Whole Leaf Tobacco (Don Carey) – FDA Warning Letter

The FDA's Center for Tobacco Products reviewed Whole Leaf Tobacco's website, wholeleaftobacco.com, and determined that their cigarette and/or roll-your-own tobacco products are distributed in the U.S. These products, including Turkish Light and Flue Cured Virginia "Lemon," are defined as tobacco products under the FD&C Act.

The FDA found several products adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products sold without an FDA order. Violations include using descriptors like "light," "mild," or similar terms (e.g., Turkish Light, Flue Cured Virginia "Lemon" described as "mild," 50 lbs. Flue Cured Virginia Light, Maryland 609 described as "used for lighter cigarettes"). Additionally, products were advertised as having reduced levels of substances (e.g., Maryland 609 as "lower in nicotine," Threshed/Stripped Tobacco 11 pound bag and 50 lbs. Threshed Stripped Flue Cured Tobacco as "medium/low nicotine content").

These claims classify the products as modified risk tobacco products under section 911(b)(2)(A) of the FD&C Act. Selling such products without an FDA order under section 911(g) renders them adulterated.

Whole Leaf Tobacco must immediately correct these violations and ensure all tobacco products