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Testimony Before the New Jersey Governor’s Electronic Smoking Device Task Force regarding adult use of electronic cigarettes and vaping devices

September 24, 2019

Testimony Before the New Jersey Governor’s Electronic Smoking Device Task Force regarding adult use of electronic cigarettes and vaping devices and solutions to address youth usage while maintaining adult access to such products.

Testimony Before the New Jersey Governor’s Electronic Smoking Device Task Force
Lindsey Stroud, State Government Relations Manager
The Heartland Institute
September 24, 2019

 

 

Chairwoman Perischilli and Members of the Committee:

 

Thank you for taking the time today to discuss the issue of adult use of electronic cigarettes and vaping devices. My name is Lindsey Stroud. I’m a state government relations manager at The Heartland Institute, a 35-year-old independent, national, nonprofit organization whose mission is to discover, develop, and promote free-market solutions to social and economic problems. Heartland is headquartered in Illinois and focuses on providing national, state, and local elected officials with reliable and timely research and analyses on important policy issues. In my role at Heartland, I have extensively studied the use of tobacco harm reduction products, including electronic cigarettes and vaping devices. In 2017, I co-authored, Vaping, E-Cigarettes, and Public Policy Toward Alternatives to Smoking. This year, I authored Tobacco Harm Reduction 101: A Guidebook for Policy Makers. Additionally, I have written numerous Research & Commentaries and several op-eds on e-cigarettes. I also host a Heartland Podcast series: Voices of Vapers. Heartland would like to submit the following testimony.

 

Electronic Cigarettes & Vaping Devices

Introduced to the U.S. market in 2007, there are different types of e-cigarettes and vapor products: “first generation or so-called cig-alikes, second-generation tank systems, and even larger third-generation or personal vaporizers.”[1] Cig-alikes are similar in size and shape to traditional cigarettes. They are typically composed of three parts: a cartridge that contains an e-liquid with or without nicotine, an atomizer used to heat the e-liquid to vapor, and a battery. The second and third-generation models, also known as “vaping” devices, are sub grouped into two categories: closed and open systems. Closed systems contain a disposable cartridge the user discards after consumption. Open systems contain a tank users can refill with e-liquid. Like cig-alikes, closed and open vaping systems contain an e-liquid, an atomizer with a heating element, and a battery, as well as other electronic components. Unlike the cig-alikes, however, the vaping systems are customizable, with users choosing their own modules, or “mods,” as well as flavorings and nicotine level.

E-cigarettes are regulated. The U.S. Food and Drug Administration (FDA) has had authority to regulate e-cigarettes since 2012.  In 2016, FDA issued deeming regulations that extended the agency’s regulatory authority to include electronic cigarettes and other THR products.[2] All companies “engaged in the preparation, manufacture, compounding, repackaging, relabeling or processing of finished tobacco products” now must register with FDA.[3] FDA’s regulations require e-cigarette manufacturers to comply with regulations governing tobacco, including completing a lengthy and expensive study process called the “premarket tobacco application” (PMTA). Beginning on August 8, 2016, no new e-cigarette product, including flavors and nicotine products, can be sold in the United States without first receiving premarket tobacco application approval from FDA. This one requirement alone will have a devastating effect on the industry. FDA estimates each PMTA will cost $330,000.[4]

E-cigarettes have emerged as an effective smoking cessation tool, with a recent study in the New England Journal of Medicine finding their use to be “twice as effective” as nicotine replacement therapy (i.e. gums and lozenges), in helping smokers quit.[5] Since their introduction to the U.S. market, an estimated three million American adults have used these products to quit combustible cigarettes.[6]

 

Health Effects of Electronic Cigarettes & Vaping Devices

Despite recent media reports, e-cigarettes are significantly less harmful than combustible cigarettes. Public health statements on the harms of e-cigarettes include:

●       Public Health England: In 2015, Public Health England, a leading health agency in the United Kingdom and similar to the FDA found “that using [e-cigarettes are] around 95% safer than smoking,” and that their use “could help reducing smoking related disease, death and health inequalities.”[7] In 2018, the agency reiterated their findings, finding vaping to be “at least 95% less harmful than smoking.”[8]

●       The Royal College of Physicians: In 2016, the Royal College of Physicians found the use of e-cigarettes and vaping devices “unlikely to exceed 5% of the risk of harm from smoking tobacco.”[9] The Royal College of Physicians (RCP) is another United Kingdom-based public health organization, and the same public group the United States relied on for its 1964 Surgeon General’s report on smoking and health. 

●       The National Academies of Sciences, Engineering, and Medicine: In January 2018, the academy noted “using current generation e-cigarettes is less harmful than smoking.”[10]

●       The American Cancer Society: Most recently, the American Cancer Society noted that “e-cigarette use is likely to be significantly less harmful for adults than smoking regular cigarettes.”[11] This is attributed to the fact that “e-cigarettes do not contain or burn tobacco.”

A 2017 study in BMJ’s peer-reviewed journal Tobacco Control examined health outcomes using “a strategy of switching cigarette smokers to e-cigarette use … in the USA to accelerate tobacco control progress.”[12] The authors concluded that replacing e-cigarettes “for tobacco cigarettes would result in an estimated 6.6 million fewer deaths and more than 86 million fewer life-years lost.”

