FDA ruling clears tobacco lozenges for sale

By Associated Press
Posted March 23 at 1:31 p.m.

Tobacco maker Star Scientific Inc. said Wednesday that the Food and Drug Administration has informed it  that two of its dissolvable tobacco lozenges aren’t covered by the law regulating tobacco, clearing the way for them to be marketed.

The small Virginia company, which has sold tobacco products that dissolve in the user’s mouth since 2001, said the FDA’s Center for Tobacco Products say that its Ariva-BDL and Stonewall-BDL products aren’t subject to regulation.

The news drove Star’s stock up 33 cents, or 9 percent, to $3.95.

Star Scientific had asked the FDA to certify the lozenges as “modified risk” tobacco products under a 2009 law, making itself the test case for a big issue of whether the agency would allow certain products to be marketed as less harmful than cigarettes.

The company says the lozenges contain “below detectable levels” of certain cancer-causing chemicals found in tobacco and its smoke. The tablets contain tobacco’s addictive component, nicotine. Star Scientific has said its method of tobacco cultivation and preparation creates tobacco leaves with low levels of some carcinogens.

How the FDA handles “modified-risk” products is being closely watched by the public health community and bigger tobacco companies, which are looking for new products to sell as they face declining cigarette demand.

But Star Scientific said the agency’s notices from Dr. Lawrence Deyton, the center’s director said, “At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject” to the law and that based on the company’s submissions, the products are not subject to regulation.

In a statement Wednesday, the FDA said it recognizes there are uncertainties whether nicotine-containing products derived from tobacco should be regulated as drugs or tobacco products. The agency added that it is considering its legal and regulatory options regarding these products.

Star Scientific had believed the products fell under the jurisdiction of the Center for Tobacco Products, and the company was somewhat surprised by the agency’s determination, spokeswoman Sara Troy Machir said in an interview with The Associated Press.

However, the distinction may come in how the product is made.

“Yes they are absolutely tobacco products under the definition, but when we get into the manufacturing process that’s where we are hamstrung because it’s absolutely proprietary information,” Machir said.

The FDA still must address the issue of dissolvable tobacco. By next March, its scientific advisory panel must complete a report and recommendations on the products being sold by Star and other tobacco companies. The agency also has expressed concerns that dissolvable products contain a lot of nicotine and could be particularly appealing to kids and young adults.

R.J. Reynolds, which is owned by Reynolds American Inc. in Winston-Salem, N.C., is test-marketing dissolvable, finely milled tobacco tablets, strips and a toothpick shape under the names Camel Orbs, Camel Strips and Camel Sticks. Richmond-based Altria Group Inc., owner of the nation’s largest tobacco company, Philip Morris USA, is test marketing wooden sticks coated with finely milled tobacco under the top-selling Marlboro brand in Kansas.

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