FDA Moves to Combat the “Epidemic of Youth E-Cigarette Use”

“DSC_0216”by takemetoklinghovillage is licensed under CC BY-NC-SA 2.0

William Malson, Associate Member, University of Cincinnati Law Review

Background

On August 8, 2016, the U.S. Food and Drug Administration (“FDA”) finalized a rule extending its regulatory authority over all tobacco products, including electronic nicotine delivery systems (“ENDS”)—commonly referred to as e-cigarettes.[1] With this rule, all ENDS products were expected to file premarket tobacco product applications with the FDA within two years.[2]Although the FDA has generated 8,600 warning letters and more than 1,000 civil penalties to retailers under the rule, some companies have ignored the law completely,[3] and adolescent use of ENDS products has continued to rise.[4] On September 11, 2019, the FDA announced that it intends to finalize a compliance policy that would prioritize the agency’s enforcement of the application rule for non-tobacco-flavored e-cigarettes, clearing the market of unauthorized products—including all flavors.[5] According to Alex Azar, Secretary of Health and Human Services, the upcoming enforcement is meant to “reverse the deeply concerning epidemic of youth e-cigarette use.”[6]

We’ve been here before. In 2009, the FDA banned cigarettes with “certain kid-appealing flavors” in an effort to protect children from the dangers of cigarettes.[7] Ten years later, it’s not clear that vaping is as big a threat as smoking—or even that the original ban helped. 

Adolescent Vapers: Attracted to the Flavor?

In 2004, 17-year-old smokers were more than three times as likely as those over the age of 25 to smoke flavored cigarettes.[8] According to the director of the FDA’s Center for Tobacco Products in 2009, it was the flavoring that made cigarettes more appealing to youth, prompting a nationwide ban on flavored cigarettes that took effect that year.[9] Today, underage teens are roughly 16-timesas likely to report current use of JUULs[10]— a specific ENDS product that looks like a tall USB flash drive and comes in flavors like Mango, Fruit and Creme.[11] In 2011, less than two percent of high school students reported having used ENDS products in the previous month. By 2015, that number jumped to 16%.[12] In 2018, over 37% of high school seniors reported “any vaping” in the past year.[13]

But it’s not just the flavor that’s attracting teenagers. On July 24, 2019, the Subcommittee on Economics and Consumer Policy of the House Committee on Oversight and Reform heard testimony[14] that JUUL presented to students at school in April 2017 under the guise of an “anti-addiction talk.”[15] According to students present at the talk, the speaker claimed that the FDA would approve JUUL as “99% safer than cigarettes” any day, that it was totally safe, and that the speaker even told one student that he should recommend JUUL to his nicotine-addicted friend who, unbeknownst to the speaker, was in fact the student’s 14 year old classmate who was addicted not to cigarettes, but to JUUL.[16] The speaker even took out a JUUL and showed it to the students, calling it the “iPhone of Vapes.”[17]

The Risks of Vaping

JUUL dominates the vaping market, with a market share of 71.4% as of August 10, 2019.[18] A single JUUL-pod contains either 23mg or 40mg of nicotine, depending on the desired strength.[19] Non-JUUL ENDS products such as “clearomizers”[20]are refillable tanks that hold about 3mL of liquid (“e-liquid”) that comes in various nicotine strengths ranging from 0mg/mL to 24mg/mL.[21] Put in a JUUL-sized pod, that’s up to 16.8mg of nicotine. Cigarettes, although containing up to 12mg of nicotine, only impart roughly 2mg to the user,[22] as most of the drug is removed through the filter or vaporized in the environment.[23] From an addiction perspective, vaping poses serious risks. But the other risks associated with smoking may be significantly lower.

Smoking leads to disease and disability and harms nearly every organ of the body.[24] Cigarettes in particular contain approximately 600 ingredients, releasing more than 7,000 chemicals when burned.[25] 250 of these chemicals are known to be harmful, and 69 are known to cause cancer.[26] In contrast, the only chemicals e-liquid theoretically needs to contain are propylene glycol, vegetable glycerin, flavoring, and optionally, nicotine.[27] Flavoring comes in the form of aldehydes such as cinnamaldehyde, which imparts a cinnamon taste,[28] benzaldehyde, which imparts an almond taste,[29] or a combination of any number of flavoring chemicals. But once mixed together, chemicals interact with each other in unexpected ways, creating new substances altogether.[30] One study found upwards of 64 substances in e-liquid—82 when vaped—some of them unidentified.[31]

While vaping is not completely safe, it is certainly safer. According to Michael Blaha, M.D., director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, “there’s almost no doubt that [vaping] expose[s] you to fewer toxic chemicals than traditional cigarettes.”[32] On September 12, 2019, the Centers for Disease Control and Prevention (“CDC”) reported that there have been 380 cases of lung illness and six deaths related to ENDS product use.[33] Compared to the 480,000 deaths annually in the United States from smoking,[34] vapers can take some solace that their chances of serious illness or death are relatively low.[35]

Will the Ban Work?

