EWSG, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Mr. Glaubinger regarding tobacco products sold on http://www.ryotobacco.com and http://www.pipetobacco.com. The FDA determined these websites are affiliated and offer cigarette and/or roll-your-own tobacco products, despite some being labeled as "pipe tobacco," due to their overall presentation and proximity to cigarette accessories.

The products are deemed adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (e.g., "light," "mild" descriptors like Gawith Hoggarth Smooth Tobacco-Gold, Kensington Pipe Tobacco- Old Virginia, Texas Tobacco- Mild Pipe tobacco) sold without an FDA order.

Additionally, products like Gawith Hoggarth Top Black Cherry, Gawith Hoggarth Smooth Tobacco- Light Vanilla, and Kensington Pipe Tobacco- Old Kentucky (chocolate) are adulterated under section 902(5) of the FD&C Act for containing characterizing flavors, which is prohibited for cigarettes and cigarette tobacco. If these products do not contain characterizing flavors, they are misbranded under section 903(a)(1) or 903(a)(7)(A) for false or misleading labeling/advertising.

The FDA requires immediate corrective actions, including discontinuing violative promotion, advertising, sale, and distribution. A written response detailing corrective actions and a compliance plan is required within 15 working days to