Comments from Richard Besser, MD, on
the U.S. FDA Compliance Policy Regarding Flavored Electronic Nicotine Delivery Systems and Flavored Cigars

The following comments were submitted by Richard Besser, MD, Robert Wood Johnson Foundation (RWJF) President and CEO, on the draft guidance on modifying the U.S. Food and Drug Administration (FDA) compliance policy regarding flavored electronic nicotine delivery systems (ENDS) and flavored cigars.  

The Robert Wood Johnson Foundation supports FDA’s decision to revise its compliance policy to reduce youth access to flavored ENDS and cigars. To achieve this goal and adequately protect youth, however, we believe the final guidance should be stronger. Specifically, the final guidance should remove all non-tobacco ENDS flavors, including mint and menthol, until and unless they receive an FDA marketing order. In addition, we urge FDA to move quickly to issue proposed and final rules banning all flavored cigars and menthol cigarettes.

RWJF’s Commitment to Protecting Youth from Tobacco¹

RWJF is the nation's largest philanthropy dedicated to improving health and health care in the United States. We are working alongside others to build a national Culture of Health that provides everyone in America a fair and just opportunity for health and well-being. Improving and protecting the health and well-being of youth is critical to achieving this vision. All young people require support on the road to becoming healthy and productive adults. By creating supportive environments that promote healthy choices for all youth, we can create a healthier, fairer, and more prosperous future.

We have long recognized that strong tobacco-control policies can help youth and adults make healthier choices. When RWJF began working on tobacco control in 1991, the smoking rate among high school students was spiking upward, increasing from 28.3 percent in 1991 to 36.4 percent in 1997.² Working with multiple stakeholders, we initially focused many of our resources on reducing uptake among youth, and between 1997 and 2017, cigarette use among high school students dropped from 36.4 percent to 7.6 percent.^3,4 Over the years, RWJF has continued to invest resources to prevent young people from smoking, reduce exposure to secondhand smoke, and help smokers quit by focusing on policy and systems changes—such as higher tobacco excise taxes; the spread and enforcement of smoke-free indoor air laws; improved access to evidence-based cessation treatments; and since 2009, FDA’s federal regulation of tobacco products. These investments have contributed to a public health movement that has saved millions of lives.⁵

Despite this tremendous success, the prevalence of tobacco products continue to undermine our efforts to build a Culture of Health and advance health equity. Smoking remains the number one cause of preventable death in the United States and disproportionately harms many at-risk and/or marginalized populations, including: African Americans, American Indians, lower-income people, people who identify as lesbian, gay, bisexual, or transgender; and people with behavioral health and substance use conditions.⁶ In light of the enormous toll that smoking exacts on our society and because we know that almost all tobacco use starts during youth and young adulthood,⁷ it is critical that we continue to reduce  initiation of tobacco products among young people, particularly those from marginalized populations that have been disproportionately harmed by tobacco products.

Reversal of Progress on Youth Smoking

We are deeply concerned that the current marketing of flavored ENDS products, and the ongoing sale of flavored cigars, could reverse the nation’s progress in reducing youth smoking and youth addiction to nicotine, and could exacerbate persistent tobacco-related health disparities. High school students’ increasing use of ENDS “has erased recent progress in reducing overall tobacco product use among youth.”⁸ Between 2009 and 2017, use of any tobacco product among high school students decreased from 23.9 percent⁹ to 19.6 percent.¹⁰ However, in 2018, use of any tobacco product among high school students increased to 27.1 percent.¹¹ This marked increase in overall tobacco use was driven by a sharp rise in e-cigarette use among high school students: during the 2017-2018 period, e-cigarette use grew 77.8 percent, from 11.7 percent to 20.8 percent.¹²

The dramatic increase in ENDS use among youth is concerning, both because ENDS pose direct health risks, and because they may lead to the use of combustible tobacco products. Although

ENDS are generally considered to be less harmful than combustible tobacco products,¹³ they carry significant risks, including for increased nicotine exposure and addiction.¹⁴ Flavored ENDS may carry additional risks: for example, the National Academies of Science, Engineering, and Medicine (NASEM) concluded that, “Independent of nicotine, exposure to particulates and flavorings in e-cigarette aerosols could also potentially impair lung function.”¹⁵

