February 3, 2010 - U.S. health officials are seeking more information about the possible attraction and addiction of flavored, dissolvable tobacco products that regulators worry look too much like candy and can entice children. The products, made by Reynolds American Inc's R.J. Reynolds Tobacco Co and by Star Scientific Inc, contain powdered "smokeless" tobacco and are brightly colored, with flavors such as coffee and mint. R.J. Reynolds Tobacco Co to promote these products at the test market c-stores distributes sampler packs of Camel Dissolvables.
Companies have argued that the products, which include dissolvable tablets, are aimed at adults who must deal with a growing number of smoking bans in public places as well as those looking to stop smoking.
But the U.S. Food and Drug Administration, in letters to Reynolds and Star Scientific released late Tuesday, said it was concerned that the products could draw in children and teenagers. Use of the products could lead to nicotine addiction and could even cause health problems from the ingestion of too much nicotine, the FDA said. (C-store update - let's ban all flavored tobacco products..)
While laws vary among the U.S. states, most limit tobacco purchase to those 18 and older.
FDA 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," Lawrence Deyton, head of the FDA's Center for Tobacco Products, wrote February 1, 2010.
The letters come as the FDA prepares to hold its first public meeting on tobacco issues later this year. Agency officials have quickly moved to flex their new oversight of tobacco products after a new law granted them the power last year.
Any move by the FDA to further regulate or even remove dissolvable tobacco products from the U.S. market would be a huge blow to Star Scientific. The one-time cigarette manufacturer has shifted its focus to making products it says expose consumers to lower levels of toxins.
Sara Troy Machir, a spokeswoman for Star Scientific, said the company was not surprised by the letter and would cooperate fully. "We're happy to share information with them," Machir said, adding that Star's smokeless products -- Ariva and Stonewall -- have been on the market for 10 years.
Representatives for R.J. Reynolds did not immediately respond to requests for comment. R.J. Reynolds markets three types of similar products under its Camel brand that deliver dissolvable nicotine in tablet, mouth strip and small matchstick-like forms.
The two companies have been embroiled in a patent dispute over some of the technology behind the dissolvable products. (Star Scientific denied new trial in patent infringement - files appeal..)
While FDA in its letters to the two companies acknowledged the products are marketed to adults, it nonetheless asked both manufacturers for extensive information on research and marketing practices for the products. Star Scientific and Reynolds have two months to respond.
The FDA Letter to Industry on Dissolvable Smokeless Tobacco Products:
R.J. Reynolds Tobacco Company..
Star Scientific, Inc
Reference: FDA probes candy-like tobacco products, Reporting by Susan Heavey, editing by Gerald E. McCormick, Reuters, 2/3/2010.