Comment to U.S. Food and Drug Administration Regarding Modifications to Compliance Policy for Certain Deemed Tobacco Products
Comment to U.S. Food and Drug Administration urging the agency to reconsider modifying their finalized rule to hasten the deadline for manufacturers of flavored tobacco products to submit their Premarket Tobacco Product Applications.
Dr. Norman Sharpless
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE: Docket No. 2019-04765: Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry; Availability
Dear Acting Commissioner Sharpless:
The Food and Drug Administration (FDA) has signaled its intent to modify the agency’s compliance policy for certain deemed tobacco products, namely electronic cigarettes and vaping devices. The agency plans on limiting the availability of flavored tobacco products and moving up the date manufacturers must submit pre-market tobacco product applications (PMTAs) from August 8, 2022, to August 8, 2021.
As a nonprofit organization that has defended smokers’ rights for decades, The Heartland Institute fears this action by FDA will eliminate access to tobacco harm reduction (THR) products, which have helped an estimated three million U.S. adults quit smoking.
FDA officials say they are merely responding to what the agency has declared an “epidemic” of youth e-cigarette use. While FDA’s concern is laudable, removing flavored products from the market will significantly eliminate many THR products for adults who use these tools to help them quit smoking tobacco. Additionally, reducing the timeframe for manufacturers to submit PMTAs would force many companies to close, as these applications are expensive and extremely time-consuming.
Moreover, as the agency’s 2016 deeming regulations also applied to other tobacco products, including cigars, this current modification could punish manufacturers that are currently not under scrutiny.
Prior to 2016, FDA “regulated cigarettes, smokeless, and roll-your-own tobacco.”[i] In 2016, FDA issued a final rule that extended FDA’s authority so that it can regulate all tobacco products, including cigars, hookah tobacco, and even e-cigarettes, which don’t include tobacco.
The regulations require manufacturers and retailers to comply with FDA regulations, including a lengthy and expensive study process known as a “premarket tobacco application.” Beginning on August 8, 2016, no new e-cigarette or tobacco product can come to the U.S. market unless it acquires a premarket tobacco application by FDA.
Based on FDA’s rule, newly deemed tobacco product manufacturers must request approval from the agency by August 8, 2022, before they can market their products.[ii] The current proposed modifications would reduce manufacturers’ time for compliance by one year and could significantly reduce the number of manufacturers in the marketplace.
E-cigarettes have emerged as an effective tool for helping smokers quit using tobacco. An Annals of Internal Medicine study estimated that of the nearly 10 million U.S. adult vapers in the United States, three million have quit smoking using e-cigarettes.[iii]
Moreover, clinical trials have produced significant evidence showing e-cigarettes are a useful smoking-cessation tool. In 2016, the Royal College of Physicians (RCP), one of the world’s oldest and most prestigious medical societies, responded to claims that e-cigarettes do not help smokers quit in a landmark report, titled Nicotine Without Smoke: Tobacco Harm Reduction. RCP noted “the available evidence to date indicates that e-cigarettes are being used almost exclusively as safer alternatives to smoked tobacco, by confirmed smokers who are trying to reduce harm to themselves or others from smoking, or to quit smoking completely.”[iv]
A more recent study, published in 2019 in The New England Journal of Medicine, found e-cigarettes are twice as effective as nicotine replacement therapy (NRT) in helping smokers quit.[v] The authors noted of the 100 participants reporting abstinence during a 52-week follow up, “80% … were using e-cigarettes ... and 9% were using” NRT products in the NRT group.[vi]
It’s important to note FDA’s modifications apply only to flavored tobacco products, excluding tobacco, menthol, and mint flavored tobacco products. Flavors are a crucial component of e-cigarettes and vaping devices.
A 2013 International Journal of Environmental Research and Public Health study concluded that flavors in e-cigarettes “appear to contribute to both perceived pleaser and the effort to reduce cigarette consumption or quit smoking.”[vii]
A 2015 online survey conducted by the Consumer Advocates for Smoke-Free Alternatives Association examined 27,343 Americans over the age of 18. Seventy-two percent of the respondents “credited tasty flavors with helping them give up tobacco.”[viii] Of the respondents that were still smoking, “53% say interesting flavors are helping move them toward quitting.”
