Vitalie Rotaru – FDA Warning Letter, Sep 30, 2011

The FDA Center for Tobacco Products reviewed Vitalie Rotaru's website, discount-cigarettes.us, and determined that cigarette products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Several products, including Pall Mall Blue, L&M Blue Label, and Bond Street Fine cigarettes, are promoted using descriptors like "light," "Lights," or "Super Lights." These are considered "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act. Offering these without an FDA order under section 911(g) renders them adulterated under section 902(8) of the FD&C Act.

Additionally, flavored cigarettes such as Kiss Strawberry Superslim, Kiss Fresh Apple Superslim, Esse Aura Green Apple, Esse Aura Pink Strawberry, Richmond Cherry, Aroma Rich Apple, Aroma Rich Rum & Cherry, and Lady Rose Slims are offered. Section 907(a)(1)(A) of the FD&C Act prohibits cigarettes from containing characterizing flavors other than tobacco or menthol. Therefore, these flavored cigarettes are adulterated under section 902(5) of the FD&C Act. If they do not contain a characterizing flavor, their labeling is false and misleading, making them misbranded under section 903(a)(1) of the FD&C Act.