Star Scientific seeks FDA approval for “safer” smokeless tobacco

Star Scientific Inc. is seeking the U.S. Food and Drug Administration’s approval to market its smokeless tobacco lozenges as a reduced-risk product, setting up a key test for the federal agency’s new regulatory powers over tobacco.

Star, a small Richmond-area company that makes two best smoking brands of smokeless products, said yesterday that it had filed an application with the FDA to market a new version of its Ariva smokeless tobacco as a “modified risk” product. If approved, the company could make advertising claims that the product has fewer toxins and health risks than conventional tobacco products.

A spokeswoman for the FDA said yesterday the agency could neither confirm nor deny that it had received an application.

Star has been selling Ariva, a lozenge-like product made from powdered, flavored tobacco, for almost 10 years, and the company has long touted its use of a tobacco-curing process designed to greatly reduce certain carcinogens called tobacco-specific nitrosamines.

Star’s request to the FDA is likely the first of many that tobacco companies will submit to the agency to sell novel tobacco products as potentially less hazardous than conventional products such as cigarettes. Smokeless tobacco has increasingly become the focus of those efforts.

Henrico County-based Altria Group Inc., parent company of cigarette maker Philip Morris USA, has moved aggressively into the smokeless tobacco market and has submitted comments to the FDA suggesting the agency should treat smokeless products as less hazardous than cigarettes.

“FDA has to start looking at this from a standpoint of what these products are, whether they reduce risk, what is the scientific evidence for that, and how should they be monitored, marketed and labeled,” said Scott Ballin, a tobacco and health policy consultant in Washington.

Congress passed legislation last year that for the first time gives the FDA authority to regulate tobacco products. That legislation sets out standards a tobacco product must meet to qualify as “modified risk.”

The legislation says the FDA must determine that the product would “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users.” The FDA also must find that the product would “benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products,” according to the legislation.

Sales of Star’s smokeless products have been rising but are still tiny in the $4 billion U.S. smokeless tobacco market. Star, which has been operating at a loss for the past six years, said in its most recent quarterly earnings report that net sales of its dissolvable smokeless tobacco products were $600,000 for the first nine months of 2009, compared to $300,000 for the same period in 2008.

Tobacco-control and public-health groups have raised objections to Star’s products in the past, arguing they could be misleading to consumers and enticing to children.

The FDA, which is still in the process of establishing its new Center for Tobacco Products, responded to those concerns this month by asking Star Scientific to disclose any research or data about use and misuse of its products. The agency asked for the same information from the nation’s second-largest tobacco company, R.J. Reynolds Tobacco Co., for similar products it has introduced.

In December 2001, 18 public-health groups petitioned the FDA to classify Star’s Ariva product as a drug, which would have placed it under the same regulatory scrutiny as pharmaceuticals. The FDA denied that petition, responding that the product met the definition of a “customarily marketed” smokeless tobacco and thus did not fall under the agency’s regulatory authority at the time.


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