FDA WARNING_LETTER - Diamond-Herpanacine of PA, Inc. - September 01, 2025

On January 22, 2026, the FDA issued a warning letter to Diamond-Herpanacine of PA, Inc. following a review of the company’s websites and social media profiles conducted in September 2025. The investigation focused on products marketed as dietary supplements, specifically Diamond Eye Health and Herpanacine Skin Support. The FDA determined that the company was making unauthorized health claims that suggested these products could cure, treat, or prevent various diseases, including macular degeneration, cataracts, herpes, shingles, and eczema. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these claims classify the products as unapproved new drugs rather than dietary supplements. Additionally, the FDA found the products to be misbranded because they lacked adequate directions for use; specifically, they are intended for conditions that require professional medical supervision and cannot be safely managed by a layperson. The company is required to provide a written response within 15 working days detailing the corrective steps taken to address these violations and prevent their recurrence. Failure to comply may lead to legal actions such as product seizures or court-ordered injunctions.