Saturday, October 3, 2009

Star Scientific plans to seek FDA approval for new products

"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.

"Tobacco is still tobacco. This might further encourage people to smoke since it will be marketed with lower cancer-causing agents. However, it does not eliminate the fact that cigarettes are really dangerous to our health especially of the members of the family who got to inhale the smoke."

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