Dwyer & Manning Inc – FDA Warning Letter

The FDA issued a Warning Letter to Mr. Miller regarding violations observed on the website http://www.makerollyourowncigarettes.com. The FDA determined that cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products offered for sale are subject to FDA jurisdiction.

The website promotes loose tobacco products labeled as "pipe tobacco" (e.g., Peter Stokkebye branded products) as cigarette tobacco and/or roll-your-own tobacco, making them subject to relevant regulations.

Several cigarette tobacco and/or roll-your-own tobacco products are deemed adulterated under section 902(8) of the FD&C Act because they are marketed as "modified risk tobacco products" without an FDA order. Examples include products described with terms like "light," "lighter," "Ultra Light," "mild," and "milder" (e.g., 1839 Blue Premium Cigarette Tobacco, Bali Shag White, Kentucky Select Blue/Gold/Silver, McClintock Blue, Peter Stokkebye Danish Export/Norwegian).

Additionally, smokeless tobacco products (e.g., Oliver Twist, Stoker’s) are misbranded under section 903(a)(7)(A) of the FD&C Act because their advertisements on the website fail to include required health warning statements as mandated by the Comprehensive Smokeless Tobacco Health Education Act of 1986.

The FDA requires immediate corrective