Role of Flavors in Electronic Cigarettes & Vaping Devices

E-cigarette flavors have a vital role in moving and keeping people away from combustible cigarettes. Restrictions on flavors could lead former smokers back to cigarettes. Evidence of flavor presence exists in use of smokeless tobacco, which is also considered a tobacco harm reduction tool.

A 2013 study examined data from five studies on smokeless tobacco use to gauge users’ “choice of brand flavor.”[13] Researchers noted that a majority of respondents’ “first and current choice of product was flavored, specifically mint or wintergreen.” The analysis also found a significant number of smokeless tobacco users moved to flavored smokeless tobacco after using non-flavored smokeless tobacco at initiation. Despite growing alarmism, the researchers noted that “flavored products did not appear to lead to greater dependence or increased exposure to nicotine or carcinogens.”

Additional research has been dedicated to the role of flavorings in e-cigarettes and vaping devices.

●       A 2013 study by the Onassis Cardiac Surgery Center concluded flavors in e-cigarettes “appear to contribute to both perceived pleasure and the effort to reduce cigarette consumption or quit smoking.”[14]

●       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 “credit[ed] interesting flavors with helping them quit.”[15] 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%).”[16]

●       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.”[17] Moreover, 83.2 percent and 72.3 percent of survey respondents reported vaping fruit and dessert flavors, respectively, “at least some of the time.”[18]

Restrictions on flavors could drive former smokers back to combustible cigarettes. A 2017 study by the National Bureau of Economic Research 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.[19] Additionally, a 2018 “systematic review of research examining consumer preference” for flavors concluded adults “in general also preferred sweet flavors.”[20]

Flavor Bans Are Unlikely to Reduce Youth Use of E-Cigarettes

As flavor bans are relatively new policies, there is little data on the long-term effects of such prohibitions. However, The Heartland Institute recently analyzed the California Youth Tobacco Survey (CYTS), finding that flavor bans have not reduced youth use of electronic cigarettes and vaping devices.[21]

Santa Clara County, California, banned flavored tobacco products to age-restricted stores in 2014. To purchase a flavored tobacco product in the county, the retail establishment must bar persons under 21 from entering. Despite this, data from the 2017-18 California Student Tobacco Survey for Santa Clara County found “the vast majority of high school students (82.3%) in Santa Clara County who were current tobacco users reported using a flavored tobacco product.”[22] Popular flavored products included “current hookah users (82.9%), e-cigarette users (82.6%), and [little cigars] users (82.3%).” Regarding combustible cigarettes, 62.9 percent of respondents “reported using menthol/mint cigarettes in the last 30 days.”

More pointedly, youth e-cigarette use in Santa Clara County has increased while the flavor ban has been in effect. For example, in the 2015-16 CYTS, 7.5 percent of Santa Clara high school students reported current use of e-cigarettes.[23] In the 2017-18 CYTS, this increased to 10.7 percent.[24]

Contra Costa County, another municipality in California that has restricted the sale of flavored e-cigarettes, has also experienced a recent increase in youth vaping rates. Although the 2015-16 CYTS survey encompassed other localities including Marin, San Francisco, San Mateo, and Solana, the 2017-2018 CYTS survey reported only on Contra Costa. In 2015-16, 8.3 percent of high school students in the various localities reported current use of electronic cigarettes and vaping devices. In the 2017-18 CYST survey of solely Contra Costa County high school students, this number increased to 17.2 percent reporting current e-cigarette use.

Further, banning certain types of e-cigarette products could increase youth use of other tobacco products, including combustible cigarettes. Existing data reveal regulations on e-cigarettes increase youth combustible cigarette use. After initiating a task force to combat youth e-cigarette sales, Lancaster County, Nebraska reported sales of vaping products to minors decreased “from 21.2 percent in 2017 to 5.3 percent in 2018.”[25] Meanwhile, sales of non-vaping tobacco products increased during the same period, from 5.9 to 8.7 percent. A 2015 study by the Yale School of Public Health reached similar conclusions, finding bans on the sales of e-cigarettes to youth increased smoking rates by “1.0 percentage point.”[26]

Tobacco 21 (T-21) is another restrictive policy that has had little effect on youth e-cigarette use.[27]

Hawaii was the first state to raise the tobacco purchasing age to 21, which went into effect January 1, 2016. In 2015, 22.2 and 5.0 percent of Hawaiian high school and middle school students, respectively, reported ever using an e-cigarette product, according to the 2015 Hawai’i Youth Tobacco Survey.[28] Moreover, 12.9 percent of high school students and 7.6 percent of middle school students reported current e-cigarette use, or any use of an e-cigarette product within 30 days of the survey.

Despite T-21 taking effect in 2016, data from the 2017 Hawai’i Youth Tobacco Survey found e-cigarette use among high school and middle school students actually increased.[29] In 2017, 39.4 percent of high school students reported use of e-cigarettes—a 43 percent rise. Additionally, Hawaiian high school students reporting current use of e-cigarettes (within the past 30 days) also increased to 20.9 percent—a 38 percent surge.

What’s more, Hawaiian middle school students’ use of e-cigarettes also increased. In 2017, 21.9 percent of middle school students reported e-cigarette use—an increase of 77 percent from 2015. Current e-cigarette use among middle school students grew to 11.5 percent.

