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Adam Susser is an associate in the food and drug and tobacco and e-vapor practices at Keller and Heckman. He advises clients on regulatory and compliance matters in industries overseen by the U.S. Food and Drug Administration (FDA), including the pharmaceutical, medical device, food, dietary supplement, and tobacco industries.

Mr. Susser is frequently asked to present on FDA regulations at industry conferences hosted by the Food and Drug Law Institute (FDLI) and publishes FDA related articles in various forums including FDLI’s Update Magazine.

Mr. Susser graduated with honors from the University of Chicago Law School where he received the Burton and Adrienne Glazov Academic Merit Scholarship. In addition, he devotes his time to many pro bono and community service projects including the D.C. Bar’s Landlord-Tenant Resource Center. Mr. Susser has a background in political science and, while in law school, worked as a legal intern for the Transportation Security Administration (TSA) within the Department of Homeland Security.

In FDA’s latest effort to implement its comprehensive plan for tobacco and nicotine regulation, the Agency published two additional advanced notice of proposed rulemakings (ANPRMs) concerning regulation of premium cigars and tobacco product flavors.  Specifically, on March 21, 2018, the FDA published an ANPRM, “Regulation of Flavors in Tobacco Products,” which solicited comments on, among things, the role of flavors (other than tobacco) (hereinafter, “flavors”) on initiation and patterns of tobacco product use and on transitioning combustible to non-combustible tobacco product use.[1]  The next week, on March 26, 2018, the FDA published another ANPRM, “Regulation of Premium Cigars,” which requested input on the definition and use patterns of premium cigars as well as public health considerations associated with premium cigars.[2]  While these regulatory actions were initially promised in FDA’s July 28, 2017 comprehensive plan for tobacco and nicotine regulation, publication of the ANPRMs in the Federal Register provide an indication of the Agency’s regulatory priorities going forward. [3]

Flavored Tobacco Products ANPRM

In the ANPRM regarding regulation of tobacco product flavors, FDA requests comments on, among other topics, the following:

  • The Role of Flavors (other than tobacco) in Tobacco Products: FDA requested studies or information regarding the role of flavors generally in tobacco products, as well as the appropriateness of extrapolating research from other areas (e.g., consumer products) to the tobacco space.[4]
  • Flavors (other than tobacco) and Initiation and Patterns of Tobacco Product Use, Particularly Among Youth and Young Adults: FDA requested studies or information regarding the role of flavors in: (1) initiation and/or patterns of use of combusted and non-combusted tobacco products among youth and young adults; (2) in non-combusted tobacco products on initiation of tobacco product use or progression to use of other tobacco products among youth and young adults.[5]
  • Flavors (other than tobacco) and cessation, dual use, and relapse among current and former tobacco product users: FDA requested information on the role of flavors in helping adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products. Further, FDA requested studies or information concerning the role of flavors in non-combusted tobacco products on the likelihood of: (i) cessation of combusted tobacco product use; (ii) cessation of all tobacco product use; and (iii) uptake of dual use of combusted and non-combusted tobacco products among current and former tobacco product users.”[6]  FDA also requested information on the role of flavors in combusted products on the likelihood of: (1) delayed or impeded cessation among users who would have otherwise quit combusted tobacco product use; or (2) delayed or impeded cessation among users who would have otherwise quit all tobacco product use.  FDA also solicited studies or information regarding the role of flavors in non-combusted tobacco on the likelihood that former combusted tobacco product users relapse.[7]
  • Additional Public Health Considerations: FDA requested studies or information regarding (1) the potential toxicity or adverse health effects to the user or others from any flavors (e.g., flavor additives, compounds or ingredients) in tobacco products; (2) the impact of public health efforts by local jurisdictions, States, and members of the international community to impose restrictions on the manufacture, marketing, sale or distribution of all or a subset of tobacco products with flavors, including but not limited to, cigars, ENDS, menthol cigarettes, and smokeless tobacco products; (3) consumer perceptions of the health risk of tobacco products with flavors when compared to other tobacco products both with and without flavors; (4) consumer perceptions, if any, of the addictiveness of tobacco products with flavors.

