FDA WARNING_LETTER - www.cigarettes.co

The FDA's Center for Tobacco Products issued a Warning Letter to Mr. Ghaith after reviewing his website, http://www.cigarettes.co, which offered cigarette products for sale to U.S. customers. The FDA determined these products are tobacco products subject to its jurisdiction. The letter identifies two primary categories of violations. First, several cigarette products, including those described as "Lights" or "Ultra Lights," are deemed adulterated under section 902(8) of the FD&C Act. These are considered modified risk tobacco products under section 911(b)(2)(A)(ii) due to their descriptors and are being sold without the required FDA order under section 911(g). Second, various flavored cigarette products, such as "Aroma Rich Apple" and "Richmond Cherry," are adulterated under section 902(5) of the FD&C Act because they purport to contain artificial or natural characterizing flavors, which is prohibited by section 907(a)(1)(A). Alternatively, if these flavored products do not contain such flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) for false or misleading labeling. The FDA requires immediate correction of these violations and similar issues, along with a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, and import refusal.