Vape Shop Owners/Managers’ Opinions About FDA Regulation of E-Cigarettes

Abstract

Introduction

In the United States, prominent sources of vaping products are specialty vape shops, which are subject to Food and Drug Administration (FDA) regulation. This study interviewed vape shop owners/managers to assess: (1) reasons for entering into or engaging in vape shop retail; (2) personnel training, particularly with regard to FDA and state regulations; and (3) how existing regulations are perceived and the anticipated impact of future regulation.

Aims and Methods

The current study involved phone–based semi-structured interviews of 45 vape shop owners/managers in six metropolitan statistical areas (Atlanta, Boston, Minneapolis, Oklahoma City, San Diego, and Seattle) during Summer 2018 as FDA regulations regarding minimum age verification, bans on product sampling, and health warnings (among others) were first being implemented.

Results

Vape shop owners/managers reported: (1) entering the industry with positive intentions for their customers, (2) training their personnel to adhere to regulations and provide good customer service, and (3) significant concerns about the impact of FDA regulations. With regard to the latter, participants reported mistrust of the intentions of the FDA regulations, financial implications of the regulations (particularly for small businesses), difficulty understanding and interpreting the regulations, insufficient evidence to support the regulations, negative impact on customer service, negative impact on product offerings and product innovation/advancement, and negative implications of flavor bans and/or restrictions on sale of flavors.

Conclusions

These findings indicate the complexities in implementing tobacco regulations, particularly from the perspective of the vape shop industry. Current findings should inform future regulatory actions and efforts to assess compliance with regulations.

Implications

Current and impending FDA regulation of vaping products present a critical period for examining regulatory impact on the vape shop industry. Current results indicated that many vape shop owners/managers reporting positive intentions for engaging in the vaping product industry and in training vape shop personnel to adhere to regulations. However, the majority reported concerns about FDA regulation and other state/local regulations that could have negative implications for their industry. Particular concerns include difficulty understanding the regulations due to complexity, vagueness, and changes in language and/or interpretation over time. These issues have implications for compliance that must be addressed.

Introduction

Over the past decade, e-cigarettes—or vaping products—have emerged globally.¹ Critical in the e-cigarette retail context are vape shops,² which are tobacco specialty stores that predominately sell vaping devices and nicotine e-liquids but not conventional tobacco products.³ Coincidentally, there has been a rapid expansion domestically and globally of vape shops.⁴

Marketing in vape shops is distinct from other traditional tobacco retailers (e.g., convenience stores),³ which typically sell closed systems, such as disposable/single-use products as well as prefilled pods and cartridges. Vape shops sell other devices as well, including open systems that consumers fill with e-liquids, as well as herbal/dry chamber vaporizers, wet/dry vaporizers, pods, cartridge–based products, and others.³ Particularly relevant, more advanced vaping devices may better help smoking cessation efforts.^5,6 Vape shops also feature various accessories and e-liquid flavors³ (critical in consumer appeal⁷), and many promote sampling and socializing at tasting bars.^3,8 Vape shops use these and other marketing strategies (e.g., product advertising and price promotions)^3,9 to expand tobacco markets, attract new users, promote continued use, and build brand loyalty—both with regard to products and to the retailer themselves (e.g., customer service and product offerings).^10–12 Advertising can influence how and why consumers vape^3,13,14 as well as perceptions of product safety or use for cessation.^8,13–15

In 2016, the US Food and Drug Administration finalized a rule extending its authority beyond cigarettes to all tobacco products (or nicotine-containing products derived from tobacco leaf), including vaping products (see Table 1 for regulations and timeline).¹⁶ This is critical given that despite e-cigarettes delivering potentially fewer harmful chemicals than traditional cigarettes and potentially supporting cessation efforts,^17–20 e-cigarettes contain chemicals that may increase risks of addiction and disease (e.g., cardiovascular, lung, and pulmonary, cancer)^17,21 and e-cigarette/vaping use–associated lung injury.²²

Table 1.

