National Academies Report on E-Cigarettes Shows Need for FDA Regulation to Protect Kids and Assess E

The comprehensive report on electronic cigarettes issued today by the National Academies of Sciences, Engineering, and Medicine finds that, while smokers who switch completely to e-cigarettes are exposed to lower levels of toxic substances, little is known about the long-term health effects of e-cigarette use and there is only “limited evidence that e-cigarettes may be effective aids to promote smoking cessation.” In addition, the report raises serious concerns because it finds there is “substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.”

It is deeply troubling that there are still so many unanswered questions about the impact of e-cigarettes on public health despite the fact they have been on the market for a decade and are being used by millions of kids and adults. This report underscores the need for full and immediate FDA regulation of e-cigarettes in order to obtain the information needed to provide the public and smokers with the answers to these vital questions, to prevent these products from undermining decades of progress in reducing youth smoking, and to assess and identify which, if any, specific e-cigarettes are effective at helping smokers quit all tobacco products or switch completely away from cigarettes.

This report shows what happens when a new product is introduced without meaningful government oversight. It demonstrates why the FDA should fully and aggressively implement the overdue e-cigarette regulations that took effect in August 2016. The FDA should reverse a decision it made last year to delay until August 2022 a key requirement that e-cigarettes already on the market undergo scientific review by the FDA. In addition, the FDA should enforce the requirement that manufacturers who introduce new or modified products provide detailed information about these products and undergo FDA review before these products are allowed on the market.

Unless the FDA takes these steps, products that clearly appeal to kids – including many sold in candy flavors like gummy bear and cotton candy – will remain on the market for years to come and new ones will be introduced. In addition, smokers who want to quit will have no idea which, if any, e-cigarettes have been shown to be helpful, and manufacturers will have no incentive to invest in developing products that will actually help smokers quit.

Based on a thorough review of the scientific evidence to date regarding e-cigarettes, the National Academies report finds that there are still many unanswered questions about the impact of e-cigarettes on the health of both individuals and the population as a whole.

In one of its most troubling findings, the report demonstrates that youth e-cigarette use is a serious problem that cannot be ignored. Numerous surveys show that e-cigarettes have become the most commonly used tobacco product among youth, surpassing traditional cigarettes. A growing number of studies have also found that youth who use e-cigarettes are more likely to subsequently use traditional cigarettes. Today’s report concludes, “There is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.”

Other key findings include:

• On the issue of smoking cessation, the report concludes, “Overall, there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.” While noting there is “moderate evidence from observational studies that more frequent use of e-cigarettes is associated with increased likelihood of cessation,” it also concludes, “There is insufficient evidence from randomized controlled trials about the effectiveness of e-cigarettes as cessation aids compared with no treatment or to Food and Drug Administration-approved smoking cessation treatments.”
• The most critical scientific questions about the health effects of e-cigarette use remain unanswered. While smokers who switch completely to e-cigarettes reduce their exposure to toxic and carcinogenic substances, the report also finds, “There is conclusive evidence that in addition to nicotine, most e-cigarette products contain and emit numerous potentially toxic substances.” The report finds that while e-cigarettes are likely to be far less harmful than conventional cigarettes, “the implications for long-term effects on morbidity and mortality are not yet clear” and there is insufficient evidence to draw meaningful conclusions about the risks e-cigarettes pose for diseases like cancer and heart disease.
• Significantly, the report finds there is enormous variability among e-cigarette products that impacts exposure to nicotine and toxic substances and therefore could impact the relative health risks and addictiveness of these products, as well as their effect on youth initiation and smoking cessation.

The magnitude of what we don’t know about e-cigarettes is the direct result of the failure of the FDA to effectively regulate these products. The FDA should quickly reverse its decision to exempt products already on the market from FDA review for years to come. The FDA should also take additional action to prevent youth use of e-cigarettes, including banning the use of flavors unless manufacturers have demonstrated to the FDA that particular flavors help smokers quit or switch completely and do not attract youth. Studies have shown that flavors play a key role in youth use of e-cigarettes, with the FDA’s own data showing that 81 percent of current youth e-cigarette users cited flavors as a reason for their use of the product.

This report also shows why Congress must reject a proposal, contained in a House appropriations bill, to greatly weaken FDA oversight of e-cigarettes (and cigars) already on the market, including the candy-flavored products that appeal to kids.

As today’s report demonstrates, effective FDA regulation is key to minimizing the risks and realizing any potential benefits of e-cigarettes.