FDA approves low-nicotine cigarettes but balks at general regulation
After conducting a “rigorous science-based review” the U.S. Food and Drug Administration (FDA) has finally approved two new low-nicotine cigarettes for the US market. The announcement comes less than a month after the FDA faced criticism for seemingly backing down on its landmark 2017 initiative to strongly regulate nicotine levels in tobacco products.
In mid-2017 the FDA revealed a powerful plan to reduce tobacco-related disease and death. The approach placed nicotine squarely in the firing line. While understanding nicotine may not be the most harmful chemical in a cigarette, FDA commissioner at the time Scott Gottlieb, recognized nicotine as the addictive element that hooked tobacco smokers.
“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Gottlieb in the FDA’s landmark 2017 announcement.
The plan was to investigate ways to lower nicotine levels in cigarettes, and unsurprisingly, tobacco companies were not fans of the FDA plan. Stock markets instantly responded to the FDA announcement and tobacco company stocks plunged. An estimated US$60 billion was lost on tobacco stocks the day the FDA made the revelation.
Critics of the plan claimed reducing nicotine levels in cigarettes would not reduce smoking rates, or related deaths. It was suggested smokers would simply smoke more cigarettes, and inhale more deeply, to chase the anticipated nicotine hit.
Countering that argument was a study published in The New England Journal of Medicine in mid-2018. The study, which was funded by the FDA, found the majority of evidence suggests nicotine reduction in cigarettes would increase rates of quitting, decrease the number of cigarettes smoked per day, and potentially save millions of lives. One model cited in the study strikingly found reducing nicotine levels could cut smoking rates from 15 percent to less than 2 percent.
Following the 2017 announcement not much movement was seen from the FDA across the subsequent years. Then, in November 2019, the proposed nicotine-reduction plan simply disappeared from FDA regulatory documents.
The move followed a recent reversal from the Trump administration, after initially floating a curb on sales of flavored vaping products, before suggesting those plans had been put on hold. While an FDA spokesperson suggested these recent actions do not imply the agency has abandoned tobacco and nicotine regulation altogether, it is now focusing “on regulations that reflect its most immediate priorities.”
“FDA continues to gather evidence and data on an ongoing basis regarding all tobacco products,” said FDA spokesman Michael Felberbaum.
In the wake of reports revealing the FDA had seemingly dropped the nicotine reduction regulation plan it had so boldly announced in 2017, stocks in tobacco companies quickly rose. It was suspected intense lobbying from tobacco companies underpinned the Trump administration’s shift in reversing the FDA’s tobacco regulatory plans.
It has also been reported that Joe Grogan, head of the White House’s Domestic Policy Council, has referred to the FDA’s general oversight of tobacco in the United States as, “a huge waste of time.”
Perhaps attempting to counter this narrative surrounding the FDA’s recent inaction on tobacco control it revealed on Tuesday December 17 that it has approved two new low-nicotine cigarettes. Other similar low-nicotine cigarettes are currently available in the US marketplace, however, this is the first new combustable tobacco product to be approved by the FDA since its oversight of the tobacco market began in 2009.
The two cigarette products approved are claimed to have nicotine content between 0.2 to 0.7 mg per cigarette, compared to the 10 to 14 mg nicotine content found in many standard cigarettes. In announcing the approval the FDA noted its scientific review did conclude the new low-nicotine products should decrease cigarette consumption.
“As part of the FDA’s scientific review, the agency considered whether smokers who switch to reduced nicotine cigarettes would either smoke more cigarettes or change the way they smoked, such as taking a bigger puff, in order to get the same level of nicotine they would have from smoking conventional cigarettes,” the FDA’s statement says. “Generally, the FDA determined that smokers of reduced nicotine cigarettes tend to actually decrease the number of cigarettes smoked per day and that they do not change the intensity of their puff or inhalation.”
Low-nicotine cigarettes (with around 0.1 mg of nicotine per cigarette) are certainly already available in the United States, but it is no surprise tobacco companies do not make those low-nicotine levels a prominently visible characteristic of these products. As Stanford historian Robert Proctor notes, tobacco companies are well aware of the optimum nicotine level necessary in cigarettes to maintain addiction and it is not commercially useful to promote products below that threshold.
"Cigarette makers today keep the nicotine at 1 percent – 2 percent by weight, having found this to be the sweet spot for creating smoker ‘satisfaction’ (one of several industry code words for nicotine addiction)," Proctor wrote in a 2017 editorial discussing the FDA initial nicotine reduction plan. "Reducing this percentage by a factor of ten – to 0.1 percent or 0.2 percent – would make it very difficult for cigarettes to create or sustain addiction. Reducing it even further would make addiction virtually impossible."
The move by the FDA to approve a new low-nicotine cigarette is certainly one that will be welcomed by public health advocates, however, it verges on a token gesture from an organization attempting to assuage a growing concern it's abandoning a previously announced move to more strongly regulate the tobacco industry.