FDA considers lowering nicotine levels in cigarettes

Mandatory nicotine level regulation in cigarettes may help prevent 33 million young people from smoking, and stop 5 million adults from smoking, in one year, the United States Food and Drug Administration has said.

Office of the US Food and Drug Administration

The United States government has said it will consider regulating to lower nicotine levels in cigarettes, in an effort to avoid millions of tobacco-related deaths across the country.

The Food and Drug Administration (FDA), the government agency responsible for evaluating the safety and efficacy of medicines in the United States, has announced an advance notice of proposed rulemaking (ANPRM) to explore a product standard, to lower nicotine in cigarettes to minimally or non-addictive levels, as part of its comprehensive plan on tobacco and nicotine regulation.

If the FDA is successful in making lower-nicotine levels in cigarettes mandatory in the country, 33 million young people could be prevented from smoking regularly, and around 5 million additional adult smokers could stop smoking within one year, the agency said.

FDA commissioner Scott Gottlieb said: “Given their combination of toxicity, addictiveness, prevalence and effect on non-users, it’s clear that to maximise the possible public health benefits of our regulation, we must focus our efforts on the death and disease caused by addiction to combustible cigarettes.”

The FDA’s plan stresses the importance of “harm reduction” — such as encouraging people to switch from traditional cigarettes to alternative to e-cigarettes.

Mr Gottlieb said the ANPRM provided “a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes”.

He said it will “seek comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard”.

To help inform its findings and recommendations, the FDA said it would consider public input on such questions as what potential maximum nicotine level would be appropriate for the protection of public health, and whether standards for products should be implemented all at once, or gradually.

A spokesperson for UK campaigning health charity Action on Smoking and Health, said: “Currently, nicotine reduction is not under serious consideration in the UK; it was not part of the Department of Health’s Tobacco Control Plan published in July and would require legislation.”



Last updated
The Pharmaceutical Journal, PJ, April 2018, Vol 300, No 7912;300(7912):DOI:10.1211/PJ.2018.20204579

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