FDA WARNING_LETTER - Intimate Rose - August 31, 2025

The FDA issued a warning letter to Intimate Rose on September 9, 2025, following a review of their website in August 2025. The inspection revealed that the company offers compounded drug products, including semaglutide and tirzepatide, with claims that are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggest that the compounded products have the same active ingredients as FDA-approved drugs like Ozempic, Wegovy, Mounjaro, and Zepbound, which is not accurate since compounded drugs are not FDA-approved. Consequently, these products are considered misbranded and their introduction into interstate commerce violates section 301(a) of the FDCA.

The FDA requires Intimate Rose to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must provide a written response within 15 working days detailing the steps taken to address the violations and prevent future occurrences. This response should include documentation supporting their corrective measures. Failure to comply may result in legal actions such as product seizure or injunctions. Intimate Rose is also advised that if their products are not in violation, they should provide supporting information for FDA review. The letter underscores the company"s responsibility to ensure compliance with federal laws and FDA regulations.