Benefits of Nicotine

Although nicotine in tobacco is the main reason individuals get hooked on smoking tobacco cigarettes, the nicotine itself is not considered a highly hazardous substance. Nicotine does not cause cancer, nor does it contribute to the development of pulmonary disease or cardiovascular disease.[30]

Nicotine is considered a mild stimulant and/or relaxant. It has many of the same properties as caffeine, a highly addicting substance that’s safely consumed by tens of millions of Americans every single day in a wide variety of products. Both nicotine and caffeine enhance concentration and mental performance, produce a sense of well-being, and elevate mood. Both raise heart rates and blood pressure levels temporarily during use. Additionally, abstinence after regular use of both these substances can be difficult and even “unachievable for many users.”[31]

There is no significant scientific evidence connecting major health problems with the use of nicotine alone. However, because nicotine enters the body along with many harmful chemicals while smoking combustible cigarettes, many erroneously believe that it is the nicotine in cigarettes that causes hazardous health conditions such as cancer.

According to Raymond Niaura, Ph.D., professor of social and behavioral sciences at New York University’s College of Global Public Health, existing evidence “indicates that nicotine itself, while not completely benign, carries substantially lower risks than smoking.”[32] This conclusion is shared by the U.S. surgeon general and the U.K. Royal College of Physicians, which agrees “nicotine, while addictive, is not the primary cause of smoking-related diseases.”[33]

In a comprehensive study of nicotine health effects, Niaura noted “that even very high doses of medicinal nicotine had little effect on cardiovascular function.” Emphasizing “a continuum of harm among combustible and noncombustible, nicotine containing products,” Niaura urged the use of alternative nicotine products, with “the goal of moving users away from the most addictive, appealing and toxic combustibles to less harmful alternatives—ideally FDA approved [modified-risk tobacco products.]”[34]

Latest Vaping-Related Hospitalizations Are Linked to Illicit Products

Recent media headlines have exaggerated claims of vaping-related hospitalizations. To date, no single product has been identified as the cause of such health issues. Further, these hospitalizations are increasingly linked to the use of vaping products containing tetrahydrocannabinol (THC).

Officials in seven states (California, Illinois, Indiana, Kansas, Minnesota, Missouri, and Oregon) have confirmed recent deaths to lung disease in individuals that had reported recent e-cigarette use.[35] [36] [37] [38] [39] [40] [41]

The Oregon Health Authority reported an individual who died in July “had recently used an e-cigarette or vaping device containing cannabis.”[42] The Minnesota Department of Health reported an individual died from a “lung injury [that] was associated with vaping illicit THC products.”[43]

Other states have also linked hospitalizations to the use of THC devices. The Connecticut Department of Public Health “interviewed 9 of the 13 [state] patients with vaping-related injury.”[44] All nine patients reported using THC-containing vaping devices. The Utah Department of Health noted that 90 percent of their state’s patients with vaping-related illnesses “self-reported vaping THC.”[45]

These are similar to findings from the Wisconsin Department of Health Services (WDHS), which first reported vaping-related hospitalizations on July 25, noting the “names and types of products used remain unknown.”[46] On August 29, WDHS reported 89 percent of patients interviewed had “reported using e-cigarettes or other vaping devices to inhale THC products, such as waxes and oils.”[47] WDHS urged residents to stop using products that “may include chemicals or additives that are unknown, unregulated, and unsafe.”

A September 6 report in The New England Journal of Medicine examined hospitalizations in Illinois and Wisconsin. Of the 53 case patients the authors examined, 84 percent “reported having used [THC] products in e-cigarette devices.”[48] Although patients reported “a wide variety of products and devices,” 21 of the 41 patients interviewed stated using a “THC product … marketed under the ‘Dank Vape’ label.” This is alarming because empty packaging for that and other known brands is available for purchase by many online retailers, as well as empty devices, or “cartridges.” Instructions on how to infuse THC in vaping devices is easy to find on YouTube.

Moreover, FDA is urging consumers “to avoid buying vaping products on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.”[49]

Myth: Formaldehyde in E-Cigarettes Poses Health Risks

Opponents of e-cigarettes often assert these products contain harmful levels of formaldehyde. They base this assertion on a New England Journal of Medicine article titled “Hidden Formaldehyde in E-Cigarette Aerosols.”[50] However, there are strong reasons to believe formaldehyde does not pose a risk to e-cigarette users.

The experiment described in the New England Journal of Medicine article produced formaldehyde by overheating e-cigarettes, a process called “dry puffing.” Although this process can result in harmful levels of formaldehyde, the resulting vapor tastes so bad that users do not inhale it. Thus, the formaldehyde produced under these conditions is not “hidden” at all and not dangerous, because it is contained in vapor that users find intolerable.

This finding was verified by a careful examination of the New England Journal of Medicine report.[51] In that study, researchers replicated the overheating technique and compared its results to heating at “lower, normal vaping power.” Under “normal vaping power” conditions, the researchers found levels of formaldehyde were minimal, “only 20 micrograms,” which is about two-thirds the amount of formaldehyde in combustible tobacco cigarettes.[52]

In a separate study, the Centers for Disease Control and Prevention (CDC) sampled air quality in a vape shop after several users had vaped. CDC tested formaldehyde levels in the shop and found they were “well below” various health agencies’ recommended levels of exposure, including the Occupational Safety and Health Administration’s personal exposure limit and action level.