ENDS products also may serve as a gateway to more dangerous, combustible tobacco products. NASEM concluded that there is “substantial evidence that e-cigarette use increases risk of ever using combustible tobacco cigarettes among youth and young adults.”¹⁶ And an analysis of data from the Population Assessment of Tobacco and Health (PATH) study found that from 2013 to 2016, e-cigarette use among youth ages 12 to 15 was associated with more than four times the odds of trying cigarettes, and nearly three times the odds of current cigarette use. The researchers estimate that this translates to over 43,000 current youth cigarette smokers who might not have become smokers without e-cigarettes¹⁷—and that was before the recent surge in ENDS use among youth.

The impact of ENDS on tobacco-related health disparities is still uncertain, but we know that smoking cessation rates are lower among many of the marginalized populations that are disproportionately harmed by tobacco.¹⁸ Therefore, even if these groups are no more likely than other groups to start using ENDS, they may face greater barriers to quitting, and may be at increased risk for long-term addiction.

Cigars are not as popular among high school students as ENDS, but pose greater risks for, and disproportionately harm, black youth. The draft guidance notes that cigarillos expose users to toxic and carcinogenic chemicals and that although the level of nicotine in these products is similar to the levels in cigarettes, the levels of carcinogens that get inhaled and exhaled by smokers of cigarillos may actually exceed the levels in cigarettes.¹⁹ In 2018, almost as many high school students used cigars as cigarettes (7.6 percent v. 8.1 percent), and cigars were the most commonly used tobacco product among black high school students (9.2 percent).²⁰

The sharp increase in ENDS use among high school students, and the persistent use of cigars, likely result, in part, from the advertising tactics used to market these products. According to the Surgeon General, “E-cigarette companies appear to be using many of the advertising tactics the tobacco industry used to persuade a new generation of young people to use their products. Companies are promoting their products through television and radio advertisements that use celebrities, sexual content, and claims of independence to glamorize these addictive product and make them appealing to young people.”²¹ The 2016 National Youth Tobacco Survey (NYTS) found that 78.2 percent of middle and high school students had been exposed to e-cigarette advertisements.²² Another study found that 82 percent of 12-17 year olds, and 88 percent of 18-21 year olds, reported seeing e-cigarette advertising in 2015.²³ Meanwhile, some reports suggest tobacco companies may be continuing to target black youth with candy-flavored cigars.^{24, 25} Youth are receptive to this advertising,²⁶ and multiple studies have shown that exposure to e-cigarette advertising is associated with increased e-cigarette use.²⁷

We need to do more to create supportive retail and online environments that protect youth from these dangerous products. The draft guidance is a step in the right direction, but the final guidance and future rules need to be stronger so that all young people have a fair and just opportunity to achieve their fullest potential.

FDA’s Final Guidance Should Remove All Non-Tobacco ENDS Flavors, Including Mint and Menthol, Until and Unless They Receive an FDA Marketing Order

To protect youth from the risks posed by flavored ENDS products, FDA’s final guidance should: (1) apply to all non-tobacco flavored ENDS products, including mint and menthol; and (2) remove flavored ENDS products until and unless they receive an FDA marketing order.

Mint and Menthol ENDS Flavors Should Be Subject to the Same Enforcement Restrictions as Other Non-Tobacco ENDS Flavors

As FDA has recognized, the availability of flavors likely contributes to the popularity of ENDS among youth. According to the 2016 Surgeon General report, “E-cigarettes are marketed by promoting flavors and using a wide variety of media channels and approaches that have been used in the past for marketing conventional tobacco products to youth and young adults.” ²⁸ Internal FDA analysis of data from the 2016-2017 wave of the Population Assessment of Tobacco and Health (PATH) indicates that, among 12- to 17-year-old ENDS users, 96.1 percent initiate use with a flavored product, 97 percent have used a flavored ENDS product in the past month, and 70.3 percent say they used ENDS products “because they come in flavors I like.” ²⁹ In light of this evidence, it is appropriate that FDA is taking steps to restrict youth access to flavored ENDS.

