FDA WARNING_LETTER - Join Josie - December 31, 2025
The FDA issued a Warning Letter to Join Josie on February 20, 2026, following a December 2025 review of its website, joinjosie.com, which offers compounded semaglutide and tirzepatide drug products. The agency identified significant violations related to the misbranding of these drugs under the Federal Food, Drug, and Cosmetic Act. Key issues include false or misleading claims on the website. Join Josie inaccurately presented itself as the compounder of these drugs on product labels, and falsely implied FDA approval or evaluation for safety and effectiveness. This was done by stating their products contained "The same active ingredient found in the FDA-approved brand Wegovy®" and "The same active ingredient found in the FDA-approved brand Zepbound®," despite compounded drugs not being FDA-approved. These practices represent the introduction of misbranded drugs into interstate commerce. Join Josie must provide a written response within fifteen working days, detailing corrective actions and steps to prevent recurrence. This includes identifying actual compounders, supplying labeling samples, and revising or removing all false or misleading website claims. Failure to comply may result in legal actions.
ID · 6e80a93f-a171-4a86-8d36-6b8de2ca2a64
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