FDA WARNING_LETTER - SimpleRx - August 31, 2025

The FDA issued a Warning Letter to SimpleRx on September 9, 2025, following a review of their website, https://rxmadesimple.com, in August 2025. The FDA identified that SimpleRx 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 are equivalent to FDA-approved drugs, which they are not, leading to their classification as misbranded drugs.

The regulatory framework cited includes sections 502(a), 502(bb), and 301(a) of the FDCA, which address misbranding and the unlawful introduction of such products into interstate commerce. The FDA emphasizes that the receipt and delivery of misbranded drugs also violate section 301(c) of the FDCA.

SimpleRx is required to take immediate corrective actions, including ceasing the use of misleading language on their website. The company must respond in writing within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent recurrence. Failure to comply may result in legal actions such as product seizure or injunctions. SimpleRx is also advised to provide reasoning and supporting information if they believe their products do not violate the FDCA. Correspondence should clearly reference the Warning Letter, and any inquiries can be directed to the FDA"s specified contact email.