According to then-commissioner of the FDA, in 2009, the ban on flavored cigarettes was targeted to reduce the number of children who become regular smokers.[36] But did it even work?

FIGURE 1: Estimated percentage of high school students who currently use any tobacco product, any combustible tobacco product, tobacco product types, and selected tobacco products[37]

Cigarette Use Among High School Students — United States, 1991–2009, CDC (Jul. 9, 2010), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5926a1.htm

According to CDC data, shown above, cigarette use declined from above 15% in 2011 to below 10% in 2017. But previous CDC data indicate that cigarette use was already on the decline.

FIGURE 2. Percentage of high school students who had ever smoked cigarettes, were current cigarette users, and were current frequent cigarette users.[38]

Cigarette Use Among High School Students — United States, 1991–2009, CDC (Jul. 9, 2010), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5926a1.htm

For current cigarette use, the prevalence increased from 27.5% in 1991 to 36.4% in 1997, declined to 21.9% in 2003, and then declined more gradually, to 19.5% in 2009. For current frequent cigarette use, the prevalence increased from 12.7% in 1991 to 16.8% in 1999, declined to 9.7% in 2003, and then declined more gradually, to 7.3% in 2009. For all three measures, rates began to decline in the late 1990s, but the rate of decline slowed during 2003—2009.

To combat high school student cigarette use, the CDC advocated for “reductions in advertising, promotions, and commercial availability of tobacco products . . . combined with full implementation of communitywide, comprehensive tobacco control programs.”[39]

Perhaps, given the inconclusiveness of the previous ban’s effectiveness, the next step ought to be stricter advertising regulations, instead of eliminating thousands of vape shops and potentially hundreds of thousands of jobs.[40]


[1]Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS), FDA (current as of Sept. 12, 2019), https://www.fda.gov/tobacco-products/products-ingredients-components/vaporizers-e-cigarettes-and-other-electronic-nicotine-delivery-systems-ends [https://perma.cc/5HKF-U7C4].

[2]See Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products, FDA (Sept. 11, 2019), https://www.fda.gov/news-events/press-announcements/trump-administration-combating-epidemic-youth-e-cigarette-use-plan-clear-market-unauthorized-non [https://perma.cc/9FC8-QEYG]; Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products, U.S. Dep’t of Health & Hum. Serv. (Sept. 11, 2019), https://www.hhs.gov/about/news/2019/09/11/trump-administration-combating-epidemic-youth-ecigarette-use-plan-clear-market.html [https://perma.cc/PZS2-CFQM].

[3]Devin Coldewey, FDA says Juul “ignored the law’ and warns it may take action, TechCrunch (Sept. 9, 2019), https://techcrunch.com/2019/09/09/fda-says-juul-ignored-the-law-and-warns-it-may-take-action/ [https://perma.cc/G7PY-E5X4].

[4]See FDA, supranote 2; Teens using vaping devices in record numbers, Nat’l Inst. on Drug Abuse (Dec. 17, 2018), https://www.drugabuse.gov/news-events/news-releases/2018/12/teens-using-vaping-devices-in-record-numbers [https://perma.cc/VGY7-THDB].

[5]See FDA, supra note 2.

[6]Id.

[7]Menthol and Other Flavors in Tobacco Products, FDA (current as of Jul. 20, 2018), https://www.fda.gov/tobacco-products/products-ingredients-components/menthol-and-other-flavors-tobacco-products [https://perma.cc/2B4J-9U4M].

[8]Gardiner Harris, Flavors Banned From Cigarettes to Deter Youths, N.Y. Times (Sept. 22, 2009), https://www.nytimes.com/2009/09/23/health/policy/23fda.html [https://perma.cc/6SPQ-3PAW].

[9]Daniel J. DeNoon, FDA Bans Flavored Cigarettes, WebMD (Sept. 22, 2009), https://www.webmd.com/smoking-cessation/news/20090922/fda-bans-flavored-cigarettes#1 [https://perma.cc/Y5R8-HLTJ].

[10]Salynn Boyles, Survey: Teens Using JUUL E-cigs More Than Young Adults, MedPageToday(Oct. 30, 2018), https://www.medpagetoday.com/pulmonology/smoking/76032 [https://perma.cc/FF3G-ZNPT].

