On April 13, Chicago convenience stores started selling the first ultra-low nicotine cigarettes to be cleared by the Food and Drug Administration (FDA) as Modified Risk Tobacco Products (MRTPs).
The MRTP designation granted last December allows 22nd Century Group, which manufactures VLN King and VLN Menthol cigarettes, to make explicit marketing claims about their products. The company can state that each product contains “95% less nicotine”, “helps reduce your nicotine intake” and “significantly reduces your nicotine”.
However, they are not “FDA approved” or considered “safe.”
VLN King and VLN Menthol cigarettes will be available at more than 150 Circle K stores in Chicago and launch 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 may seem indistinguishable from the pre-market tobacco product application (PMTA) process that the steam companies have been through for the last year or so. The PMTAs required companies to prove, on a case-by-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 to a safer alternative. alternative, without introducing a new generation to nicotine.
But a PMTA does do not allow a manufacturer to make claims of reduced risk, even if that essentially implies it. A MRTP Is. Clive Bates, tobacco control expert and former director of Action on Smoking and Health (UK), said an MRTP is about communication.
“The FDA is involved in promoting a bogus harm reduction product here when genuine products are available.”
Ironically, some tobacco harm reduction proponents believe that the 22nd century MRTP designation may actually lead to further misinformation. Because the FDA has also been reluctant to approve e-cigarettes, which countless health authorities say are far safer than combustible cigarettes, people like Bates believe confusion around the dangers of nicotine will persist. The harmful component of cigarettes, after all, is not nicotine—Iit’s tobacco.
“If mad scientists got 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 out the door, much less give them a marketing authorization and allow them to make claims so easily subject to misinterpretation,” Bates said. Filtered. “The FDA is involved in promoting a bogus harm reduction product here, while genuine harm reduction products are available to smokers.”
Recently, the FDA flirted with the idea reduce the amount of nicotine in cigarettes to zero. For some in tobacco control, the logic goes, remove as much nicotine as possible from cigarettes will give more people a reason not to smoke because they will have alternatives that won’t continue their addiction.
According to the law, the agency cannot demand nicotine levels in cigarettes to be lowered literally to zero. But that may require them to get as close as possible — a move that will likely end in legal action from the biggest tobacco companies.
“People smoke cigarettes to get nicotine like they want cars to move, workout to get fit and use guns to shoot,” David Sweanor, an industry expert and chair of the advisory board of the Center for Health Law, Policy and Ethics at the University of OttawaTold Filtered. “Getting all the toxic smoke without nicotine seems as viable an idea as selling cars that can’t move, offering muscle soreness with no fitness gain, or marketing guns that can’t discharge bullets.”
Photograph by Tomasz Sienicki via Wikimedia Commons/Creative Commons 2.5