In a contemporaneous statement accompanying the ANPRM, FDA Commissioner Scott Gottlieb, M.D called upon all stakeholders to “share data, research, and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products.[1]  Importantly, the FDA Commissioner also requested “personal stories” from individuals that have been aided by flavors in making the transition between combustible tobacco cigarettes and vaping.  As seen in the litigation surrounding the deeming rule, these regulatory comments could be cited in any future litigation regarding either of these issues.

Comments are due on the tobacco product flavors ANPRM by June 19, 2018.

Premium Cigars ANPRM

In the preamble to the ANPRM regarding premium cigars, FDA noted that it received “numerous comments on the deeming proposed rule with respect to premium cigars, both in favor of, and against, regulating these products.”[8]  However, FDA explains that there was a lack of data supporting the opinions expressed in the comments received by the Agency regarding the Deeming Rule.  For that reason, the ANPRM explains that “FDA is seeking comments, evidence, information, data, and analysis that were not submitted in response to the proposed deeming rule” that could inform FDA’s thinking with respect to regulation of premium cigars.[9]

As an example of the type of information that would be responsive to the ANPRM, FDA cites a PATH Study Paper, which analyzed findings from the 2013-2014 Population Assessment of Tobacco and Health (PATH) Study with a focus on smokers of filtered cigars, cigarillos, and traditional cigars, which were further classified by study authors as either “premium” or “nonpremium.”[10]  That study concluded that “use characteristics, cigar smoking patterns, and dual smoking with cigarettes varied by cigar type.”[11]

Specifically, in the ANPRM, FDA requests comments on, among other topics, the following:

  • Definition of Premium Cigars: Among other things, FDA requested comments from the public concerning the defining characteristics of premium cigars, which may include: size; tobacco filler type; fermentation type; wrapper and binder composition; where the tobacco used for premium cigar filler or wrappers is grown; presence or absence of a filter or mouthpiece; manufacturing and assembly process; rate of production; presence or absence of flavor imparting compounds, flavor additives, or characterizing flavors other than tobacco; presence or absence of any additives other than cigar glue; nicotine content; tar and carbon monoxide delivery amounts; retail price; frequency with which price changes; packaging quantity and size; any action directed to consumers by a retailer or manufacturer.[12]
  • Use Patterns of Premium Cigars: FDA solicited studies or information regarding, among other things, and as compared to other cigars: (1) the potential role of premium cigars on tobacco initiation and progression to use of other tobacco products; (2) behavioral data related to dual use of premium cigars and other tobacco products; (3) the frequency and intensity of premium cigar use; (4) the proportion of premium cigar smokers showing symptoms of dependence; (5) the abuse liability of premium cigars; (6) the impact of premium cigar labeling, advertising, and marketing efforts on patterns of use.  Lastly, FDA also requested information on the extent to which users of other tobacco products might switch to premium cigars if FDA were to exempt premium cigars from regulation or regulate premium cigars differently from other cigars.[13]
  • Public health considerations associated with premium cigars: FDA requested studies or information regarding, among other things, and as compared to other cigars: (1) nicotine concentrations for premium cigars; (2) the risk of cancer, heart disease, aortic aneurysm, periodontal disease, stroke, and chronic obstructive pulmonary disease associated with premium cigar use; (3) the addictiveness, and consumer perceptions of the addictiveness, of premium cigars; (4) the required warning statements for premium cigars; and (5) the applicable manufacturing, marketing, sale, distribution, advertising, and labeling and/or packaging requirements and restrictions in the FDCA and its implementing regulations and whether they should be applied differently to premium cigars.

Comments are due on the premium cigar ANPRM by June 25, 2018.

Summary

An Advanced Notice of Proposed Rulemaking constitutes the earliest (and optional) stage of the administrative process that must be followed before eventually issuing an administrative rule.  As such, there is still ample time for efforts to influence the FDA’s regulatory approach to both premium cigars and tobacco product flavors by submitting comments to the administrative docket.  Companies or individuals interested in providing such feedback should consult with counsel to determine the best approach to maximize their impact with FDA.

[1]              See FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., on Efforts to Reduce Tobacco Use, Especially Among Youth, by Exploring Options to Address the Role of Flavors – including Menthol – in Tobacco Products, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601690.htm?utm_source=CTPEblast&utm_medium=email&utm_term=sro&utm_content=pressrelease&utm_campaign=ctp-flavanprm.

