Public Submission Select Committee on Tobacco Harm Reduction
Public Submission Select Committee on Tobacco Harm Reduction Senate
Parliament of Australia 5 November, 2020 Lindsey Stroud Tobacco Harm Reduction 101
Members of the Committee,
Thank you for your time in addressing the timely issue of regulating electronic cigarettes and vapor products. Below are submitted comments addressing how e-cigarettes have been regulated in the United States and an analysis of their role in cessation and youth usage.
History of E-Cigarettes in the United States
E-cigarettes and vaping devices were introduced in the United States in 2007, and since that time, their effectiveness and safety have been questioned by many policymakers and public policy organizations, despite ample evidence proving their efficacy and public health benefits. Rather than focusing on their potential for reducing smoking of health-harming combustible tobacco cigarettes, policymakers have erroneously equated e-cigarettes with combustible tobacco cigarettes, ignoring crucial differences.
Since their introduction to the U.S. market, an estimated three million American adults have used these products to quit combustible cigarettes.
R.J. Reynolds introduced some of the first HNB products when it released Premier in the 1980s and a similar product, Eclipse, in the 1990s. Unfortunately, these products were not well received and little developed in the United States until Ruyan, in 2007, introduced e-cigarettes to the market. .
In 2008, FDA tried to ban imports of e-cigarettes. FDA officials argued they were unapproved drug delivery devices. FDA then blocked a shipment of e-cigarettes by Sottera, Inc., the manufacturer of NJOY, an early cig-alike.
In April 2009, Sottera filed a lawsuit challenging the ban, and in December 2012, the U.S. Court of Appeals ruled “e-cigarettes could be regulated as tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act,” while dismissing FDA’s original attempt to regulate e-cigarettes as a drug delivery device, which would have banned them from U.S. markets.
In 2016, FDA issued deeming regulations that extended the agency’s regulatory authority to include electronic cigarettes and other THR products. All companies “engaged in the preparation, manufacture, compounding, repackaging, relabeling or processing of finished tobacco products” now must register with FDA.4
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.
FDA also restricted sales of e-cigarettes to individuals aged 18 or older, and the agency has banned e-cigarette distribution in vending machines. FDA further requires child-resistant packaging for every e-cigarette product. In November 2019, President Donald Trump issued an executive order, which raised the age to purchase tobacco and vapor products, form 18 years to 21. Prior to this, many states had already raised tobacco and vapor product sales age to 21.
Other regulatory requirements in the deeming rules include submitting to FDA ingredient listings, harmful and potentially harmful constituents, and substantial equivalency applications. In addition to the regulations imposed by the federal government, many states regulate electronic cigarettes.
In September 2020, per a court order, all vapor product manufacturers were required to submit a PMTA to the FDA. These PMTAs included listings of all products manufactured – including all ingredients and/or components, manufacturing processes and standard operating procedures, comprehensive literature reviews, and individual surveys of customers.
Product manufacturers were ordered to prove that their product had been on the market prior to the August 8, 2016 deadline. Further, they had to also provide evidence that their products would not be used by nonsmokers and/or minors.
FDA is prioritizing enforcement of products that are more appealing to youth. For example, the agency cited new data “from the 2020 National Youth Tobacco Survey (NYTS), will also inform the FDA’s enforcement and other actions, and flavored disposable [e-cigarettes] will now be an enforcement priority for the agency.”
The task of regulating all vapor products in the United States will be a daunting one, as the agency noted that they “may receive application for several million products.”
Further, many American and foreign manufacturers are members of trade associations which require strict adherence to age restrictions and marketing targeted to minors.
For example, 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.” More than 1,300 companies participated in the program in 2015. 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.
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.” 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.”
Role of Vaping in Cessation in the United States
The Centers for Disease Control and Prevention (CDC) issued a May 2020 report of adult e-cigarette use. In 2018, there were an estimated 8.1 million American adults that were current users of e-cigarettes and vapor products.
The CDC noted that men were more likely than women to have ever used a vapor product and use decreased as age increased. Notably, adult e-cigarette users in the United States were current and/or former smokers. Indeed, the number of adults that had ever used an e-cigarette and were current e-cigarette users “was highest among former cigarette smokers who quit within the past year.” Further, e-cigarette use was “lowest among those who never smoked cigarette,” and only 1.1 percent of current e-cigarette users reported having never smoked combustible cigarettes.
A 2018 study by the Rand Corporation examined vapor product use among military members. In Rand’s Health Related Behaviors Survey Substance Use Among U.S. Active-Duty, “13.9 percent of service members were current cigarette smokers, and 7.4 percent smoked cigarettes daily.” Among the general population, 16.8 percent of Americans were current smokers, and 12.9 percent were daily smokers.
