On Wednesday, tobacco manufacturer Star Scientific Inc. announced that the FDA responded to its application seeking "modified risk tobacco product" status for Ariva-BDL and Stonewall-BDL. Surprisingly, the Agency did not respond by either approving or denying Star Scientific's request. Instead, the FDA notified the company that these products are not subject to FDA jurisdiction because they are not "tobacco products" under the Family Smoking Prevention and Tobacco Control Act.
According to an Associated Press article by Michael Felberbaum: "Tobacco maker Star Scientific Inc. said Wednesday that the Food and Drug Administration has informed the company that two of its dissolvable tobacco lozenges aren't covered by the law regulating tobacco, clearing the way for them to be marketed and sold. 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 says that its Ariva-BDL and Stonewall-BDL products aren't subject to regulation. ... Star Scientific had asked the FDA to certify the products 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." ...
"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 currently subject to regulation."
The Rest of the Story
Ariva-BDL and Stonewall-BDL clearly are tobacco products under the Family Smoking Prevention and Tobacco Control Act. As it did with electronic cigarettes, the FDA's Center for Tobacco Products is misunderstanding the clear definition of "tobacco product" that was laid out for it by Congress.
The Center for Tobacco Products doesn't seem to understand that it can't simply regulate products the way it wants to. It has to follow its Congressional mandate, which was clearly laid out in the Tobacco Act.
And according to that act, these dissolvable products, which are derived from powdered tobacco and placed in the mouth, are undoubtedly tobacco products. Specifically, the law defines them as smokeless tobacco products.
Star Scientific didn't have a problem understanding this definition, as it appropriately applied to the FDA for designation of these products as modified risk tobacco products. It is unclear why the FDA's Center for Tobacco Products is the only one which cannot read and understand a clear and simple definition.
The Tobacco Act defines tobacco products as follows: "The term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."
There is no question that Ariva-BDL and Stonewall-BDL are made or derived from tobacco and are intended for human consumption. Star Scientific acknowledges this in its own press release, stating that: "Ariva-BDL, a dissolvable tobacco lozenge with wintergreen flavoring, is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits ("BDL") by most current standards of measure."
Furthermore, the Tobacco Act provides a specific definition for smokeless tobacco: "The term ‘smokeless tobacco’ means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity."
Star Scientific acknowledges that Ariva and Stonewall consist of powdered tobacco that are placed in the oral cavity. It states: "Both products are pieces of powdered and compressed StarCured tobacco that dissolve completely in the mouth and leave no residue." Thus, it seems quite clear that these products are smokeless tobacco products under the law. That the BDL varieties of these products are made from tobacco with lower nitrosamine levels does not alter the fundamental definition of these products as tobacco products. Neither does the apparent fact that these products consist of tobacco that is somehow compressed and may not actually consist of a powder.
The intent of Congress was clear: dissolvable tobacco products were to be regulated as smokeless tobacco. By taking this action, the FDA has created a loophole that is clearly inconsistent with the intent of the Congress.
The broader implication of this story is that the FDA is truly struggling with the task of regulating tobacco. As I argued long before the legislation was enacted, regulating a deadly product simply does not fit into the Agency's regulatory mission or experience. Putting tobacco under the FDA's jurisdiction was a bad idea from the beginning. Every day that unfolds we see yet another manifestation of the folly of this decision.