Azim Chowdhury and Sam Jockel have been published in the latest Issue of Food and Drug Law Institute Update Magazine, “Spotlight on Tobacco – Future Developments in the Regulation of Electronic Nicotine Delivery Systems: Potential Over-the-Counter Pathway.” Update is open access online. To read the article, click here. This article is republished with the permission of FDLI.
On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting. While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner Gottlieb focused a portion of his remarks on the use of Electronic Nicotine Delivery Systems (ENDS) as tobacco harm reduction or smoking cessation tools and FDA’s role in their regulation.
“Preservation of E-Cigarettes”
According to Commissioner Gottlieb, utilizing scientific evidence and supporting new research to inform tobacco regulatory actions that protect public health is one of the primary missions of FDA’s CTP. Utilizing regulatory science to better understand e-cigarettes, Commissioner Gottlieb confirmed again that not all tobacco products are equally harmful, but that a “continuum of risk” exists, stating, “[w]e believe in the concept of a continuum of risk related to tobacco products, and we believe there is a role for modified risk products. Further, we want to preserve e-cigs as one among a number of possible options for adult smokers and believe that fully transitioning smokers to ENDS can reduce the morbidity and mortality associated with tobacco use.” Preservation of e-cigs as a possible option for adult smokers entails better understanding “the potential benefits of electronic nicotine products as smoking cessation tools.”
In his remarks, the Commissioner highlighted a recent report by the National Academies of Sciences (NAS), entitled “Public Health Consequences of E-Cigarettes.” You can read a summary of that report in a previous blog post here. Commissioned by FDA, the report makes clear, among other things, the reduced harm of e-cigarettes compared to smoking cigarettes and that completely switching from regular use of combustible cigarettes to e-cigarettes results in reduced short-term adverse health outcomes in several organ systems.
Acknowledging those findings, Commissioner Gottlieb noted, “[p]otentially less harmful products – including the wide diversity of ENDS and other novel tobacco products – must be put through an appropriate series of regulatory gates to fully evaluate their risks and maximize their potential benefits.”
The Commissioner’s praise of vapor products as a potential reduced harm alternative for smokers, however, apparently does not apply to adolescents, for whom FDA maintains there is never a good reason to use any tobacco product, reduced harm or not – a position that has been criticized in some public health circles.
“Appropriate Series of Regulatory Gates” in the Context of the Deeming Rule Appeal
The Commissioner’s remarks on e-cigarettes were delivered in the midst of a lawsuit filed by Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (appellants) challenging aspects of the Tobacco Control Act (TCA) and FDA’s Deeming Rule now pending before the U.S. Court of Appeals for the D.C. Circuit. This blog has been closely following the litigation, previously summarizing Appellants’ opening brief, as well as FDA’s brief and appellants reply brief. A list of all briefs can be found at the end of this blog post.
The Commissioner’s June 18 remarks, acknowledging the benefits of e-cigarettes as tools for adult smoking cessation, follow previous statements by Commissioner Gottlieb, the agency itself, the American Cancer Society (ACS), and an FDA-commissioned report acknowledging the lower risk associated with e-cigarettes in comparison to combustible tobacco and e-cigarettes’ potential public health benefits. As set forth at the outset of appellants’ final reply brief in the Deeming Rule appeal, those statements and findings include:
- FDA stated numerous times during the rulemaking that vapor products are less harmful than traditional cigarettes.
- In announcing its Comprehensive Plan for regulating tobacco and nicotine, FDA recognized it must “strik[e] an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.”
- FDA Commissioner Gottlieb and Mitch Zeller, Director of FDA’s Center for Tobacco Products, wrote in the New England Journal of Medicine that vapor products, when combined with measures to reduce nicotine levels in cigarettes, “represent a promising foundation for a comprehensive approach to tobacco harm reduction.”
- One of FDA’s supporting amici, the ACS, recently determined, “[b]ased on currently available evidence, using current generation e-cigarettes is less harmful than smoking cigarettes,” and concluded “switching to the exclusive use of e-cigarettes is preferable to continuing to smoke combustible products.”
- A recent NAS report commissioned by FDA, which the Commissioner mentioned in his June 18 remarks, confirms vaping is less risky than smoking. The report, which is based on a review of over 800 articles, found: (i) conclusive evidence that completely substituting vaping with smoking reduces exposure to numerous toxicants and carcinogens; (ii) current evidence shows vapor products are less harmful than cigarettes; (iii) substituting vaping for smoking significantly reduces levels of biomarkers of exposure to toxicants; and (iv) vaping exclusively might be useful as a cessation aid in smokers.”
