FDA WARNING_LETTER - GSC Products, LLC - March 01, 2026

On May 18, 2026, the FDA issued a warning letter to GSC Products, LLC, following a review of the company’s websites and online storefronts in March 2026. The investigation focused on the "SINUS PLUMBER Headache Nasal Spray," which the agency determined is being sold as an unapproved and misbranded drug in violation of the Federal Food, Drug, and Cosmetic Act. The primary issue is that the product makes medical claims—such as treating migraines, cluster headaches, and inflammation—without having the necessary FDA approval for safety and effectiveness. Under the current regulatory framework for over-the-counter internal pain relievers, such medications must be administered orally to be considered safe for general use; however, this product is marketed as a nasal spray. Additionally, the formula contains several active ingredients, including capsaicin, feverfew, and peppermint oil, that are not permitted for use in this specific class of drugs. The FDA has mandated that GSC Products, LLC, provide a written response within 15 business days. This response must outline the specific steps taken to correct the violations and the company’s plan to prevent future occurrences. Failure to address these concerns promptly may result in regulatory or legal action, including product seizures or injunctions.