Aspen Aesthetics dba Fifty 410
FDA issued a warning letter to Aspen Aesthetics dba Fifty 410 (Prosper, TX) on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found two categories of misbranding violations: (1) the product labels displayed on the website identified 'Fifty 410' as the compounder when it is not, constituting a false or misleading representation under FDCA §§ 502(a) and 502(bb); and (2) the claim 'clinically proven ingredients' falsely implied FDA approval or evaluation for safety and effectiveness for unapproved compounded drugs. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (2)
clinically proven ingredients
The compounded semaglutide and tirzepatide products displayed on your website identify "Fifty 410" on the pictured label, suggesting Fifty 410 is the compounder of those drugs when in fact it is not.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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