Comment to All Party Parliamentary Group for Vaping UK Parliament Regarding Regulating Tobacco Harm Reduction Products

Chair Pawsey and members of the Committee,

Thank you for inquiry on regulating tobacco harm reduction products, including electronic cigarettes. My name is Lindsey Stroud and I am a Policy Analyst with the Taxpayers Protection Alliance (TPA). TPA is a non-profit, non-partisan organization with headquarters in Washington, DC, that is dedicated to educating the public through the research, analysis and dissemination of information on the government’s effects on the economy.

E-Cigarette Regulations in the United States

Going back more than a decade, the United States has been regulating e-cigarette and vaping devices. 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.^[i]

In 2016, FDA issued deeming regulations that extended the agency’s regulatory authority to include electronic cigarettes and other THR products.^[ii] All companies “engaged in the preparation, manufacture, compounding, repackaging, relabeling or processing of finished tobacco products” now must register with FDA.^[iii]

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.

FDA also restricts 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. Other regulatory requirements include submitting to FDA ingredient listings, harmful and potentially harmful constituents, and substantial equivalency applications.

States have also imposed their own regulations on vapor products. Some states – including Massachusetts, New Jersey, New York and Rhode Island – prohibit the sale of flavored vapor products. The city of San Francisco has gone a step further and banned the sale of all e-cigarette products. Over a dozen states impose an excise tax on vapor products and numerous states have introduced other regulatory measures, including banning the use of e-cigarettes where combustible cigarettes are already banned.

Premarket Tobacco Product Applications (PMTA)

In the United States, the most arduous of the FDA’s deeming regulations is the premarket tobacco product application (PMTA).

The PMTA’s include various requirements consisting of seven modules including:  

• Module 1 – A cover letter, administrative information, table of contents, market date documentation, Master File documents, Quality Statement, and any other relevant documents pertaining to the PMTA.
• Module 2 – Summaries, including product description and manufacturing summary, environmental impact summary, and indexes of all studies and references mentioned in the PMTA. Overview of the target market for the newly deemed tobacco products, including a summary of the consumer survey, company marketing information, including promotional material and social media, and finally information on how the company prevents youth use, and how the new product is not in violation of the FD&C Act Section 907.
• Module 3 – Product description and manufacturing information, including standard operating procedures and good manufacturing processes.
• Modules 4, 5, and 6 – Clinical and nonclinical studies, including harmful and potentially harmful (HPHC) testing.
• Module 7 – Environmental assessments.

Ultimately, vaping manufacturers must ensure that their products are not being marketed to both minors and non-cigarette users. In the PMTA, this is exemplified by the FD&C Act. Below is a draft of what small, open-system e-liquid companies used in their submission:

Identifying reference to any tobacco product standard under section 907 of the FD&C Act.

Section 907 of the FD&C Act specifically deals with leaf tobacco cigarettes and has no reference to ENDS products.

However, these references in section 907 will be addressed as we feel it is pertinent for the FDA to make decision on granting a PMTA for COMPANY’s Open ENDS, E-Liquid products mentioned in this PMTA.

Determinations:

1. In making a finding described in subparagraph (A), the Secretary shall consider scientific evidence concerning
2. the risks and benefits to the population as a whole, including users and nonusers of tobacco products, of the proposed standard;
3. the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

• the increased or decreased likelihood that those who do not use tobacco products will start using such products.

COMPANY has found through both existing scientific studies and self-administered surveys of customers that its Open ENDS, E-Liquid products meet the determinations under section 907 of the FD&C act as indicated below.

1. As evidenced in the “Review of Current Literature Regarding Electronic Nicotine Delivery Systems (ENDS) & E-Liquid as of July 2020,” found in Modules 4, 5, & 6; scientific studies have found the risks associated with ENDS products are significantly less harmful than traditional cigarettes. Although there are no studies that examine the long-term effects of ENDS products on adult users, the aforementioned literature review highlights studies that have demonstrated that ENDS products are less toxic than combustible cigarettes. Further, other mentioned studies note the effects of ENDS on particular body systems, including the heart, vascular and respiratory systems, finding a reduced harm than combustible cigarettes.
2. COMPANY’S survey of customers, also found in the aforementioned literature review, finds COMPANY’s ENDS, Open, E-Liquid products are overwhelmingly used by adults to quit smoking. Indeed, in the customer survey, ___ percent of respondents noted that they had quit smoking using COMPANY’s ENDS, Open E-Liquid products. In fact, many were worried of potential bans, with ___ percent of respondents reporting they would go back to combustible cigarettes should COMPANY’s ENDS, Open E-Liquid products not be available.

