FDA WARNING_LETTER - MD Cigars LLC

The FDA Center for Tobacco Products reviewed the website http://www.mdcigars.com and found that cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products are offered for sale to U.S. customers. The website's presentation, including categories like "Roll your own Tobacco" and promotions like "make a Carton of Cigarettes for about $12 Bucks!", indicates the loose tobacco products (e.g., Bali Shag, Gambler, Top) meet the definitions of "cigarette tobacco" and/or "roll-your-own tobacco" under the FD&C Act.

The FDA determined that Starter Kit No. 1 and Starter Kit No. 2, described as "Light," are "modified risk tobacco products" under section 911(b)(2)(A)(ii) of the FD&C Act. Selling these without an FDA order under section 911(g) makes them adulterated under section 902(8) of the FD&C Act.

Additionally, numerous smokeless tobacco products (e.g., Looseleaf Chew varieties, Mint Snuff varieties) offered on the website lack required health warning statements. This absence of warnings misbrands these products under section 903(a)(1) and/or section 903(a)(7)(A) of the FD&C Act. The letter also notes the requirement for quarterly rotation of warning statements on advertising