FDA should, however, apply the same restrictions to mint and menthol ENDS as it does to other flavored ENDS. According to the draft guidance, the agency’s rationale for exempting mint- and menthol-flavored ENDS from its revised compliance policy is that adults exhibit a stronger preference for these flavors than youth do. FDA is concerned that “adults may be at risk of migrating back to cigarettes, which continue to be available in menthol flavor, in the absence of access to mint- and menthol-flavored ENDS products.”³⁰

There are several reasons we believe this rationale is flawed. First, recent evidence indicates that mint and menthol ENDS are popular among youth, and their popularity may be growing. The NYTS found that the percentage of high school ENDS users who reported using menthol- or mint- flavored e-cigarettes in the past 30 days increased from 42.3 percent in 2017 to 51.2 percent in 2018.³¹ This finding was not addressed in the draft guidance and should be considered in the final guidance. The three published studies that were cited in the draft guidance were all based on earlier surveys conducted in 2014 and/or 2015.^32-34 It is also important to note that the two categories of flavors identified in the draft guidance as the most popular—“fruit” and “candy/other sweets”—each include a much broader range of flavors than mint and menthol. It is entirely possible, therefore, that mint and menthol are actually more popular among youth than many of the individual fruit or candy flavors that would be targeted for increased enforcement under the draft guidance.

Second, a recent systematic review found there is not conclusive evidence that flavored e-cigarettes help adult smokers quit or switch from combusted tobacco products.³⁵ It is, therefore, not clear that removing mint or menthol ENDS flavors from the market would actually increase adult smokers’ risk of “migrating back to cigarettes.”

Third, any risk of adults migrating back to cigarettes results from the fact—as acknowledged in the draft guidance—that cigarettes “continue to be available in menthol flavor.”  Therefore, rather than continuing to allow youth to access mint and menthol ENDS flavors, FDA should address this purported risk by issuing a rule that bans the sale of menthol cigarettes. Such a ban would reduce tobacco use and health disparities, and could save millions of lives.³⁶

Finally, there is no evidence in the draft guidance that the sales restrictions it outlines would prevent adults from purchasing the products that are covered by those restrictions. Therefore, it is unclear why applying those restrictions to mint and menthol ENDS flavors would induce adult smokers to return to cigarettes. To be clear, we believe that the sales restrictions in the draft guidance do not go far enough to protect youth from flavored ENDS products, and we acknowledge that the restrictions we recommend would prevent adults from accessing all non-tobacco flavored ENDS products—at least until the manufacturers received FDA market orders for specific flavored products. We provide our rationale for that recommendation in the section below. We want to note in this section, however, that the sales restrictions outlined in the draft guidance would still allow adults to access all flavored ENDS; there is, therefore, no reason to exempt mint and menthol ENDS flavors from those sales restrictions even if there were sufficient evidence that mint and menthol ENDS flavors help smokers quit or switch from cigarettes.

FDA Should Remove All Non-Tobacco ENDS Flavors Until and Unless They Receive a Marketing Order from FDA

In light of the risks associated with ENDS use, the evidence that non-tobacco flavored ENDS products increase youth uptake, and the lack of evidence that flavors help smokers’ quit smoking, FDA should remove all non-tobacco flavored ENDS products that have not received a marketing order. To receive a marketing order for a flavored product, manufacturers should be required to demonstrate that the flavored product helps smokers completely quit using combusted tobacco products and that the public health benefits of the flavoring outweigh the public health burdens associated with the potential for youth initiation.