[1]              Regulation of Flavors in Tobacco Products, 83 Fed. Reg. 12294 (Mar. 21, 2018);

[2]              Regulation of Premium Cigars, 83 Fed. Reg. 12901 (Mar. 26, 2018).

[3]              FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of tobacco-related disease and death (July 28, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm.

[4]              83 Fed. Reg. 12994, 12998-99 (Mar. 21, 2018).

[5]              83 Fed. Reg. 12999.

[6]              Id.

[7]              Id.

[8]              83 Fed. Reg. 12901, 12902 (Mar. 26, 2018).

[9]              83 Fed. Reg. 12902. (emphasis added).

[10]             83 Fed. Reg. 12902-03, citing, Catherine G. Corey, MPSH et al., U.S. Adult Cigar Smoking patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) study, 2013-2014, Nicotine & Tobacco Research (Sept. 15, 2017), available at https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx209/4159211?redirectedFrom=fulltext.

[11]             Catherine G. Corey, MPSH et al., U.S. Adult Cigar Smoking patterns, Purchasing Behaviors, and Reasons for Use According to Cigar Type: Findings from the Population Assessment of Tobacco and Health (PATH) study, 2013-2014, Nicotine & Tobacco Research (Sept. 15, 2017), available at https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntx209/4159211?redirectedFrom=fulltext.

[12]             83 Fed. Reg. 12903.

[13]             83 Fed. Reg. 12904.

 

In the U.S. Food and Drug Administration’s (FDA’s) latest effort to implement its comprehensive regulatory plan[1] to shift the trajectory of tobacco-related disease and death, the Agency issued, on March 15, 2018, an advanced notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set a maximum nicotine level for cigarettes.[2]  As described in a contemporaneous statement issued by FDA Commissioner Scott Gottlieb, M.D., the ANPRM provides a wide-ranging review of the current scientific understanding about the role nicotine plays in addiction.[3]  Moreover, the ANPRM clarifies that FDA is considering “issuance of a product standard to set a maximum nicotine level in cigarettes so that they are minimally addictive or nonaddictive.”[4]

As detailed below, FDA requests in the ANPRM comments on, among other topics, the following:

  • Scope: Should the potential maximum nicotine level apply only to cigarettes or should it include other combustible tobacco products as well?
  • Maximum Nicotine Level: What is the maximum nicotine level that should be used as the threshold for “minimally addictive” or “non-addictive” levels?
  • Implementation: Should the maximum nicotine level for cigarettes propose a single target (where nicotine is reduced all at once or a stepped-down approach (where nicotine is reduced gradually over time through a sequence of incremental levels)?  Relatedly, what is the proper timeframe to implement a possible maximum nicotine level?
  • Analytical Testing Method: Should FDA specify a method for manufacturers to use to detect the level of nicotine in their products? If so, which method should be used?

Comments are due by June 14, 2018.

Scope of FDA’s Proposed Tobacco Product Standard

In the ANPRM, FDA seeks comments on whether the standard should cover any or all of the following products:  combusted cigarettes (which FDA has previously interpreted to include kreteks and bidis), cigarette tobacco, roll-your-own (RYO) tobacco, some or all cigars (e.g., including large and “premium” cigars), pipe tobacco, and waterpipe tobacco.[5]  Importantly, the Agency explains that “any nicotine tobacco product standard would cover all brands in a particular product category and, therefore, those products currently on the market and any new tobacco products would be expected to adhere to the standard.”[6]  Key questions raised by the ANPRM also include whether so-called “premium” cigars should be regulated differently from other cigars and whether waterpipe tobacco products should be excluded because they are unlikely to be migration substitutes or dual use candidates.[7]

Identification and Implementation of Appropriate Maximum Nicotine Level

With respect to nicotine levels in cigarettes, FDA requested comments on a potential maximum nicotine level that would be “minimally addictive” or “non addictive” and appropriate for the protection of public health, recognizing that the Family Smoking Prevention and Tobacco Control Act specifically prohibits FDA from “requiring the reduction of nicotine yields of a tobacco product to zero.”[8]  Indeed, FDA is particularly interested in comments concerning the merits of nicotine levels of 0.3, 0.4, and 0.5 mg nicotine/g of tobacco filler.[9]  In addition, the ANPRM requests comments on how any potential maximum nicotine level should be measured (e.g., nicotine yield, nicotine in tobacco filler, something else), how the threshold of nicotine addiction should be measured, and whether the product standard should specify a method for manufacturers to use to detect the level of nicotine in their products.[10]  Further, FDA requests comments on whether a maximum nicotine level for cigarettes should propose either a single target (where the nicotine is reduced all at once) or a stepped-down approach (where the nicotine is reduced gradually over time through a sequence of incremental levels and implementation dates).[11]

