FDA WARNING_LETTER - Karl Bergman

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Bergman after reviewing his websites, http://www.pennycigarettes.com and http://www.saveonfags.com, which offer tobacco products for sale to U.S. customers. The FDA determined that certain products are adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, Hilton Platinum cigarettes, promoted as "Hilton Lights," are considered modified risk tobacco products and are adulterated under section 902(8) of the FD&C Act because they are offered without a required FDA order. Additionally, flavored cigarettes, including Kiss Super Slims Fresh Apple, Richmond Cherry, and Sobranie Mints, are adulterated under section 902(5) of the FD&C Act for containing characterizing flavors, violating section 907(a)(1)(A). Alternatively, if these flavored cigarettes lack characterizing flavors, their labeling is deemed false and misleading, rendering them misbranded under section 903(a)(1).

Mr. Bergman is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinuing violative promotion and sales. Failure to comply may result in further FDA enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction, with adulterated and misbranded products subject to detention upon importation.