A 2017 study discovered older adults “use of an e-cigarette flavored with something other than tobacco (69.3%) was … significantly higher than the same at initiation (44.1%).”[ix] Thus, e-cigarette users often first consume tobacco flavored e-liquids and products but then transition to other flavors, helping aid their cessation of combustible cigarettes.
Another 2017 study examined the impact of a flavor ban in electronic cigarettes and vaping devices. The authors concluded banning flavors “would result in increased choice of combustible cigarettes,” and they said they expect e-cigarette use to decline by approximately 10 percent if flavors are banned.[x]
A 2018 “systematic review of research examining consumer preference” for flavors concluded adults “in general also preferred sweet flavors,”[xi] and a 2018 survey of nearly 70,000 American adult vapers “found flavors play a vital role in the use of electronic cigarettes and vaping devices.”[xii] Eighty-three percent and 72 percent of survey respondents reported vaping fruit or dessert flavors, respectively, “at least some of the time.”[xiii]
Moreover, research by Dr. Edward Anselm, R Street Institute senior fellow and medical director of Health Republic Insurance of New Jersey, concluded the presence of flavorings in e-cigarettes greatly helps smokers quit using traditional tobacco cigarettes. Anselm also notes concerns over “flavoring as a tool to recruit children are overblown,” and he rightly points out there are no specific “kids flavors” for e-cigarettes.[xiv] There is no “evidence that suggests children are drawn to tobacco products specifically because of flavor.”
FDA’s effort to modify the deeming regulations would ultimately restrict access to products that have helped millions of adult smokers quit using tobacco, and thus presumably force many current vapers back to combustible cigarettes, ultimately harming public health.
FDA’s proposed modification would force flavored cigar manufacturers to submit PMTAs in a shortened time period, despite there being no evidence of a cigar-use epidemic among youth.
According to the Centers for Disease Control and Prevention, 7.6 percent of high school students reported cigar use in 2018.[xv] This is down from 7.7 percent of high school students reporting cigar use in 2016.[xvi] Recent data also indicates cigar use is greater among adults, with “more than half cigar sales are to white males between the ages of 25-44.”[xvii]
Additionally, evidence indicates adults enjoy flavored cigars. In an analysis from the 2009–10 National Adult Tobacco Survey, researchers found 42.9 percent of adult cigar smokers smoked flavored cigars.[xviii] FDA’s proposed modifications to cigars are questionable, as the risks associated with cigars are relatively minimal compared to combustible cigarettes.
Heartland Senior Fellow Brad Rodu examined an FDA staff report that found “smoking up to two cigars a day is associated with minimal significant health risks.”[xix] Rodu notes that although cigar use is not “completely safe,” it is “neither associated with significantly increased risks for death from all causes, nor smoking-related cancers.”
Further, the agency’s proposed regulations will negatively impact a growing market. Sales of cigars grew in 2018, reaching “nearly $3.5 billion, an increase of 11.04%.”[xx]
FDA’s current proposal was created in response to an uptick in youth e-cigarette use. The 2009 Family Smoking Prevention and Tobacco Control Act banned sales of tobacco products to minors.[xxi] All states in the United States restrict tobacco sales to minors, and 14 states have restricted tobacco sales to adults 21 years old or older.[xxii]
The Smoke-Free Alternatives Trade Association provides “Age to Vape” signage to vape shops endorsing local laws “to show that [the] industry supports sensible age restrictions.”[xxiii] More than 1,300 companies participated in the program in 2015.[xxiv] The Consumer Advocates for Smoke Free Alternatives Association “supports laws that prohibit underaged sales and urges strict enforcement of laws” that ban access to e-cigarettes for young people.[xxv]
Associations representing vaping manufacturers also support banning sales and marketing to minors. The American E-Liquid Manufacturing Association (AEMSA) “advocates electronic cigarette products for adult use only.”[xxvi] AEMSA supports a “ban on sales to minors.” The Vapor Technology Association requires members to “refrain from knowingly marketing Vapor Products to Minors, which is strictly prohibited.”[xxvii]
Additionally, many tobacco companies that are now selling e-cigarettes are continuing to discourage and prevent youth access to these THR products. The R.J. Reynolds Vapor Company is the manufacturer of Vuse, a brand of e-cigarettes. In a 2016 interview, Reynolds American, Inc. noted the company does not advertise to minors. The company’s advertising of Vuse “is in line with [their] commitment to reducing youth exposure to tobacco-related products and messaging.”[xxviii]
Altria is another company that sells tobacco and THR products, including smokeless tobacco and electronic cigarettes. Over the past 20 years, Altria has funded programs aimed at reducing underage tobacco usage, including its “Talk. They’ll Listen” campaign on television, radio, and in print; the Parent Resource Center; Teenage Attitudes and Behavior Study; and by implementing an underage tobacco sales prevention policy.[xxix] In 2013, Altria invested more than $21 million in its Success 360° program, designed to help “organizations better deliver effective programs to middle school kids by promoting health development and avoiding risky behaviors like tobacco use.”[xxx]
In 2018, JUUL, the manufacturer of some of the most popular vaping devices, announced it “will invest $30 million over three years in strategies” to prevent youth access to its e-cigarettes.[xxxi]
FDA’s decision to move forward the date for PMTAs to be submitted will threaten harm reduction and choice for millions of American adults. The agency should instead consider its current timeline and the efforts the industries of both e-cigarettes and flavored cigars are doing to address youth use.
