FDA issues proposed rule to lower nicotine in cigarettes

The agency issued an advanced notice of proposed rulemaking on lowering the permitted level of nicotine in cigarettes to minimal or non-addictive levels.

By Allen Cone
FDA issues proposed rule to lower nicotine in cigarettes
Food and Drug Administration Commissioner Dr. Scott Gottlieb announced Thursday the agency is taking regulatory steps to lower the amount of nicotine in cigarettes to make them less addictive. Photo by underworld/Shutterstock

March 15 (UPI) -- The Food and Drug Administration announced Thursday it is taking regulatory steps to lower the amount of nicotine in cigarettes to make them less addictive.

FDA Commissioner Dr. Scott Gottlieb said in a statement the agency is beginning the process of changing the nicotine levels in cigarettes. The FDA, which got permission to regulate tobacco products in 2009, hasn't mandated nicotine levels before.


"As part of our comprehensive plan on tobacco and nicotine regulation announced last summer, we're issuing an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels," Gottlieb said. "This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country."

Last July, two months after taking office, Gottlieb said the FDA would focus on reducing nicotine levels to make them less addictive, and make other nicotine products, including patches and gum, more safe.

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Although the FDA can't ban tobacco-based products, it has imposed limits on sales and marketing.


Tobacco makers were forced to admit to deliberately making cigarettes more addictive in a current ad campaign that began last November.

Despite warnings on cigarettes and restricted sales to minors, 15 percent of U.S. adults still smoke, according to the Centers for Disease Control and Prevention.

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"Despite years of aggressive efforts to tackle the leading cause of preventable disease and death in the United States, tobacco use -- largely cigarette smoking -- still kills more than 480,000 Americans every single year," Gottlieb said.

"Tobacco use also costs nearly $300 billion a year in direct health care and lost productivity. In fact, cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users. 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."

Gottlieb cited a study being published in the New England Journal of Medicine that projects the effects of a reduction in nicotine levels.

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"By the year 2100, the analysis estimates that more than 33 million people -- mostly youth and young adults -- would have avoided becoming regular smokers," he said. "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."


He said he is optimistic the change will save lives.

"No statistical model can truly capture the full impact of this effort -- including the joy from years of quality life gained with a loved one, or how much pain and suffering would be avoided for millions of families across the country," he said. "Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes. And this unprecedented public health opportunity, contrasted against the cost of doing nothing, weighs heavily on me."

Most manufactured cigarettes currently contain 10-15 mg of nicotine per cigarette. On average, smokers absorb 10 percent of the nicotine contained, with the typical systemic intake of 1-2 mg of nicotine per cigarette, according to the National Institutes of Health.

The FDA plans to seek comment on nicotine content changes in cigarettes as well as possibly limiting menthol in cigarettes and regulating premium cigars.

Gottlieb took over as FDA commissioner on May 11, 2017. He previously worked in FDA and then entered the private sector as a physician, medical policy expert and public health advocate


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