FDA Takes Troubling Step in Telling Star Scientific Two Smokeless Tobacco Products Are Not Subject to Regulation

WASHINGTON, D.C. (March 23, 2011) — It is inexplicable and troubling that the U.S. Food and Drug Administration has told Star Scientific Inc. that the company's Ariva-BDL and Stonewall-BDL smokeless tobacco products are not currently subject to FDA regulation. The FDA has created a loophole where no loophole existed in the law and issued an invitation to tobacco companies to introduce new unregulated tobacco products. This is exactly what Congress sought to prevent when it passed the 2009 law granting the FDA authority over tobacco products. The FDA should reverse course and close this dangerous loophole immediately.

When it granted the FDA authority over tobacco products, Congress explicitly included smokeless tobacco in that authority, and Star Scientific's products clearly meet the law's definition of smokeless tobacco. The law defines smokeless tobacco as '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 itself has described Ariva-BDL and Stonewall-BDL as 'dissolvable smokeless tobacco products' that are 'made with flue-cured tobacco.' It defies Congressional intent for FDA to claim that Star Scientific's products are not smokeless tobacco products.

The FDA should reverse course immediately and regulate these products as required by the law.