Lean Dreams LLC dba LeanDreams
FDA issued a warning letter to Lean Dreams LLC dba LeanDreams in September 2025 after reviewing their website and finding that marketing claims for compounded semaglutide and tirzepatide falsely implied equivalence to FDA-approved drugs (Ozempic, Wegovy, Mounjaro, Zepbound). The claims were deemed false or misleading under FDCA sections 502(a) and 502(bb), rendering the products misbranded. FDA demanded the company cease using the offending language and provide a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.
Flagged claims (2)
Compounded Semaglutide has the same active ingredient as Ozempic and Wegovy.
With compounded Tirzepatide, you get the same active ingredient found in Mounjaro and Zepbound.
Required actions (2)
You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).
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.
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