FDA Blunders by Favoring Combustible Cigarettes Over Vastly Safer Smoke-Free Products
The U.S. Food and Drug Administration last month authorized the marketing of two combusted, filtered cigarettes as modified risk tobacco products. The products, 22nd Century Group Inc.’s “VLN (Very Low Nicotine) King” and “VLN Menthol King,” which produce all of the smoke and thousands of toxins of traditional cigarettes but practically none of the nicotine, are the first combustibles to be awarded MRTP status.
Many tobacco research and policy experts question how VLN cigarettes met the FDA’s tough MRTP standard, which requires products to “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”
Reducing nicotine won’t reduce risk, as nicotine doesn’t cause lung and other cancers, heart attacks, strokes, emphysema, or any other smoking-related illness. VLNCs may deliver nicotine in trace levels, but it’s the smoke that kills. Where is the “benefit” to smokers, or to population health?
In a press release, Mitch Zeller, director of the FDA’s Center for Tobacco Products, supported the MRTP certification of these combustible cigarettes with unverified smoking cessation claims. He stated that the “data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” but how the FDA reached this conclusion calls into question the agency’s tobacco policies and priorities.
As pointed out by Clive Bates, author of “The Counterfactual,” the “FDA/NIH has financially supported the company’s application by buying its cigarettes and using independent research organizations and investigators in the United States to provide the evidence to support its case.”
A search of the NIH funding database using the term “low nicotine cigarette” identifies 698 projects totaling $286 million in the past decade. This does not mean that all of the money was invested in VLNCs, but at the very least it shows that the subject was a buzzword used by researchers to capture considerable federal financial support.
Clive Bates also noted, “Any other tobacco or vape company would need to present extensive trials that it conducted itself and at its own expense, something that would be prohibitively expensive for most companies. But not so for 22nd Century.”
In essence, the FDA is advancing the government’s objective to “create a world free of tobacco (and nicotine) use” by spending hundreds of millions of taxpayer dollars to fund research so that it can authorize a private company’s combustible cigarettes for the purported benefit of smokers and the general population.
The FDA also appears to be fast-tracking combustible VLNCs over smoke-free oral tobacco and nicotine products, which flies in the face of scientific research. The FDA authorized the VLNC MRTP after 31 months of review, while the agency continues to slow-walk MRTP reviews for Camel Snus (58 months and counting) and Copenhagen moist snuff (46 months and counting). Research dating back 28 years demonstrates smokeless products are 98% less hazardous than cigarettes.
The FDA’s decision to remove nicotine but keep the smoke is dead wrong. The agency has doubled down by failing to authorize the sale — and acknowledge the vastly lower risks — of thousands of vapor and oral products already being used by millions of former smokers. The result, regulatory purgatory, places smokeless tobacco and vapor products in interminable limbo and represents regulation at its deadliest as nearly half a million smokers die each year.
Dr. Brad Rodu is a professor of medicine and holds an endowed chair in tobacco harm reduction research at the University of Louisville. For 28 years he has published medical research and has written commentaries about tobacco harm reduction, which involves permanent nicotine maintenance with safer tobacco products by smokers who are unable or unwilling to achieve abstinence. Follow him on Twitter @BradRodu or contact him at [email protected].