United States: FDA approves reduced nicotine cigarettes

June 27, 2022

Par: National Committee Against Smoking

Dernière mise à jour: June 27, 2022

Temps de lecture: 6 minutes

Under President Joe Biden's leadership, the Food and Drug Administration (FDA) is considering reducing the nicotine content of cigarettes to make them less addictive, hoping to reduce smoking-related mortality.

The FDA has announced that it wants to limit the maximum nicotine content of cigarettes to a level that is non-addictive or significantly minimizes addiction.[1]. She hopes to reduce the significant mortality caused by smoking, currently estimated at 480,000 deaths annually in the United States. One of the objectives of this measure would be to prevent millions of young Americans from becoming smokers, and thus to stop them from "replacing" the millions of other smokers decimated by tobacco and its industry. Another objective would be to make it easier for the two-thirds of smokers who wish to quit smoking to free themselves from their addiction.

A project awaited for ten years

The idea of a low-nicotine cigarette is not entirely new, as it has already been studied for around ten years, with clinical trials supporting it.[2], and that it had been issued for a time during the year 2017, before being put on hold[3]The FDA has not set a deadline for the effective implementation of this measure, as the consultation process and the foreseeable legal challenges from the tobacco industry could take several years. Some experts estimate that it could take about a year before the FDA can issue a regulatory proposal.[4], which then risks having to face a long legal process.

The FDA also stated that it is continuing its long process of approving various types of e-cigarettes, which has enabled it to approve the marketing of 6.7 million products and to withdraw more than one million products from the market. It is also threatening to withdraw its authorization for the JUUL brand, one of the leading e-cigarette brands in the United States.[5]Altria, which markets Marlboro in the United States and acquired 35 %s from JUUL in 2018, claims to have already reduced its stake in the company by tenfold, as it has lost its position as the leader in the US e-cigarette market in recent years.

Clear satisfaction of public health actors

Public health associations unanimously applauded the decision by the FDA and President Biden. Last April, they criticized the FDA when it authorized the marketing of the first reduced-nicotine cigarettes, marketed under the name 22nd Century, on the grounds that the introduction of a single brand was pointless if a reduced nicotine level was not applied to all cigarette brands. They also criticized the FDA for granting 22nd Century the ability to market menthol cigarettes, even though menthol flavors had just been banned from cigarettes and cigars after a long and historic legal battle.[6].

These associations are now calling for the swiftest possible implementation of this decision, in order to limit the introduction of new people to smoked tobacco as soon as possible. They are also calling for all tobacco products and all e-cigarettes to be covered by this upcoming regulation, not just smoked cigarettes. Finally, they emphasize that the fight against smoking cannot be reduced to a single measure and that a series of actions, including tax increases, a ban on all flavors, the widespread use of standardized plain packaging, and a ban on promotion, including online, must be implemented simultaneously to significantly reduce smoking prevalence.

Tobacco industry opposition

Since the first reduced-yield cigarettes went on sale, the tobacco industry can no longer argue that this process is technically impossible. Believing that drastically reducing nicotine content is not a solution, manufacturers prefer to promote their heated tobacco processes more than any other nicotine product. Heated tobacco is not only much more profitable for the industry, but above all, it delivers nicotine in a kinetics close to that of smoked cigarettes. The main function of the nicotine peak thus obtained in a short time is to quickly addict young smokers and maintain this addiction in other smokers. Such nicotine peaks are almost as quickly obtained with disposable e-cigarettes and certain other types of e-cigarettes, raising concerns about the sudden expansion of these products.

A reduced nicotine level would especially threaten the product that made the tobacco industry successful and continues to represent more than 70 % of its revenue: the smoked cigarette. The progressive optimization of nicotine delivery since the 1960s, in particular by adding ammonia, menthol or sugars to cigarettes, had facilitated the transition to addiction for a large number of smokers and had significantly contributed to the spread of smoking. Manufacturers then tried to "to convince the world that the responsibility [for smoking] lies with the people who smoke, not with the industry that makes these products", as mentioned by the organization Action On Smoking and Health (ASH)[7]. Giving up the pillar of its prosperity may therefore seem unimaginable for the tobacco industry, which has already made it clear that it will, once again, wage a fierce legal battle against this new measure. The intention expressed by certain manufacturers, such as Philip Morris International (PMI), to one day achieve "a world without smoke" appears more than ever contradictory with their real behavior.

Keywords: reduced nicotine cigarettes, FDA, tobacco industry