AACR and ASCO release updated e-cigarette policy statement; FDA action should follow

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To understand the state of affairs with electronic nicotine delivery systems (ENDS), you have to go back to 2006, when ENDS, such as e-cigarettes, became widely available.

They were initially slow to build popularity, but then undertook a dramatic rise, with a massive 400% increase between 2012 and 2014 among high school students. This triggered concern that the great progress made against nicotine addiction and tobacco use may be threatened by these devices.

In 2015, to address the growing prevalence of ENDS use among youth and young adults, the American Association for Cancer Research and the American Society of Clinical Oncology published a joint statement which called on FDA to step up and classify ENDS as tobacco products to bring them under FDA’s regulatory jurisdiction. 

Since then, ENDS became increasingly prevalent among America’s youth. This rate of increase of use by youth peaked in 2019. Youth use dropped during the pandemic, when many kids were attending school virtually and there were fewer opportunities for young people to congregate. 

But new data from this year estimates more than two million high school students are using ENDS, a 24% increase compared to 2021. 

To address this ongoing problem, AACR and ASCO collaborated on an updated policy statement, which was simultaneously published in AACR’s journal Clinical Cancer Research and ASCO’s Journal of Clinical Oncology on Oct. 26. The statement includes the most up-to-date research on what we are learning about ENDS use, what it means for cancer research, and what policymakers and regulators should do to address this problem as soon as possible. 

ENDS are not just a problem for America’s youth. The evidence is clear that millions of adults, in particular young adults, who have never smoked have been drawn to ENDS and are now addicted. 

The statement includes the most up-to-date research on what we are learning about ENDS use, what it means for cancer research, and what policymakers and regulators should do to address this problem as soon as possible.

Since our 2015 statement, new studies have found links between ENDS and DNA damage and inflammation, key early steps in cancer development. As someone who has spent decades developing novel therapies while treating patients with lung cancer, this new generation hooked on nicotine is a big concern. 

A central part of this concern is that a young person who uses ENDS is more likely to later begin smoking combustible tobacco, with studies finding that people who use ENDS are about three times more likely to smoke a combustible cigarette than people who have never used ENDS.

We need to end the appeal of these products in the first place. Key driving forces for ENDS initiation are flavors, such as dessert, menthol, and fruit flavors, which alter the perception of health risks and make them easier to consume. Almost 85% of youth who use ENDS use flavored products—and very few of them are choosing ENDS with tobacco flavoring. Studies have shown that fruit flavors, in particular, increase the likelihood of teens trying ENDS six-fold. 

The science is clear: prohibiting flavored ENDS (other than tobacco flavoring) would be a powerful strategy to reduce the appeal of these products for youth and young adults who have never smoked.

Indeed, on the same day that our statement was published, FDA took a first-of-its-kind step to deny applications to sell several menthol-flavored e-cigarette products. These are the first menthol e-cigarette products to be denied based on a full scientific review from FDA, where the company was required to prove their products would be beneficial for public health.

These products are now prohibited from being manufactured or sold in the United States. As we applaud this action, we hope that it indicates that FDA will deny the additional pending applications for flavored ENDS products. 

In addition to banning non-tobacco flavors from products that contain nicotine, we need more urgent action from FDA and Congress. Here are other steps policymakers should take:

  • Tax all products that contain nicotine in a manner that reduces tobacco use and promotes public health;
  • Regulate predatory tobacco advertising practices, especially those designed to appeal to youth;
  • Limit of the sale of tobacco products, including ENDS, to stores or areas within stores that require age verification upon entrance, and increase enforcement of the minimum age to legally purchase tobacco products; and
  • Support research on the long-term health impacts of ENDS use, strategies for ENDS cessation, and how ENDS impact tobacco related disparities.

We know combustible tobacco products are the biggest preventable cause of cancer—at least 18 types of cancer. That’s been known for a while and continues to be a major focus of AACR and ASCO. 

Many claim that ENDS can be used as tobacco cessation tools, but evidence to date is insufficient to demonstrate these claims. In fact, every major U.S. health authority has said there is insufficient evidence for ENDS to be considered a cessation tool, and no manufacturer has applied to FDA to run the appropriate clinical trials. However, there are established, evidence-based methods to help people quit smoking, including bupropion, varenicline, nicotine replacement therapies, and counseling.

More research is needed to fully understand the long-term impact of ENDS on cancer development, effects on the overall health of individuals who use them, and how they impact tobacco-related disparities.

For now, we would invite manufacturers to take their products, submit an Investigational New Drug Application, and perform controlled trials to determine whether these devices do indeed treat nicotine addiction. 

Until then, policymakers should do all they can to reduce the appeal of these products to youth and adults who do not smoke and ensure that we are not sitting by while more Americans are getting hooked on nicotine.

Roy S. Herbst, MD, PhD
Deputy director, Ensign Professor of Medicine, Yale Cancer Center; Assistant dean for translational research, Yale School of Medicine; Chair, AACR Science Policy and Government Affairs Committee; Member, AACR Board of Directors
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