This approach would incentivize manufacturers to quickly submit complete and accurate marketing applications to FDA to get products back to market that FDA determines are appropriate for the protection of public health. By contrast, under the draft guidance, manufacturers of flavored ENDS products have little incentive to submit applications for FDA review until the August 2021 deadline. Although Commissioner Gottlieb has encouraged manufacturers “not wait to submit premarket tobacco product applications,”³⁷ the draft guidance provides no clear benefits to manufacturers who submit their applications early. By waiting until the 2021 deadline, manufacturers can assure their products will remain on the market, without FDA review, for over two years and, in all likelihood, longer since the draft guidance allows products to remain on the market indefinitely once an application for premarket review has been submitted to FDA. We are concerned that, if FDA implements the premarket application timeline in the draft guidance, the vast majority of manufacturers will wait as long as possible to submit their applications. This could lead FDA to be inundated with marketing applications in August 2021 and could create significant delays in the review process.

Non-tobacco flavored ENDS have been on the market without FDA review for long enough. The National Youth Tobacco Survey began collecting data on e-cigarette use among high school students in 2011.³⁸ In that year, 220,000 or 1.5% of high-school students used e-cigarettes.³⁹ In 2014, FDA issued a proposed rule to deem tobacco products, including e-cigarettes, subject to FDA regulatory authority and noted that e-cigarettes “are being marketed with characterizing flavors, and that these flavors can be especially attractive to youth.”⁴⁰ In 2018, 3.05 million or 20.8% of high school students used e-cigarettes.⁴¹ Given the dramatic increase in ENDS use since 2011 and the sharp acceleration in use between 2017 and 2018,⁴² we cannot afford to allow flavored ENDS to remain on the market for another two years (or more) without undergoing FDA review.

FDA Should Quickly Issue Proposed and Final Rules Banning All Flavored Cigars

We support FDA’s proposal to remove from the market all flavored cigars, including mint and menthol, that entered the market between February 15, 2007 and August 8, 2016. As the draft guidance notes, “Cigars are associated with significant risk and provide no public health benefit.”⁴³ Moreover, flavored cigars appeal to minors and many youth cigar and cigarillo users report that their first cigar or cigarillo was flavored: 25.9 percent for youth who have ever used a traditional cigar, 33.5 percent for youth who have ever used a filtered cigar, and 56.8 percent for youth who have ever used a cigarillo.⁴⁴ Although FDA’s final guidance cannot apply to flavored cigars (or other products) that were on the market as of February 15, 2007, FDA can and should move quickly to issue proposed and final rules banning all flavored cigars.

Conclusion: Building a Culture of Health for the Next Generation

We applaud FDA for recognizing the importance of creating a retail environment for tobacco products that encourages youth to make healthier choices. We are reassured by the tremendous advances our nation has made in reducing the toll of tobacco use, and we believe that, working together, we have the opportunity to finally end the tobacco epidemic and build a Culture of Health for the next generation.

References

¹ The term “tobacco” in this document refers to commercial tobacco, not ceremonial or traditional tobacco. RWJF recognizes the important role that ceremonial and traditional tobacco play for many Tribal Nations, and our tobacco-related work focuses on eliminating the harms and inequities associated with commercial tobacco.

² Center for Public Program Evaluation. 2011. The Tobacco Campaigns of the Robert Wood Johnson Foundation and Collaborators, 1991–2010. Princeton, N.J.: Robert Wood Johnson Foundation. Accessed April 1, 2019. www.rwjf.org/en/library/research/2011/04/the-tobacco-campaigns-.html  

³ Centers for Disease Control and Prevention. 2010. Cigarette Use Among High School Students—United States, 1991–2009. Morbidity and Mortality Weekly Report 59, (26): 797-801. Accessed April 1, 2019. www.cdc.gov/mmwr/preview/mmwrhtml/mm5926a1.htm?s_cid=mm5926a

⁴ Wang, Teresa W., Andrea Gentzke, Saida Sharapova, et al. 2018. Tobacco Product Use Among Middle and High School Students—United States, 2011-2017. Morbidity and Mortality Weekly Report 67 (22): 629-633. Accessed April 1, 2019. www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm

⁵ Holford, Theodore R., Rafael Meza, Kenneth Warner, et al. 2014. Tobacco Control and the Reduction in Smoking-Related Premature Deaths in the United States, 1964-2012. Journal of the American Medical Association 311 (2): 164-171.

