FDA Announces Plan to Lower Nicotine in Cigarettes to Non-Addictive Levels

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The US Food and Drug Administration (FDA) has announced a new comprehensive plan for tobacco and nicotine regulation designed to serve as a road map to better protect American children and reduce tobacco-related disease and death.

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

These new efforts will place nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The FDA was given the power to regulate the tobacco industry in the Family Smoking Prevention and Tobacco Control Act in 2009.

“A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources,” Gottlieb said. “FDA stands ready to do its share.”

In his remarks, Gottlieb directed the FDA’s Center for Tobacco Products to develop a comprehensive nicotine regulatory plan aimed at confronting and altering cigarette addiction. He also tasked the agency with reviewing existing literature on the topic of cigarette addiction. Gottlieb plans to develop an Advance Notice of Proposed Rulemaking to identify issues the FDA could address under its authority to regulate nicotine in combustible cigarettes and render them minimally or non-addictive.

“We have the potential to improve the lives of tens of millions of currently addicted cigarette smokers, and future generations of kids,” Gottlieb said. “But if we’re going to meaningfully improve the public health, we need to be willing to take a hard look at our entire approach to tobacco, to make sure we have the right regulatory gates in place to evaluate products, and to focus more squarely on the nicotine.”

The FDA is attempting to strike a balance between regulation and encouraging the development of innovative tobacco products that may be less dangerous than cigarettes. To do this, the agency is providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. Specifically, it will delay a regulation requiring that cigars and e-cigarettes be approved by the agency. According to an FDA press release, this action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing, and addictive.

For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.

“Looking at ways to reduce nicotine levels in cigarettes so that they are minimally or non-addictive, while not altering the nicotine content of non-combustible products such as e-cigarettes, is a cornerstone of our new and more comprehensive approach to effective tobacco regulation,” Gottlieb said. “As I see it, taking the next step and addressing nicotine is not just within our authority; it’s an enormous public health opportunity and falls squarely within FDA’s mission.”