FDA WARNING_LETTER - www.smokerdirect.com

The FDA's Center for Tobacco Products reviewed smokerdirect.com and found cigarette products offered for sale in the U.S. that violate the FD&C Act.

**Violations:**

1. **Modified Risk Tobacco Products (MRTPs):** Products described as "light," "mild," or with reduced substance levels (e.g., "Dunhill Lights," "Marlboro Gold Original Gold Marlboro Lights," "Pall Mall Menthol Lights," "Star Mild" as "low tar and nicotine") are considered MRTPs under section 911(b)(2)(A)(ii) and (i) of the FD&C Act. Selling these without an FDA order under section 911(g) renders them adulterated under section 902(8) of the FD&C Act.

2. **Flavored Cigarettes:** Products like "Clas Mild (Clove)," "Sampoerna A Mild 12 (Clove)," and others purporting to contain a characterizing flavor (other than tobacco or menthol) violate section 907(a)(1)(A) of the FD&C Act. These are adulterated under section 902(5). If they do not contain the stated flavor, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling/advertising