FDA WARNING_LETTER - Famous Smoke Shop-PA, Inc

The FDA Center for Tobacco Products issued a Warning Letter to Mr. Zaretsky after reviewing famous-smoke.com, which offers cigarette tobacco and/or roll-your-own tobacco products for sale in the United States. The FDA determined that the website markets Criss-Cross "pipe tobacco," specifically Criss-Cross Mint Blend, as cigarette tobacco and/or roll-your-own tobacco, meeting the definitions under the FD&C Act. The primary violation is that the Criss-Cross Mint Blend product is deemed adulterated under section 902(5) of the FD&C Act because it purports to contain a natural or artificial characterizing flavor (mint). This violates section 907(a)(1)(A) of the FD&C Act, which prohibits such flavors (other than tobacco or menthol) in these tobacco products. Alternatively, if the product does not actually contain a characterizing flavor, it is misbranded under section 903(a)(1) or 903(a)(7)(A) due to false or misleading labeling and advertising. The FDA requires immediate corrective actions for this and similar violations, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act across all sales channels. A written response detailing corrective actions, including dates of discontinuing violative sales and a compliance plan, must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import refusal.