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Star Looking to Market Reduced Risk Products Source from: Tobacco Reporter 09/24/2009 Star Scientific says it is to seek approval to market in the US a number of tobacco products as presenting a "modified risk"- presumably a reduced risk - to consumers.
The company will seek approval from the Food and Drug Administration under the Family Smoking Prevention and Tobacco Control Act once formulation and testing of the products are completed next year.
Star says the dissolvable smokeless tobacco products will include tobacco produced using a patented method of leaf cultivation, curing and preparation.
The new curing process, the subject of a patent application filed in December last year, is said to produce leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured(R) curing process.
Star says the new process will enable it to produce tobacco with the lowest toxin levels anywhere in the world.
Dr. Curtis Wright, chief medical officer for Rock Creek Pharmaceuticals, Star Scientific's pharmaceutical division, said he was excited to see how low the nitrosamine content of the new material would be once it was processed and formulated.
"Laboratory testing of some of the tobacco leaf samples after curing has revealed levels for NNN and NNK, the most lethal forms of TSNAs, below 10 parts per billion," he said.
"These values are comparable to NNN and NNK levels found in several nicotine replacement therapy products as reported by a University of Minnesota research team in December, 2007." Enditem
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