FDA says tobacco law doesn't apply to two smokeless lozenges

It's not often a tobacco company gets released from government regulation without asking.

But that's apparently what happened to Star Scientific Inc. after it asked the Food and Drug Administration to treat two versions of its smokeless, dissolvable tobacco lozenges as "modified risk" because they contain lower levels of carcinogens than other tobacco products.

The most demamded tobacco products are cigarettes as Marlboro Gold cigarettes or Winston cigarettes.

The FDA responded that the products aren't considered smokeless tobacco at all and don't come under the 2009 tobacco law, according to a Star Scientific announcement on Wednesday.

"We were very surprised. We obviously believed that these were smokeless tobacco products under the act," said Sara Troy Machir, Star Scientific's vice president for communications and investor relations.

Why FDA judged Ariva-BDL and Stonewall-BDL exempt from the tobacco law is a mystery.

Both the FDA and Star Scientific declined to release copies of the agency's decision because they said it contained confidential commercial information.

Machir said the FDA cited "details of the manufacturing process" -- which are secret – in exempting the products from oversight.

In a statement, the FDA said it recognizes that "there are uncertainties regarding the regulatory status of a variety of nicotine-containing products" including whether they should be regulated as drugs or tobacco.

The agency said it's "considering its legal and regulatory options regarding these products."

Star Scientific's announcement caused consternation among anti-tobacco activists who said it opens a loophole other smokeless tobacco makers will attempt to exploit.

The decision is puzzling and disappointing because the tobacco law "does not distinguish among smokeless tobacco products based on manufacturing process," said Matt Myers of the Campaign for Tobacco-Free Kids.

"The FDA's handling of this creates unnecessary uncertainty and the potential for widespread abuse," Myers said.

Lynn Kozlowski, dean of the School of Public Health at the University of Buffalo, said the decision highlights the difficulties in precisely defining everything a new law is supposed to cover.

"On one hand, you have common sense and on the other hand definitions and sometimes they don't mesh," Kozlowski said. "I can only speculate that there's something about [Star Scientific's] process that isn't covered by the definition FDA is using."