Star Scientific asks FDA to certify lozenge less harmful..

February 22, 2010 - Star Scientific, Glen Allen, Virginia, asks U.S. Food and Drug Administration (FDA) to certify Ariva-BDL lozenges as less harmful than traditional forms of tobacco.

Star requested Friday, February 19th that Ariva-BDL, a dissolvable tobacco lozenge with wintergreen flavoring, be approved as a “modified risk” product under the Family Smoking Prevention and Tobacco Control Act.

Ariva-BDL, a dissolvable tobacco lozenge with wintergreen flavoring, is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits (BDL) by most current standards of measure. TSNAs have been identified in scientific literature since the early 1950s as one of the most deadly and abundant groups of carcinogens in tobacco and its smoke.

The filing by Star is expected to be one of many such applications that will be filed by tobacco purveyors in the coming years. How the FDA views Star’s request could have wider implications for industry giants such as Reynolds American Inc., which also hope to be able to communicate to consumers that certain smokeless-tobacco products pose significantly lower health risks than conventional cigarettes.

The federal tobacco law sets a high bar to make such claims. Not only must a company demonstrate with scientific support that a product will reduce tobacco-related harm for individual users, but also benefit the overall health of the U.S. population.

Star, formed more than a decade ago, has been an industry pioneer in creating low-carcinogen tobacco tablets that are designed to appeal to smokers who find themselves in situations where they can’t or don’t want to smoke. But its products, sold under the Ariva and Stonewall brands in some drug and convenience stores, have gained little traction in the marketplace. (Ariva, launched in 2001, was developed for adult dependent smokers who cannot or choose not to smoke. Stonewall Hard Snuff, launched in mid-2003, is an alternative for adults who use traditional smokeless tobacco products or who identify themselves as "heavy smokers.")

Star has recently come out with a blister pack (packaging in which a product is sealed between a cardboard backing and clear plastic cover) for Stonewall lozenges.

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Stonewall Hard Snuff Packaging - front..

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Stonewall Hard Snuff Packaging - back..

Retail sales of smokeless tobacco in the U.S. total about $4 billion a year, mostly coming from moist snuff. Tobacco tablets such as Ariva represent a much smaller sub-category of the smokeless segment.

Ariva-BDL, which isn’t currently available in stores, is an improved version of Star’s existing products, lowering levels of toxins known as nitrosamines. Star, in a news release expected to be made public Monday, February 22nd said it believes the new product, if approved by the FDA, will be attractive to other companies, which could license it and help it become widely available to smokers.

It isn’t clear when the FDA might rule on Star’s application. The FDA has said it intends to take up to 360 days to decide on requests to certify products as “modified risk,” but that this timetable is preliminary and could change.

Reynolds, based in Winston-Salem, N.C., has been test-marketing for about a year its own various dissolvable tobacco products, including lozenges known as Camel Orbs.

How the FDA treats Star’s application for Ariva-BDL may indicate how the agency will regulate smokeless-tobacco products, which studies have shown are significantly safer than cigarettes. There’s a schism among public-health officials about whether smokers should be encouraged to move to smokeless-tobacco products. Some argue such policies could save lives, while others say they could prompt nonusers to try tobacco and become addicted to nicotine.

The FDA, concerned that dissolvable products may appeal to children and adolescents, recently asked Reynolds and Star Scientific to provide their research on how such products are perceived by people ages 25 and under. Representatives of both companies said Sunday that their products are made for, and marketed to, adult tobacco users. The products appear in the tobacco sections of retailers. Both companies are working on responses to the agency.

Star suffered a blow last June when a jury ruled against the company in a federal lawsuit accusing R.J. Reynolds Tobacco Co. of infringing on Star patents covering a carcinogen-lowering process for curing tobacco. The company had sought several hundred million dollars from RJR, a unit of Reynolds American Inc., the maker of Camel and Pall Mall cigarettes. Star is appealing the decision. (Star Scientific denied new trial in patent infringement - files appeal..)

Star Scientific Inc. plans to introduce a nutraceutical (any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of disease) in 2010 that would help adult smokers maintain a nicotine-free metabolism.

Reference: Tobacco Lozenges Seek FDA Stamp by David Kesmodel, Online.wsj, 2/22/2010; Star Scientific Files Application With FDA for Ariva-BDL Seeks approval to market lozenge as "modified risk" tobacco product under act, CSP Daily News, 2/23/2010.

Some related Star Scientific news briefs:
Star Scientific denied new trial in patent infringement - files appeal..;
Star Scientific - NASDAQ trading symbol changed to CIGX..;
Star Scientific - new product (in 2010) to help adult smokers maintain a nicotine-free metabolism..;
Star Scientific - will use its low-nitrosamine tobacco curing process to formulate smokeless tobacco dissolvable smokeless products..
Star Scientific - q2 2009 report..;
Star Scientific - Filing patent for zero-nitrosamine tobacco curing process..;
Star Scientific - 2008 annual report/Stonewall vs other OTC NRTs..;
Star Scientific Corporate Study Stonewall Lozenge in NRT..;
Star Scientific Files Third Quarter Financial Report..;
Star Scientific wants to augment sales of their tobacco lozenges..;
Star Scientific , second quarter 2008, sales down 23.6%..;
Star Scientific Applauds Recent State Legislation - Banning Smoking in Cars with Children..