Surprise: FDA tells Star Scientific its dissolvable tobacco lozenge not regulated under tobacco law

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In a surprise ruling, the FDA determined last week that tobacco product maker Star Scientific Inc. is free to market and sell its Ariva-BDL and Stonewall-BDL dissolvable tobacco lozenges independent of FDA regulation since the products do not fall under the jurisdiction of the 2009 Family Smoking Prevention and Tobacco Control Act.

Explaining the FDA’s decision, Dr. Lawrence Deyton, the director of the FDA’s new Center for Tobacco Products, stated, “At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject” to the law, and these particular Star Scientific products are not currently subject to regulation.

ACSH was pleased the FDA recognized its limit to regulate certain tobacco products. “At least they acknowledge that dissolvable tobacco products don’t fall under the purview of the FDA,” adds ACSH's Dr. Gilbert Ross. “We remain optimistic that clean nicotine delivery products will receive similar regulatory treatment since they are effective tools as part of harm reduction strategies.”