Timeline for FDA Enforcement for Newly Covered Tobacco Products

FDA policy	Enforcement date
Minimum sales age of 18 and age verification under 27	August 8, 2016
Prohibition on vending machine sales except adults-only facilities	August 8, 2016
Prohibition on free samples*	August 8, 2016
Regulation of adulterated products	August 8, 2016
Prohibition on false or misleading advertising	August 8, 2016
Required premarket review of modified risk tobacco products	August 8, 2016
Required disclosure of health-related documents	February 8, 2017
Required registration of manufacturers and disclosure of product lists	October 12, 2017
Prohibition of the use of “light,” “mild,” “low,” or similar descriptors	November 8, 2017 + 30 day sell-off period
Required disclosure of ingredients, substances, compounds, and additives	May 8, 2018
Required warning labels	August 10, 2018
Required disclosure of harmful and potentially harmful constituents	November 8, 2019

Requirements currently apply to cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco.

*The FDA has stated that “allowing prospective adult buyers to smell or handle one of the newly deemed products is not considered distribution of a ‘free sample’ as long as the free product is not actually consumed, in whole or in part, in the retail facility and the prospective buyer does not leave the facility with a free tobacco product.” 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; Final Rule, 81 Fed. Reg. 28,974, 29,026 (May 10, 2016) (to be codified at 21 C.F.R. pts. 1100, 1140, and 1143)).

Source: https://publichealthlawcenter.org/sites/default/files/resources/tclc-fda-deemingreg-regulation-authority-Dec2016.pdf.

Food and Drug Administration (FDA) regulations may uniquely impact vape shops.²³ For example, free sampling of e-liquids with nicotine, which was historically offered at vape shop tasting bars,^8,24,25 is now disallowed under federal regulations. Health warnings are required on all products/ads, which is relevant given that some marketing endorses vaping for cessation or harm reduction.^8,26–28 With concern about youth appeal, the FDA issued warnings to manufacturers, distributors, and retailers for selling e-liquids with cartoon–like imagery on advertising/labeling in 2018,²⁹ and more recently eliminated the sale of flavored pod and cartridge–based products (albeit excluding menthol and disposable products that also appeal to youth).³⁰ More comprehensive restrictions on flavors, or total bans on the sale of vaping products, exist in some states and more than 200 localities.³¹ At the time of data collection, federal regulations required age verification with a photograph ID for anyone under age 27 to purchase tobacco products; states and localities may also have legislation regarding age verification to enter vape shops. This is important since young adults represent a large vape shop market segment,²⁴ and some vape shops (15%–27%^8,32,33) have no minimum age signage and allow minors to enter.²⁴

FDA regulations may have implications for the livelihood of the vape shop industry and could lead to supplanting independent shops with larger chains.^34,35 A substantial proportion of vape shop revenues come from e-liquids; ³² vape shops manufacturing their own e-liquids subjects them to greater FDA oversight. A substantial proportion of vape shops are small businesses² or single-store owners.³² These businesses may not be as resilient to regulation roll out and lack the capacity to seek market approval to sell customized e-liquids. Moreover, prior research has documented that many people working in the vape shop industry are former smokers who used vaping to quit smoking traditional cigarettes or reduce harm, believe that their products are effective for these purposes and largely safe, and want to help their consumers.^28,36,37

Understanding retailer opinions and interpretations of regulation is critical to inform enforcement and to anticipate regulatory impact on the vape shop industry. To address this important area, we interviewed vape shop owners/managers to assess: (1) reasons for entering into or engaging in the vape shop retail market; (2) how personnel are trained, particularly with regard to FDA and state regulations; and (3) how existing regulations are perceived and the anticipated impact of future regulation.