Although e-cigarettes can contain formaldehyde, when used properly, vaping devices produce significantly lower levels of the substance than those reported in the New England Journal of Medicine study and lower than the levels of formaldehyde found in traditional combustible cigarettes.[53]

Myth: E-Cigarettes Cause ‘Popcorn Lung’

Another false claim made by opponents of e-cigarettes is that using these THR products causes the health condition bronchiolitis obliterans, commonly called “popcorn lung.”

In 2015, a study was published in the journal Environmental Health Perspectives that found e-cigarettes contain chemicals linked to popcorn lung, such as diacetyl, acetyl propionyl, and acetoin.[54] These chemical agents are used to provide the “buttery” flavors in e-cigarettes. Of the 51 flavored e-cigarettes tested in the study, flavoring chemicals linked to popcorn lung were found in 47 samples. Diacetyl was determined to be present in 39 samples.

The researchers associated their findings with similar exposures experienced by workers in microwave popcorn factories. These workers have been determined to be susceptible to popcorn lung by established medical research.[55]

The 2015 Environmental Health Perspectives study alarmed public health officials and the media, many of whom claimed e-cigarettes can cause popcorn lung, despite substantial flaws in the research. For example, to analyze the chemicals, the researchers in the Environmental Health Perspectives study “used an aggressive procedure that vaped the samples dry.”[56] The “puffs” analyzed lasted eight seconds, considerably longer than normal “puffing.” This longer period likely produced “higher-than-normal temperatures, combustion, and smoke.”[57]

Further, the authors of the Environmental Health Perspectives study failed to mention in their report that cigarette smoke contains the same chemical agents causing concerns about potential links between popcorn lung and e-cigarettes. In fact, combustible cigarette smokers are exposed to 750 times more diacetyl in tobacco cigarettes.[58] And yet, to date, there has been no association between smoking tobacco cigarettes and popcorn lung.

Perhaps most importantly, there have been no known cases of an e-cigarette user being diagnosed with popcorn lung as a result of his or her e-cigarette use. In 2017, researchers published a three and-half-year observational study that found no indications e-liquids cause popcorn lung in users. According to the study’s authors, “no features consistent with early signs of bronchiolitis obliterans were described in any of the [e-cigarette users observed].”[59]

It’s also important to note that to ensure the safety of their products, many vaping e-liquid manufacturers have since 2015 chosen to not include the ingredients associated with popcorn lung in their e-liquids.

Fact: New Jersey Retailers Have Sold More Cigarettes and Cigars to Minors than E-Cigarettes

The FDA performs routine compliance checks, in which the agency “conducts inspections of tobacco product retailers to determine a retailer’s compliance with federal laws and regulations.”[60]

From September 1, 2018 to August 31, 2019, FDA finalized decisions on 4,667 tobacco product compliance checks on retailers in New Jersey.[61] Of these, only 543, or 11.6 percent involved sales to minors. Of the 543 sales to minors, only 95, or 17 percent, involved sales of electronic cigarette and vaping devices.

It should be noted that only 13 retailers identifying as liquor, tobacco, or vape shops were found in violation. Overwhelmingly, convenience stores in New Jersey including 7-Eleven, Exxon, Shell, Speedway, and Sunoco sold more vaping devices to minors, with 24 violations in the aforementioned time period.

Surprisingly, retailers were in violation of selling larger amounts of other tobacco products to minors, with cigarettes comprising 54 percent of minor sales with 297 violations, and cigars consisting of 137 violations, or 25 percent of sales to minors.

Local Solutions Can Address Youth E-Cigarette Use

As lawmakers deal with state-based solutions, many localities are implementing their own strategies to combat youth e-cigarette use. As mentioned prior, Lancaster County, Nebraska enacted a task force to combat youth e-cigarette sales, decreasing such sales “from 21.2 percent in 2017 to 5.3 percent in 2018.”[62]

In May 2019, the Cherokee County School Board in Georgia, unanimously approved a new “anti-vaping policy” for the school district. Beginning in 2019, any student in possession of an e-cigarette or vaping device “will be treated as if they are in possession of felony-level marijuana CBD and THC oil.”[63] Cherokee School Board Attorney Tom Roach called it “an extreme measure, but this is an extreme situation that deserves an extra measure.”[64]

Board members in other school districts believe tougher punishments need to be in place for students who violate vaping rules. Chris Brady, a board member of the Jefferson County Public School district in Kentucky believes students caught with e-cigarettes on school property “should be treated with the same seriousness as alcohol.”[65]

There is evidence that school policies restricting or banning certain products can reduce youth use. A study of 8th and 9th grade students showed their insights on drinking and school policy. In short, respondents’ “perceptions of lax enforcement [of drinking policies] predicted an increased risk of self-reported drinking.”[66]

Instead of punishing minors for using adult-restricted products, many laws are relaxing punishments, even though youth are using e-cigarettes in the classroom including “vaping behind binders [the students] had placed upright on their desks.”[67]

Lawmakers should refrain from policies that would restrict adult access to e-cigarettes and vaping devices. Working in conjunction with local school boards and health departments, policymakers should develop strategies that include punishments and effective task forces that would greatly reduce youth e-cigarette use.