The finding is significant because military service members now smoke at lower rates than the general population. Historically, smoking rates among service members have been higher than the national average. In 2011, 24.5 percent “of service members reported cigarette use in the past 30 days,” compared to 20.6 percent of civilians.
The Rand analysis also finds a significant portion of military service members use electronic cigarettes, as 35.7 percent reported they have tried e-cigarettes, 12.4 percent reported being current past-month users, and 11.1 percent reported being daily users. These numbers are noteworthy because scant research exists on e-cigarette use among military service members.
E-cigarettes and vapor products are also more effective than other nicotine replacement therapies (NRT) in helping smokes quit. A 2019 study published in The New England Journal of Medicine finds the use of electronic cigarettes and vaping devices to be “twice as effective as nicotine replacement at helping smokers quit.”
In a “two group, pragmatic, multi-center, individually randomized, controlled trial,” researchers analyzed 886 randomized participants to examine the effects of e-cigarettes and nicotine replacement therapy (NRT) on smoking cessation. The participants, who were mostly “middle aged smokers,” were broken into an NRT group and an e-cigarette group.
More than 78 percent completed the 52-week follow up conducted by the researchers.
More than100 participants reported abstinence during the 52-week follow up. Researchers found “80% … were using e-cigarettes at 52 weeks in the e-cigarette group and 9% were using” NRT products in the NRT group. Overall, the researchers concluded a higher abstinence rate in the group of e-cigarette users, with 18.0 percent. Participants in the NRT group reported a 9.9 percent one-year abstinence rate. E-cigarettes provided “greater satisfaction and were rated as more helpful to refrain from smoking” than NRT products.
In terms of smoking-related health issues, researchers found that “among participants who reported cough or phlegm at baseline, significantly more were symptom-free at the 52-week follow up in the e-cigarette group” compared to the NRT group. The researchers did run “an exploratory analysis that controlled for abstinence status at 52 weeks” and found no difference in results.
There is no evidence that e-cigarette use lead to combustible cigarette use. In fact, in the United States, there have been instances in which bans were ineffective at reducing youth vapor product use.
In April 2018, the ban on flavored e-cigarettes and vapor products went into effect in San Francisco and in January, 2020, the city had implemented a full ban on any electronic vapor product. Unfortunately, these endeavors have failed to lower youth tobacco and vapor product use.
Data from a snapshot of the 2019 Youth Risk Behavior Survey show that 16 percent of San Francisco high school students had used a vapor product on at least one occasion in 2019, an increase from 7.1 percent that had used an e-cigarette in 2017. Current daily use more than doubled from 0.7 percent of high school students in 2017 to 1.9 percent of San Francisco high school students reporting using an e-cigarette every day in 2019.
Worse, despite nearly a decade of significant declines, youth use of combustible cigarettes seems to be on the rise in Frisco. In 2009, 35.6 percent of San Francisco high school students reported ever trying combustible cigarettes. This figure continued to decline to 16.7 percent in 2017. In 2019, the declining trend reversed and 18.6 percent of high school students reported ever trying a combustible cigarette. Similarly, current cigarette use increased from 4.7 percent of San Francisco high school students in 2017 to 6.5 percent in 2019.
Public health officials may be prone to attribute the increase use of combustible cigarettes to vaping products, yet in cities and states where looser regulations exist, youth combustible smoking continues to decline.
In Seattle, WA, combustible cigarette use decreased between 2016 and 2018 among students between grades 6 and 12 as noted in the Seattle Public Schools Healthy Youth Survey. In 2016, 7.025 percent of Seattle youth between grades 6 and 12 reported smoking cigarettes 1 to 2 times in the 30 days prior to the survey, this decreased to 2.025 percent in 2018.
According to the Indiana Youth Survey, in Indiana, past 30-day use of combustible cigarettes among high school students declined from 9 percent in 2017 to 7.3 percent in 2018. Unfortunately, despite a decline between 2015 and 2017, e-cigarette use among Indiana students in grades 7 through 12 “increased significantly,” with 16.9 percent reporting using a vapor product on at least one day in the past month.
Data from the 2017 YRBSS also indicate that a decrease in youth vapor product use correlated to an increase in youth combustible cigarette use in some states. For example, in Michigan, in 2015, 10 percent of Michigan high school students reported current combustible cigarette use and 23 percent reported current e-cigarette use. In 2017, combustible cigarette use increased to 10.5 percent of high school students (a 4.8 percent increase), while youth vaping use decreased by 55.4 percent, to 14.8 percent of Michigan high school students.
