Nicotine levels in cigarettes could see a significant reduction under regulatory options being considered by the Food and Drug Administration.

Cigarettes “are the only legal consumer product that, when used as intended, will kill half all long-term users,” FDA Commissioner Scott Gottlieb, MD, said in a statement announcing the effort.

The agency is seeking comment on a proposed regulation regarding “a potential maximum nicotine level that would be appropriate for the protection of public health, in light of scientific evidence about the addictive properties of nicotine in cigarettes.” An advance notice of proposed rule making was posted online March 15 and is scheduled for publication in the Federal Register on March 16.

The FDA also is seeking comments on a number of other areas to help inform potential regulatory action down the road, including whether a new standard for lower nicotine levels should be implemented at once or whether a phased-in approach should be taken; whether FDA should specify a method for manufacturers to use in order to detect nicotine levels in their products; and whether the proposed lower level is technically achievable.

The agency also is seeking comment on potential unintended effects of lowering the amount of nicotine in cigarettes, such as turning to other combustible tobacco products such as cigars in conjunction with or as a replacement for cigarette use; increasing the number of cigarettes smoked, or seeking comparable nicotine from noncombustible tobacco sources.

At this time, FDA is not suggesting what the target might be on a specific nicotine level. While the advanced notice asks specifically about the “merits of nicotine levels like 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler,” it is not suggesting that this is the range being considered.

“Not to prejudge any possible proposed rule that we would do or any possible level, that is the purpose of an advanced proposed rule making, but we share all the science that we are aware of, and we characterize the studies that have been done to date in trying to find out what that right level is,” Mitch Zeller, director of the FDA Center for Tobacco Products, said during a March 15 press call.

He said that the FDA aiming to make sure the level is low enough that it cannot be compensated for by smoking more or inhaling deeper and holding the breath in longer, much like how smokers compensated when they smoked “light” cigarettes in the unregulated market.

Mr. Zeller said that seeking comments on those levels is based on the scientific evidence that is laid out in the advanced notice, but it is not necessarily foreshadowing where the standard will be set.

Drastically reducing the amount of nicotine in cigarettes is expected to significantly lower not only the number of people addicted to cigarettes but also as the negative health effects of nicotine addiction, FDA experts wrote in a perspective piece published March 15 in the New England Journal of Medicine ( doi: 10.1065/NEJMsr1714617 ).

“Our findings show that reducing the nicotine level in cigarettes has the potential to substantially reduce the enormous burden of smoking-related death and disease,” Benjamin J. Apelberg, PhD, director of the Division of Population Health Science, Office of Science, within the FDA Center for Tobacco Products, and his colleagues, wrote in the report.

Modeling for the implementation of a lower nicotine level policy suggests that smoking prevalence will decline from a median of 12.8% in baseline scenario to a median of 10.8% within a year of implementation, with the increase related to smoking cessation.

“We estimate that approximately 5 million additional smokers would quit smoking within a year after implementation of the hypothetical policy,” Dr. Apelberg and his colleagues wrote. “By 2060, smoking prevalence drops from 7.9% in the baseline scenario to 1.4% in the policy scenario.”

Their analysis is based on a nicotine level that is “so low that there would not be enough nicotine available in cigarette tobacco for smokers to sustain addiction,” they noted.

The FDA plans to release two more advanced notices of proposed rule making related to using regulatory levers to reduce cigarette smoking, including one that addresses flavoring in tobacco and one related to the regulation of premium cigars. Other than the 90-day comment period related to the advanced notices, the agency has not set any deadlines on when it will act.

“Legally, we are not going to prejudge how long this will take or what will happen,” Mr. Zeller said. “This is an early step in what could be a potential rule-making process using the product standard authority. We will take a long and hard look at all the comments that come in over the next 90 days and based upon our review of all the information, all the comments that come in, all the feedback that we have, we will then make a decision about taking the next step in the rule-making process.”

gtwachtman@frontlinemedcom.com

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