Fact: New Jersey Spends Little Tobacco Moneys on Education and Prevention, Owes Billions on Future Tobacco Moneys

It’s disingenuous that policymakers in New Jersey would restrict adult access to tobacco harm reduction products while the state spends little of its existing tobacco settlement payments and taxes on helping smokers quit.

In 2019, New Jersey received an estimated $919.6 million in tobacco taxes and settlement payments, yet spent only $7.2 million, or 0.007 percent, on education and prevention programs.[68]

Worse, New Jersey has securitized future payments from the Master Settlement Agreement (MSA). In 1996, New Jersey became the sixth state to sue large tobacco manufacturers to recoup smoking-related health care costs. Then-New Jersey Gov. Christine Todd Whitman claimed tobacco “companies may have known something that they withheld from the public.”[69]

In 1998, 46 states (including New Jersey), Washington DC, and four U.S. territories settled with the tobacco companies, reaching the MSA. With this, tobacco manufacturers agreed to “annual payments in perpetuity” to the states.[70] New Jersey was expected “to receive approximately $7.2 billion from the settlement over the cost of 20 years.”[71]

Unfortunately, to balance a budget deficit, Garden State lawmakers “securitized $3.8 billion of the total $7.5 billion it was due to cover budget deficits in fiscal 2003 and 2004.”[72] Even more troublesome, New Jersey used capital appreciation bonds. These bonds allowed the state to not make any payments until the bonds mature, often “40 years or more,” meanwhile, “the interest compounds into a huge balanced owed.”[73]

Further, these bonds are costly, with the state losing millions of dollars. In 2007, the state issued two bonds; 1A CAB and 1C CAB. “1B CAB raised $126 million from investors,” promising to “repay $855 million at maturity in 2041,” with New Jersey paying 500-plus times more than what was received.[74] The state currently owes on existing bonds. According to the Office of Public Finance of the State of New Jersey, the state has an outstanding balance of $2.882 billion in tobacco bonds.[75]

Cigarette consumption has been on the decline, even prior to electronic cigarettes coming to market. As MSA payments are based on cigarette sales, declining consumption rates adversely affect tobacco bonds. New Jersey has already had to address the issues with its tobacco bonds.

In 2018, New Jersey sold “tobacco refunding bonds,” to strip tobacco bond “debt of its junk rating.”[76] Like many other states, the 2007 bonds were issued due to “assumptions that cigarette smoking declines would not exceed 4 percent annually,” but cigarette “consumption will continue to decline as much as 8.72 percent.”[77]

Further, the use of electronic cigarettes and vaping devices will lead to great declines, leading to the question of whether lawmakers care about the health of smokers, or the health of their tobacco bonds. 

*****

Rather than punishing former smokers, New Jersey should invest more into tobacco control programs to address youth use of electronic cigarettes and vaping devices.

It is disingenuous that lawmakers would purport to protect public health yet restrict access to safer products. Moreover, after selling future tobacco settlement payments, New Jersey is relying on smokers to meet the state’s debt obligations, which e-cigarettes undermine. Rather than restricting access to tobacco harm reduction products and flavored products, lawmakers should encourage the use of e-cigarettes and earmark adequate funding for smoking education and prevention programs.

Thank you for your time today.

 

For more information about The Heartland Institute’s work, please visit our website at www.heartland.org, or contact Lindsey Stroud by phone at 757/354-8170 or by email at lstroud@heartland.org.

 

 

[1] WHO Framework Convention on Tobacco Control, “Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems (ANDS/ENNDS),” August 2016, http://www.who.int/fctc/cop/cop7/FCTC_ COP_7_11_EN.pdf.

[2] U.S. Food and Drug Administration, “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; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products,” Federal Register, May 10, 2016, http://bit.ly/2x90ef.

[3] Keller and Heckman LLP, “FDA’s Establishment Registration and Product Listing Deadline is Fast Approaching – Are You Prepared?” December 15, 2016, https://www.khlaw.com/FDAs-Establishment-Registration-and-Product-Listing-Deadline-is-Fast-Approaching---Are-You-Prepared.

[4] Susan Adams, “E-Cigarette Manufacturers Say New Regulations Will Devastate The Industry,” Forbes, May 5, 2016, https://www.forbes.com/sites/ susanadams/2016/05/05/e-cigarette-manufacturers-say-new-regulations-will-devastate-the-industry/#6aa5124a66d4.

[5] Lindsey Stroud, “Randomized Trial Finds E-Cigarettes are More Effective Smoking 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.

[6] M. Mirbolouk et al., “Prevalence and Distribution of E-Cigarette Use Among U.S. Adults: Behavioral Risk Factor Surveillance System,” Annals of Internal Medicine, August 28, 2016, https://annals.org/aim/article-abstract/2698112/prevalence-distribution-e-cigarette-use-among-u-s-adults-behavioral.

[7] A. McNeill et al., “E-cigarettes: an evidence update,” Public Health England, August, 2015, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data

[8] A. McNeill et al., “Evidence review of e-cigarettes and heated tobacco products 2018,” Public Health England, February 2018, https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/684963/Evidence_review_of_e-cigarettes_and_heated_tobacco_products_2018.pdf.

