FDA takes first step in drafting rule to cut nicotine levels in cigarettes

FDA takes first step in drafting rule to cut nicotine levels in cigarettes
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The Food and Drug Administration (FDA) on Thursday took the first step in creating a new rule to reduce the level of nicotine allowed in cigarettes to nonaddictive levels.

In an advanced notice of proposed rulemaking, FDA asked the public to submit comments over the next 90 days on the impact of a product standard for the maximum nicotine level in cigarettes.

“Tobacco use causes a tremendous toll of death and disease every year and these effects are ultimately the result of addiction to the nicotine contained in combustible cigarettes, leading to repeated exposure to toxicants from such cigarettes,” the agency said in the notice.


“This nicotine addiction causes users to engage in compulsive use, makes quitting less likely and, therefore, repeatedly exposes them and others to thousands of toxicants in combusted tobacco products.”

The FDA first announced in July that it was planning to start a public dialogue about writing such a rule.

“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,” FDA Commissioner Scott Gottlieb said at the time.

The agency is asking the public to weigh what the appropriate nicotine level should be, how the limits should be implemented, how nicotine levels should be tested, the economic impact and the possible countereffects, like whether it would create a black market for cigarettes with more nicotine.

According to its calculations, the agency estimates that by the year 2100 its rule could stop 33 million young adults from starting to smoke, but said it’s likely to increase the number of people using e-cigarettes and other noncombustible tobacco products.

In a statement, the Campaign for Tobacco-Free Kids called the agency’s proposal a bold plan and urged officials to act quickly.

“There is no other single action our country can take that would prevent more young people from smoking or save more lives,” Matthew Myers, the campaign’s president, said.

“This is truly a once-in-a-lifetime opportunity to greatly accelerate progress in reducing tobacco use — the nation’s No. 1 cause of preventable death — and bring us closer to eliminating the death and disease it causes.”

But Myers said the FDA should reduce nicotine levels in all combustible tobacco products, not just cigarettes, to prevent people from switching to other harmful products.