Momentum Health 360 dba Momentum Health
FDA issued a warning letter to Momentum Health 360 dba Momentum Health (Newport Beach, CA) following a March 2026 review of their website, which markets compounded semaglutide, tirzepatide, and liraglutide products. The agency found the website made false or misleading claims by implying the compounded drugs share FDA-approved status with branded GLP-1 products (Ozempic®, Wegovy®, Mounjaro®, Zepbound™), falsely labeled Momentum Health as the compounder, and misrepresented the compounding facility as 'FDA-licensed.' These representations caused the products to be misbranded under FD&C Act §§ 502(a) and 502(bb), and FDA warned that failure to correct violations may result in seizure or injunction.
Flagged claims (4)
Our platform provides seamless access to advanced GLP-1 medications, such as compounded Semaglutide (found in Ozempic® and Wegovy®) and Tirzepatide (found in Mounjaro® and Zepbound™)…
Compounded Semaglutide refers to a medication meticulously formulated [sic] FDA-licensed compounding facility….
Same active ingredient in Mounjaro® and Zepbound™…
Same active ingredient in Wegovy® and Ozempic®…
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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