ARIVA-BDL and STONEWALL-BDL modified risk tobacco products are currently not subject to Chapter IX in the Federal Food Drug & Cosmetic Act, CTP director says.
Star Scientific Inc. announced that the company has received notices from the Food and Drug Administration (FDA) regarding its pending ARIVA-BDL and STONEWALL-BDL modified risk tobacco product applications.
The notices from Lawrence Deyton, MD, MSPH, director of the FDA Center for Tobacco Products (CTP), state, in part, “Not all tobacco products are currently subject to Chapter IX of the FDCA [Federal Food Drug & Cosmetic Act]. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based upon the information in your submission, [ARIVA-BDL and Stonewall-BDL are] not currently subject to Chapter IX requirements.”
The FDA’s determination that Ariva-BDL and Stonewall-BDL are not tobacco products that are currently regulated under Chapter IX of the FDCA clears the way for Star to proceed with marketing these products.
“We are pleased to have received a determination from the FDA on Ariva-BDL™ and Stonewall-BDL,” said Paul Perito, Star’s chairman, president and chief operating officer. “It is clear from the notices we received that the Center for Tobacco Products does not believe these products are subject to regulation under FDC Act Chapter IX at this time. We intend to move forward with marketing and distribution of Ariva-BDL and Stonewall BDL, and these initiatives will be undertaken consistent with our belief that adult tobacco users should be able to have information about the toxin levels in all tobacco products.”