[9] Royal College of Physicians, Nicotine without Smoke: Tobacco Harm Reduction, April, 2016, https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0.

[10] Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems, “Public Health Consequences of E-Cigarettes,” The National Academies of Science, Engineering, and Medicine, 2018, https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes.

[11] The American Cancer Society, “What Do We Know About E-cigarettes? June 19, 2019, https://www.cancer.org/cancer/cancer-causes/tobacco-and-cancer/e-cigarettes.html.

[12] David T. Levy et al., “Potential deaths averted in USA by replacing cigarettes with e-cigarettes,” Tobacco Control, October 2, 2017, http://tobaccocontrol.bmj.com/content/early/2017/08/30/tobaccocontrol-2017-053759.info.   

[13] Andrew J. Oliver et al., “Flavored and Nonflavored Smokeless Tobacco Products: Rate, Pattern of Use, and Effects,” Nicotine & Tobacco Research, January 2013, 15(1): 88-92, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524058/.

[14] Konstantinos E. Farsalinos et al., “Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey,” International Journal of Environmental Research and Public Health 10 (December 2013): 7,272–82, http://www.mdpi.com/1660-4601/10/12/7272.

[15] Carl V. Phillips, “CASAA ecig survey results,” Consumer Advocates for Smoke-free Alternatives Association, January 4, 2016, https://casaa.org/wp-content/uploads/CASAA-Vaping-Survey-Results-CVP-post-4-January-2016.pdf.

[16] M.B. Harrell et al., “Flavored e-cigarette use: Characterizing youth, young adult, and adult users,” Preventative Medicine Reports, Vol. 5, March 2017, pp. 33–40, https://www.sciencedirect.com/science/article/pii/S2211335516301346

[17] 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.

[18] 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/.

[19] 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.

[20] 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.

[21] Lindsey Stroud, “Flavor Bans Do Not Reduce Youth E-Cigarette Use,” Research & Commentary, The Heartland Institute, August 29, 2019, https://www.heartland.org/publications-resources/publications/research--commentary-flavor-bans-do-not-reduce-youth-e-cigarette-use.

[22] Shu-Hong Zhu, Ph.D., et al., “Tobacco Use among High School Students in Santa Clara County: Findings from the 2017-18 California Student Tobacco Survey,” Center for Research and Intervention in Tobacco Control, University of California, San Diego, 2019, https://www.sccgov.org/sites/phd/hi/tf/Documents/castudent-survey-2019.pdf

[23] Shu-Hon Zhu, Ph.D., et al., “California Youth Tobacco Survey 2015-16: Results of the Statewide Student Survey, Grades 8, 10, and 12,” Center for Research Intervention in Tobacco Control, University of California, San Diego, https://www.cdph.ca.gov/Programs/CCDPHP/DCDIC/CTCB/CDPH%20Document%20Library/ResearchandEvaluation/Reports/CSTS%2015-16%20Report%20FINAL.pdf

[24] Shu-Hong Zhu, Ph.D., et al., “Results of the Statewide 2017-18 California Student Tobacco Survey,” Center for Research Intervention in Tobacco Control, University of California, San Diego, https://www.cdph.ca.gov/Programs/CCDPHP/DCDIC/CTCB/CDPH%20Document%20Library/ResearchandEvaluation/Reports/2017-18CaliforniaStudentTobaccoSurveyBiennialReport.pdf.

[26] Lindsey Stroud, “How Do Electronic Cigarettes Affect Adolescent Smoking,” Research & Commentary, The Heartland Institute, March 28, 2016, https://www.heartland.org/publications-resources/publications/research--commentary-how-do-electronic-cigarettes-affect-adolescent-smoking?fbclid=IwAR3MXDoO2v8rmSyez8yhSxLDNe_pTQJAPzbKRlWx8AIMTZeBMsMg88o7xnw.

[27] Lindsey Stroud, “Tobacco 21 Laws Do Not Reduce Youth E-Cigarette Use,” Research & Commentary, May 1, 2019, https://www.heartland.org/publications-resources/publications/research--commentary-tobacco-21-laws-do-not-reduce-youth-e-cigarette-use.

[28] Lance Ching, Ph.D., et al., “Data Highlights from the 2015 Hawai’i Youth Tobacco Survey,” Hawai’i State Department of Health, April 15, 2016, http://www.hawaiihealthmatters.org/content/sites/hawaii/2015_HYTS_FINAL_June2016.pdf.

[29] Lance Ching, Ph.D., et al., “Data Highlights from the 2017 Hawai’i Youth Tobacco Survey,” Hawai’i State Department of Health, June 29, 2018, http://www.hawaiihealthmatters.org/content/sites/hawaii/YTS_2017_Report.pdf.

[30] 7 Brad Rodu, “The True Consequences of E-Cig and Vape Use,” Presentation at the National Association of Tobacco Outlets’ Annual Meeting, April 22, 2015. Full presentation available from author upon request.

[31] Ibid.

