FDA WARNING_LETTER - Intimate Rose - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Intimate Rose, a company based in Kansas City, Missouri. The letter followed a review of the company"s website in August 2025, which revealed that Intimate Rose was marketing compounded versions of semaglutide and tirzepatide. The FDA determined that the company’s marketing claims were false or misleading because they suggested these products contained the "same active ingredient" as FDA-approved medications such as Ozempic, Wegovy, Mounjaro, and Zepbound. Because compounded drugs do not undergo the same FDA approval process, representing them as equivalent to approved drugs violates the Federal Food, Drug, and Cosmetic Act (FDCA). Under this regulatory framework, the products are considered misbranded, and their sale in interstate commerce is illegal. The FDA has instructed Intimate Rose to immediately cease using the misleading language and to address all violations of federal law. The company is required to submit a written response within 15 working days detailing the corrective actions taken and the steps implemented to prevent future recurrences. Failure to comply could result in further legal consequences, including product seizure or injunctions.