FDA WARNING_LETTER - www.e-tobaccos.com

The FDA's Center for Tobacco Products issued a Warning Letter to e-tobaccos.com after reviewing its website, which offers various tobacco products for sale in the U.S. The FDA determined that the company is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Family Smoking Prevention and Tobacco Control Act. Key violations include selling "modified risk tobacco products" (e.g., roll-your-own tobacco described as "mild") without an FDA order, rendering them adulterated under 21 U.S.C. § 387b(8). Additionally, the company offers flavored cigarette, cigarette tobacco, and roll-your-own tobacco products (e.g., cherry, chocolate, vanilla). These are adulterated under 21 U.S.C. § 387b(5) if they contain characterizing flavors, or misbranded under 21 U.S.C. § 387c(a)(1) or § 387c(a)(7)(A) if their labeling falsely purports to contain such flavors. Furthermore, the company failed to include required health warning label statements in advertisements for smokeless tobacco products (e.g., Chema Mint, Gawith Apricot), leading to misbranding under 21 U.S.C. § 387c(a)(7)(A). The letter also noted the requirement for quarterly rotation of warning statements. The FDA mandates immediate correction of all identified and similar violations, ensuring full compliance with the FD&C Act. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative activities, and a compliance plan. Failure to comply could result in severe penalties, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and product detention.