Weightless Medical LLC dba WeightCare
FDA issued a warning letter to Weightless Medical LLC dba WeightCare on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labels identifying 'WeightCare' as the compounder when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (1)
WeightCare
Required actions (5)
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)].
Identifying the entities that produce the compounded products offered on your website;
Providing a representative sample of labeling for such products;
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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