[32] Raymond Niaura, “Re-thinking nicotine and its effects,”  Truth Initiative,  accessed June 5, 2019, http://vapit.it/wp-content/uploads/2016/12/ReThinking-Nicotine.pdf

[33] Peter N. Lee, “Summary of the Epidemiological Evidence Relating SNUS to Health,” Regulatory Toxicology and Pharmacology, March 2011, https:// www.sciencedirect.com/science/article/pii/S0273230010002229?via%3Dihub.

[34] Raymond Niaura, supra note 32.

[35] County of Los Angeles Public Health, “Press Release: Public Health Investigates First Death Associated with E-Cigarettes in LA County,” September 6, 2019, http://publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=2137.

[36] Illinois Department of Public Health, “Illinois Resident Experiencing Respiratory Illness After Vaping Dies,” August 23, 2019, http://www.dph.illinois.gov/news/illinois-resident-experiencing-respiratory-illness-after-vaping-dies.

[37] ,” Indiana State Department of Health, “Indiana Health Officials Report First Vaping-Related Death,” September 6, 2019, https://calendar.in.gov/site/isdh/event/indiana-health-officials-report-first-vaping-related-death/.

[38] Kansas Department of Health and Environment, “Health Officials Report Death in Vaping Related Lung Disease,” September 10, 2019, https://khap2.kdhe.state.ks.us/NewsRelease/PDFs/9-10-19%20vaping.pdf.

[39]Minnesota Department of Health, “Health officials report death in a patient hospitalized for vaping-related lung injury,” September 6, 2019, https://www.health.state.mn.us/news/pressrel/2019/lunginjury090619.html.

[40] Missouri Department of Health & Senior Services, “DHSS Announces First Vaping-Associated Death in Missouri – Eighth Nationally,” September 19, 2019, https://health.mo.gov/news/newsitem/uuid/6aa00c1e-504f-43a0-ad83-7b01390cfe8b/dhss-announces-first-vaping-associated-death-in-missouri-eighth-nationally.

[41] Oregon Health Authority, “State investigating death from severe lung illness linked to vaping,” September 3, 2019, https://www.oregon.gov/oha/ERD/Pages/State-Investigating-Death-Severe-Lung-Illness-Link-Vaping.aspx.

[42] Ibid.

[43] Minnesota Department of Health, supra note 32.

[44] Connecticut Department of Public Health, “Department of Public Health reports two additional Cases of Severe Lung Injury Related to Vaping, for a total of 13 cases; one person currently hospitalized,” September 19, 2019, https://portal.ct.gov/DPH/Press-Room/Press-Releases---2019/DPH-Reports-two-additional-Cases-of-Severe-Lung-Injury-Related-to-Vaping.

[45] Utah Department of Health, “Lung Disease Investigation,” September 16, 2019, https://health.utah.gov/lung-disease-investigation.

[46] Wisconsin Department of Health Services, “Severe Pulmonary Disease Among Adolescent who Reported Vaping,” July 25, 2019, https://www.dhs.wisconsin.gov/dph/memos/beoh/2019-02.pdf.

[47] Wisconsin Department of Heath Services, “Majority of Wisconsin Lung Disease Patients Who Reported Vaping Cite THC Products,” August 29, 2019, https://www.dhs.wisconsin.gov/news/releases/082919.htm.

[48] Jennifer E. Layden, M.D., Ph.D., et al., “Pulmonary Illness Related to E-Cigarette Use in Illinois and Wisconsin – Preliminary Report,” The New England Journal of Medicine, September 6, 2019, https://www.nejm.org/doi/full/10.1056/NEJMoa1911614?fbclid=IwAR0kTs_r_tf_FmGLzEWRoaLk7-yS1URk9xe1euOoKQuwpZwx0CN79edr5Do.

[49] U.S. Food and Drug Administration, “Vaping Illnesses: Consumers can Help Protect Themselves by Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products,” September 6, 2019, https://www.fda.gov/consumers/consumer-updates/vaping-illnesses-consumers-can-help-protect-themselves-avoiding-tetrahydrocannabinol-thc-containing.

[50] R. Paul Jensen et al., “Hidden Formaldehyde in E-Cigarette Aerosols,” The New England Journal of Medicine, Volume 394, January 2015, pp. 392– 394, http://www.nejm.org/doi/full/10.1056/NEJMc1413069.

[51] K.E. Faralinos et al., “E-cigarettes emit very high formaldehyde levels only in conditions that are aversive to users: A republican study under verified realistic use conditions.,” Food and Chemical Toxicology, August 31, 2017, https://www.ncbi.nlm.nih.gov/pubmed/28864295.

[52] Brad Rodu, “Antidote to NEJM ‘formaldehype’ arrives at last,” R Street Institute, September 19, 2017, https://www.rstreet.org/2017/09/19/antidoteto-nejm-formaldehype-arrives-at-last.

[53] Leonard M. Zwack, et al., “Evaluation of Chemical Exposures at a Vape Shop,” Health Hazard Evaluation Report, U.S. Department of Health and Human Services, Centers for disease Control and Prevention, National Institute for Occupational Safety and Health, 2015, https://www.cdc.gov/niosh/hhe/reports/pdfs/2015-0107-3279.pdf.

[54] Joseph G. Allen et al., “Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes,” Environmental Health Perspectives, Volume 124, June 2016, pp. 733–739, http://ehp.niehs.nih.gov/15-10185.

