Star Branch Seeks FDA Approval to Sell New Products

Tobacco maker Star Corporation said it developed a wet smokeless tobacco with a lower carcinogenic chemical content than any other tobacco product on the market.

This small company in Virginia sells mouth-watering tobacco blocks. It said on January 4 that it plans to request the FDA in the near future to approve the sale of this new product as a safer item than any competitive product.

Stellar hopes that the product it develops will be the first tobacco product to receive FDA approval as a less dangerous alternative to other forms of tobacco.

Star Corp said that the FDA is developing a "reduced harm" label that is the new product Stonewall Moist-BDL, because it contains tobacco-specific carcinogens 90% to 99% less than other smokeless tobacco products.

The U.S. Federal Center for Disease Control and Prevention said that since smokeless tobacco contains 28 types of carcinogens, smokeless tobacco is not a safe substitute for smoking cigarettes. However, a report issued by the Royal Society of Doctors in 2007 stated that some smokeless tobacco products are less harmful than cigarettes.

Curtis Wright, senior vice president and clinical director of Rock Creek Pharmaceuticals, a subsidiary of Stellar, said the new product could "significantly" reduce the amount of carcinogenic substances that wet smokeless tobacco users are exposed to.

The FDA is still considering similar applications filed by Stellar for its two dissolvable tobacco products. Starcoin has sold dissolvable tobacco under the Ariva and Stonewall brands since 2001.

More often than not, sales of cigarettes have been declining due to factors such as tax increases, people’s concerns about health, smoking bans, and social stigma attached to tobacco. Larger tobacco companies are observing the FDA's response to Stellar's application to find clues about what they will be able to sell to replace cigarette revenue.

In 2009, the FDA obtained the authority to evaluate tobacco products and approve certain tobacco products to be safer than other tobacco products. However, for the FDA to resolve the issue of guidelines for such products, it may take another year for it to issue a permit only after the completion of such guidelines.

According to the U.S. Centers for Disease Control and Prevention, about one in five Americans smoke, which is a quarter lower than in 1995. About 3% of American adults use smokeless tobacco; in recent years, the smokeless tobacco sector has grown by about 7%.

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