Methods

Participants and Procedures

The Vape shop Advertising, Place characteristics, and Effects Surveillance study examines the vape shop retail environment in six metropolitan statistical areas (MSAs): Atlanta-Sandy Springs-Roswell (Georgia), Boston-Cambridge-Newton (Massachusetts), Minneapolis-St. Paul-Bloomington (Minnesota), Oklahoma City (Oklahoma), San Diego-Carlsbad (California), and Seattle-Tacoma-Bellevue (Washington). These MSAs were selected for representation across US regions and their variability in terms of state tobacco control policies (see Supplementary Table S1).^31,38 For example, across all categories (tobacco prevention, smoke-free air, cessation access, tobacco taxation, and Tobacco 21), California earned all A-grades but one, Massachusetts and Minnesota earned at least two A grades, and Washington, Oklahoma and Georgia earned predominately D and/or F grades. A similar gradient also applies to vaping. At the time of assessment, California and Minnesota taxed vaping products; California, Minnesota, and Washington required licenses for retail sales of vaping products.³¹ No MSA in this study had local sales restrictions on vaping products or flavored tobacco at the time of assessment. In addition, California and Washington had retail markets for recreational marijuana. Detailed information on the parent study and the sampling frame for vape shops is detailed elsewhere.³⁹

Shop owners/managers were invited to participate in semi-structured interviews during the process of conducting 179 point-of-sale assessments across the six MSAs (~30 in each MSA).³⁹ The sampling frame of the vape shops assessed are detailed elsewhere.³⁹ In brief, we searched “vaporizer store” on Google and “vape shops” on Yelp to identify stores in the six states tagged by retailers or customers as vape shops, restricted lists to stores with complete addresses, eliminated duplicate entries, geocoded records to latitude/longitude using ArcGIS v10.1, used a telephone protocol to confirm that stores met eligibility criteria (i.e., sold vape products but not other tobacco products), and then randomly selected 30 vapes shops within 25 miles of the MSA centroid for point-of-sale assessments.

Shop owners/managers of the 179 vape shops assessed were contacted via email and/or phone call to assess/confirm willingness to participate and schedule an interview; 140 owners/managers indicated interest in participating in qualitative interviews (communicated in person at the time of the point-of-sale audit or via email/phone). Of the 80 (57.1%) who consented (when called to complete/schedule the interview), 45 (56.2%) participated in the interviews (Loss of those consented was largely due to inability to reach those who consented at times scheduled for interviews.). Participation rates varied across the MSAs: 22% in Oklahoma City; 20% in Seattle; 18% in Atlanta, Boston and Minneapolis, respectively; 10% in San Diego.

Data Collection

Owner/manager interviews were conducted from July to September 2018. consolidated criteria for reporting qualitative research guided the implementation and analyses of the semi-structured interviews.⁴⁰ The interview guide was developed and pilot tested through mock interviews to ensure clarity and comprehensiveness; the guide was revised after the first three interviews. The interview assessed: (1) personnel vape shop involvement (i.e., Can you tell me how you got involved in the vape shop industry? Among your sales associates, what are some common/main reasons for working at a vape shop?), (2) personnel training characteristics (i.e., When you hire sales associates, what kind of a training process is involved? What types of issues do you address in the training?), and (3) perceptions of pending FDA regulations (Table 1), their impact, and future implications (i.e., How is your shop being affected by the pending/new FDA regulations? How is your shop being affected by any state regulations? Which regulations have most adversely impacted your shop? How? What regulations do you think will adversely impact your shop in the future? How? What challenges have you had in understanding or navigating the new regulations? Which regulations have been the most difficult to understand or navigate? What resources are you using to help understand or navigate the new regulations?). Short-answer questions were asked to elicit descriptions of vape shops and marketing (e.g., product offerings and promotional strategies), as well as sociodemographic characteristics of participants.

Interviews (~15–30 min in duration) were facilitated by four MPH graduate students (one male, three female) trained in qualitative data collection. All interviews were audiorecorded for subsequent coding. Participants were compensated a $30 Amazon e-gift card.

