FDA WARNING_LETTER - The Sabagh Group Inc/lighterusa.com - March 15, 2026

The FDA issued a Warning Letter to The Sabagh Group Inc./lighterusa.com on February 13, 2026, after reviewing its website. The company was found to be illegally offering for sale and distribution unapproved "new tobacco products," specifically Zyn Nicotine Pouches Cool Blueberry – 5 Pack and Zyn Nicotine Pouches Cool Watermelon – 5 Pack. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these nicotine pouch products are considered tobacco products subject to FDA jurisdiction and require premarket authorization. The agency determined that these products lack the necessary marketing authorization orders, rendering them both adulterated and misbranded under the FD&C Act. The FDA mandates that The Sabagh Group Inc. take prompt action to address these violations, including immediately ceasing the sale and distribution of the unauthorized products. The company is required to submit a written response within 15 working days, outlining its corrective actions and its plan to ensure ongoing compliance with the FD&C Act and its implementing regulations.