FDA WARNING_LETTER - Reset IV, LLC dba Reset IV - August 31, 2025

The FDA issued a warning letter to Reset IV on September 9, 2025, following an inspection of their website in August 2025. The inspection revealed that Reset IV was offering compounded drug products, specifically semaglutide and tirzepatide, with claims that were deemed false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggested that the compounded products were equivalent to FDA-approved drugs, which they are not, resulting in the products being classified as misbranded.

The regulatory framework cited includes sections 502(a), 502(bb), and 301(a) of the FDCA, which prohibit the introduction of misbranded drugs into interstate commerce. The FDA emphasized that the violations noted are not exhaustive, and Reset IV is responsible for ensuring compliance with all federal laws and FDA regulations.

The FDA requires Reset IV to take immediate corrective actions, such as ceasing the misleading claims. The company must respond in writing within 15 working days, detailing the steps taken to address the violations and prevent recurrence. Failure to comply may result in legal actions, including seizure and injunction. Reset IV is also advised that if their products are not in violation, they should provide supporting information for consideration. Correspondence should be directed to the Office of Compounding Quality and Compliance.