The U.S. Food and Drug Administration (FDA) has finally approved two new low-nicotine cigarettes to enter the U.S. market after a “rigorous scientific review,”media reported. Less than a month ago, the FDA was criticized for supporting its 2017 initiative to enforce nicotine levels in tobacco products.
In mid-2017, the FDA announced a robust plan to reduce tobacco-related diseases and deaths. Although it is understood that nicotine may not be the most harmful chemical in cigarettes, then-FDA Director Scott Gottlieb acknowledged that nicotine is an addictive element that attracts smokers.
“Because nicotine is both the root cause of addiction and the core of the solution to the addiction problem, addressing nicotine addiction levels in combustible cigarettes must be part of the FDA’s strategy to address the devastating addiction crisis that threatens American families,” Gottlieb said in the FDA’s landmark 2017 announcement.
The plan aims to look at ways to reduce nicotine levels in cigarettes, and it’s no surprise that tobacco companies don’t like the FDA plan. Stocks immediately responded to the FDA’s announcement, and tobacco companies’ shares plunged. The FDA’s disclosure comes on the same day that the tobacco industry estimated it would lose about $60 billion.
Critics of the program claim that reducing nicotine levels in cigarettes does not reduce smoking rates or associated deaths. Opposing this argument is a study published in the New England Journal of Medicine in mid-2018. The FDA-funded study found that most of the evidence suggests that reducing nicotine levels in cigarettes increases smoking cessation rates, reduces the number of cigarettes smoked daily, and could save millions of lives. A model cited in the study found that lowering nicotine levels could reduce the proportion of smokers from 15 percent to less than 2 percent.
After the 2017 announcement, the FDA did not introduce additional measures in the following period. In November 2019, the proposed nicotine reduction program disappeared from FDA regulatory filings.
The move comes after the Trump administration signaled that the plans had been shelved, but recently announced restrictions on the sale of flavored e-cigarettes. And an FDA spokesman suggested that these recent actions do not mean that the agency has abandoned full regulation of tobacco and nicotine, and that it is now focusing on “rules that reflect its most immediate priorities.” “The FDA will continue to collect evidence and data on all tobacco products on an ongoing scale,” said Michael Felberbaum, a spokesman for the FDA. “
Shares of tobacco companies rose sharply after reports that the FDA appeared to abandon its 2017 plan to reduce nicotine. Some suspect that strong lobbying by tobacco companies has supported the Trump administration’s shift in reversing the FDA’s tobacco regulatory program. It was also reported that Joe Grogan, head of the White House’s Domestic Policy Committee, called the FDA’s overall oversight of American tobacco a “huge waste of time.”
On December 17th the FDA announced that it had approved two new low-nicotine cigarette products, possibly in an attempt to refute the FDA’s recent inaction on tobacco control. There are other similar low-nicotine cigarettes in the U.S. market, but this is the first FDA-approved combustible tobacco product since the FDA began monitoring the tobacco market in 2009.
Manufacturers of both cigarette products claim to have between 0.2 and 0.7 milligrams of nicotine per cigarette, while many standard cigarettes have nicotine levels of 10 to 14 milligrams. In announcing the approval, the FDA noted that its scientific review did conclude that new low-nicotine products should reduce cigarette consumption.
As part of the FDA’s scientific review, the agency considered whether smokers who switch to nicotine-reducing cigarettes would smoke more cigarettes or change the way they smoke in order to get the same levels of nicotine they get from regular cigarettes. The FDA said in a statement. “Typically, the FDA determines that reducing nicotine use by smokers actually reduces the number of cigarettes smoked daily, and they do not change their smoking intensity.” “
Robert Proctor, a historian at the University of Tanford, points out that tobacco companies are well aware of the optimal nicotine levels necessary to maintain addiction in cigarettes, and that promoting products below that threshold is not commercially useful. “Cigarette manufacturers today limit nicotine levels to 1 to 2 percent, and found that this is the best level to ‘satisfaction’ smokers,” Proctor wrote in a 2017 editorial discussing the FDA’s initial nicotine reduction program. Reducing this percentage to one in ten – to 0.1% or 0.2% – can make it difficult for cigarettes to produce or maintain addiction. It is almost impossible to further reduce the rate of cigarette addiction. “