• COMPANY’s survey of customers also found that ENDS, Open, E-Liquid products are not overwhelmingly used by nonusers of tobacco products, specifically combustible cigarettes. Indeed, in the customer survey, ____ percent of customers reported ever-use of combustible cigarette products. Only ____ percent not using combustible cigarette products prior to ENDS use.

Companies were required to submit their PMTAs to the FDA by September 9, 2020 and the agency has been inundated with hundreds of millions of applications. In August, 2020, the agency noted that there were “over 400 million deemed products listed with FDA.”^[iv] On May 20, 2021, FDA announced a list of deemed tobacco products which included “over 6 million products.”^[v]

Ultimately, many companies may not make it through the entire PMTA due to the costs associated with testing their products. FDA continues to “tweak” their requirements in regards to testing. Prior to the submission deadline, manufacturers were expected to test ALL the companies e-liquid that varied. If a manufacturer produced two flavors of e-liquid in three different nicotine strengths and two different sized bottles, the manufacturer would be required to test all 12 different products. This is highly redundant and also extremely expensive. Prior to the 2020, FDA estimates each PMTA will cost $330,000.^[vi]

Effects of E-Cigarettes in the United States

Despite the alarmism from the media and some public health officials, e-cigarettes have been effective at reducing smoking rates in the United States. In an analysis of all 50 states and the District of Columbia, Taxpayers Protection Alliance found that e-cigarettes in 46 states, e-cigarettes were more effective than suing tobacco companies, in reducing smoking rates among young adults.^[vii]

Between 1998 and 2008, smoking rates among young adults decreased by 15.5 percent from 27.7 percent of adult smokers being between 18 to 24 years old in 1998 to 23.4 percent in 2008. Between 2009 and 2019, or the years after e-cigarette’s market emerge in the United States, smoking rates among young adults decreased by 47 percent, to 11.9 percent of current smokers aged between 18 and 24 years old in 2019. (See Supplemental Graph)

Flavors Are Important for Smoking Cessation

E-cigarette and vaping opponents often falsely argue product flavorings, which have been shown to greatly enhance users’ experiences, are meant to encourage underaged youth to use these products.

In January 2014, a Tobacco Control study found there was a total of 466 e-liquid brands that distributed 7,764 unique e-liquid flavors.83 A search of FDA’s product registration database yields thousands of results for registered e-liquids, including flavors such as “coffee,” “mango,” and “strawberry.”^[viii]

Flavors are an essential component of e-cigarettes’ commercial success and their effectiveness in helping smokers quit combustible tobacco. A 2013 internet study by Konstantinos Farsalinos et al. concluded flavors in e-cigarettes “appear to contribute to both perceived pleasure and the effort to reduce cigarette consumption or quit smoking.”^[ix]

Similarly, a 2015 online poll conducted by the Consumer Advocates for Smoke-Free Alternatives Association found among the 27,343 Americans aged 18 or older that were surveyed, 72 percent “credited tasty flavors [in e-cigarette products] with helping them give up tobacco.”^[x] Of the respondents who indicated they were still smoking combustible tobacco products, “53% [said] interesting flavors are helping move them toward quitting.”

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,” ^[xi] with 83.2 percent and 72.3 percent of survey respondents reporting use of vaping fruit and dessert flavors, respectively, “at least some of the time.”^[xii] Additionally, research by Dr. Edward Anselm, a senior fellow for the R Street Institute and senior fellow and medical director of Health Republic Insurance of New Jersey, concludes the presence of flavorings in e-cigarettes significantly helps smokers quit using traditional tobacco cigarettes.^[xiii] Anselm also notes concerns over “flavoring as a tool to recruit children are overblown,” in large part because there is no “evidence that suggests children are drawn to tobacco products specifically because of flavor.”

US Youth Overwhelmingly Vape Because of Friends, and Other Reasons – Not Flavors

Despite media alarmism, many American high school students are not overwhelmingly using vapor products due to flavors. Indeed, in analyses of state youth tobacco use surveys, other factors including social sources are most often cited among youth for reasons to use e-cigarettes and vapor products.

