United States: FDA validates the principle of reduced nicotine content 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, and hopes to reduce smoking-related deaths.

The FDA has announced that it wants to limit the maximum nicotine content of cigarettes to a level that is non-addictive or greatly minimizes addiction.[1]. It hopes to reduce the significant mortality caused by smoking, currently estimated at 480,000 deaths per year 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 "replacing" the millions of other smokers decimated by tobacco and its industry. Another objective would be to allow the two-thirds of smokers who wish to quit smoking to escape their addiction more easily.

A project awaited for ten years

The idea of a cigarette with reduced nicotine content is not entirely new, as it has already been studied for around ten years, with clinical trials to support it.[2], and that it had been issued for a time during the year 2017, before being put into hibernation[3]The FDA has not set a deadline for the measure to be implemented, as the consultation process and the expected legal challenges from the tobacco industry could take several years. Some experts estimate that it could take about a year before the FDA could issue a proposed regulation.[4], which then risks having to face a long legal process.

The FDA also said it is continuing its long work of approving different types of electronic cigarettes, which has allowed it to validate the marketing of 6.7 million products and to withdraw more than a million products from the market. It is thus threatening to withdraw its authorization from the JUUL brand, one of the main brands of electronic cigarettes in the United States.[5]Altria, which markets Marlboro in the United States and acquired 35 % from JUUL in 2018, claims to have already reduced by ten its stake in this company, which has lost its place as leader in the US e-cigarette market in recent years.

Clear satisfaction of public health actors

Public health groups unanimously applauded the FDA and President Biden’s decision. In April, they criticized the FDA when it approved the first reduced-nicotine cigarettes, marketed under the name 22nd Century, on the grounds that introducing a single brand was pointless if a reduced nicotine level was not applied to all cigarette brands. They also criticized the FDA for allowing 22nd Century to sell menthol cigarettes, even though menthol flavors had just been banned in cigarettes and cigars after a long and historic legal battle.[6].

These associations are now calling for the fastest possible implementation of this decision, in order to limit the introduction of new people to smoked tobacco as soon as possible. They are also asking that all tobacco products and all electronic cigarettes be covered by this upcoming regulation, and not exclusively smoked cigarettes. Finally, they stress that the fight against smoking cannot be summed up in a single measure and that a set of actions, including in particular the increase in taxes, the banning of all flavours, the generalisation of standardised neutral packaging and the banning of promotion, including online, must be carried out simultaneously to significantly reduce the prevalence of smoking.

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 highlight their heated tobacco processes, more than any other nicotine product. Heated tobacco is indeed not only much more profitable for the industry, but above all it allows nicotine to be delivered in a kinetics close to that of smoked cigarettes. The nicotine peak thus obtained in a short time has the main function of quickly making young smokers dependent and maintaining this dependency in other smokers. Such nicotine peaks are almost as quickly obtained with disposable electronic cigarettes and certain other types of electronic cigarettes, raising concern 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 great many smokers and had greatly contributed to the spread of smoking. Manufacturers had then tried to "to convince the world that the responsibility [for smoking] lies with the people who smoke, not 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 displayed 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

M.F.