Tobacco

Star Scientific Files Application With FDA for Ariva-BDL

Seeks approval to market lozenge as "modified risk" tobacco product under act
GLEN ALLEN, Va. -- Star Scientific Inc. said that on February 19, the company filed an application with the federal Food & Drug Administration (FDA) for approval to market Ariva-BDL as a "modified risk" tobacco product under the Family Smoking Prevention & Tobacco Control Act of 2009. According to the company, this submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

Ariva-BDL, a dissolvable tobacco lozenge with wintergreen [image-nocss] flavoring, is 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. TSNAs have been identified in scientific literature since the early 1950s as one of the most deadly and abundant groups of carcinogens in tobacco and its smoke.

Achieving this reduction, known within Star as ZNT (zero-nitrosamine tobacco) was accomplished by new work on the StarCured tobacco curing technology that originally was developed in the 1990s. This innovation is the subject of a patent application filed in December 2008. A recent article by Rickert et al. (Regulatory Toxicology and Pharmacology 2009;53(2):121-33) reported total TSNA levels in currently marketed popular moist snuff and "pouch" tobacco products that ranged from 8,814 to 14,557 parts per billion, said Star. This range is 1,000 times greater than the levels measured in Ariva-BDL, as outlined in the company's submission.

As a completely dissolvable lozenge, Ariva-BDL would offer an alternativewith greatly reduced toxin levelsto adult smokers of both genders, the company added.

Star said that it introduced dissolvable smokeless tobacco to the marketplace almost 10 years ago when it launched Ariva in 2001, and Stonewall Hard Snuff in 2003. Both products are pieces of powdered and compressed StarCured tobacco that dissolve completely in the mouth and leave no residue.

Ariva, launched in 2001, was developed for adult dependent smokers who cannot or choose not to smoke. Stonewall Hard Snuff, launched in mid-2003, is an alternative for adults who use traditional smokeless tobacco products or who identify themselves as "heavy smokers."

The company believes that Ariva-BDL, if approved, will be "highly attractive to other companies." For this reason, Star has committed to exploring opportunities for sublicensing agreements with both domestic and international entities, it said, so that Ariva-BDL can be made available as broadly as possible to adult dependent smokers.

Glen Allen, Va.-based Star Scientific is a technology company with a mission to reduce the harm associated with tobacco at every level. It is engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins, principally through the utilization of the innovative StarCured tobacco curing technology. Through its Rock Creek Pharmaceuticals subsidiary, it is also involved in the development of nutraceuticas as well as products to address neurological and mood disorders.

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