In 2017, among Hawaiian high school students that had ever used e-cigarettes, 26.4 percent cited flavors as a reason for e-cigarette use, compared to 38.9 percent that reported “other.”^[xiv]

According to results from the 2018 YRBS, Maryland high school students reported using flavored vapor products, but flavors weren’t overwhelmingly cited by e-cigarette users as a reason for use.^[xv] When asked about the “main reason” Maryland high school users used flavors only 3.2 percent responded “flavors.” Conversely, 13 percent reported because “friend/family used them,” 11.7 percent reported “other,” and 3.8 percent reported using e-cigarettes because they were less harmful than other tobacco products.

In 2019, among all Montana high school students, only 7 percent reported using vapor products because of flavors, compared to 13.5 percent that reported using e-cigarettes because of “friend or family member used them.”^[xvi] Further, 25.9 percent of Montana high school students reported using vapor products for “some other reason.”

In 2019, among all students, 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 and 15.9 percent reported using e-cigarettes “for some other reason.”^[xvii]

In 2017, among current e-cigarette users, only 17 percent of Vermont high school students reported flavors as a reason to use e-cigarettes. Comparatively, 35 percent cited friends and/or family members and 33 percent cited “other.”^[xviii]

In 2019, among high school students that were current e-cigarette users, 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.^[xix]

Lastly, in 2017, among all Virginia high school students, only 6.2 percent reported using e-cigarettes because of flavors, while 11.3 percent used them because a friend and/or family member used them.^[xx] In 2019, among all Virginia high school students, only 3.9 percent reported using e-cigarettes because of flavors, 12.1 used for some other reason, and 9.6 used them because of friends and/or family members.^[xxi] (See Supplemental Graphs 2)

Effects of Flavor Bans

Flavor bans have had little effect on reducing youth e-cigarette use and may lead to increased combustible cigarette rates, as evidenced in San Francisco, California.^[xxii]

In April 2018, a ban on the sale of flavored e-cigarettes and vapor products went into effect in San Francisco and in January of 2020, the city implemented a full ban on any electronic vapor product. Unfortunately, these measures have failed to lower youth tobacco and vapor product use.

Data from an analysis 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 – a 125 percent increase from 2017 when 7.1 percent of San Francisco high school students reported using an e-cigarette.^[xxiii] 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 or vapor product 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.

An April 2020 study in Addictive Behavior Reports examined the impact of San Francisco’s flavor ban on young adults by surveying a sample of San Francisco residents aged 18 to 34 years.^[xxiv] Although the ban did have an effect in decreasing vaping rates, the authors noted “a significant increase in cigarette smoking” among participants aged 18 to 24 years old.

Other municipal flavor bans have also had no effect on youth e-cigarette use.^[xxv] For example, Santa Clara County, California, banned flavored tobacco products to age-restricted stores in 2014. Despite this, youth e-cigarette use increased. In the 2015-16 California Youth Tobacco Survey (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.

Policy Recommendations

It is imperative that the UK continue on with policies that promote the use of tobacco harm reduction products, including electronic cigarettes and heat-not-burn technologies. Such products have helped millions of smokers quit smoking and their use should be promoted and endorsed – not restricted.

Although the US does provide valuable insight into possible regulations of vapor products, the UK should not endorse any policies that are more restrictive than the US’s PMTA. Although many manufactures in the United States have made it past acceptance, the process of testing each individual product, including thousands of different flavored e-liquids, may be too expensive for most small manufacturers. Any and all policies must take into consideration the cost and burden on small businesses.

[i] Consumer Advocates for Smoke-Free Alternatives Association, “A Historical Timeline of Electronic Cigarettes,” n.d., http://casaa.org/historicaltimeline-of-electronic-cigarettes.

[ii] 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.

[iii] 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.

[iv] U.S. Food and Drug Administration, “Perspective: FDA’s Preparations for the September 9 Submission Deadline, August 31, 2020, https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-preparations-september-9-submission-deadline.

[v] U.S. Food and Drug Administration, “Update on FDA’s Application Review: PMTA List Posted, Progress Metrics Updated,” May 20, 2021, https://www.fda.gov/tobacco-products/ctp-newsroom/update-fdas-application-review-pmta-list-posted-progress-metrics-updated.

[vi] 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.  

