FDA WARNING_LETTER - nicoprof.com

The Food and Drug Administration (FDA) issued a warning letter dated April 17, 2026, to nicoprof.com regarding the illegal sale of unauthorized tobacco products through their website. Following a review of the company"s online platform, the FDA determined that the firm is distributing nicotine pouch products, specifically ZYN Cool Blueberry and ZYN Red Fruits (9mg), to U.S. customers without the necessary marketing authorization. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), nicotine pouches are classified as tobacco products. To be legally marketed in the United States, any product not commercially available before February 15, 2007, must undergo an FDA review and receive a formal marketing order. Because nicoprof.com lacks these authorizations, the listed products are considered adulterated and misbranded. The FDA noted that the violations identified are not exhaustive and that the company is responsible for ensuring all its offerings comply with federal law. The FDA requires nicoprof.com to submit a written response within 15 working days of receiving the letter. This response must outline the specific actions taken to address the violations, including the dates sales were halted and the company"s plan to prevent future infractions. Failure to comply may result in serious consequences, such as civil money penalties, product seizures, or court-ordered injunctions. Furthermore, unauthorized products offered for import may be detained or denied entry into the country.