FDA WARNING_LETTER - swedishproducts.online - February 13, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to swedishproducts.online on February 13, 2026, after determining the company was offering unauthorized nicotine pouch products for sale to customers in the United States. The primary violation centers on the marketing of "new tobacco products" without the legally required premarket authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products containing nicotine from any source fall under FDA jurisdiction and must comply with its requirements. The FDA identified specific products, including DOPE Ice Mango 16mg and DOPE Freeze 16mg, as new tobacco products that lack the necessary marketing authorization orders, making them adulterated and misbranded. swedishproducts.online is required to take prompt action to address these violations. The company must submit a written response within 15 working days, detailing steps taken to discontinue the sale and distribution of these non-compliant products, and outlining a plan for maintaining full compliance with the FD&C Act and its implementing regulations. Failure to comply may lead to further regulatory actions.