U.S. Food and Drug Administration’s comprehensive to regulate tobacco and nicotine first-and-foremost seeks to better protect our nation’s youth, as well as future generations, from the disease and death caused by tobacco use.
As a public health agency, it’s important that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain non-combustible forms of tobacco products. We are issuing an advance notice of proposed rulemaking (ANPRM) and calling upon all stakeholders to share data, research and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products. We want to consider the most impactful regulatory options the FDA could pursue to address this issue.
Each day in the United States, more than 2,300 youth under the age of 18 years smoke their first cigarette, and nearly 1,900 youth smoke their first cigar. In particular, among youth who have ever tried a cigar, more than 65 percent have reported that their first cigar use was flavored. Additionally, youth and young adult smokers are disproportionately more likely to smoke menthol than nonmenthol cigarettes. And we know that youth who initiate smoking with menthol cigarettes (compared with youth who initiate with non-menthol cigarettes) may be at greater risk of progression from experimentation to established smoking and nicotine dependence.
With all this in mind, given our new policy framework and more recent evolutions in the tobacco marketplace, we believe it’s important that we re-examine the issue of flavors as we work to best protect public health and significantly reduce tobacco-related disease and death. We must give serious consideration to the ways in which we might further address flavors in combustible tobacco products like menthol in cigarettes and the fruit and candy-flavored little cigars and cigarillos. We must also consider how best to address flavors in non-combustible products like e-cigarettes – given both their clear appeal to youth but also the potential role certain flavors may play in helping some adult smokers transition to potentially less harmful tobacco products.
And the ANPRM specifically seeks data on this issue. But these personal stories are important to me as we shape our overall approach to smoking cessation. And it’s important to me that we uphold the FDA’s responsibility to consider all sides and take into account, among other things, the risks and benefits to the population as a whole.
As we pursue additional steps to keep kids from using tobacco products, we are also continuing to invest in our compelling, science-based campaigns to educate youth about the dangers of all tobacco products, and this includes e-cigarettes as well. We will use all of these tools to best protect kids.Ultimately, we’re working to ensure our policies achieve the greatest public health benefit.
As such, we’re proceeding with the utmost caution by securing more information about both the potential positives and negatives of flavors in youth initiation and getting adult smokers to quit or transition to potentially less harmful products.
The public docket for this ANPRM will be open for 90 days starting tomorrow. This action follows another important step forward in our multi-year roadmap to achieve a world where combustible cigarettes would no longer create or sustain addiction, and where adults who still seek nicotine could get it from alternative and potentially less harmful sources.
As with everything we do to protect and promote the public health, we’re committed to ensuring we have the proper science-based regulatory foundation to apply the powerful tools given to the FDA by Congress to meaningfully reduce the public health burden of tobacco use, protect youth and provide pathways for beneficial innovations to reach consumers.