Despite these recent statements, FDA continues to take a hard line in the pending appeal, where the agency argues: (1) the Modified Risk Tobacco Product (MRTP) provision in Section 911 of the TCA does not violate the First Amendment of the U.S. Constitution; (2) the free sample ban is a “price regulation,” so it is not subject to First Amendment protections; and (3) the Premarket Tobacco Application (PMTA) process was statutorily required and did not authorize nor require FDA to modify those requirements for vapor products. Each of these positions, as explained by appellants in the appeal, work against promoting continuum of risk and achieving risk reduction:
- Modified Risk Tobacco Product (MRTP) Claims: FDA’s defense of the MRTP provision will ultimately prevent vapor companies from making truthful statements and conveying information that would help adult consumers make informed decisions regarding vaping. As set out in appellants’ briefs, the incredibly onerous and expensive MRTP authorization process, which no company has been able to achieve yet, is ultimately a restriction on the First Amendment rights of consumers in the marketplace to obtain product-related information so they can make educated decisions.
- Free Sample Ban: Similarly, FDA downplays free samples as a mere “price regulation,” which are not subject to First Amendment challenge. To the contrary, and as demonstrated by appellants in their briefs, free samples allow manufacturers to pass on product information that adult consumers demand when contemplating a switch from more harmful cigarettes, and are thus protected under the First Amendment.
- The Premarket Tobacco Application (PMTA): FDA’s one-size-fits-all PMTA process for vapor products, which involves satisfying all pre-market review requirements for less risky vapor products, will also force the vast majority of vapor companies and less harmful vapor products out of the market absent some tailoring of certain requirements.
Oral arguments in the Deeming Rule appeal have been scheduled for September 11, 2018 before the U.S. Court of Appeals for the D.C. Circuit.
Links to all appeal briefs:
- February 12, 2018: Appellants Nicopure and Right to be Smoke-Free file opening brief
- February 20, 2018: Amicus briefs in support of appellants filed by: Washington Legal Foundation, NJOY, State of Iowa and CASAA
- May 2, 2018: Appellee FDA’s brief filed
- May 9, 2018: Amicus briefs in support of FDA filed by: Public Citizen, Yale Law School Scholars, Public Health Law Center, and various public health groups (American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Thoracic Society, Campaign for Tobacco-Free Kids, and Truth Initiative)
- May 16, 2018: Appellants Nicopure and Right to be Smoke-Free file reply brief
- June 5, 2018: Appellee FDA files a final copy of its opening brief with updated citations to the administrative record
- June 6, 2018: Appellants Nicopure and Right to Smoke-Free file final copies of their opening and reply briefs with updated citations to the administrative record
The Right to be Smoke-Free Coalition and Nicopure Labs are represented in the appeal by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury. For more information on the lawsuit and to contribute to the appeal efforts, visit www.r2bsmokefree.org.
 Gottlieb, S. (2018, June 18). FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science. Speech presented at Tobacco Regulatory Science Program Meeting, White Oak, MD. Available at https://www.fda.gov/NewsEvents/Speeches/ucm611033.htm.
 National Academies of Science, Engineering and Medicine: Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems, The Public Health Consequences of E-Cigarettes (eds. Kathleen Stratton et al., 2018), available at https://tinyurl.com/ya4w37kb.
 Opening brief of appellants at 7. Available at Gottlieb, S. (2018, June 18). FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science. Speech presented at Tobacco Regulatory Science Program Meeting, White Oak, MD. Retrieved from https://www.fda.gov/NewsEvents/Speeches/ucm611033.htm.
 FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death (July 28, 2017), https://tinyurl.com/y7bybf6c.
 ACS, Position Statement on Electronic Cigarettes (Feb. 15, 2018), https://tinyurl.com/ybadn9cl; see also a summary of ACS’s most recent position statement in a previous blog post, available at https://www.thecontinuumofrisk.com/2018/06/american-cancer-society-acknowledges-reduced-harm-electronic-nicotine-delivery-systems-warns-dangers-misleading-consumers/.
On June 11, 2018, the American Cancer Society (“ACS”) released a statement entitled, “The American Cancer Society Public Health Statement on Eliminating Combustible Tobacco Use in the United States’ (“Statement”). The Statement sets forth the ACS’s goal of eliminating exposure to combustible tobacco smoke and provides three strategies for the ACS to enhance its approach in tobacco prevention and control.
This Statement follows its earlier “Position Statement on Electronic Cigarettes,” released on February 15, 2018, which acknowledged, for the first time, that e-cigarettes, also known as Electronic Nicotine Delivery Systems (ENDS), play an important role in helping certain smokers quit. In that prior position, ACS suggested that physicians should encourage individuals that will not use FDA-approved cessation medicines to switch to using ENDS. This latest Statement takes that position further, as the ACS commits to joining in on efforts to better understand how or whether ENDS might be integrated into evidence-based cessation options, and the organization also warns about the misinformation given to consumers about those products.
