FDA WARNING_LETTER - www.online-smoke.com - July 29, 2011

The FDA issued a Warning Letter to online-smoke.com on July 29, 2011, after reviewing their website and determining that cigarette products were offered for sale to U.S. customers. The FDA found several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, products advertised with descriptors like "Light," "Ultra Light," "Super Light," and "Extra Light" (e.g., Chesterfield Classic Blue Lights, Davidoff Gold Lights, Pall Mall Azure Super Light) were deemed "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act. These products were offered for sale without an FDA order in effect under section 911(g), rendering them adulterated under section 902(8) of the FD&C Act.

Additionally, "Kiss Fresh Apple Superslims" cigarettes were identified as containing a characterizing flavor (apple), violating section 907(a)(1)(A) of the FD&C Act, which prohibits such flavors in cigarettes (other than tobacco or menthol). This makes them adulterated under section 902(5) of the FD&C Act. If they do not contain a characterizing flavor, their labeling is considered false and misleading, making them misbranded under section 903(a)(1).

The FDA requires immediate correction of these violations and