FDA Allows Marketing of Modified Risk Tobacco Product

Star Scientific — manufacturer of the dissolvable tobacco products Ariva and Stonewall — has announced that it is poised to market these products as modified risk. To our knowledge, Star Scientific was the first company to submit an application to FDA to market its products as having a lower risk of heath ailments resulting from the use of tobacco.

The FDA apparently determined that although Ariva and Stonewall, which are made of ground tobacco compressed into a pill and dissolve in the mouth, are “tobacco products” subject to future regulation under the Tobacco Control Act, but are not considered “smokeless tobacco” that is currently subject to regulation. Under the FDA’s interpretion, FDA presumably it would have to enact additional regulations covering these products.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.