According to the 2019 Michigan YRBSS, current use of combustible cigarette products is at an all-time low, at 4.5 percent of high school students. This is a 133.3 percent decrease from 2017 rates and a 122.2 percent decrease from 2015 rates. Regarding current e-cigarette use, in 2019, 20.8 percent of high school students reported using a vapor product, a 28.8 percent increase from 2017, but a 10.6 percent decrease from 2015 vaping rates.
This is similar to earlier research. A study published by a Yale researcher in April 2015 examines the causal impact of access to electronic cigarettes, commonly called “e-cigarettes,” on teen smoking and questions whether state bans raise or reduce teen smoking rates. The study, which was conducted by Abigail S. Friedman at the Department of Health Policy and Management at the Yale School of Public Health, concludes, “[A]nalyses consistently find that electronic cigarette access reduces teen smoking,” rather than increases it, a claim often made by opponents of electronic cigarettes.
The study focused on claims suggesting e-cigarettes increase smoking rates, especially for teens. One of the most widely used criticisms made against e-cigarettes is they create a significant “gateway effect,” meaning many people who would otherwise never smoke tobacco do so because they were introduced to a supposedly similar product, such as electronic cigarettes. Another claim is e-cigarettes reduce the social stigma associated with traditional cigarettes, creating more users. A third attack on e-cigarettes is they lower the cost of addiction, which theoretically leads to higher tobacco smoking rates, a phenomenon called “harm reduction.”
Using state-level data on smoking rates and bans, as well as data from the National Survey on Drug Use and Health and the National Youth Tobacco Survey, the study found state bans on the sale of e-cigarettes to minors create “a statistically significant 1.0 percentage point increase in recent cigarette smoking rates among 12 to 17-year olds.” The study also found the greater the access to electronic cigarettes, the greater the drop in the state’s smoking rate. According to the study, a 1 percentage point increase in people using an e-cigarette at some point in their lives yields a 0.65 to 0.83 percentage point drop-in smoking rates among teens aged 14 to 18.
This analysis has been exhibited in real life. or example, Lancaster County, Nebraska reported a reduction in sales of vaping products to minors “from 21.2 percent in 2017 to 5.3 percent in 2018.” During the same period, non-vaping tobacco product sales to minors increased, from 5.9 to 8.7 percent.
Youth Vapor Product Use in the United States
According to the CDC, youth vaping declined in 2020, but disposable vapor product use increased. Many policymakers in the United States tend to look at flavors in vapor products, but youth are overwhelmingly using such products due to peer pressure – their friends and/or family members use these products.
Only 23.9 percent of Connecticut high school students reported “flavors” as a reason for using e-cigarettes in 2017, compared to 41.6 percent who reported they used a vapor product because a friend and/or family member had used them. Similarly, only 26.4 percent of Hawaii high school students cited flavors as a reason to use e-cigarettes in 2017. In 2019, only 4.5 percent of Rhode Island high school students claimed to have used e-cigarettes because they were available in flavors, while 12.5 cited the influence of a friend and/or family member who used them. Only 17 percent of Vermont high school students reported flavors as a reason to use e-cigarettes in 2017, and 33 percent cited friends and family members. In 2019, only 10 percent of Vermont youth that used e-cigarettes cited flavors as a primary reason for using e-cigarettes, while 17 percent of Vermont high school students reported using e-cigarettes because their family and/or friends used them. Lastly, only 6.2 percent of Virginia high school students reported using e-cigarettes because of flavors, while 11.3 percent used them because a friend and/or family member used them.
A more recent May 2020 “research letter” published in JAMA examined a survey of 1,129 respondents between 14 and 24 years old. Only 4.7 percent of respondents reported “flavors” as a reason for JUUL use, compared to 62.2 percent of respondents that cited social reasons. A June 2020 study by a Yale researcher noted that flavored e-cigarette use “was no more associated with youth smoking initiation than vaping tobacco-flavors.”
According to data from the California Youth Tobacco Survey (CYTS), flavor bans have not reduced youth use of electronic cigarettes and vaping devices.
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.” 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. In the 2017-18 CYTS, this increased to 10.7 percent.
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 included 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.
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.” In 2018, the agency reiterated their findings, finding vaping to be “at least 95% less harmful than smoking.”
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.” 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.”
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.” This is attributed to the fact that “e-cigarettes do not contain or burn tobacco.”
It is disingenuous that policymakers would purport to protect public health yet restrict access to safer products. Rather than restricting access to tobacco harm reduction products and flavored tobacco products, lawmakers should encourage use of e-cigarettes and earmark adequate funding for smoking education and prevention programs.
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