FDA WARNING_LETTER - Biopreventative Company LLC dba Biopreventative - August 31, 2025

The FDA issued a warning letter to Biopreventative on September 9, 2025, following a review of their website in August 2025. The inspection identified that Biopreventative"s website offered compounded drug products, including tadalafil, 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 suggest that their compounded products are equivalent to FDA-approved drugs, which they are not, thus misbranding the products and violating section 301(a) of the FDCA.

The FDA highlighted that the introduction or delivery of these misbranded products into interstate commerce is prohibited. Biopreventative is required to take immediate corrective actions, including ceasing the misleading claims. The company must respond within 15 working days, detailing the steps taken to rectify the violations and prevent future occurrences. Failure to comply may result in legal actions such as seizure or injunction.

Biopreventative is responsible for ensuring compliance with all federal laws and FDA regulations. The FDA also warned that if the company is based outside the U.S., its products could be detained or refused entry. The letter serves as a formal notice of the FDA"s concerns and provides an opportunity for Biopreventative to address these issues.