Data Analysis

All audio recordings were uploaded to a secure, password–protected computer and transcribed verbatim by a professional service. Qualitative data were analyzed using MAXQDA 12 (Berlin, Germany: www.maxqda.com/) and thematic analyses. Two authors (trained MPH-level study personnel) independently reviewed all transcripts, which they then used to generate preliminary codes using deductive and inductive coding methods.⁴¹ All codes were compiled and developed into a codebook for analysis. Primary (i.e., major topics) and secondary codes (i.e., recurrent themes within primary topics) were established. Then, each transcript was fully and independently analyzed by two additional MPH graduate students and coded using the preliminary codebook that was developed. All new codes that arose during coding were added to the codebook and applied to all transcripts. Codes were compared, and consensus for coding was reached (Kappa = 93.3%). Final codes were used to identify themes, and relevant and representative quotes were chosen based on representativeness and clarity. Balancing the controversy in qualitative research regarding whether to quantify qualitative results, we chose to indicate the frequency with which themes were provided by participants by quantizing them as “all”, “almost all”, “most”, “the majority”, “some”, and “a few”.⁴² Additionally, descriptive statistics were conducted to characterize the qualitative study sample, using SPSS 23.0.

Results

Participant and Vape Shop Characteristics

Participants were predominately male (82.2%) and non-Hispanic White (77.8%), and average age was 36.2 years (SD = 11.4) (Table 2). Most participants (64.4%) were managers, and 73.3% had been employed at their vape shop for at least 2 years. The majority (86.7%) had ever smoked cigarettes in their lifetime, and 8.9% reported past 30-day smoking. Nearly, all participants (95.6%) used e-cigarettes in the past 30 days.

Table 2.

Participants and Vape Shop Characteristics, n = 45

Variable	M (SD) or N (%)
MSA, N (%)
Atlanta	9 (20.0)
Boston	8 (17.8)
Minneapolis	8 (17.8)
Oklahoma City	10 (22.2)
San Diego	4 (8.9)
Seattle	6 (13.3)
Sociodemographics
Age, M (SD)	36.2 (11.4)
Sex, N (%)
Female	8 (17.8)
Male	37 (82.2)
Race/ethnicity, N (%)
White	35 (77.8)
Other	10 (22.2)
Use history
Cigarette use, N (%)
Ever use	39 (86.7)
Past 30-day use	4 (8.9)
E-cigarette use, N (%)
Ever use	45 (100.0)
Past 30-day use	43 (95.6)
Vape shop-related characteristics
Participant position, N (%)
Owner	14 (31.1)
Manager	29 (64.4)
Other	2 (4.4)
Participant employment duration, N (%)
Less than 1 year	6 (13.3)
1–2 years	6 (13.3)
More than 2 years	33 (73.3)
Chain (i.e., more than one location), N (%)
Yes	18 (40.0)
No	27 (60.0)
Duration of store operation, N (%)
Less than 1 year	3 (6.7)
1–2 years	2 (4.4)
More than 2 years	40 (88.9)
Vape shop product availability
E-liquids, N (%)
Vape shop’s own e-liquid brand	32 (71.1)
Other e-liquid brands	43 (95.6)
Nicotine salt (separate from device)	39 (86.7)
CBD	20 (44.4)
Average % revenue from e-liquids, M (SD)	65.6 (18.4)
Vape shop marketing, N (%)
Word of mouth	45 (100.0)
Special events	29 (64.4)
Community events	25 (55.6)
Print ad	23 (51.1)
Marketing agent	14 (31.1)
Broadcast	8 (17.8)
Online media presence
Facebook	40 (88.9)
Own website	31 (68.9)
Instagram	30 (66.7)
Yelp	15 (33.3)
Twitter	7 (15.6)
In-store advertisements
Veteran/military discounts	43 (95.6)
Loyalty/rewards programs	33 (73.3)
Daily/weekly specials	28 (62.2)
Price specials	24 (53.3)
Customer database	21 (46.7)
Happy hour	16 (35.6)
Raffles/coupons	15 (33.3)
Flavor of the week	10 (22.2)
College student discounts	10 (22.2)
Online ordering	12 (26.7)

The majority of vape shops (60.0%) were chains (i.e., more than one location), and 88.9% were open for more than 2 years. The vast majority of vape shops (71.1%) sold their own brand of e-liquids, 95.6% sold other e-liquid brands, 86.7% sold e-liquids with nicotine salts (separate from a device), and 44.4% sold e-liquids containing CBD. Participants reported that, on average, 65.6% (SD = 18.4) of revenue came from e-liquid sales. A broad range of marketing strategies were used, relying heavily on word of mouth (100.0%), special events (64.4%), community events (55.6%), online media—particularly Facebook (88.9%), their own websites (68.9%), and Instagram (66.7%), and a broad range of in-store advertisements—particularly veteran/military discounts (95.6%), loyalty/rewards programs (73.3%), daily/weekly specials (62.2%), and price specials (53.3%).

