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FDA moves to lower nicotine in cigarettes

16 March 2018

Gottlieb noted that although a potential nicotine product standard is at the forefront of the FDA's approach, the FDA is also moving forward with other aspects of its tobacco and nicotine regulation plan, including better protection for children against the marketing of tobacco products, seeking comment on the role of flavors in the initiation, use and cessation of tobacco products, and modernizing the development of medicinal nicotine replacement products.

The agency announced last summer that it wants to cut nicotine levels 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. Additionally, the current smoking rate of 15% could drop as low as 1.4% and more than 8 million tobacco-related deaths could be avoided through the end of the century, according to the statement.

A study released Thursday in the New England Journal of Medicine projected that cutting nicotine to a non-addictive level could mean five million fewer smokers in the first year of implementation.

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Scott Gottlieb said Thursday the agency would propose the rule, opening a long bureaucratic process.

"When I returned to the U.S. Food and Drug Administration past year, it was immediately clear that tackling tobacco use - and cigarette smoking in particular - would be one of the most important actions I could take to advance public health", the statement said.

Tobacco kills more than 480,000 Americans each year and costs $300 billion a year in health care.

The agency cited research that could support reducing levels of nicotine to 0.3 to 0.5 milligrams per cigarette.

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Lead author Samir Soneji said, E-cigarettes will likely cause more public health harm than public health benefit unless ways can be found to substantially decrease the number of adolescents and young adults who vape and increase the number of smokers who use e-cigarettes to successfully quit smoking.

"It is critical that the FDA move as quickly as possible to turn this plan into reality", said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

Tobacco companies have carefully engineered their products to be as addictive as possible, said Mitch Zeller, director of the FDA's Center for Tobacco Products.

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FDA moves to lower nicotine in cigarettes