" Claims
On June 8, 2026, FDA issued a warning letter to Maximus Health, Inc. dba Maximus after a May 2026 review of maximustribe.com, which offers compounded semaglutide and tirzepatide products. FDA cites claims for compounded semaglutide and tirzepatide products including "Clinically studied ingredients," "Proven to lose weight effectively," and sourcing from "FDA approved pharmacies," saying the claims represent unapproved compounded products as FDA-approved and that FDA grants no approval or license to pharmacies. FDA requested a written response within 15 business days.
What this meansFDA does not approve or license compounding pharmacies, so "FDA-approved pharmacy" language on a provider's site is worth questioning — how a provider describes its pharmacy partners says a lot about how carefully it operates.
Source: FDA original ↗