Reasons for Vape Shop Industry Involvement

Supplementary Table S2 presents themes and subthemes identified and representative quotations, respectively. Reasons for entering the vape retail industry included personal beliefs in product efficacy, with the majority of participants reporting being able to quit or cut down on their own smoking and a desire to help others do the same. Relatedly, some spoke of the draw to the industry to serve the public good and assist in smoking cessation within their community. Some also reported feeling that that vaping represented a promising business prospect, given the need for smoking cessation and the initial boom of the vape shop market. Some indicated that the intrigue of the technology and science were a primary driver. Some also appreciated or were drawn to the “vape shop culture.”

Vape Shop Personnel Training

The majority of owners/managers indicated that some baseline knowledge of vaping is a requirement for hiring. The majority participants prioritized customer service, specifically helping consumers find the desired devices and e-liquids. Some also mentioned that product recommendations were aimed at ensuring the best odds of tobacco use cessation among consumers. The majority also indicated the importance of personnel understanding and being able to convey how to use products safely and care for the safety of products, particularly the battery.

Most participants discussed training regarding federal and state regulations relevant to vape shops. One regulation that most participants indicated as a focal point of training was age verification policies. Some indicated that they provided training around the types of claims that were not permitted, specifically cessation or harm reduction claims. A few specified tactics to ensure compliance, such as signing contracts with personnel.

Perceptions of FDA Regulations

When asked about their general impressions of FDA regulations, the majority indicated various negative perceptions. Among the most prominent were mistrust of the intentions of the FDA regulations. Some felt that the FDA was trying to drive smaller shops out of business, only leaving big companies in the market. Some comments were also made that appeared to allude to beliefs that the FDA was colluding with the tobacco industry; they suggested that the e-cigarette market was being scrutinized more than cigarettes had ever been. Some pondered whether the reason e-cigarettes are being scrutinized is because they could reduce cigarette consumption.

Another major theme that emerged when asked about FDA regulations broadly was difficulty understanding and interpreting the regulations. The majority felt that they were too complex and written in legal jargon, making it difficult for small business owners to navigate. Some even felt that the FDA regulations were designed to be vague perhaps as a way to entrap vape shops that may interpret the regulations ways deemed noncompliant. Most also indicated the challenges of keeping up with the rapidly changing regulations. For example, some discussed losing money due to relabeling inventory or due to inventory loss related to trying to comply with the regulations. Almost all participants commented on the financial implications of the FDA regulations, particularly with regard to costs related to manufacturing their own brand of e-liquids.

Some indicated that they believed that the FDA regulations were insufficiently substantiated by any evidence base. Further, some indicated being disgruntled by how the blanket categorization of “tobacco products” had been applied to everything related to e-cigarettes, including the devices without any e-liquids, the components of the devices, and e-liquids without nicotine. Finally, some indicated concern about the future of both their vape shops and the broader vaping/e-cigarette industry.

Interpreting the “No Free Sampling” Regulation

The majority indicated that one example of a vague regulation was regarding “no free sampling.” There were a few different ways in which owners/managers dealt with the regulation and the vagueness of it. Some interpreted the law to mean that free sampling was allowed as long as the e-liquids did not contain nicotine. Some owners/managers exploited loopholes by charging a small fee per sample (better if connected to our observations here), establishing customer loyalty/rewards programs so that a small membership fee permitted sampling, or working the cost for samples into subsequent transactions or the cost of a bottle of e-liquid. Rather than offering samples, some owners/managers allowed customers to smell e-liquid flavors.