Technical Challenges Associated with Implementation

The ANPRM also acknowledges the technical challenges associated with implementation of a maximum nicotine standard.  Indeed, FDA explains that “significant nicotine reductions in cigarettes and other combusted tobacco products can be achieved principally through tobacco blending and cross-breeding plants, genetic engineering, and chemical extraction.”[12]  Similarly, FDA notes that “agricultural practices (e.g., controlled growing conditions, fertilization, and harvest) as well as more recent, novel techniques also can help to reduce nicotine levels.”  With that in mind, FDA explains that it is considering the proper timeframe to allow adequate time for industry to comply with a possible tobacco product standard setting a maximum nicotine level.  Relatedly, the ANPRM requests data and information regarding the potential costs, including the potential costs to farmers, to implement such a standard.

Countervailing Effects of Potential Nicotine Standard

Notably, the ANPRM also outlines several possible countervailing effects of a potential nicotine tobacco product standard, including: (1) continued combustible tobacco product use (e.g., current users switching to, or using simultaneously (i.e., dual use), a different combusted tobacco product to maintain their nicotine dependence; (2) continued very low nicotine cigarette smoking with altered behaviors (e.g., increase in number of cigarettes smoked, increased depth of inhalation); (3) cigarette users adding nicotine in liquid or other form to their combusted tobacco product; and (4) increased illicit trade of tobacco products.[13]  FDA plans to consider each of these potential unintended consequences before moving forward with issuing a potential maximum nicotine level for combustible tobacco products.

Projected Health Benefits

As explained in FDA Commissioner Gottlieb’s statement accompanying the ANPRM, new estimates included in the ANPRM and to be published in the New England Journal of Medicine, evaluate a potential policy scenario whereby a maximum nicotine level is implemented.  By the year 2100, the median estimate from the model, based on the experts’ estimates of potential initiation rates because of the policy, is that more than 33 million youth and young adults who would have otherwise initiated regular smoking would not start as a result of the hypothetical policy scenario.[14]  Further, using expert estimates for the percent of current smokers who would quit smoking after implementation of the policy, approximately 5 million additional smokers are estimated to quit smoking within one year after implementation of the standard.[15]  Under the same model, by 2060, it is estimated that a median value of almost 3 million deaths due to tobacco would be avoided.[16]

Impact of Potential Maximum Nicotine Level on Electronic Nicotine Delivery Systems (ENDS)

Of note for the vapor industry, in the Agency’s discussion of the effects of FDA’s potential tobacco product standard establishing a maximum nicotine level for cigarettes, FDA essentially acknowledges, as it has in the past, that ENDS products are less harmful than cigarettes.  Indeed, FDA explains “former smokers that choose to switch completely to a potentially less harmful nicotine product (e.g., electronic nicotine delivery systems (ENDS)) to maintain their nicotine dose also would, to the extent that those products result in less harm, significantly reduce their risk of tobacco-related death and disease.”[17]  By implication, this statement appears to tacitly accept that current combustible tobacco product users are likely to switch to ENDS products not covered by the potential maximum nicotine level rule.

Indeed, this result was recognized in a 2018 update (discussed in the ANPRM) to a previously published discrete system dynamic population model that compared projected outcomes for a status quo scenario (in which no maximum nicotine level is implemented) with outcomes for a policy scenario in which a hypothetical regulation lowering nicotine in cigarettes and selected other combusted tobacco products, to minimally addictive levels.[18]  Importantly, the model of the potential effects of the maximum nicotine level for cigarettes projected a simultaneous reduction in cigarette smoking and an increase in non-combusted tobacco product use.[19]   Lastly, in an industry conference call held on March 15, 2018 to announce the ANPRM, Mitch Zeller, the Director of the Center for Tobacco Products, expressly acknowledged the Agency’s obligation under Commissioner Gottlieb’s new comprehensive plan to ensure that nicotine remains on the market in less harmful forms as FDA works to implement a potential maximum nicotine level for combustible cigarettes.

