ANALYSIS: FDA's Middle Road

Under regulation, what does the future hold for new tobacco products?
OAK BROOK, Ill. -- For all the polemics surrounding FDA's jurisdiction over tobacco, it is precisely last week's move by Star Scientific Inc. that buoys tobacco manufacturers about the future of their business but also stokes their starkest concern.

Star Scientific, best known for its Stonewall products, will submit an application of approval under the Family Smoking Prevention & Tobacco Control Act of 2009 to market Stonewall Moist-BDL as a modified-risk tobacco product. (Click here for previous CSP Daily News coverage.)

The terms are technical, but the impact is great for those banking their future on ultra-low carcinogenic products. While most retail operators and tobacco manufacturers opposed empowering the U.S. Food & Drug Administration to regulate tobacco products, a number of non-cigarette makers muted their opposition in 2008-09.

Their restraint rested with insider appreciation and years of testing that showed moist smokeless, snus and the nascent wave of oral tobacco products produce significantly less tobacco-specific notrosamines (TSNAs), which scientists cite as one of the leading cancer-causing agents in tobacco leaf and smoke.

A few years ago, a leading OTP manufacturer told me, "I can't support FDA oversight. I don't believe in it, and there are too many 'ifs' that could harm my business. But if the FDA does eventually gain jurisdiction, you can bet that we're going to seek classification as a reduced-harm or reduced-risk product."

And that's the holy grail for not only Star Scientific, but many of the cigarette and OTP companies. This explains why these businesses are collectively investing tens of millions of dollars to pioneer new, smoke-free lines that aim to radically reshape the tobacco industry over the next five to eight years.

Star Scientific chairman and president Paul Perito said it right: "It is clear that the means are available for all tobacco companies to reduce well-established toxins in the tobacco they use in manufacturing."

What the tobacco companies are waiting for is to see if the FDA will recognize and establish a tiered approach that modifies the kind of warnings issued on every unit of tobacco. Will the agency publicly acknowledge that dissolvable products are "less bad" or "less dangerous" for consumers?

"We're not looking for them to say it's 'better for you'," one tobacco maker told me. "But we also don't want them to say that all tobacco is equally bad for you. And that's where we are today."

FDA's Dilemma

Asked specifically about Star Scientific's planned application, the FDA's tobacco division--the Center for Tobacco Products, led by Dr. Lawrence Deyton--offered a careful response. "On the question about modified-risk products, FDA is not going to speculate about a possible product submission," Kathleen Quinn told CSP Daily News in an email.

"However," said Quinn, acting director of the Center's Office of Health Communication & Education, "modified risk is a provision in the Tobacco Control Act, which outlines a path for manufacturers to legally market a product. Should a company present a modified risk tobacco product to FDA, the agency will evaluate it."

Not surprisingly, the FDA's Center for Tobacco Products walks a delicate tightrope. Empowered by Congress to regulate tobacco, the center has been bombarded by anti-tobacco advocates to ban menthol, to uphold and intensify current marketing restrictions and, essentially, take necessary steps to drastically cut consumption of any and all tobacco products.

These groups assert that any effort by the FDA to establish various grades of risk is no different than the FDA giving its seal of approval for consumers to ingest products inherently bad for them.

At the same time, realpolitik suggests that tobacco is a critical cash cow to city, state and federal coffers; is the funding backbone of the children's health program, SCHIP; employs directly and indirectly hundreds of thousands of people, if not millions; and is a vital industry in parts of the country, from the Carolinas to the Appalachians.

Pro-tobacco advocates received a boost last week when one of their staunchest critics resigned from the FDA Tobacco Products Scientific Advisory Committee (TPSAC), which will be hearing evidence this week about menthol and is expected to issue a recommendation by March. Gregory N. Connelly resigned from the panel, accusing it of being too cautious in attacking menthol and nicotine, according to media reports.

His reaction should not come as a surprise--and should calm the waters among retailers who might reflexively castigate anything government related.

Expect the FDA to tread cautiously when it comes to new arenas of tobacco innovation;that it may very well deliver a middle-road recipe that permits some new forms of tobacco to enter the marketplace, but with restrictions that will be cumbersome but not unworkable.

[Agree or disagree? Email your comments to CSP Vice President/Group Editor Mitch Morrison at]

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