Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors - including menthol - in tobacco products

The thought of any child starting down a path of a lifelong addiction to tobacco, which could ultimately lead to their death, is unacceptable. We need to take every effort to prevent kids from getting hooked on nicotine. To that end, the U.S. Food and Drug Administration’s comprehensive plan we announced last summer 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.

In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation. And 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’re taking a critical step in advancing these goals. 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.

The concerns around flavors in tobacco are not new. For years we have recognized that flavors in these products appeal to kids and promote youth initiation. The data backs this up, and as a result, Congress prohibited the use of most characterizing flavors in cigarettes. 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.

As noted in ANPRM, youth consistently report product flavoring as a leading reason for using tobacco products. Flavors may disguise the taste of tobacco. But flavored cigarettes and little cigars are every bit as addictive as any other tobacco products, have the same harmful health effects and may even make it harder to quit. In fact, there’s evidence indicating that youth tobacco users who reported their first tobacco product was flavored had a higher prevalence of current tobacco product use compared to youth whose first product was not flavored. 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.

Because almost 90 percent of adult smokers started smoking by the age of 18, it’s imperative we look at new ways we can ensure that kids don’t progress from experimentation to regular use.

But when it comes to flavors in non-combustible products like electronic nicotine delivery systems or e-cigarettes we recognize the issue involves additional considerations. Here, it’s possible for flavors to do both harm and good. The troubling reality is that e-cigarettes are the most commonly used tobacco product among middle and high school students, and flavors are identified as one of the top three reasons for use. Given these findings, we need to be wary of the role flavors play in attracting youth to initiate on any tobacco product that could lead to regular use – something we clearly want to avoid. No child should use any tobacco products, including e-cigarettes. At the same time, we’re aware that certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products.

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.

I’ve talked to ex-smokers, who’ve told me that they quit cigarettes altogether and that they now vape. And they’ve also told me it was the flavors that helped them make that transition off combustible cigarettes. Now I know anecdotes aren’t the same as data. 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.

Let us be clear. There is no acceptable number of children using tobacco products, and we share the belief that these products should never be marketed to, sold to or used by kids. We have and will continue to enforce existing laws, including those that are aimed at preventing inappropriate targeting of children and that prohibit retailers from selling tobacco products, including e-cigarettes, to minors. 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. Through this lens, the ANPRM we’re issuing today seeks comments, data, research results or other information on topics, including, but not limited to:

The role that flavors play in initiation and patterns of tobacco use, particularly among youth and young adults;
The role that flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products;
The role that flavors in non-combusted tobacco products may play in quitting combusted tobacco products use, quitting all tobacco use or starting to use more than one type of tobacco product;
Consumer perceptions of health risks and addictiveness of flavored tobacco products;
Whether certain flavors used in tobacco products present potential adverse health effects to users or others; and
The impact of local, state and international efforts to restrict the sale or marketing of flavored tobacco 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.

In March, we issued an ANPRM to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels – a pivotal step in a comprehensive plan that we believe could help avoid millions of tobacco-related deaths across the country. This is just the beginning of our efforts.

We’ll continue to seek public input on a variety of significant topics as we advance our policy framework, which includes exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive.

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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.