[11]What JUULpod flavors and nicotine strengths does JUUL offer?, JUUL, https://support.juul.com/hc/en-us/articles/360023529913-What-JUULpod-flavors-and-nicotine-strengths-does-JUUL-offer- [https://perma.cc/6JEF-TJWC] (last visited Sept. 13, 2019).

[12]Jessica L. Barrington-Trimis & Adam M. Leventhal, Adolescents’ Use of “Pod Mod” E-Cigarettes — Urgent Concerns, 379 New Eng. J. of Med. 1099, 1099(Sept. 20, 2018).

[13]See Nat’l Inst. on Drug Abuse, supra, note 3.

[14]Examining JUUL’s Role in the Youth Nicotine Epidemic: Part I, House Comm. on Oversight and Reform: Subcomm. on Econ. and Consumer Pol’y(Jul. 24, 2019, 9:00 AM), https://oversight.house.gov/legislation/hearings/examining-juul-s-role-in-the-youth-nicotine-epidemic-part-i [https://perma.cc/AB9G-7TL7].

[15]House Comm. on Oversight and Reform: Subcomm. on Econ. and Consumer Pol’y, Examining JUUL’s Role in the Youth Nicotine Epidemic: Part I, YouTube (Jul. 24, 2019), https://youtu.be/m3iEMrAd83o, at 52:25—53:15.

[16]See Id. at 1:20:20—1:21:20; FDA, Warning Letter: JUUL Labs, Inc. (current as of Sept. 9, 2019), https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/juul-labs-inc-590950-09092019 [https://perma.cc/TB63-DSZ7].

[17]See House Comm. on Oversight and Reform, supra, note 13, at 53:15—53:26.

[18]Angelica LaVito, Juul’s momentum slips as NJOY woos customers with dollar e-cigarettes, CNBC (Aug. 20, 2019, 1:22 PM), https://www.cnbc.com/2019/08/20/juuls-momentum-slips-as-njoy-woos-customers-with-dollar-e-cigarettes.html [https://perma.cc/T847-APK2].

[19]How much nicotine is in a JUULpod?, JUUL, https://support.juul.com/hc/en-us/articles/360026223453-How-much-nicotine-is-in-a-JUULpod- [https://perma.cc/RB6T-SFHM] (last visited Sept. 13, 2019); but seeTalih et al., Characteristics and toxicant emissions of JUUL electronic cigarettes, Tobacco Control: Online(Feb. 11, 2019), https://tobaccocontrol.bmj.com/content/early/2019/02/21/tobaccocontrol-2018-054616.full [https://perma.cc/S35J-J9DN] (finding JUUL to contain 69mg/mL of nicotine, or 48.3mg).

[20]Spyros Papamichail, Atomizers vs. Clearomizers vs Cartomizers: Everything You Need to Know, Vaping360 (Oct. 2, 2018), https://vaping360.com/best-vape-tanks/atomizers-clearomizers-cartomizers/#what-is-a-clearomizer [https://perma.cc/4GMP-23LD].

[21]VU102 Finding Your Nicotine Strength, Mister-E-Liquid (2019), https://www.mister-e-liquid.com/vu102-finding-your-nicotine-strength/ [https://perma.cc/QY9Y-NU8A].

[22]Bernd Mayer, How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century, 88 Archives of Toxicology 5, 5 (2014).

[23]Vieira et al., Quantification of Nicotine in Commercial Brand Cigarettes, 38 Biochemistry and Molecular Biology Educ. 330, 331(2010).

[24]Smoking & Tobacco Use: Fast Facts,CDC (last reviewed Feb. 6, 2019), https://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm [https://perma.cc/8BT7-2246].

[25]What’s In a Cigarette?, Am. Lung Ass’n (last updated Aug. 20, 2019), https://www.lung.org/stop-smoking/smoking-facts/whats-in-a-cigarette.html [https://perma.cc/5U8Q-CGFM].

[26]Harms of Cigarette Smoking and Health Benefits of Quitting, Nat’l Cancer Inst. (last reviewed Dec. 19, 2017), https://www.cancer.gov/about-cancer/causes-prevention/risk/tobacco/cessation-fact-sheet#what-harmful-chemicals-does-tobacco-smoke-contain [https://perma.cc/BSE9-CFD7].

[27]What are the Ingredients in Vape Juice?, blu (Jul. 3, 2017), https://www.blu.com/en/US/what-are-the-ingredients-in-e-liquid.html [https://perma.cc/ZR9J-HRNH].

