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Star Scientific Seeks FDA Approval for Tobacco Lozenge
Author:Chenli    Source:www.medpagetoday.com    Number of clicks :     Update time:2011-04-20 11:05
A company want to get approval from FDA for its safer tobacoo products.

WASHINGTON -- A small company in Virginia says it's the first to apply for special approval from the FDA to certify its tobacco product as a safer alternative to traditional tobacco products.

The company, Star Scientific, based in Glen Allen, Va., is seeking a "modified risk" approval for its Ariva-BDL, a wintergreen-flavored, dissolving tobacco lozenge.

The "modified risk" classification certifies that a product is less harmful than traditional tobacco products. In order to make such a claim, the company must not only prove that its product will reduce tobacco-related harm for individuals, but also that it will benefit the overall health of the U.S. population.

A spokesperson for the FDA said she could neither confirm nor deny that the company is indeed the first to file for the modified risk status.

The landmark Family Smoking and Prevention Tobacco Control Act -- signed into law last year -- gave the FDA broad regulatory authority over tobacco products for the first time. While the agency can't ban all tobacco sales out-of-hand, it has significant regulatory clout, especially when it comes to permitting the sale of new, so-called safer, tobacco products.

Star Scientific, which calls itself "a technology company with a focus on reducing tobacco-related harm" claims its product is a much safer alternative to smoking and to traditional smokeless tobacco products. Star's president, Paul Perito, said the company has the data to prove it.

The toxin levels in its Ariva lozenges are 1/1000th as great as moist snuff tobacco products, according to a news release from the company.

Perito, who worked on drug addiction issues in the Nixon administration, called "combustive tobacco" (meaning cigarettes) a "destructive compound" that trumps heroin and cocaine. He said his company advocates quitting smoking, but recognizes that millions haven't been able to quit.

"What is the alternative?," he asked. "Cessation products, for one. The second alternative is to use less toxic forms of tobacco, and we believe that we have achieved the lowest level of the major carcinogens in smokeless tobacco."

While the company maintains its product is aimed squarely at adults, Lawrence Deyton, MD, director of the FDA's new Center for Tobacco Products (CTP) has expressed concern about the product's appeal to kids.

"CTP is concerned that children and adolescents may find dissolvable tobacco products particularly appealing, given the brightly colored packaging, candy-like appearance, and easily concealable size of many of these products," Deyton wrote in a Feb. 1 letter to Star Scientific.

"Are these lozenges simply a tobacco candy?" asked Erika Sward, director of national advocacy for the American Lung Association. "Are kids popping them? These are things the FDA will have to consider."

Perito said that in the decade that Ariva has been on the market, the company isn't aware of kids using the product. Ariva's customers are between the ages of 30 and 70, and more than half are women, he said.

Sward said she thinks it's appropriate for the FDA to make the call on whether a products is "lower risk," because before the tobacco law, companies could make such claims on their own.

If the FDA does decide that Star Scientific's lozenges are a lower-risk product, the floodgates could be open for similar products marketed to consumers as a safer alternative to smoking.

And that could be a cause for concern, Sward said, because any such product "maintains an addiction to nicotine."

It could take up to one year for the FDA to make a decision on approval, according to guidance documents on the agency's Web site. The Tobacco Products Scientific Advisory Committee will first have to meet and issue its recommendations to the FDA.

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