FDA WARNING_LETTER - shopcigarettes.com

The FDA's Center for Tobacco Products issued a Warning Letter after reviewing the websites http://www.shopcigarettes.com, http://www.dutyfreesmoke.com, and http://www.smokerdirect.com, which offer cigarette products for sale in the U.S. The FDA determined these products are tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Modified Risk Tobacco Product Violations:** Several cigarette products (e.g., Dunhill Lights, Lucky Strike Lights, Star Mild) are sold using descriptors like "Lights," "low tar and nicotine," or similar terms. These are considered "modified risk tobacco products" under section 911(b)(2)(A)(ii) and (i) of the FD&C Act. Selling these without an FDA order in effect under section 911(g) renders them adulterated under section 902(8) of the FD&C Act. 2. **Flavored Cigarette Violations:** Products like "Clas Mild" and "Sampoerna A Mild" are offered with purported characterizing flavors (e.g., clove). Section 907(a)(1)(A) of the FD&C Act prohibits cigarettes from containing artificial or natural flavors (other than tobacco or menthol) as a characterizing flavor. Violating this provision makes the products adulterated under section 902(