FDA WARNING_LETTER - Woodland Sedgwick LLC

The FDA's Center for Tobacco Products reviewed the website http://www.blackcatcigars.com and determined that Black Cat Premium – Danish Blend cigarette tobacco and/or roll-your-own tobacco products are offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act. The FDA found that the product is described as "mild" on the website, which designates it as a "modified risk tobacco product" under section 911(b)(2)(A)(ii) of the FD&C Act. Consequently, the product is adulterated under section 902(8) of the FD&C Act because it is being sold or distributed without an FDA order in effect under section 911(g) that permits such sale or distribution. The Warning Letter requires immediate correction of these violations and similar issues, ensuring all tobacco products and related labeling/advertising comply with the FD&C Act. A written response detailing corrective actions, including dates of discontinuance of violative activities and a compliance plan, must be submitted within 15 working days. Failure to comply may lead to further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imports.