FITISH
FDA issued a warning letter to FITISH (Fort Worth, TX) in June 2026 after reviewing their website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The agency found that FITISH's labeling falsely implied it was the compounder of the drugs, and that website claims associating the compounded products with FDA-approved brand-name drugs (Ozempic, Mounjaro, Zepbound) misrepresented the products as FDA-approved or evaluated for safety and effectiveness. 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). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Tirzepatide is the active ingredient in Mounjaro® and Zepbound®
Semaglutide is the active ingredient in ozempic
the compounded semaglutide and tirzepatide products displayed on your website identify "FITISH" on the pictured label, suggesting FITISH is the compounder of those drugs when in fact it is not
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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