Online-Smokes – FDA Warning Letter

The FDA reviewed Smokes-Online.com and determined that cigarette products offered for sale to U.S. customers are tobacco products under section 201(rr) of the FD&C Act. Several products are adulterated under section 902(8) because they are promoted as modified risk tobacco products (MRTPs) without an FDA order. Specifically, products like "Chesterfield Classic Bronze Ultra Lights" and "Davidoff Gold Lights" use descriptors such as "Light," "Ultra Light," "Super Light," and "Extra Light," classifying them as MRTPs under section 911(b)(2)(A)(ii). Introducing MRTPs into interstate commerce without an FDA order under section 911(g) is a violation.

Additionally, "Kiss Fresh Apple Superslims" cigarettes are adulterated under section 902(5) or misbranded under section 903(a)(1). These products are purported to contain a characterizing apple flavor, which is prohibited for cigarettes under section 907(a)(1)(A) as of September 22, 2009, unless it is tobacco or menthol. If the product does not contain a characterizing flavor, its labeling is false and misleading, leading to misbranding.

The FDA requires immediate correction of these violations and submission of a written response within 15 working days detailing corrective actions, including dates of discontinued