“Rapidly Changing Tobacco Marketplace” and the Consumer Misperception about ENDS
The ACS’s stated highest priority is to eliminate cancer caused by tobacco use as cigarette smoking is the leading cause of mortality in the U.S. Placing its Statement in the context of what is calls, “the rapidly changing tobacco marketplace today,” the ACS acknowledges that tobacco control has increasingly become a social justice issue, as the percentage of smokers at the greatest risk (e.g. because of their low socioeconomic status, lower educational attainment, etc.) has risen markedly.
Given today’s landscape, the Statement highlights the need for consumers to receive accurate information about different tobacco products and the role that nicotine plays in disease. Citing numerous studies and reports, the Statement posits that although the “current generation ENDS are markedly less harmful than combustible tobacco products,” “[m]any adults believe, erroneously, that ENDS are as harmful as combustible tobacco products, and the level of public understanding has deteriorated overtime.” The Statements cites the Monitoring the Future study, which reported that as of 2017, “e-cigarettes have one of the lowest levels of perceived risk for regular use of all drugs, including alcohol,” among adolescents. And to contrast e-cigarette use with combustible (burned) tobacco products, the Statement notes that while ENDS delivers nicotine, flavor additives and other chemicals, they do not actually burn tobacco – a process that yields an estimated 7000 chemicals, including at least 70 carcinogens.
Three Strategies to Eliminate All Combustible Tobacco Use: Lending Support to Further Utilizing ENDS for Tobacco Cessation
The Statement outlines three separate strategies to eliminate all combustible tobacco use-all of which involve some component linked to ENDS.
- Promote Increased Access and Utilization of Cessation Options for Smokers, With an Emphasis on Preventing Dual Use
As part of its first strategic effort, the ACS will work to promote tobacco-cessation strategies and develop health care provider and consumer-facing materials with information on the risks associated with tobacco products and cessation treatment options. As a part of this communications strategy, the ACS notes that it intends to communicate to consumers that current-generation ENDS are less harmful than combustible tobacco products, and it provides that the ACS will contribute to research to determine how or whether ENDS might be integrated into evidence-based cessation options.
- Prevent Initiation of ENDS by Youth and Other High-Risk Demographic Groups
Despite noting the lesser risks associated with ENDS relative to combustible tobacco use, the Statement still holds that protecting youth from cigarette smoking and the use of novel tobacco products remains a priority. The ACS will advocate for tobacco-free policies, including ENDS in all cases, as well as for policies to raise the minimum age for sale of all tobacco products, including ENDS. The ACS makes clear that it will continue to oppose what it calls, “the widespread exposure of youth to e-cigarette advertising.”
- Promote and Support a Comprehensive Tobacco and Nicotine Regulatory Framework
As part of its broader regulatory strategy, the Statement describes a “continuum of risk” for tobacco products, noting that while science is mixed, ENDS are likely to be much less harmful that combustible tobacco products. Among other proposals, the Statement again commits to conduct further scientific research, including research related to the short-term and long-term risks of using ENDS and the impact of ENDS on tobacco use behavior.
Taking its February 15, 2018 statement on electronic cigarettes one step further, this latest announcement by the ACS makes clear that the organization intends to contribute to further research on whether e-cigarettes may be utilized for tobacco cessation strategies. However, the ACS continues to advocate for tobacco-free policies, which include the use of ENDS, and the organization remains concerned about preventing youth initiation of ENDS, which has fallen dramatically since 2015, along with all tobacco use.
 The American Cancer Society Public Health Statement on Eliminating Combustible Tobacco Use in the United States (Clifford E. Douglas, et al., 2018) available at https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21455 (hereinafter, referred to as the “Statement”).
 American Cancer Society Position Statement on Electronic Cigarettes (2018) available at https://www.cancer.org/healthy/stay-away-from-tobacco/e-cigarette-position-statement.html.
 Statement, supra n.1. at 1.
 Id., supra n.1. at 5.
 Id., supra n.1. at 2.
 Id., supra n.1. at 4.
 Id., supra n.1. at 1.
 Johnston LD, Miech RA, O’Malley PM, Bachman JG, Schulenberg JE, Patrick ME. Monitoring the Future: National Survey Results on Drug Use, 1975‐2017. Overview, Key Findings on Adolescent Drug Use. Ann Arbor, MI: Institute for Social Research, The University of Michigan; 2018. monitoringthefuture.org/pubs/monographs/mtf‐overview2017.pdf.
 Id., supra n.1. at 1.
 Id., supra n.1. at 2-3.
 Id., supra n.1. at 3.
 Id., supra n.1. at 3.
 Id., supra n.1. at 4.
 Id., supra n.1. at 4.
 Id., supra n.1. at 4.
 Id., supra n.1. at 5.