FDA WARNING_LETTER - www.abroadcigarettes.com

The FDA's Center for Tobacco Products reviewed abroadcigarettes.com and found cigarette products offered for sale in the U.S. that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The agency determined that several cigarette products are adulterated as "modified risk tobacco products" under section 902(8) of the FD&C Act because they are sold or distributed using descriptors like "Light" or "Ultra Light" without an FDA order in effect. Examples include "Bond Special Selection" and "Marlboro Gold." Additionally, the website offers flavored cigarette products, such as "Aroma Rich Apple" and "Kiss Mohito," which are purported to contain artificial or natural characterizing flavors. These flavored cigarettes are adulterated under section 902(5) of the FD&C Act, as section 907(a)(1)(A) prohibits characterizing flavors (other than tobacco or menthol) in cigarettes. If these products do not contain characterizing flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling/advertising. The FDA requires immediate correction of these violations and submission of a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a compliance plan. Failure to comply could lead to civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction, and products may be detained upon import.