[28]Showing metabocard for Cinnamaldehyde (HMDB0003441), The Hum. Metabolome Database, http://www.hmdb.ca/metabolites/HMDB0003441 [https://perma.cc/V8ZM-LBDX] (last visited Sept. 13, 2019).

[29]Showing metabocard for Benzaldehyde (HMDB0006115), The Hum. Metabolome Database, http://www.hmdb.ca/metabolites/HMDB0006115 [https://perma.cc/YK5C-4297] (last visited Sept. 13, 2019).

[30]Erythropel et al., Formation of flavorant—propylene Glycol Adducts with Novel Toxicological Properties in Chemically Unstable E-Cigarette Liquids, 21 Nicotine & Tobacco Res. 1248, 1248 (2019).

[31]Herrington, JS & Myers, C, Electronic cigarette solutions and resultant aerosol profile, 1418 J. of Chromatography A 192, 192 (2015).

[32]Michael Joseph Blaha, 5 Vaping Facts You Need to Know, John Hopkins Med.(2019), https://www.hopkinsmedicine.org/health/wellness-and-prevention/5-truths-you-need-to-know-about-vaping [https://perma.cc/LQ44-RTTU].

[33]Outbreak of Lung Disease Associated with E-Cigarette Use, or Vaping, CDC (Sept. 12, 2019), https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html [https://perma.cc/N94Z-Q2Y6].

[34]See CDC, supra note 21.

[35]A rate of 480,000 deaths for approximately 40 million adult smokers in the U.S. equals a mortality risk of 1.2%, or 1 in 83.3. About 3.7% of adults used e-cigarettes in 2014, translating to 9.06 million vapers. A rate of 386 serious illnesses or deaths for those 9.06 million vapers equals a risk of 0.0043%, or 1 in 23,467. SeeSmoking & Tobacco Use: Data and Statistics, CDC(last reviewed Feb. 28, 2019), https://www.cdc.gov/tobacco/data_statistics/index.htm [https://perma.cc/R4NY-EB5P]; Charlotte A. Schoenborn & Renee M. Gindi, Electronic Cigarette Use Among Adults: United States, 2014, CDC(Oct. 2015), https://www.cdc.gov/nchs/data/databriefs/db217.pdf [https://perma.cc/6TGJ-5BBP]; Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States, States, Counties, and Puerto Rico Commonwealth and Municipios: April 1, 2010 to July 1, 2018: 2018 Population Estimates, U.S. Census Bureau: Am. Fact Finder, 4 (Apr. 1, 2018), https://factfinder.census.gov/faces/nav/jsf/pages/community_facts.xhtml (click on “Age” on the left sidebar, then “Annual Population Estimates for Selected Age Groups by Sex” in the body of the page, then “Print” under Actions). 

[36]See Harris, supra, note 6.

[37]Gentzke et al., Vital Signs: Tobacco Product Use Among Middle and High School Students — United States, 2011-2018,CDC(last reviewed Feb. 14, 2019), https://www.cdc.gov/mmwr/volumes/68/wr/mm6806e1.htm?s_cid=osh-vs-mmwr-full-001 [https://perma.cc/GLB4-SLQT].

[38]Cigarette Use Among High School Students — United States, 1991–2009, CDC (Jul. 9, 2010), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5926a1.htm [https://perma.cc/XR9W-NWJY].

[39]Id.

[40]The number of vape shops in the U.S. is difficult to pin down. One study looking at the proximity of vape shops to college campuses identified 9,945 shops in 2015. In 2014, the Smoke-Free Alternatives Trade Association, a vaping industry group, estimated the number of vape shops in the U.S. to be 35,000. To complicate matters, smoke shops, which sell traditional tobacco products and added ENDS products to their inventory, might number over a hundred thousand: California alone claims to regulate more than “34,000 retailers with tobacco licenses and vape shops.” SeeHongying Dai & Jianqiang Hao, Geographic density and proximity of vape shops to colleges in the USA, 26 TOBACCO CONTROL 379, 379 (2017); Mike Esterl, Big Tobacco’s E-Cigarette Push Gets a Reality Check, The Wall St. J.(Aug. 26, 2014, 2:38 PM), https://www.wsj.com/articles/big-tobaccos-e-cig-push-gets-a-reality-check-1409078319 [https://perma.cc/7UHF-SUFB]; New California Tobacco Laws Go Into Effect,Cal. Dep’t. of Pub. Health(Jun. 9, 2016), https://www.cdph.ca.gov/Programs/OPA/Pages/NR16-035.aspx [https://perma.cc/A2MY-PUDY].