FDA WARNING_LETTER - www.cigarettes-online-store.com

The FDA's Center for Tobacco Products reviewed the website http://www.cigarettes-online-store.com and found cigarette products offered for sale to U.S. customers, which are subject to FDA jurisdiction. The agency determined that several products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (e.g., labeled as "light," "mild," or claiming reduced substance levels like "low tar and nicotine") sold without a required FDA order under section 911(g). Additionally, other cigarette products, such as "Aroma Rich Apple" and "Richmond Cherry," are offered for sale purporting to contain a natural or artificial characterizing flavor (other than tobacco or menthol), violating section 907(a)(1)(A) and rendering them adulterated under section 902(5) of the FD&C Act. If these products do not contain the advertised flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling. The firm must immediately correct these violations, discontinue all violative promotion, advertising, sale, and distribution, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.