 

______________________________________________________

[1] FDA News Release, FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of tobacco-related disease and death (July 28, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm.

[2] FDA, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-05345.pdf (pre-publication copy), at 1.

[3] FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on Pivotal Public Health Step to Dramatically Reduce Smoking Rates by Lowering Nicotine in Combustible Cigarettes to Minimally or Non-Additive Levels, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM601039.htm?utm_campaign=Statement_ANPRM%20to%20reduce%20nicotine%20in%20cigs&utm_medium=email&utm_source=Eloqua.

[4] Id., at 6

[5] Id., at 7.

[6] Id., at 8.

[7] Id., at 33.

[8] 21 U.S.C. § 387g(d)(3)(B)

[9] Tobacco Product Standard for Nicotine Level of Combusted Cigarettes Advanced Notice of Proposed Rulemaking (ANPRM), at 9.

[10] Id., at 9.

[11] Id., at 9

[12] Id., at 10.

[13] Id., at 10-12; See also FDA, Draft Concept Paper, “Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard (Mar. 15, 2018), available at https://www.fda.gov/downloads/tobaccoproducts/newsevents/ucm601047.pdf.

[14] Id., at 74.

[15] Id., at 75.

[16] Id., at 75.

[17] Id., at 26.

[18] Id., at 69.

[19] Id., at 74.

Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems Releases Report Documenting Massive Review of Existing Scientific Literature

On January 23, 2018, the National Academies of Sciences, Engineering and Medicine (hereinafter referred to as the “National Academies”) Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems (ENDS) (hereinafter referred to as the “Committee”) released a report entitled, “Public Health Consequences of E-Cigarettes” (hereinafter referred to as the “Report”).[1] The Report, which was the result of the Committee’s review of over 800 articles identified from a massive literature search of six different databases, noted that the Committee found sufficient literature to suggest that, “while there are risks associated with e-cigarettes, compared with combustible tobacco cigarettes, e-cigarettes contain fewer toxicants; can deliver nicotine in a manner similar to combustible tobacco cigarettes; show significantly less biological activity in a number of in vitro, animal, and human systems; and might be useful as a cessation aid in smokers who use e-cigarettes exclusively.”[2] In sum, the Report acknowledges that vaping is significantly less harmful than smoking traditional combustible tobacco cigarettes

Background on the Report
The Consolidated Appropriations Act of 2016 included language directing the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration (FDA) to “contract with the Institute of Medicine to conduct an in-depth evaluation of available evidence of health effects from e-cigarettes and recommendations for future federally funded research.”[3] CTP contracted with the National Academies to convene an ad-hoc committee to conduct this evaluation, which resulted in the creation of the Committee. The Committee’s literature review included an analysis of data on both short-term and long-term health effects in: (1) users of ENDS, including health effects associated with the use of these devices (e.g., cigalikes, tank systems, mods); (2) vulnerable populations of users (e.g., youth, pregnant women, individuals with underlying medical conditions (e.g., heart disease, pulmonary disease); and (3) non-users of ENDS exposed to second-hand and third-hand aerosol generated by use of these devices.[4]

The Report Concludes That Vapor Products Are Less Harmful Than Combustible Tobacco Cigarettes
Perhaps the most significant aspect of the Report is the Committee’s implicit and explicit conclusion that e-cigarettes are safer than combustible tobacco cigarettes. Although the Report is more cautious than the Royal College of Physicians Report,[5] the Committee nevertheless acknowledged that the “current evidence points to e-cigarettes being less harmful than combustible tobacco cigarettes.”[6]

Moreover, several of the Report’s findings bolster the Committee’s conclusion that e-cigarettes are less harmful than combustible tobacco cigarettes. For example, the Committee found “conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.”[7] Indeed, all cross-sectional and longitudinal studies comparing exposure to nicotine and toxicants in smokers who substituted e-cigarettes for their combustible cigarettes, showed that smokers who substitute e-cigarettes for their combustible cigarettes had significantly reduced levels of biomarkers of exposure to potentially toxic chemicals.[8] Similarly, the Committee observed that “although some studies found similar harm from e-cigarettes, no studies found that e-cigarettes were more harmful than combustible tobacco cigarettes among combustible tobacco cigarette smokers who switched to exclusive e-cigarette use.”[9]

