Join Josie
FDA issued a warning letter to Join Josie, a website offering compounded semaglutide and tirzepatide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The site falsely displayed the 'Join Josie' label on compounded drug products, implying the company was the compounder when it was not, and made misleading claims linking its compounded products to FDA-approved brands Wegovy® and Zepbound®, implying FDA approval or evaluation that does not exist. FDA found these representations false or misleading, constituting misbranding and prohibited interstate commerce under section 301(a). Join Josie was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.
Flagged claims (3)
The same active ingredient found in the FDA-approved brand Zepbound®.
The same active ingredient found in the FDA-approved brand Wegovy®.
Join Josie
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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