Star Seeking FDA Approval of ‘Modified-Risk’ Tobacco Product

PETERSBURG, Va. — Star Scientific Inc., makers of low-nitrosamine smokeless tobacco products, said that the company will use a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process is the subject of a patent application, filed in December 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured curing process, the company tobacco

The International Agency for Research on Cancer previously has reported on the low levels of nitrosamines in Star’s products, the company added. Star said it believes that this process will enable it to achieve the lowest toxin levels anywhere in the world.

Star said that it plans to submit the products to the U.S. Food & Drug Administration (FDA) for approval to market as “modified-risk” tobacco products, under Section 911 of the new Family Smoking Prevention & Tobacco Control Act, once formulation and testing of the new product is completed in early 2010.

Late last week, Star submitted comments to the FDA in response to the agency’s request for input on the regulatory framework established by the act, which was signed into law by President Obama in June 2009. Click here to view the comments.

The comments focus on the need for tobacco product labeling that lists the levels of the most lethal carcinogens in the products in a way that is clear to adult tobacco users.

Paul L. Perito, Star’s chairman and president, said, “Adult tobacco users need to have access to information about the spectrum of harm associated with tobacco use in order to be able make informed choices about the products they purchase.” He added that he hopes clear and accurate labeling will be one of the cornerstones of tobacco regulation policy.

The company also formally nominated Curtis Wright, MD, MPH, chief medical officer for Rock Creek Pharmaceuticals, Star Scientific’s pharmaceutical division, for a position on the Scientific Advisory Committee that has been established by the FDA under the new legislation. In a letter submitted to the agency on September 21, the company pointed out that “Dr. Wright has an enormous breadth of experience in the area of addictive substances, and eight years of his career were spent at the [FDA]…Dr. Wright can contribute not only as a scientist, but also as an executive with significant industry experience. ”

Petersburg, Va.-based Star Scientific is a technology-oriented tobacco company with a stated mission of toxin reduction. It is engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins (principally TSNAs), through the use the StarCured tobacco curing technology, and in sublicensing that technology to others.

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