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 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.”
A spokesman for RJ Reynolds , maker of Camel Orbs and other dissolvable smokeless tobacco, declined to comment on whether the company would seek to exempt those products from FDA oversight.
A spokesman for Altria, the parent of Philip Morris USA, which also makes smokeless tobacco products, also declined to comment.
Machin said Star Scientific, of Glen Allen, Va., applied for a “modified risk” designation from the FDA in 2010 in order to highlight low levels of some carcinogens in Ariva-BDL and Stonewall-BDL resulting from the way the company grows and cures its tobacco.
The “BDL” in the names refer to “below detectable levels” of certain carcinogens.
Machin said Star Scientific was the first company to apply for modified-risk designations for products under the tobacco law.
The FDA decision clears the way for Star Scientific to begin marketing the two products, something Machin says the company will do by positioning them as less harmful than cigarettes.
Ironically, the company can’t explicitly say that Ariva-BDL and Stonewall-BDL are “modified risk” because that term has a precise meaning under the tobacco law -- which no longer applies, Machir said.
David Sweanor, a law professor and tobacco expert at the University of Ottawa, said the FDA’s actions may reflect a reluctance to tackle the issue of risk reduction, which requires acknowledging a difference in the health risks of smokeless tobacco use and smoking.
“It may be that FDA’s saying, ‘we’re here primarily to deal with smoking,’” said Sweanor.
Sweanor and other anti-smoking advocates think the agency should acknowledge smokeless tobacco as a less harmful alternative to cigarettes. That’s because death and sickness rates are significantly lower for smokeless users than for smokers.
But the FDA and some anti-tobacco advocates worry that smokeless tobacco also can be a pathway to smoking, especially for children and young adults.
The Star Scientific announcement is the second FDA-related action in a week that left some public health advocates scratching their heads.
Last week, an FDA advisory panel evaluating the public health impact of menthol in cigarettes declared that removing mentholated cigarettes from the U.S. market would improve public health. But the panel stopped short of recommending that FDA impose such a ban.