FDA Proposes Cutting Nicotine Level in CIgarettes

The advance notice of proposed rulemaking published March 16 is a step toward cutting the level of nicotine in cigarettes to "minimally or non-addictive levels," with FDA Commissioner Dr. Scott Gottlieb calling it "a pivotal step ... that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction."

The U.S. Food and Drug Administration is accepting comments until June 14 on an advance notice of proposed rulemaking published March 16 that is a step toward cutting the level of nicotine in cigarettes to "minimally or non-addictive levels," with FDA Commissioner Dr. Scott Gottlieb calling it "a pivotal step ... that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or switch to potentially less harmful products."

The ANPRM asks for comments about what maximum nicotine level would be appropriate in a nicotine tobacco product standard, how the maximum nicotine level should be measured, and how the threshold of nicotine addiction should be measured. "FDA is particularly interested in comments about the merits of nicotine levels like 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler, as well as other levels of nicotine," it says. FDA also requests any information on additional scientific data and research that would provide information about specific groups in the general population that may have an increased sensitivity to nicotine's reinforcing effects.

"We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort," Gottlieb said in his March 15 statement. "Notably, new estimates included in the ANPRM that are being published in the New England Journal of Medicine evaluate one possible policy scenario for a nicotine product standard. If this scenario were implemented, this analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation. And with this scenario, an even greater impact could be felt over time: by the year 2100, the analysis estimates that more than 33 million people – mostly youth and young adults – would have avoided becoming regular smokers. And smoking rates could drop from the current 15 percent to as low as 1.4 percent. All told, this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century – an undeniable public health benefit."

"We're at a crossroads when it comes to addressing nicotine addiction and smoking in this country – with important new tools to address this devastating public health burden," he wrote. "And although a potential nicotine product standard for cigarettes is the cornerstone of our approach, we also continue to push forward on additional pieces of the FDA's multi-year plan designed to work in concert to better protect kids and significantly reduce tobacco-related disease and death. We said from the outset that ours was a comprehensive approach that requires us to pursue all of its parts in tandem."

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