Star Scientific Inc. wants to be the first company seeking approval from federal regulators to sell so-called “modified-risk” tobacco products with reduced toxins.
The Petersburg-based company, which makes smokeless tobacco products, said yesterday that it plans to ask the Food and Drug Administration next year for approval to market its products as potentially less risky to consumers’ health.
Congress passed legislation this year that for the first time gives the FDA authority to regulate tobacco products. The legislation also lets tobacco companies submit products for scientific review by the FDA and approval to be marketed as “modified-risk.”
Star did not provide details about any new products, which it said are still in development. Company spokeswoman Sara Machir said one would be similar to the dissolvable, lozenge-like smokeless tobacco products the company now sells under brand names Stonewall and Ariva.
“What would distinguish it is the even significantly lower nitrosamine levels,” she said. Nitrosamines are cancer-causing agents considered by some researchers to be the most significant harmful elements in smokeless tobacco.
Star obtained a patent in 2001 for a tobacco-curing process that reduces nitrosamines. In 2001, the company filed a patent-infringement lawsuit against cigarette maker R.J. Reynolds Tobacco Co. A federal jury in Baltimore returned a verdict for Reynolds in June, but Star is seeking a new trial.
Now, Star says it has developed a new method for cultivation, curing and preparation of tobacco that further reduces nitrosamine levels. The company’s shares rose 13 percent, or 13 cents, to $1.11 yesterday on the Nasdaq stock market.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said it is difficult to predict how quickly tobacco companies will come forward to seek approval from the FDA for reduced-risk tobacco products.
The agency must consider the potential broad impact of those products on public health, he said.
“The benefit of the new law is that these decisions will now be based on science from an objective viewpoint,” he said.
source: http://www2.timesdispatch.com/
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