⁶ Centers for Disease Control and Prevention. 2018. “Tobacco-Related Disparities.” Last modified March 28. www.cdc.gov/tobacco/disparities/index.htm

⁷ Wang, Teresa W, et al. 2018.

⁸ Gentzke, Andrea S., MeLisa Creamer, Karen A. Cullen, et al. 2019. Vital Signs: Tobacco Product Use Among Middle and High School Students—United States, 2011-2018. Morbidity and Mortality Weekly Report 68 (6): 157-164. Accessed April 1, 2019. www.cdc.gov/mmwr/volumes/68/wr/mm6806e1.htm

⁹ Centers for Disease Control and Prevention. 2012. Current Tobacco Use Among Middle and High School Students—United States, 2011. Morbidity and Mortality Weekly Report 61 (31): 581-585. Accessed April 1, 2019. www.cdc.gov/mmwr/preview/mmwrhtml/mm6131a1.htm

¹⁰ Gentzke, Andrea S., et al. 2019.

¹¹ Gentzke, Andrea S., et al. 2019.

¹² Gentzke, Andrea S., et al. 2019.

¹³ National Academies of Sciences, Engineering, and Medicine (NASEM). 2018. Public Health Consequences of E-Cigarettes. Washington, DC: National Academies Press. Accessed April 1, 2019. www.nationalacademies.org/hmd/Reports/2018/public-health-consequences-of-e-cigarettes.aspx

¹⁴ Office of the Surgeon General. 2016. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Accessed April 1, 2019. https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf

¹⁵ National Academies of Sciences, Engineering, and Medicine (NASEM). 2018.

¹⁶ National Academies of Sciences, Engineering, and Medicine (NASEM). 2018.

¹⁷ Berry, Kaitlyn M, Jessica L. Fetterman, Emilia J. Benjamin, et al. 2019. Association of Electronic Cigarette Use with Subsequent Initiation of Tobacco Cigarettes in US Youths. JAMA Network Open 2 (2): 1-13. Accessed April 1, 2019. doi:10.1001/jamanetworkopen.2018.7794.

¹⁸ Centers for Disease Control and Prevention. 2018.

¹⁹ U.S. Food and Drug Administration. 2019a. Modifications to Compliance Policy for Certain Deemed Products: Guidance for Industry, Draft Guidance. Silver Spring, MD: U.S. Food and Drug Administration. Accessed April 1, 2019. www.federalregister.gov/documents/2019/03/14/2019-04765/modifications-to-compliance-policy-for-certain-deemed-tobacco-products-draft-guidance-for-industry

²⁰ Gentzke, Andrea S., et al. 2019.

²¹ Office of the Surgeon General. 2016.

²² Marynak, Kristy, Andrea Gentzke, Teresa W. Wang, et al. 2018. Exposure to Electronic Cigarette Advertising Among Middle School and High School Students—United States, 2014-2016. Morbidity and Mortality Weekly Report 67(10): 294-299. Accessed April 1, 2019. www.cdc.gov/mmwr/volumes/67/wr/mm6710a3.htm

²³ Truth Initiative. 2015. Vaporized: Youth and Young Adult Exposure to E-Cigarette Marketing. Washington, DC: Truth Initiative. Accessed April 1, 2019. https://truthinitiative.org/research-resources/tobacco-industry-marketing/vaporized-majority-youth-exposed-e-cigarette

²⁴ Edney, Anna, and Jeff Green. 2019. “Tobacco Companies Target Black Teens with Candy Flavored Cigars.” Bloomberg, February 21. www.bloomberg.com/news/articles/2019-02-21/tobacco-companies-target-black-teens- -candy-flavored-cigars Accessed April 1, 2019.

²⁵ Truth Initiative. 2019. “How Tobacco Companies Are Enlisting Music Artists Like Cardi B to Promote Tobacco.” News, April 9. Accessed April 1, 2019. https://truthinitiative.org/news/enlisting-music-artists-like-cardi-b-promote-tobacco-products

²⁶ Pierce, John P., James D. Sargent, Martha M. White. 2017. Receptivity to Tobacco Advertising and Susceptibility to Tobacco Products. Pediatrics 139 (6): 1-10. doi: 10.1542/peds.2016-3353. Accessed April 1, 2019. https://pediatrics.aappublications.org/content/139/6/e20163353

²⁷ Marynak, Kristy, et al. 2018.

