FDA to propose cut in nicotine levels in cigarettes

The US regulatory body argues that nicotine is most harmful when delivered through smoke in cigarettes.

Stacked cigarettes

A new plan for tobacco and nicotine regulation has been announced by the US regulatory body, which could result in nicotine levels in cigarettes being lowered.

The US Food and Drug Administration (FDA) has revealed a strategy for tobacco and nicotine regulation designed to “better protect children and significantly reduce tobacco-related disease and death”. The administration’s new plan focuses on nicotine, and the issue of addiction, which forms the basis of its tobacco regulation efforts.

Part of the FDA’s approach will be to demonstrate a greater awareness that nicotine — while highly addictive — is most harmful when delivered through smoke particles in combustible cigarettes.

According to the regulatory body, tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every year.

The FDA’s plan also pushes back deadlines for manufacturers of e-cigarettes to provide information to achieve FDA approval, moving them from 2018 to 2022 to strike “an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes”.

The agency said it would “seek input from the public on a variety of significant topics”, including approaches to regulating “kid-appealing flavours in e-cigarettes and cigars”.

The agency also intends to examine actions to increase access and use of FDA-approved medicinal nicotine products.

Kills half of all long-term users

Commenting on the strategy, FDA commissioner Scott Gottlieb said: “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes — the only legal consumer product that, when used as intended, will kill half of all long-term users.

“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts — and we believe it’s vital that we pursue this common ground.”

Responding to the FDA plan, Linda Bauld, deputy director of the UK Centre for Tobacco and Alcohol Studies, said that while “broadly” the UK had the same level of nicotine in its cigarettes as the US, the organisation was not proposing to follow the administration’s strategy to reduce nicotine levels.

“This is because we’re not so worried about nicotine as about the many other chemicals that go into cigarettes. If you reduce nicotine in cigarettes people may smoke harder and longer to get as much nicotine as they can, which also means they are taking in more toxins,” Bauld warned.

“Part of the agenda” for the centre was to “gradually move people away from tobacco towards other, safer, nicotine products, including e-cigarettes”, she said.

She added that for pharmacy, the announcement by the FDA means that “this brings the US in line with the UK in terms of policy on electronic cigarettes — that smokers finding it difficult to quit should be encouraged to use them”.

Last updated
The Pharmaceutical Journal, FDA to propose cut in nicotine levels in cigarettes;Online:DOI:10.1211/PJ.2017.20203331

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