FDA WARNING_LETTER - swisschlz.com - May 01, 2026

The FDA’s Center for Tobacco Products issued a Warning Letter to swisschlz.com on May 1, 2026, following an evaluation of the company’s online retail operations. The agency determined that the firm is offering unauthorized nicotine pouch products, such as CHLZ - Black Cherry and CHLZ - Peppermint, for sale and distribution within the United States. According to the regulatory framework established by the Federal Food, Drug, and Cosmetic Act, nicotine products derived from any source are classified as tobacco products. Any such product introduced to the market after February 15, 2007, is considered a "new tobacco product" and requires formal FDA authorization before it can be legally sold. Because swisschlz.com did not obtain the necessary marketing orders, these products are considered to be in violation of federal law. The FDA warned that continuing to sell these unauthorized items could lead to significant enforcement actions, including civil money penalties, product seizures, or legal injunctions. Additionally, any violative products attempted to be imported into the country may be detained or refused entry. To resolve these issues, the company must provide a written response to the FDA within 15 working days. This response should outline the specific steps taken to correct the violations, provide dates when the sale of the products was discontinued, and describe a plan to ensure future compliance with federal regulations.