FDA WARNING_LETTER - npouches.com - May 01, 2026

On May 19, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to npouches.com following a review of the company"s website. The agency determined that the firm is selling unauthorized dissolvable tobacco products, specifically "Hyde Nic Strips – Cool Mint 2mg," to customers in the United States without the required legal permission. Under the Federal Food, Drug, and Cosmetic Act, any tobacco product not on the market before February 2007 is considered a "new tobacco product" and must receive formal marketing authorization from the FDA. Because these nicotine strips lack such authorization, they are being sold in violation of federal safety and marketing regulations. Beyond the lack of permits, the FDA expressed grave concern that the product"s design and packaging closely imitate common breath strips. This resemblance makes the product highly attractive to youth and increases the risk of accidental ingestion by young children. The FDA warned that the nicotine levels in these strips could lead to acute toxicity or seizures in children under six years old. The company must provide a written response to the FDA within 15 working days, outlining the specific steps taken to address these violations and confirming that the unauthorized products have been removed from sale. Continued non-compliance could lead to severe consequences, including product seizures, financial penalties, or legal injunctions.