The company had applied to market its products as having "modified risk." Instead, it received notices that its Ariva-BDL and Stonewall-BDL dissolvable lozenges do not fall under the current tobacco products described in the federal Food, Drug & Cosmetic Act--clearing the way for marketing.
The notices from Lawrence Deyton, director of the FDA CTP, state, in part, "Not all tobacco products are currently subject to Chapter IX of the FDCA. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based [image-nocss] upon the information in your submission, [Ariva-BDL and Stonewall-BDL are] not currently subject to Chapter IX requirements."
According to Chapter IX, the term "smokeless tobacco" means "any tobacco product that consists of cut, ground, powdered or leaf tobacco and that is intended to be placed in the oral or nasal cavity."
Sara Troy Machir, vice president of communications & investor relations at Star Scientific, told Tobacco E-News"We were surprised, but we certainly are pleased that we have the opportunity to bring these products to market,"
The BDL in the product name stands for the fact that they are made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits (BDL) by most current standards of measure.
The company currently has Ariva and Stonewall dissolvable lozenges on the marketplace, but it hopes to add the BDL products, which use a "further innovated tobacco curing process," later this year.
Machir said it could take months to prepare the products, and market them consistent with the company's believe "that adult tobacco consumers need to have information about toxins in all tobacco products."
She added, "We have always had a very clearly articulated mission that we really want to focus on ways to reduce the harm associated with tobacco." Star has also submitted a modified risk application for a moist smokeless tobacco, but hasn't heard yet on the status of that application.
It is unclear whether the decision would affect other dissolvables in the marketplace from manufacturers such as R.J. Reynolds and Altria Group Inc.
Machir said the letter from the FDA referenced the company's proprietary manufacturing process. "We aren't privy to and certainly don't know how other companies manufacture their products," she added.
Kara Henschel, spokesperson for the FDA's Center for Tobacco Products, told Tobacco E-News," FDA recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products."
She added, "FDA is currently considering its legal and regulatory options regarding these products."
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