On May 10, 2016, the US Food and Drug Administration (FDA) finalized its long-awaited “deeming” rule, extending its regulatory authority to pipe tobacco, hookah tobacco, cigars, and—most controversially—e-cigarettes.1 The FDA’s assertion of jurisdiction over e-cigarettes was necessary and long overdue. As the Surgeon General has summarized, “exposing the developing brain to nicotine has been shown to alter its structure and function in a way that introduces long-lasting vulnerability for addiction to nicotine and other substances of abuse.” The recent rise in youth e-cigarette use (“vaping”) is therefore a worrying sign for public health. Now, the FDA must work to implement its new authority in a way that best protects children from lifelong addiction to nicotine.
While the deeming rule is a promising step toward sensible regulation of e-cigarettes, public health groups appropriately criticized the FDA for not going far enough. For example, the Campaign for Tobacco-Free Kids commented that the rule “does nothing to restrict the irresponsible marketing of e-cigarettes or the use of sweet e-cigarette flavors such as gummy bear and cotton candy.” This Viewpoint discusses how the FDA can build upon the deeming rule to further protect youth by regulating e-cigarette advertising and flavors.
Since 2011, when the FDA announced its intent to issue a deeming rule, the e-cigarette market in the United States has exploded (though it remains only a fraction of the size of the cigarette market). E-cigarettes transformed from a little-known curiosity sold in mall kiosks to a well-recognized product available at gas stations, pharmacies, and thousands of new “vape shops.” Troublingly, youth use of e-cigarettes also spiked dramatically. The percentage of high school students reporting e-cigarette use in the past 30 days skyrocketed from 1.5% in 2011 to 16% in 2015.1 In addition to nicotine’s negative effects on brain development, other youth-related concerns include the presence of respiratory toxicants in flavored e-cigarettes2 and the potential interference of e-cigarette use with lung growth and function.3
E-cigarettes may prove to be a less harmful alternative for current cigarette smokers, although the long-term health effects of e-cigarette use are unknown at this point. However, the potential public health benefits of e-cigarettes may be undercut if there is significant uptake by young nonsmokers, and particularly if e-cigarette use serves as “gateway” to smoking conventional cigarettes. One particularly disconcerting sign is that several recent US longitudinal cohort studies suggest that younger nonsmokers could transition from e-cigarettes to combustible cigarettes once addicted to nicotine.4,5
The deeming rule addresses some of the youth-related concerns about e-cigarettes by banning sales to minors (which most states had already done), requiring warning labels, and reigning in false or unverified health claims. The rule did not, however, extend the congressional ban on cigarette TV advertisements to e-cigarettes or otherwise limit promotional tactics that might appeal to youth, nor did it address the role played by flavors in attracting youth to e-cigarette use.
Youth-oriented advertising should be a priority topic for future FDA regulation, as greater exposure to e-cigarette advertisements—on the internet, in newspapers and magazines, in retail stores, and on television—is associated with higher odds of current e-cigarette use.6 Some e-cigarette companies are using “youth-resonant themes such as rebellion, glamour, and sex; celebrity endorsements; and sports and music sponsorships”—all strategies taken from the cigarette companies’ old playbook.7 The deeming rule provides the FDA with the power to impose future restrictions on advertisements that might appeal to youth, but since such restrictions were not included in the deeming rule, the FDA would need to initiate an entirely new rulemaking procedure to further regulate e-cigarette advertising—a process that could take years.
The FDA may have been wary of taking on the issue of youth-oriented advertising because any such restrictions would surely face a First Amendment lawsuit. In 2012, the FDA’s attempt to require graphic warning labels on cigarette packages and advertisements was voided by an appeals court decision concluding that the warnings violated the industry’s First Amendment free speech rights.8 This prior decision may have influenced the FDA’s decision to take a cautious approach to regulating e-cigarette advertisements. In our view, the cigarette warnings decision was the result of the appellate court’s ideological antagonism toward regulations viewed as “paternalistic,” more so than the FDA’s supposed lack of evidentiary support. Thus, changes in personnel on both the federal appeals court and the Supreme Court might provide an opening to revisit this issue and push for further restrictions on tobacco and e-cigarette marketing. Indeed, although the courts have been skeptical of restrictions on “commercial speech,” the regulation of e-cigarettes may present a uniquely attractive context in which to challenge this trend. Given the history of cigarette advertising and use in the 20th century—where widespread cigarette advertising and use became the norm before the health risks were fully understood, with devastating consequences—the FDA is in a strong position to argue that a cautionary approach is needed and that the potential public benefits of e-cigarettes can only be realized if irresponsible marketing to youth is curtailed.
Public health groups had urged the FDA to include a restriction on e-cigarette flavors in the deeming rule, based on the concern that fruit- and candy-flavored e-cigarettes may appeal to youth. The final deeming rule did not do so, instead stating that such concerns must be balanced against preliminary data showing that some adults may use flavored e-cigarettes to transition from combusted tobacco use.1 This language, it was later disclosed, was added to the final rule by the White House Office of Management and Budget (OMB), which rejected the FDA’s proposal to tighten restrictions on the sale of flavored e-cigarettes. The OMB’s markup of the deeming rule also deleted 17 pages of evidence presented by the FDA supporting the need for immediate regulation of flavors in e-cigarettes and other tobacco products.9
It is not clear what led the OMB to overrule the FDA, but this latest action follows a pattern of the OMB weakening proposed FDA rules to regulate tobacco. This suggests that the FDA is facing political opposition from within the Obama administration. Consequently, although the FDA will likely fund additional research on e-cigarette flavors (which is appropriate), it is not clear that additional evidence alone will be sufficient to overcome resistance by the OMB to stronger regulation. Although both FDA and OMB leadership may change after the November election, the new FDA commissioner, Robert Califf, MD, should make it an immediate priority to address the relationship between the FDA and OMB and to stress the importance of strong tobacco-related regulations.
Regulation of e-cigarettes is critical to protecting children from lifelong nicotine addiction and its attendant consequences, potentially including progression to cigarette use. To date, the lack of any regulation has resulted in the presence of toxic contaminants in e-liquids, rampant mislabeling of products, unverified and misleading health claims, and even serious personal injuries caused by exploding e-cigarettes. While the publication of the final deeming rule is an important step forward, the FDA should use its authority to further advance the public’s health by imposing restrictions on e-cigarette advertising and renewing its effort to restrict the sale of flavored e-cigarettes.
Corresponding Author: Micah L. Berman, JD, College of Public Health and Moritz College of Law, Ohio State University, 1148 Neil Ave, Columbus, OH 43210 (email@example.com).
Published Online: September 26, 2016. doi:10.1001/jamapediatrics.2016.2255
Conflict of Interest Disclosures: Mr Berman previously served as an advisor and consultant to the FDA Center for Tobacco Products.
Berman ML, Yang YT. E-Cigarettes, Youth, and the US Food and Drug Administration’s “Deeming” Regulation. JAMA Pediatr. 2016;170(11):1039-1040. doi:10.1001/jamapediatrics.2016.2255