Further, the Committee concluded that there was “substantial evidence that completely switching from regular use of combustible tobacco cigarettes to e-cigarettes results in reduced short-term adverse health outcomes in several organ systems.”[10] In addition, studies reviewed by the Committee showed that use of an e-cigarette in indoor environments may involuntarily expose non-users to nicotine and particulates, but such exposure is at lower levels compared with exposure to secondhand tobacco smoke from combustible tobacco cigarettes.[11] The Report also noted that, “among dual users, e-cigarettes may help maintain smoking reduction.”[12]

At the same time, the Report notes that “the proportion of U.S. adults who consider [e-cigarettes] to be as harmful as combustible tobacco cigarettes has increased over time,” indicating that the public needs information related to the relative harm of e-cigarette products.[13] However, the “modified risk” provisions of the Tobacco Control Act (the “Act”) prohibit vapor companies from making truthful claims that their products present reduced-risk compared to combustible cigarettes, or even that their products do not contain or produce smoke or tar, without submitting an extensive application and securing FDA’s approval to make such claims.[14] Indeed, the modified risk standard is so stringent that it is highly unlikely any such claim will ever be approved for a vapor product.[15]

Accordingly, an unintended consequence of FDA’s approach to implementing the Act may be the proliferation of misinformation concerning the relative risks of vapor products and combustible tobacco cigarettes.[16]

Youth Use of E-Cigarettes
A frequent area of concern for courts[17], FDA, and public interest groups involves the use of e-cigarettes among youth.  As background, the Committee notes that the “proportion of youth who reported ever using e-cigarettes varies substantially across surveys” from as low as 10.7 percent to as high as 27.1 percent.[18] The Committee indicates that “early results suggest” that e-cigarette use “stabilized or decreased in youth between 2015 and 2016, despite increases between 2011 and 2015 across a range of surveys.”[19] Among those who reported having ever used an e-cigarette, youth most commonly reported using rechargeable/refillable tank-style devices, with more than half (53.4 percent) of middle and high school students reporting using only this kind of device.”[20]

In its consideration of the impact of e-cigarette use on “ever-use” of combustible tobacco products, which critically, is defined as smoking a single cigarette at any point in one’s life, the Report considers two dueling hypotheses (i.e., the diversion hypothesis and the catalyst hypothesis).  The Committee explains that e-cigarettes could have a preventive effect if the diversion hypothesis – the hypothesis that because some youth possess an elevated drive to engage in exploratory or risk-taking behavior, the availability of e-cigarettes allows such young people to satisfy their curiosity and drive for novelty without resorting to combustible tobacco cigarettes – is proven. Similarly, if the catalyst hypothesis – the hypothesis that e-cigarettes attract low risk teens who would not otherwise try combustible tobacco cigarettes and, once these teens have tried e-cigarettes, they are more likely to try combustible tobacco cigarettes – holds, e-cigarette use would increase the risk of ever-smoking.[21] Of course, e-cigarette use may also have no effect on combustible tobacco cigarette ever use in adolescents and young adults.

Keeping in mind the definition of “ever-use” noted above (i.e., smoking a single cigarette at some point) the Committee concluded, among other things, that “there is substantial evidence that e-cigarette use increases the risk of ever using combustible tobacco cigarettes among youth and young adults.”[22] While news headlines across the world ran with this conclusion to claim that e-cigarettes “lure” kids into smoking, the Report also observes that “the population-based data broadly show opposing trends in e-cigarette and cigarette use prevalence across time among U.S. youth in recent years and thus do not provide confirmatory evidence of the epidemiologic person-level positive associations of vaping and smoking.”[23] In this regard, we note that the National Youth Tobacco Survey data shows that youth smoking rates have been falling rapidly.[24] Between 2011 and 2016, current use of cigarettes by high school students fell from 15.8 percent to 8.0 percent, and use of cigars and pipes also fell.

Implications of the Report
Ultimately, the Report is the most complete analysis of existing research on the public health consequences of e-cigarettes in the United States. Further, the Report provides the imprimatur of the National Academies on a conclusion long recognized by the vaping community: e-cigarettes are significantly less harmful than combustible tobacco cigarettes.

