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The US Food and Drug Administration (FDA) has published its proposed rule to slash nicotine levels in combusted tobacco products, and confirmed that it has cleared White House review, although it is still far from certain that the rule will come into force.
The rule would mandate a nicotine maximum of 0.7 mg/g in most combusted products, most notably cigarettes – a reduction of around 95% from today’s levels, which are typically 12 mg/g or higher.
It would not apply to vapour products, heated tobacco products or nicotine pouches. Certain other, minor categories of tobacco product are also exempt.
While they are major milestones, publication of the rule and completion of the White House review are not the final steps – further reviews are needed before the measure can come into force and transform the industry, as the FDA doubtless intends.
Just short of an outright ban
The FDA is prohibited by the 2009 Tobacco Control Act from banning cigarettes outright or requiring a reduction of nicotine levels to zero. But since this rule was first discussed, there has been speculation that it is an attempt by the agency to achieve much the same effect while remaining within the letter of the law.
The proposal stems from years of research, with the FDA arguing that reducing nicotine in cigarettes and other combusted products would decrease addiction rates, make it easier for users to quit and prevent new users, especially young people, from becoming addicted. A 2018 study in The New England Journal of Medicine estimated that reducing nicotine levels could lead to 5m fewer smokers in the first year and prevent over 8m tobacco-related deaths by 2100.
The initiative to limit nicotine levels was first proposed in 2017 as part of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation under then-commissioner Scott Gottlieb. Then, in 2018, the FDA issued an advance notice of proposed rulemaking (ANPRM) that suggested nicotine levels could drop to as low as 0.3 mg/g to 0.5 mg/g, compared with the typical 15.8 mg/g in regular cigarettes.
Possible boon for alternatives
While the proposal lost momentum for some time, it regained traction under the president Joe Biden’s administration – which has prioritised public health measures. In December 2024, the FDA submitted the proposal for review by the White House’s Office of Management and Budget (OMB), completing the final regulatory step before public release.
The policy is now changing status from the ANPRM (introduced in 2018) to a notice of proposed rulemaking (NPRM), after OMB review. It will now enter a public comment period that runs until September, before further reviews and the final steps toward implementation.
While such a rule would clearly be an enormous blow to cigarette manufacturers, the proposal could benefit the novel nicotine sector, including many tobacco companies, by steering consumers toward non-combusted products like e-cigarettes and nicotine pouches. This could spur innovation in the non-combusted sector as both consumers and manufacturers seek higher-nicotine options.
Potential roadblocks ahead
Another question is whether the rule will allow enough time for other companies to introduce their own very-low-nicotine-content (VLNC) products. Innovation would need FDA approval, which could take time. However, some products could possibly be fast-tracked. These factors could shape the future of the tobacco and nicotine alternative markets in the US.
Currently, 22nd Century’s cigarettes branded VLN are the only low-nicotine cigarettes authorised by the FDA, but they remain a niche offering. Despite a recent stock price increase – likely driven by the potential nicotine cap – the company continues to struggle financially, and without a mandated nicotine cap, VLNC products in general are unlikely to compete with regular cigarettes.
Tobacco companies are likely to challenge the proposed nicotine cap through legal and lobbying efforts. Legal challenges could argue the FDA exceeded its statutory authority, failed to provide a rational basis for the rule or violated procedural requirements – such as inadequately considering public comments or not conducting necessary studies. Constitutional challenges could arise if the rule infringes on due process, the First Amendment or the Commerce Clause. Companies might also dispute the FDA’s economic analysis or argue that the rule wasn’t properly submitted to Congress under the Congressional Review Act. If successful, courts could vacate the rule, remand it for further review, or block its enforcement.
Unintended consequences
While the proposed rule has the potential to improve public health, it could also lead to unintended consequences – such as the emergence of an illicit market for high-nicotine combusted tobacco products. This has been seen in countries with strict tobacco regulations, like Bhutan, which experienced significant smuggling after banning cigarettes and saw a rise in smoking rates over time.
To address these challenges, the FDA will likely collaborate with law enforcement to monitor compliance and combat the illicit trade. Public education campaigns will also be critical in highlighting the benefits of the rule, discouraging illicit-market purchases and providing support for those who want to quit smoking.
If the rule survives legal and political opposition, manufacturers will probably have several years to comply with the FDA’s timeline. During this period, the FDA will likely ramp up communication efforts to educate the public on the rule’s benefits and address concerns about potential unintended consequences, such as a rise in illicit markets.
Biden vs Trump
The timing of the rule’s finalisation is crucial, coming just before the inauguration of president-elect Donald Trump on 20th January. Trump has indicated a more industry-friendly approach to regulation. This rule is especially important to Biden, as it represents a key part of his public health legacy. Given the challenges Biden faces in solidifying his legacy, this initiative reflects his push to leave a lasting mark on public health.
However, there’s a strong possibility that the progress of the FDA’s proposal under the next administration will not be easy. Trump’s views are always difficult to predict, but he might be sympathetic to protests raised about the impact on industry and employment, or he might want to deny Biden a major legacy achievement – much as he has opposed other aspects of Biden’s agenda. Given this, the likely challenges to the rule and the processes it still has to go through, on balance, it may well seem unlikely the nicotine cap will be implemented soon.
– Antonia Di Lorenzo and Freddie Dawson ECigIntelligence staff
Image: AI-generated
