Star Scientific Seeks New FDA Designation


Star ScientificReportedly, Virginia-based tobacco maker Star Scientific (CIGX) is going to ask the Food and Drug Administration (FDA) for approval to sell a new tobacco product as safer than any competing product.

The company sells tobacco lozenges that dissolve in the mouth and the company says that it has lower levels of cancer-causing chemicals than any other tobacco product currently on the market. Star Scientific says that the "modified-risk" label that the FDA is developing should be on the new lozenge (Stonewall Moist) because the product contains 90% to 99% less tobacco-specific carcinogens than other smokeless tobacco products.

The problem is that the Centers for Disease Control say that smokeless tobacco is not a safe substitute for smoking cigarettes because smokeless tobacco contains 28 different carcinogens. However, a UK Royal College of Physicians report conducted in 2007 states that some smokeless tobacco products are less harmful than cigarettes.

Curtis Wright, senior VP and clinical director for Star subsidiary Rock Creek Pharmaceuticals, noted that the new product could "substantially" reduce the amount of carcinogens encountered by moist tobacco users. Star's dissolvable tobacco products are already available and have been sold under the Ariva and Stonewall brands since 2001. Imagine the boost in sales the firm will see if the FDA grants the request. As noted in the story, big tobacco will be paying close attention to this decision, as it could shape the future of the tobacco industry. According to the article, the Centers for Disease Control and Prevention estimate that one in five Americans smoke, which is down from one out of four in 1995. Moreover, the smokeless tobacco contingent has increased roughly 7% in recent years. With cigarette sales slumping, cigarette alternatives (i.e. smokeless tobacco and electronic cigarettes) increasing, you can bet that big tobacco has a rooting interest for its smaller cohort Star.
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Last updated: May 22, 2013: 10:59 AM

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