Maximus Health, Inc. dba Maximus
FDA issued a warning letter to Maximus Health, Inc. dba Maximus (Santa Monica, CA) in June 2026 after reviewing their website and finding false or misleading promotional claims about compounded semaglutide and tirzepatide products. The company falsely implied these unapproved compounded drugs had been clinically studied or proven effective, and misrepresented their sourcing pharmacies as 'FDA approved' — a designation FDA does not grant to compounding facilities. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a), with FDA warning that failure to correct violations may result in seizure or injunction.
Flagged claims (4)
Proven to lose weight effectively
FDA approved pharmacies
Clinically studied to help patients….
Clinically studied ingredients.
Required actions (4)
Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.
Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
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