By Jamie Ducharme
March 15, 2018

In a historic step, the Food and Drug Administration (FDA) is moving toward limiting the amount of nicotine in cigarettes, in an effort to make them less addictive.

The agency on Thursday announced that it is proposing a rule that, if enacted, would “lower nicotine in cigarettes to minimally or non-addictive levels.” The proposal — which is still in preliminary stages and is likely to face a long legislative road — bolsters the FDA’s stated intent to step up regulations on cigarettes and nicotine addiction, and opens the process to public comment and information-gathering.

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

Congress only granted the FDA permission to regulate tobacco products in 2009. The agency last summer rolled out a multi-year plan for limiting the public health impact of tobacco and nicotine, but Thursday’s announcement is the first concrete step in moving that framework forward.

Tobacco use kills 480,000 Americans each year and costs the U.S. almost $300 billion, according to the FDA. The authors of a New England Journal of Medicine special report, also published Thursday and included in the FDA’s proposal, estimate that limiting the amount of nicotine in cigarettes could help 5 million adults quit smoking within a year. By the end of the century, according to the report, such regulations could prevent an additional 33.1 million people from becoming smokers, and save 8.5 million lives.

“We believe this unprecedented approach to nicotine and tobacco regulation not only makes sense, but also offers us the best opportunity for achieving significant, meaningful public health gain,” Gottlieb said in the statement.

The FDA is also proposing possible limitations on flavoring agents, such as menthol, that may make cigarettes more appealing and addictive, and on premium cigars, according to the statement.

Write to Jamie Ducharme at jamie.ducharme@time.com.

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