On April 13, Chicago convenience stores began selling the first very low nicotine cigarettes to be authorized by the Food and Drug Administration (FDA) as modified risk tobacco products (MRTPs).
The MRTP designation granted last December allows 22nd Century Group, which makes the VLN King and VLN Menthol cigarettes, to publish explicit marketing claims about their products. The company can state that each product contains “95 percent less nicotine,” “helps reduce your nicotine consumption” and “greatly reduces your nicotine.”
They are not, however, “FDA approved” or considered “safe.”
The VLN King and VLN Menthol cigarettes will be available in more than 150 Circle K stores around Chicago and kick off a three- to six-month pilot program, after which 22nd Century and Circle K plan to roll them out to more than 7,000 stores in 48 states.
To a layman, the MRTP process might look indistinguishable from the premarket tobacco product application (PMTA) process that vapor companies have gone through over the past year or so. PMTAs required the companies to prove, on a case-by-a case basis, that products would be “appropriate for the protection of public health”—a threshold that has come to be understood as the likelihood of pushing an adult smoker toward a safer alternative, without introducing a new generation to nicotine.
But a PMTA does not permit a manufacturer to make reduced risk claims, despite essentially implying it. An MRTP does. Clive Bates, a tobacco control expert and the former director of Action on Smoking and Health (UK), has said an MRTP is about communication.
“The FDA is implicated in promoting a fake harm reduction product here, while genuine ones are available.”
Ironically enough, some tobacco harm reductionists believe that the 22nd Century’s MRTP designation might actually lead to additional misinformation. Because the FDA has also been reticent about authorizing e-cigarettes, which countless health authorities have maintained are far safer than combustible cigarettes, people like Bates believe the confusion around the dangers of nicotine will remain. The harmful component in cigarettes, after all, is not nicotine—it’s tobacco.
“If mad scientists came together to create a vaping product with the same nicotine delivery and toxic profile as the 22nd Century VLN cigarette product, I doubt the FDA would let them through the door, let alone grant them a marketing authorization and allow them to make claims so easily open to misinterpretation,” Bates told Filter. “The FDA is implicated in promoting a fake harm reduction product here, while genuine harm reduction products are available to smokers.”
Recently, the FDA has been flirting with the idea of reducing the amount of nicotine in cigarettes to effectively zero. For some in tobacco control, the logic goes, removing as much nicotine as possible from cigarettes will give more people a reason not to smoke, as they’ll have alternatives that won’t continue their dependence.
By law the agency cannot require nicotine levels in cigarettes to be lowered literally to zero. But it can demand that they come as close as possible—a move that will likely end with lawsuits from the biggest tobacco companies.
“People smoke cigarettes to get nicotine the way they want cars to go places, do workouts to be fit and use guns to shoot,” David Sweanor, an industry expert and chair of the advisory board for the Centre for Health Law, Policy and Ethics at the University of Ottawa, told Filter. “Getting all the toxic smoke without the nicotine seems as viable an idea as selling cars that can’t move, offering muscle pain with no fitness gain or marketing guns that cannot discharge bullets.”