Star Scientific seeks OK on ‘modified-risk’ snuff

smokeless A small, Virginia-based tobacco company said Tuesday that it will seek the U.S. Food and Drug Administration’s approval to sell a new moist snuff tobacco as a “modified-risk” product with fewer cancer-causing agents.

If its application is approved, Henrico County-based Star Scientific Inc. could be the first company to win an FDA designation of a tobacco product as potentially less hazardous to health.

“I think (the tobacco industry) is going to be closely watching” the FDA’s review process on this request, said Scott Ballin, a tobacco and health-policy consultant in Washington. He expects other tobacco companies to submit other, novel products to the FDA for review.

Star Scientific said the moist smokeless tobacco product it wants to introduce would have 99 percent lower levels of a class of carcinogens called tobacco-specific nitrosamines, when compared with conventional moist snuff brands on the market.

Star Scientific spokeswoman Sara Machir said the company intends to wait for an FDA decision before introducing the smokeless product, which the company plans to market under the Stonewall brand name and manufacture at a plant in Chase City.

The FDA has said that its review process for any new tobacco product should take less than a year, Machir said.

Under the law passed by Congress in 2009 that granted the FDA authority to regulate tobacco products, the agency may approve some products as less risky than others after a scientific review.

Yet the standards to get a “modified-risk” designation are extremely tough and perhaps impossible to meet, Ballin said.

The law requires the FDA to find not only that the product significantly reduces health risks to tobacco consumers, but that it also would benefit public health overall, taking into account both tobacco users and nonusers.

“It is a substantial burden, but it focuses the attention on the right issue: Will permitting the (reduced-risk) claims reduce the number of people who die from tobacco?” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

Machir said there is a “robust body of science” indicating that reduced-toxin smokeless tobacco has the potential to reduce health risks.

Star Scientific had test-marketed a moist snuff product once before, from about 2001 to 2004, but withdrew it to focus on dissolvable tobacco lozenges. The company, which reported sales of about $695,000 in the first nine months of 2010, sells the lozenges under the brand names Stonewall and Ariva.

Star Scientific announced last year that it would petition the FDA for approval to market the dissolvable tobacco brands as modified-risk products. The FDA has not made a decision on those petitions.

A spokesman for the FDA said Tuesday that the agency does not comment on applications for pre-market review of new products.

Star Scientific’s application to the FDA also underscores the tobacco industry’s increasing focus on smokeless products as cigarette consumption declines in the United States.

Unlike cigarette sales, those of smokeless tobacco have been growing, prompting major cigarette companies such as Henrico-based Altria Group Inc. to move into the smokeless business.

That trend has raised concerns among tobacco-control advocates. “Our concern is that the promotion of those brands is leading to more kids using tobacco, not fewer adults smoking,” Myers said.

source: timesdispatch.com

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