FDA WARNING_LETTER - Intelligent Remedies, Inc. - September 01, 2025

Intelligent Remedies, Inc., based in Hawaii, received a formal warning letter from the FDA on January 23, 2026, following a review of the company’s website conducted in August and September 2025. The FDA found that the company marketed several products—including Pryenda, Athrombosyn, VIRAsol, and Curecumin—using claims that they could prevent, treat, or cure serious medical conditions such as Alzheimer’s, cancer, HIV, and blood clots. Under the Federal Food, Drug, and Cosmetic Act, these medical claims classify the products as drugs. Because these products have not been proven safe and effective through the standard FDA approval process, they are considered unapproved "new drugs." Additionally, the FDA identified the products as misbranded because they lack adequate directions for use, specifically for conditions that require professional medical supervision rather than self-treatment. The agency has directed Intelligent Remedies, Inc. to immediately address these violations and ensure compliance with federal regulations. The company is required to submit a written response within 15 working days detailing the corrective actions taken and its plan to prevent future occurrences. Failure to rectify these issues may lead to legal action, including product seizures or injunctions.