Anticipated Impact on Customer Service

When further asked about how the FDA regulations might impact their industry, some discussed how customer service might suffer, particularly how restrictions on what vape shop personnel could do to educate and support consumers about how to use devices, particularly with regard to technology support (e.g., education and demonstration) as new devices came on the market.

Anticipated Impact on Product Offerings and Innovation

A major theme that emerged was the impact on product offerings and product innovation/advancement. Regarding devices, there was both concern about how FDA regulations would impact the ongoing offering of devices currently on the market and advancement of vaping device technology. Some commented on the rationale for exempting older devices with less advanced technology and more potential risks, with a preference for allowing the more recently developed devices to stay on the market. Most who sold their own e-liquid brand voiced concerns about the cost of carrying or manufacturing their own e-liquid brands and the negative implications for their future. In addition, several owners/managers indicated that they anticipated complications regarding e-liquid manufacturing and thus decided not to manufacture their own or discontinuing their e-liquid manufacturing. Regardless of whether they were manufacturing or selling their own e-liquids, most participants were concerned that e-liquid flavors could not diversify because of the cost associated with each new flavor. They anticipated this would reduce the appeal of vaping among their consumer base with a detrimental effect on the vaping industry.

Anticipated Impact of Flavor Bans

The majority of participants indicated concerns that flavor bans and/or restrictions on sale of flavors would close their vape shop and potentially end the vape shop industry. Moreover, a few participants voiced concerns that such bans/restrictions could have a negative impact on smokers who have used or might use vaping as a way to quit smoking or reduce harm, as the limited options for e-liquid flavors could disincentivize the use of e-cigarettes.

Discussion

Among the most notable results of this study were vape shop owner/manager concerns about FDA regulation impact, as they were beginning to be enforced (during Summer 2018; see Table 1). These findings foreshadowed what has occurred since, particularly with regard to federal, state, and local regulatory efforts to reduce access among youth and to restrict sales of vaping devices and/or flavored e-liquids. Current findings align with prior research indicating that most vape shop merchants are supportive of some regulations^36,37,43 but feel that regulations should be different from traditional tobacco (e.g., cigarettes).^36,37 Indeed, participants in the current study largely took opposition with the classification of their products as tobacco products, particularly devices and parts of devices not containing nicotine or tobacco. Moreover, vape shop owners/managers were concerned that FDA regulations would put them out of business, in part because the complexity of the regulations required legal consultation, to which few of these small businesses had/have access. Prior research also indicated concerns about the tobacco industry squeezing them out of the market, largely because the tobacco industry has substantially more resources and influence and could manipulate the implementation of regulations.⁴⁴

Vape shop owners/managers in the current study were also concerned about FDA regulation impact on their consumers, for example, with regard to the types of products that could be offered and the potential stifling of innovation, also identified in earlier research before the deeming rule was issued.^37,44 Vape shop owners/managers commented on the potential dangers and lack of feasibility of only carrying earlier devices that would be grandfathered in, which have less advanced technology and less promise for aiding in cessation.⁵ Participants were concerned about FDA regulation impact on consumers identifying the right e-liquid flavors, both because of restrictions put on sampling and because regulations of e-liquid flavor offerings could limit the number of options, as also noted in a prior study.⁴³ Moreover, almost all participants indicated that, because e-liquids are a major revenue driver for the majority of vape shops—even those that do not manufacture e-liquids, any reductions of new e-liquid flavors could negatively impact business. This was particularly concerning among e-liquid manufacturers, who highlighted the cost of continuing to manufacture and diversify their e-liquid flavor offerings.

