FDA WARNING_LETTER - PolleyMed, LLC - April 01, 2026

PolleyMed, LLC received a formal warning letter from the FDA on May 14, 2026, following a regulatory review of the company"s website and social media platforms conducted in April 2026. The FDA identified significant violations regarding the marketing of SaniiSwab™, a product sold without a prescription for nasal sanitation. The primary issue is that PolleyMed, LLC markets SaniiSwab™ using unauthorized medical claims, suggesting it can sanitize the nostrils to prevent or treat diseases such as COVID-19, influenza, and various bacterial infections like MRSA. Under the Federal Food, Drug, and Cosmetic Act, these claims classify the product as a drug. However, the product is considered an "unapproved new drug" because it has not undergone the necessary FDA review process to prove it is safe and effective for its intended use. Furthermore, the FDA noted that nasal administration of such antiseptics is not permitted under current regulatory standards for over-the-counter products. Additionally, the product was found to be misbranded because the company’s website falsely claimed it was "FDA OTC approved." The FDA clarified that no such approval has been granted, making the labeling misleading to consumers. PolleyMed, LLC is required to respond within 15 business days, detailing the specific steps taken to correct these violations and explaining how they will prevent future occurrences. Failure to address these concerns promptly may result in legal actions, including product seizure or an injunction.