FDA WARNING_LETTER - Connecticut Valley Tobacconist, LLC

The FDA issued a Warning Letter to Mr. Tarnowicz of cvtobacco.com after reviewing their website, which offers cigarette and roll-your-own (RYO) tobacco products for sale in the U.S. The FDA determined that products labeled as "pipe tobacco," such as Criss Cross and Gambler Pipe Tobacco, are promoted and sold as cigarette or RYO tobacco, based on website descriptions indicating they are "Dual Purpose Pipe Tobaccos" suitable for cigarettes and comparable to cigarette tobacco. This classification subjects them to FDA jurisdiction under the FD&C Act.

The primary violation identified is the sale of flavored cigarette and RYO tobacco products, specifically Criss Cross Vanilla and Gambler Mint. Section 907(a)(1)(A) of the FD&C Act prohibits characterizing flavors (other than tobacco or menthol) in cigarettes, cigarette tobacco, and RYO tobacco. These flavored products are deemed adulterated under section 902(5) of the FD&C Act. If they do not contain characterizing flavors, they are misbranded under sections 903(a)(1) or 903(a)(7)(A) for false or misleading labeling.

The FDA requires immediate corrective actions, including discontinuing the violative promotion, advertising, sale, and distribution of these products. A written response detailing corrective actions and a compliance plan must be submitted within 15 working days. Failure to comply may result in civil