FDA Takes Steps to Lower Nicotine in Cigarettes to Non-Addictive Levels

Quitting smoking - male hand crushing cigarette

Through the issuance of the Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, the U.S. Food and Drug Administration (FDA) has taken an important step forward in our nation’s efforts to save millions of lives from the dangers of tobacco use.

In an advance notice of proposed rulemaking (ANPRM), the FDA seeks to develop a potential nicotine product standard for combustible cigarettes with nicotine levels at minimally or non-addictive levels.

Despite the significant progress that has been made in reducing smoking rates in the United States, tobacco use is still the leading preventable cause of death and disease in the U.S. Smoking is associated with 18 different types of cancer, and is costing the nation nearly $300 billion in direct health care costs and lost productivity each year.


In an advance notice of proposed rulemaking (ANPRM), the FDA seeks to develop a potential nicotine product standard for combustible cigarettes with nicotine levels at minimally or non-addictive levels..


Early start
Nine out of 10 tobacco users start before the age of 18, according to the Office of Smoking and Health of the U.S. Centers for Disease Control and Prevention (CDC). Lowering the amount of nicotine in combustible tobacco products to non-addictive levels will prevent youth who are experimenting with cigarettes and other combustible tobacco products from becoming addicted while also allowing currently addicted adult smokers to quit or switch to less harmful products.

“The FDA’s bold proposal to substantially reduce the nicotine content of cigarettes, and possibly other combustible tobacco products, will save millions of lives that would otherwise be lost as result of tobacco-related cancers and other diseases. There is no reason why we should have a highly toxic product also be highly addictive.

Leading experts
The American Association for Cancer Research’s (AACR) Tobacco and Cancer Subcommittee, includes many leading experts in the field of nicotine research and tobacco cessation, welcomes the opportunity to help shape a tobacco-free future by providing scientific expertise on the FDA’s nicotine-focused framework,” noted Dorothy K. Hatsukami, PhD, Associate Director of Cancer Prevention and Control at the University of Minnesota Masonic Cancer Center and an AACR Tobacco and Cancer Subcommittee member

In addition to the nicotine product standard, the FDA is planning to issue two ANPRMs as a part of its effort to reduce the use of combustible tobacco products among youth and adults. One ANPRM will seek comment on the role that flavors, including menthol, play in initiation, use, and cessation of tobacco products.

The second ANPRM will aim to gather additional comments and data on the regulation of premium cigars. In January, representatives from the AACR testified as part of an FDA public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how to promote innovation in these products and how they should be used and labeled.

The AACR Tobacco & Cancer Subcommittee plans to submit comments to the current and future ANPRMs in the coming weeks.

The FDA’s commitment makes it harder for future generations to become addicted to tobacco products in the first place and to allow more currently addicted smokers to quit or switch to potentially less harmful products.


Last Editorial Review: March 20, 2018

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