State Government Relations Manager
The Heartland Institute
[i] U.S. Food and Drug Administration, “FDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products,” June 14, 2018, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products.
[ii] U.S. Food and Drug Administration, “Premarket Tobacco Product Applications,” May 10, 2018, https://www.fda.gov/tobacco-products/tobacco-product-review-evaluation/premarket-tobacco-product-applications.
[iii] Mohammadhassan Mirbolouk, MD, et al., “Prevalence and Distribution of E-Cigarette Use Among U.S. Adults: Behavioral Risk Factor Surveillance System, 2016,” Annals of Internal Medicine, October 2, 2018, https://annals.org/aim/article-abstract/2698112/prevalence-distribution-e-cigarette-use-among-u-s-adults-behavioral.
[iv] Royal College of Physicians, Nicotine without Smoke: Tobacco Harm Reduction, April 2016, https://www.rcplondon.ac.uk/projects/outputs/nicotinewithout-smoke-tobacco-harm-reduction-0.
[v] Peter Hajek, Ph.D., et al., “A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy,” The New England Journal of Medicine, January 30, 2019, https://athra.org.au/wp-content/uploads/2019/01/Hajek-P.-A-randomised-trial-of-e-cigarettes-versus-nicotine-replacement-therapy.-NEJM-2019.pdf.
[vi] Lindsey Stroud, “Research & Commentary: Randomized Trial Finds E-Cigarettes Are More Effective Cessation Tool Than Nicotine Replacement Therapy,” Research & Commentary, The Heartland Institute, February 11, 2019, https://www.heartland.org/publications-resources/publications/research--commentary-randomized-trial-finds-e-cigarettes-are-more-effective-smoking-cessation-tool-than-nicotine-replacement-therapy.
[vii] Konstantinos Farsalinos et al., “Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey,” International Journal of Environmental Research and Public Health, December 17, 2013, https://www.mdpi.com/1660-4601/10/12/7272/htm.
[viii] Vape Ranks, “Large Survey Finds E-Cigarettes Do Help Smokers Quit,” January 12, 2016, https://vaperanks.com/large-survey-finds-e-cigarettes-do-help-smokers-quit/.
[ix] M.B. Harrell et al., “Flavored e-cigarette use: Characterizing youth, young adult, and adult users,” Preventative Medicine Reports, March 2017, pp. 33-40, https://www.sciencedirect.com/science/article/pii/S2211335516301346.
[x] John Buckell, Joachim Marti, and Jody L. Sindelar, “Should Flavors Be Banned in E-Cigarettes? Evidence on Adult Smokers and Recent Quitters from a Discrete Choice Experiment,” National Bureau of Economic Research, September 2017, http://www.nber.org/papers/w23865.pdf.
[xi] Samane Zare et al., “A systematic review of consumer preference for e-cigarette attributes: Flavor, nicotine strength, and type,” PLoS ONE 13(3): e0194145. https://doi.org/10.1371/journal.pone.0194145.