²⁸ Office of the Surgeon General. 2016.

²⁹ U.S. Food and Drug Administration. 2019a.

³⁰ U.S. Food and Drug Administration. 2019a.

³¹ Cullen, Karen A., Bridgette K. Ambrose, Andrea S. Gentzke. 2018. Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students—United States, 2011-2018. Morbidity and Mortality Weekly Report 67 (45): 1276-1277. Accessed April 1, 2019. www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm

³² Schneller, Liane M., Maansi Bansal-Travers, Maciej L. Goniewicz, et al. (2018). Use of Flavored Electronic Cigarette Refill Liquids Among Adults and Youth in the US—Results from Wave 2 of the Population Assessment of Tobacco and Health Study (2014-2015). PLOS One 13 (8):e0202744. Doi 10.1371/journal.pone.0202744. Accessed April 19, 2019. https://journals.plos.org/plosone/article/citation?id=10.1371/journal.pone.0202744

³³ Harrell, Melissa B., Scott R. Weaver, Alexandra Loukas, et al. (2017). Flavored E-Cigarette Use: Characterizing Youth, Young Adult, and Adult Users. Preventive Medicine Reports 5: 33-40. Accessed April 1, 2019. www.ncbi.nlm.nih.gov/pmc/articles/PMC5121224/

³⁴ Morean, Meghan E., Ellyn R. Butler, Krysten W. Bold, et al. 2018. Preferring More E-Cigarette Flavors is Associated with E-Cigarette Use Frequency Among Adolescents But Not Adults. PLoS ONE 13 (1): e0189015. Accessed April 1, 2019. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0189015

³⁵ Zare, Samane, Mehdi Nemati, and Yuqing Zheng. 2018. A Systematic Review of Consumer Preference for E-Cigarette Attributes: Flavor, Nicotine Strength, and Type. PLOS One 13 (3): e0194145. doi: 10.1371/journal.pone.0194145. Accessed April 1, 2019. www.ncbi.nlm.nih.gov/pubmed/29543907

³⁶ Robert Wood Johnson Foundation. 2018. “Comments on FDA’s Advanced Notice of Proposed Rulemaking on Regulation of Flavors in Tobacco Products.” Accessed April 1, 2019. https://www.rwjf.org/en/insights/advocacy-and-policy/regulatory-comments/comments-from-richard-besser-on-advanced-notice-of-proposed-rulemaking-on-regulation-of-flavors-in-tobacco-products.html

³⁷ U.S. Food and Drug Administration. 2019b. “Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars.” News & Events. Accessed April 15, 2019. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633291.htm

³⁸ Centers for Disease Control and Prevention. 2015. “E-Cigarette Use Triples Among Middle and High School Students in Just One Year.” Last modified April 16. www.cdc.gov/media/releases/2015/p0416-E-cigarette-use.html

³⁹ Cullen, Karen A., et al. 2019.

⁴⁰ U.S. Food and Drug Administration. 2014. “Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.” Federal Register. U.S. Department of Health and Human Services. Accessed April 16, 2019. www.federalregister.gov/documents/2014/04/25/2014-09491/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the

⁴¹ Cullen, Karen A., et al. 2019.

⁴² Gentzke, Andrea S., et al. 2019.

⁴³ U.S. Food and Drug Administration. 2019a.

⁴⁴ U.S. Food and Drug Administration. 2019a.

About the Robert Wood Johnson Foundation

For more than 45 years the Robert Wood Johnson Foundation has worked to improve health and health care. We are striving to build a national Culture of Health that will enable all to live longer, healthier lives now and for generations to come.For more information, visit www.rwjf.org. Follow the Foundation on Twitter at www.rwjf.org/twitter or on Facebook at www.rwjf.org/facebook.