Scholars examine the regulation of electronic cigarettes and their impact on public health.
ENDS products typically refer to battery-operated inhaler devices such as electronic cigarettes (e-cigarettes), pod-based products such as JUULs, and vape pens that produce an aerosol after heating a liquid. Flavored solutions that consumers inhale from e-cigarettes or vapes and then exhale can include nicotine and other chemicals.
The U.S. Food & Drug Administration (FDA) has regulated traditional tobacco products since 2009. But the agency extended its regulatory authority over ENDS products in 2016 and finalized its enforcement policy in 2020 due to “epidemic levels of youth use of e-cigarettes and the popularity of certain products among children.”
The “Deeming Rule,” which expanded FDA’s regulatory authority to “cover all products that meet the definition of a tobacco product” under the Federal Food, Drug, and Cosmetic Act, now regulates ENDS products and parts, pipe tobacco, cigars, hookah, and e-cigarette flavored solutions in addition to traditional cigarettes and tobacco.
FDA’s concern about increased use of ENDS products is not unfounded. According to the American Lung Association, between 2011 and 2019, e-cigarette use increased by 1,650 percent among middle school students and 1,733 percent among high school students.
Critics of FDA’s increased regulatory authority, however, claim that too much regulation could “push many adults who quit smoking with vaping” back to smoking traditional cigarettes. The Centers for Disease Control and Prevention, however, suggest that even if e-cigarettes could benefit some adults, more research is needed on safe substitutes for adults working to quit smoking.
This week’s Saturday Seminar examines proposals focused on the regulation of e-cigarettes.
- Congress’s plan to give FDA regulatory control over tobacco products and cigarettes has “failed to deliver on its promise,” Ohio State University’s Micah Berman claims in a Saint Louis University Journal of Health Law & Policy article. In the wake of the Family Smoking Prevention and Tobacco Control Act, which granted FDA broad regulatory authority over tobacco in 2009, the agency gave e-cigarette companies “virtually free reign to continue promoting and selling their products in a largely unregulated environment,” Berman argues. This approach led to a surge in youth e-cigarette use that FDA is “now belatedly scrambling to address.” Rather than looking to FDA as the standard-bearer for public health concerns about tobacco, Berman posits that state and local policymakers will be the most effective regulators.
- Although FDA’s current e-cigarette regulations impose new safety standards for manufacturers, they do not go far enough to address “present and known hazards inherent in the e-cigarette devices themselves,” physicians Devin K. Loewenstein of Rush University and Holly R. Middlekauff of the University of California Los Angeles Medical Center claim. In an American Journal of Preventive Medicine article, they discuss how FDA regulations fail to protect consumers from poor or careless manufacturing and design, risk of injury from spontaneous explosions, and excessive device heating capacity from e-cigarettes. Without more stringent regulations against these dangers, Loewenstein and Middlekauff argue, e-cigarettes may fail to live up to their “promise as a less harmful alternative to conventional smoking” if additional risks could cause serious injury to consumers.
- Without strong federal ENDS regulations, Mark Gottlieb of the Public Health Advocacy Institute at Northeastern University School of Law warns that the United States will “face the prospect of treating an entire generation of youth who are deeply addicted to nicotine.” In a Children article, Gottlieb blames the “epidemic” on FDA’s delayed enforcement. Unreviewed and unauthorized ENDS remained on the market for years as the products became popular among teens. For the sake of children’s health, Gottlieb encourages FDA to “remove some or all of these ENDS products from the market pending approval of premarket review applications.” He suggests that the public health consequences of the youth vaping epidemic may be so severe that FDA can decline to authorize the products for sale.
- The U.S. government and the tobacco-nicotine industry should work to move existing smokers to e-cigarettes by placing certain restrictions on cigarettes, Georgetown University Law Center’s Eric N. Lindblom argues in a Food and Drug Law Journal article. He highlights two actions that FDA could take to move current smokers to e-cigarettes and dissuade young potential smokers to choose e-cigarettes over regular tobacco use. For one, FDA could mandate low maximum levels of nicotine levels in cigarettes, which would push smokers to “secure the nicotine they crave from e-cigarettes,” according to Lindblom. In addition, banning added flavors such as menthol in smoking products could lead new youth smokers to choose flavored e-cigarettes as an alternative.
- In a Journal of Health Care Law and Policy article, William Tilburg of the Maryland Medical Cannabis Commission, Kathleen Hoke of the University of Maryland Carey Law School, and Mellissa Sager of Colorado’s Tri-County Health Department argue that federal legislation creates significant ENDS regulation gaps that state and local governments can fill. Tilburg and his coauthors point to policies—such as retail licensing, advertising and promotion bans, indoor air restrictions, taxation, and minimum price regulations—that states “can and should” adopt. Whether states incorporate ENDS into existing laws or enact new laws to specifically regulate ENDS, Tilburg and his team encourage state governments to prioritize policies that prevent increased ENDS use among youth and non-smokers.
- Vape shops and tobacco retailers are often disproportionately located near socioeconomically disadvantaged communities of color with high numbers of young adults, Carla J. Berg of the George Washington University argues in a Public Health article. Because these businesses frequently use marketing methods to target these populations, FDA must consider community demographic makeup and marketing efforts when formulating new regulations on e-cigarettes, she contends. In light of increasing sales of tobacco and e-cigarette products from vape shops, Berg suggests that FDA could limit the growth of the vape shop industry and tobacco use by expanding existing regulatory requirements—such as age verification—and marketing limitations to vape shops and retailers.
The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.