GLEN ALLEN, Va. -- A determination by the U.S. Food & Drug Administration's Center for Tobacco Products (FDA CTP) has big implications for Star Scientific Inc., and other companies have been watching closely to see what it will mean for new products that they are developing. Star Scientific has received notices that its Ariva-BDL and Stonewall-BDL modified-risk tobacco product applications do not fall under the current tobacco products described in the federal Food, Drug & Cosmetic Act (FDCA).
The notices from Lawrence Deyton, director of the FDA CTP, state, in [image-nocss] 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 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."
Ariva-BDL and Stonewall-BDL are dissolvable tobacco lozenges, 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.
As reported in a Morgan Keegan/CSP Daily News Flash yesterday, the ruling means that the company can now market those products. Paul L. Perito, Star's chairman, president and chief operating officer, said, "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."
Because the products are BDL, the implications of this ruling for other dissolvables are uncertain--but similar determinations are not out of the question.
"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," Kara Henschel, spokesperson for the CTP, told CSP Daily News. "FDA is currently considering its legal and regulatory options regarding these products."
Bill Godshall, executive director of Smokefree Pennsylvania and an advocate for dissolvables, told CSP Daily News that other companies will likely attempt to follow in Star Scientific's footsteps. "Attorneys and regulatory staff at Altria and R.J. Reynolds are probably looking into seeing if their new dissolvables also would be exempt," he said.
Earlier this year, both major tobacco companies launched dissolvable products in new test markets. "If the FDA comes out and acknowledges that all dissolvables are currently exempt from current existing [regulations], that basically opens the door for all kinds of companies to start marketing dissolvables now," Godshall said.
Glen Allen, Va.-based Star Scientific is a technology-oriented company engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins, principally through the use of the innovative StarCured tobacco curing technology.
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