[vii] Lindsey Stroud, “Tobacco & Vaping 101: 50 State Analysis,” Taxpayers Protection Alliance, April 26, 2021, https://www.protectingtaxpayers.org/harm-reduction/tobacco-vaping-101-50-state-analysis/.

[viii] U.S. Food and Drug Administration, “Search Tobacco Listings,” April 5, 2019, https://ctpocerl.fda.gov/rlapp/Products.html.

[ix] 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.

[x] Vape Ranks, “Large Survey Finds E-Cigarettes Do Help Smokers Quit,” January 12, 2016, https://vaperanks.com/large-survey-finds-e-cigarettes-dohelp-smokers-quit.

[xi] Lindsey Stroud, “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-findsflavors-play-important-role-in-tobacco-harm-reduction.

[xii] Ali Anderson, “Ex Smokers Prefer Fruity E-Liquids Says Doctor’s FDA Survey,” Vaping, August 14, 2018, https://vaping.com/blog/news/ex-smokersprefer-fruity-e-liquids-says-doctors-fda-survey.

[xiii] Edward Anselm, “The Role of Flavoring in Tobacco Harm Reduction,” Policy Study, R Street Institute, December 2015, https://2o9ub0417chl2lg6m4 3em6psi2i-wpengine.netdna-ssl.com/wp-content/uploads/2018/04/RSTREET49-1.pdf.   

[xiv] 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.

[xv] Maryland Department of Public Health, “Maryland High School Survey Detail Tables – Weighted Data,” 2018 Youth Risk Behavior Survey, 2018, https://phpa.health.maryland.gov/ccdpc/Reports/Documents/2018%20YRBS%20YTS%20Reports/Maryland/2018MDH%20Detail%20Tables.pdf.

[xvi] Montana Office of Public Instruction, “2019 Montana Youth Risk Behavior Survey High School Results,” 2019, http://opi.mt.gov/Portals/182/Page%20Files/YRBS/2019YRBS/2019_MT_YRBS_FullReport.pdf?ver=2019-08-23-083248-820.

[xvii] State of Rhode Island Department of Health, “Rhode Island High School Survey Detail Tables – Weighted Data,” 2019 Youth Risk Behavior Survey Results, 2019, https://health.ri.gov/materialbyothers/yrbs/2019HighSchoolDetailTables.pdf. 

[xviii] Vermont Department of Health, “2017 Vermont Youth Risk Behavior Survey Report Winooski SD Report,” 2018, https://www.healthvermont.gov/sites/default/files/documents/pdf/WINOOSKI_SD_%28SU017%29.pdf.

[xix] Vermont Department of Health, “2019 Vermont Youth Risk Behavior Survey Statewide Results,” March, 2020, https://www.healthvermont.gov/sites/default/files/documents/pdf/CHS_YRBS_statewide_report.pdf.

[xx] Virginia Department of Health, “Virginia High School Survey Detail Tables – Weighted Data,” 2017 Youth Risk Behavior Survey, 2017, https://www.vdh.virginia.gov/content/uploads/sites/69/2018/04/2017VAH-Detail-Tables.pdf.

[xxi] Virginia Department of Health, “Virginia High School Survey Detail Tables – Weighted Data,” 2019 Youth Risk Behavior Survey Results, 2019, https://www.vdh.virginia.gov/content/uploads/sites/69/2020/06/2019VAH-Detail-Tables.pdf.

[xxii] Lindsey Stroud, “Vaping Up, Smoking Increasing Among Teens in San Francisco – Despite Bans,” Tobacco Harm Reduction 101, July 28, 2020, https://www.thr101.org/research/2020/vaping-up-smoking-increasing-among-teens-in-san-francisco-despite-bans.

[xxiii] Centers for Disease Control and Prevention, “San Francisco, CA 2017 Results,” High School Youth Risk Behavior Survey, 2017, https://nccd.cdc.gov/youthonline/App/Results.aspx?LID=SF.

[xxiv] Yong Yang et al., “The Impact of a Comprehensive Tobacco Product Flavor Ban in San Francisco Among Young Adults,” Addictive Behavior Reports, April 1, 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186365/#!po=0.961538.

[xxv] Lindsey Stroud, “Flavor Bans Do Not Reduce Youth E-Cigarette Use,” Tobacco Harm Reduction 101, 2019, https://www.thr101.org/research/2019/flavor-bans-do-not-reduce-youth-e-cigarette-use.