 

___________________________________________

[1] National Academies of Science, Engineering and Medicine: Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems, The Public Health Consequences of E-Cigarettes (eds. Kathleen Stratton et al., 2018), available at https://tinyurl.com/ya4w37kb (hereinafter, referred to as the “Report”).

[2] Report, supra n.1., at S-9.

[3] Id., supra n.1., at 1-1, 1-2 (Box 1-1 Statement of Task).

[4] Id., supra n.1., at S-9.

[5] Tobacco Advisory Group of the Royal College of Physicians, Nicotine Without Smoke: Tobacco Harm Reduction (2016), at 87, available at https://tinyurl.com/h5ypa7s (stating, “although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure.”).

[6] Report, supra n.1., at 18-23.

[7] Id., supra n.1., at 18-13; See also Id., at 5-32 (“Conclusion 5-3. There is substantial evidence that except for nicotine, under typical conditions of use, exposure to potentially toxic substances from e-cigarettes is significantly lower compared with combustible tobacco cigarettes.”) (emphasis in original).

[8] Id., supra n.1., at 18-13.

[9] Id., supra n.1., at 18-23.

[10] Id., supra n.1, at 18-24.

[11] Id., supra n.1., at 18-28.

[12] Id., supra n.1., at 18-25.

[13] Id., supra n.1., at 18-2.

[14] 21 U.S.C. § 387k.

[15] FDA may issue a modified risk order only after the manufacturer makes numerous showings based on scientific data.  Specifically, the applicant must demonstrate that the product will:

  • significantly reduce harm and the risk of tobacco-related disease to individual users; and
  • benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

21 USC § 387k(g)(1) (emphasis added).  As to the “population effects” prong of the standard, FDA must consider:

  • relative health risks of the subject tobacco product;
  • likelihood that those who do not use tobacco products will start using the subject product (e., initiation); and
  • likelihood that users who would otherwise stop using tobacco products will start using the subject product (e., cessation)

21 USC § 387k(g)(4).

[16] See Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (hereinafter referred to as the “Act”); See also 21 U.S.C. § 387k.

[17] See e.g., Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509(6th Cir. 2012), (finding a “substantial state interest in curbing juvenile tobacco use that can be directly advanced by imposing limitations on the marketing of tobacco products.”).

[18] Report, supra n.1., at 1-3 (compare the Population Assessment of Tobacco and Health (PATH) survey (Wave 1 in 2013-2014) finding only 10.7% of youth ages 12-17 reporting ever using an e-cigarette once or twice with the National Youth Tobacco Survey finding that 27.1% of middle and high school students ever used e-cigarettes.).

[19] Id., supra n.1., at S-1, 2.

[20] Id., supra n.1., at 1-5.

[21] Id., supra n.1., at 16-3.

[22] Id., supra n.1., at 16-30 (emphasis added).

[23] Id., supra n.1, at 16-28; See also Sheila Kaplan, Vaping Can be Addictive and May Lure Teenagers to Smoking, Science Panel Concludes, The N.Y. Times (Jan. 23, 2018), available at https://tinyurl.com/y86naj7u.

[24] Jamal A, Gentzke et al. Tobacco Use Among Middle and High School Students — United States, 2011–2016, 66 MMWR Morb Mortal Wkly Rep. No. 23, at 597-603 (June 16, 2017), available at https://tinyurl.com/y8ce2w9a.

 

Azim Chowdhury and Adam Susser will participate in the FDLI Tobacco Products and Regulation and Policy Conference, which will take place October 26-27, 2017 in Washington, DC.

This KH sponsored event will bring together public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others to effectively regulate the broad spectrum of tobacco and nicotine products in the US and globally.

Azim will participate on the panel “The Future of Deeming Regulations: Policy and Litigation” which will engage in discussions about the future of the deeming regulations, including issues pertaining to litigation, regulations, legislation, and the pros and cons of extending the implementation dates to 2021 and 2022. Attention will also be given to the appropriate use of flavoring in both e-cigarettes and cigars and how it can be ensured that children and youth are not being encouraged to use these products.

Adam will present on “Overview of Tobacco Law and Regulation” during the Introduction to U.S. Tobacco Law and Regulation seminar which will explore the essentials of tobacco law and regulation including the Deeming Rule, Premarket Tobacco Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs), advertising and promotion, compliance, enforcement, and related issues.

For more information on this event, click here.