[xii] Lindsey Stroud, “Research & Commentary: Largest Vaping Survey Finds Flavors Play Important Role in Tobacco Harm Reduction,” Research & Commentary, The Heartland Institute, October 2, 2018, https://www.heartland.org/publications-resources/publications/research--commentary-largest-vaping-survey-finds-flavors-play-important-role-in-tobacco-harm-reduction.
[xiii] Ali Anderson, “Ex Smokers Prefer Fruity E-Liquids Says Doctor’s FDA Survey,” Vaping, August 14, 2018, https://vaping.com/blog/news/ex-smokers-prefer-fruity-e-liquids-says-doctors-fda-survey/.
[xiv] Edward Anselm, “The Role of Flavoring in Tobacco Harm Reduction,” R Street Policy Study, R Street Institute, December 2015, https://2o9ub0417chl2lg6m43em6psi2i-wpengine.netdna-ssl.com/wp-content/uploads/2018/04/RSTREET49-1.pdf.
[xvi] Centers for Disease Control and Prevention, “Tobacco Use Among Middle and High School Students – United States, 2011-2016,” Morbidity and Mortality Weekly Report, June 16, 2017, https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm?s_cid=mm6623a1_w.
[xvii] Howard Riell, “Cigars Hot for Now,” Convenience Store Decisions, February 11, 2019, https://cstoredecisions.com/2019/02/11/cigars-hot-for-now/.
[xviii] Brian A. King, Ph.D., et al., “Flavored Cigar Smoking Among U.S. Adults: Findings From the 2009-2010 National Adult Tobacco Survey,” Nicotine & Tobacco Research, June 24, 2012, http://misrgo.org/PDFS/NTR-Flavored-Cigars-nts178.pdf.
[xix] Brad Rodu, “FDA Study: Cancer Risks Nearly Nil for 1-2 Cigars Per Day,” Tobacco Truth, August 24, 2016, https://rodutobaccotruth.blogspot.com/2016/08/fda-study-cancer-risks-nearly-nil-for-1.html.
[xx] Howard Riell, supra note 17.
[xxi] U.S. Food and Drug Administration, “Family Smoking Prevention and Tobacco Control Act – An Overview,” January 17, 2018, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview#youth.
[xxii] Robert Langreth, “Walgreens Will Raise Age to 21 for Buying Tobacco Products,” Bloomberg, April 23, 2019, https://www.bloomberg.com/news/articles/2019-04-23/walgreens-will-raise-the-age-for-buying-tobacco-products-to-21.
[xxiii] Alyssa Stahr, “Support SFATA Today By Signing Up For Age To Vape Program,” Vape News, December 21, 2015, https://vapenews.com/vape-news/support-sfata-today-by-signing-up-for-age-to-vape-program/.
[xxiv] Cynthia Cabrera, “Perception Vs. Reality,” Vape News, August 22, 2015, https://vapenews.com/august-2015/perception-vs-reality/.
[xxvii] Vapor Technology Association, “Marketing Standards for Membership,” January 2018, https://vaportechnology.org/wp-content/uploads/2016/08/VTA-Marketing-Standards-for-Membership-FINAL-January-2018.pdf.
[xxviii] Zach Brooke, “What Recent FDA E-cigarette Regulations Mean for Marketers,” American Marketing Association, November 16, 2016, https://www.ama.org/publications/MarketingHealthServices/Pages/what-new-e-cigarette-regulation-means-for-marketers.aspx.
[xxix] “Underage Tobacco Prevention – Select Historical Documents,” Philip Morris USA, http://www.altria.com/Responsibility/Tobacco-Harm-Reduction/Helping-Reduce-Underage-Tobacco-Use/Documents/PMUSA-Select-Historical%20Programs.pdf.
[xxx] “2013 Annual Report,” Altria Group, Inc., 2013, http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9Mjc5MTc4fENoaWxkSUQ9LTF8VHlwZT0z&t=1.
[xxxi] Laura Kelly and Tom Howell Jr., “JUUL, maker of popular e-cigarettes invests $30M in youth awareness,” The Washington Times, April 25, 2018, https://www.washingtontimes.com/news/2018/apr/25/juul-maker-popular-e-cigarettes-invests-30m-youth-/.