[55] Brent D. Kerger and M. Joseph Fedoruk, “Pathology, Toxicology, and Latency of Irritant Gases Known to Cause Bronchiolitis Obliterans Disease: Does Diacetyl Fit the Pattern?” Toxicology Reports, Volume 2, 2015, pp. 1463–1472, http://www.sciencedirect.com/science/article/pii/S2214750015300767; Brad Rodu, “Red Flag for Vapers: Avoid Some Flavoring Agents,” Tobacco Truths, November 10, 2015, http://rodutobaccotruth.blogspot.com/2015/11/red-flagfor-vapors-avoid-some.html 

[56] Brad Rodu, “Is the Harvard E-Cigarette Buttery Flavor Study Credible?” Tobacco Truth, December 10, 2015, https://rodutobaccotruth.blogspot.com/2015/12/is-harvard-e-cigarette-buttery-flavor.html

[57] Ibid.

[58] Michael Siegel, “New Study Finds that Average Diacetyl Exposure from Vaping is 750 Times Lower than from Smoking,” The Rest of the Store: Tobacco and Alcohol News Analysis and Commentary, December 10, 2015, http://tobaccoanalysis.blogspot.com/2015/12/new-study-finds-thataverage-diacetyl.html

[59] Riccardo Polosa et al., “Health impacts of E-cigarettes: a prospective 3.5-year study of regular daily users who have never smoked,” Scientific Reports, November 17, 2017, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5693960.

[60] U.S. Food and Drug Administration, “CTP Compliance & Enforcement,” August 6, 2019, https://www.fda.gov/tobacco-products/compliance-enforcement-training/ctp-compliance-enforcement.

[61] U.S. Food and Drug Administration, “Compliance Check Inspections of Tobacco Product Retailers Through 8/31/19 – Search Results,” September 23, 2019, https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm.

[62] “Vapor product sales to minors decrease in 2018,” supra note 21.

[63] Etowah High School, “Message to Parents: New Anti-Vaping Policy,” May 21, 2019, https://www.cherokeek12.net/etowahhs/News/antivape19#sthash.q9nNBrWT.LPvpEjSC.dpbs.

[64] Cherokee County School District, “Board Briefs: School Board Reviews Proposed Budget, Passes Anti-Vaping Policy,” May 17, 2019, https://www.cherokeek12.net/News/board-briefs-5-17-19#sthash.zJNHlsA0.D9pKAOGM.dpbs.

[65] Sara Sidery, “JCPS board votes on punishment for students who use, sell e-cigarettes,” WDRB, July 16, 2019, https://www.wdrb.com/news/jcps-board-votes-on-punishment-for-students-who-use-sell/article_6d3a9c52-a835-11e9-b544-4b0f6a17eb46.html.

[66] Tracy J. Evans-Whipp et. al., “The impact of school alcohol policy on student drinking,” Health Education Research, June 13, 2013, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3708139/.

[67] Julie Jargon, “Vaping Moves From the Bathroom to the Classroom,” The Wall Street Journal, August 20, 2019, https://www.wsj.com/articles/vaping-moves-from-the-bathroom-to-the-classroom-11566293404.

[68] Truth Initiative, “Tobacco us in New Jersey 2019,” June 28, 2019,

[69] Brett Pulley, “Whitman Says State Will Sue Tobacco Makers on Illnesses,” The New York Times, April 12, 1996, https://www.nytimes.com/1996/04/12/nyregion/whitman-says-state-will-sue-tobacco-makers-on-illnesses.html.

[70] “The Master Settlement Agreement: An Overview,” Tobacco Control Legal Consortium, August 2015, p. 1, http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-msa-overview-2015.pdf.

[71] Global Advisors, “Some States Receive Money Annually From The Master Tobacco Settlement,” April 28, 2015, http://www.njgasp.org/some-states-receive-money-annually-from-the-master-tobacco-settlement/.

[72] Amy Worden, “Suits against tobacco firms threatened – Pa. and N.J. officials warned three companies not to cut their shares of the 1998 settlement agreement,” Inquirer Harrisburg Bureau, April 17, 2006, print.

[73] Czary Podkul and David Sleight, “How Tobacco Bonds Work, and What Can Go Wrong,” Propublica, August 18, 2014, https://www.propublica.org/article/how-tobacco-bonds-work-and-what-can-go-wrong.

[74] Czary Podkul, ““Behind New Jersey’s Tobacco Bond Bailout, A Hedge Fund’s $100 Million Payday,” Propublica, December 30, 2014, https://www.propublica.org/article/behind-new-jerseys-tobacco-bond-bailout-a-hedge-funds-100-million-payday.

[75] The Office of Public Finance of the State of New Jersey, “State of New Jersey Debt Report Fiscal Year 2017,” March 23, 2018, https://www.nj.gov/treasury/public_finance/pdf/DebtReportFY2017.pdf.

[76] Hilary Russ, “New Jersey to refund junk tobacco bonds for $3.2 billion of high-grade paper,” Reuters, March 29, 2018, https://www.reuters.com/article/us-usa-municipals-deals/new-jersey-to-refund-junk-tobacco-bonds-for-3-2-billion-of-high-grade-paper-idUSKBN1H53A7.

[77] Ibid.