FDA WARNING_LETTER - Biopreventative Company LLC dba Biopreventative - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Biopreventative Company LLC (doing business as Biopreventative) following a review of their website content in August 2025. The investigation focused on the company"s marketing of compounded drug products, specifically tadalafil. The FDA found that Biopreventative engaged in misbranding by making false or misleading claims about its products. Specifically, the company’s website suggested that its compounded tadalafil was a "compound medication" and equated it to the FDA-approved drug Cialis. Because compounded drugs are not FDA-approved, the agency determined these claims were misleading as they implied the products were identical to approved versions in safety and efficacy. These actions violate the Federal Food, Drug, and Cosmetic Act (FDCA), which prohibits the introduction of misbranded drugs into interstate commerce. To address these violations, the FDA requires Biopreventative to immediately cease the use of misleading promotional language and investigate the root causes of the compliance issues. The company must provide a written response within 15 working days outlining the specific corrective actions taken and its plan to prevent future recurrences. Failure to rectify these issues promptly could result in legal action, including product seizures or injunctions.