Star Scientific Dissolvable Tobacco Products are Not Subject to FDA Regulations

Tobacco manufacturer Star Scientific Inc. stated that the Food and Drug Administration has informed the company that two of its dissolvable tobacco pastilles are not covered by the law controlling tobacco, clearing the way for them to advertised and sold.

The Virginian tobacco company, which sold dissolvable tobacco products since 2001, declared that FDA’s Center for Tobacco Products state its Ariva-BDL and Stonewall-BDL products are not affected by the regulation.

Ariva dissolvable tobacco

The news led Star’s stock up 33%, or 9% to $3.95. Star Scientific has requested FDA to identify the products as “updated risk” tobacco products under a 2009 law.

The company stated that pastilles contain “below detectable levels” of particular cancer-causing chemicals detected in tobacco and its smoke. The pills possess tobacco’s addictive ingredient, nicotine. Star Scientific has declared that its method of tobacco growing and processing creates tobacco leaves with minimum levels of certain carcinogens.

The way how FDA controls “modified-risk” tobacco products is being thoroughly observed by the public health community and leading tobacco enterprises, which are in search of new products to sell as they face dropping cigarette demand.

But Star Scientific stated the agency’s notifications from Dr. Lawrence Deyton, the center’s chief declared, “Currently only cigarettes, smokeless tobacco and roll-your-own tobacco are subject to the given law” and that basing on the company’s submissions, the products are not controlled by the regulation.

At a conference, the FDA stated that it acknowledges there is vagueness whether nicotine-containing products produced from tobacco should be controlled as drugs or just as tobacco products. The agency also said that it is examining its legal and monitoring options concerning these products.

Star Scientific had supposed the tobacco product come under the administration of the Center for Tobacco Products, and the company was rather surprised by the agency’s decision, representative Sara Troy Machir stated in an interview. However the difference may come in how the product is produced.

“Of course they are true tobacco products under the definition, but when we analyze the manufacturing process that is where we have problems because it is completely confidential information,” Machir stated.

The FDA scientific advisory panel should complete by March its report and present advices on the products, which are sold by the Star and other tobacco manufacturers. FDA also has revealed its concerns that dissolvable tobacco products contain a lot of nicotine and could in particular attract children and young people.

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