FDA WARNING_LETTER - shopcalismokes.com

On April 10, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to shopcalismokes.com, an online retailer based in Farmington Hills, Michigan, following a review of its commercial website. The FDA determined that the company is distributing nicotine pouch products to U.S. customers that lack the necessary federal marketing authorization. Specifically, the letter identifies "Zyn Pouches Slim – Cool Skittle 15mg" and "Zyn Pouches Slim – Fizzy Cola 15mg" as unauthorized new tobacco products. Under the Federal Food, Drug, and Cosmetic Act, any tobacco product introduced or modified after February 15, 2007, must obtain a formal marketing order before it can be legally sold. Because these specific items do not have such authorization, the FDA classifies them as adulterated and misbranded. The agency has directed shopcalismokes.com to immediately address these violations and ensure all products offered for sale comply with federal law. The company is required to submit a written response within 15 working days detailing its corrective actions, including the dates it stopped selling the unauthorized products and a plan to maintain future compliance. Failure to correct these issues may result in legal consequences such as civil penalties, product seizures, or injunctions.