FDA Says Star's Tobacco Lozenges Not Subject to Regulation

Star Scientific Inc. said it can now market its dissolvable tobacco lozenges because the Food and Drug Administration (FDA) has determined that its products are not subject to the federal law regulating tobacco, The Associated Press reported March 23.

The company had applied to the FDA to have its dissolvable lozenges, Ariva-BDL and Stonewall-BDL, classified as “modified risk” products that would allow it to market them as less harmful than regular cigarettes.

In its application, Star argued that although its lozenges contained many of the same chemicals found in cigarette and tobacco smoke linked to cancer, the chemicals only appeared in “below detectable” levels in its lozenges. The company said this was due to the way it raised and prepared the tobacco it uses as an ingredient. The lozenges do contain nicotine. 

Star was surprised to learn their lozenges would not be regulated as tobacco from Dr. Lawrence Deyton, who directs the Center for Tobacco Products at the FDA. In communications with the company, Deyton stated that the 2009 federal legislation giving the agency the authority to regulate tobacco did not cover Star's lozenges, even though it covered “cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco,” according to The Associated Press. 

Sara Troy Machir, spokeswoman for Star, speculated that the FDA might be have come to its decision based on how the company's lozenges are made. She did not share details, because the company's manufacturing process is proprietary. 

Matthew L. Myers, of the Campaign for Tobacco Free Kids said in a March 23 statement that the FDA's decision had “created a loophole where no loophole existed in the law and issued an invitation to tobacco companies to introduce new unregulated tobacco products.”

He said that “[it] defies Congressional intent for FDA to claim that Star Scientific's products are not smokeless tobacco products.”

The decision did not lay to rest how the FDA will handle dissolvable tobacco products, which the agency is still studying. It has indicated concern that the products appeal to children and contain high levels of nicotine. An advisory panel studying them is scheduled to make recommendations to the agency in March 2012. 

According to The Associated Press, the FDA noted in a March 23 statement that the status of “nicotine-containing products derived from tobacco should be regulated as drugs or tobacco products” was unclear, and that it was weighing its options.  R.J. Reynolds and Altria Group Inc., (owner of Philip Morris USA) are both test marketing dissolvable tobacco products.