The US Food and Drug Administration (FDA) notified Star Scientific that their smokeless products Ariva-BDL and Stonewall-BDL are not currently subject to Chapter IX requirements.

The maker of smokeless tobacco products, Star Scientific, today said it was notified by Lawrence Deyton, director of the FDA’s Center for Tobacco Products, that "based upon the information in your submission, [Ariva-BDL and Stonewall-BDL are] not currently subject to Chapter IX requirements."
"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)."
The company based in Glen Allen, Virginia, said this decision will clear the way to proceed with marketing its Ariva-BDL and Stonewall-BDL tobacco lozenges. The dissolvable products contain reduced levels of carcinogens known as tobacco-specific nitrosamines.
The 2009 law restricts tobacco marketing and requires an FDA advisory panel to evaluate dissolvable tobacco’s impact on public health. The panel, which said last week after a yearlong analysis that menthol cigarettes may harm public health, will begin its examination of dissolvable tobacco later this year. (ci)