Some news reports have suggested that, as a result of these regulations, many shops have faced—or are beginning to face—a difficult decision: struggle to survive, close, or rebrand with a new inventory.⁴⁵ Many shop owners say that they are selling off as much inventory as possible, operating on month-to-month leases and preparing to close.⁴⁵ Others are making plans to sell pipes, tobacco products, or CBD to survive.⁴⁵ There are significant concerns about a growing number of tobacco retailers if vape shops shift to selling the broader range of tobacco products. However, one study found that, while tobacco shops’ reasons for carrying e-cigarettes were business oriented, focused on maintaining their customer base, they saw their e-cigarette consumers as using them for cessation. On the other hand, vape shop personnel reported their customers using e-cigarettes for more varied reasons (e.g., socializing).⁴⁶ Nonetheless, current findings highlight that vape shop owners/managers were considering the potential implications of legislation; however, it is difficult to distinguish if some of the loss of business for vape shops may also be a result of the negative press related to e-cigarette/vaping use–associated lung injury.

Other findings regarding vape shop owners/managers’ intentions in serving consumers echo prior literature. Many participants in this study reported entering the market in part due to their beliefs that e-cigarettes were helpful for cessation and/or harm reduction and/or experienced the benefits or vaping to aid in cessation/harm reduction (personally or among someone close to them), as documented in prior qualitative research.^28,36,37,47 However, one qualitative study indicated that some merchants also reported potentially negative experiences including failed cessation attempts, dual use of e-cigarettes and combustible cigarettes, and increased nicotine dependence.²⁸

Vape shop owners/managers in the present study also described theirvape shop personnel training approaches, particularly regarding regulations such as age-verification practices. However, such reports are undermined by findings in these same metropolitan areas, indicating that, while 95.0% of shops displayed minimum-age signage, mystery shoppers were asked for age verification at only 35.6% of vape shops upon entry and at only 23.4% upon purchase.³⁹ Moreover, prior research in these same markets indicated that 29.1% of vape shops audited had at least one sign indicating health claims and/or claims that vaping aids in cessation and ubiquitously endorsed vaping as a safer alternative to smoking and as an effective cessation aid.³⁹

The current research has implications for research and practice. Surveillance is needed to assess the impact of FDA regulations on vape shops, merchants themselves, and the broader tobacco retail landscape. How existing federal, state and local regulations impede or benefit smoking cessation warrant investigation to better inform future policies. Education of vape shop owners and managers by public health entities regarding current FDA, state, and local regulations may help clarify the rationale for such regulation, the confusion surrounding language and timelines, and the need for active enforcement to reduce youth access to tobacco. This is critical given the concerns about compliance with existing regulations³⁹ and as new products designed by major tobacco companies enter the market.⁴⁸ Unfortunately, this study did not explicitly assess what resources vape shop owners/managers used to better understand the regulations, how to comply with them, and how compliance would be assessed. Future research should consider how vape shops accommodate new regulations, and/or transition their businesses models in response to contextual changes (e.g., legalization of retail marijuana, post COVID-19).

Limitations

A limitation of this research is that it predates two major changes to the regulatory environment for tobacco: (1) a federal increase in the minimal legal sales age to 21 years old and (2) the e-cigarette/vaping use–associated lung injury crisis that brought about partial restrictions on sales of flavored vaping products at the federal level and more comprehensive restrictions in some states. A changing regulatory environment underscores the need for routine and rapid-response surveillance of vape shops. This study predates the COVID-19 pandemic, which may impact the vape retail environment in the future. Although geographic representation is a strength of the study, a low response rate limits generalizability to other vape shops/merchants in the six states where MSAs were located and in other US states or localities; this is particularly relevant given that several vape shop owners/managers were reluctant to participate, possibly due to mistrust of federally funded research/researchers and potentially negative implications for the vaping industry. Moreover, there is the possibility that social desirability encouraged participants to overstate training requirements, particularly given the rate of noncompliance with age verification in a larger of sample of vape shops in these six MSAs.³⁹ Finally, interview questions asking about positive implications and experiences of regulations could have yielded valuable information as well.

Conclusions

This study found that vape shop owners/managers report (1) entering the industry with positive intentions for their customers, (2) training their personnel to adhere to regulations and provide good customer service, and (3) significant concerns about the impact of FDA regulations. Particularly with regard to the latter, these findings provide a baseline for similar data collection efforts assessing some of these same dimensions, particularly as merchants can now give their perspectives regarding how FDA regulations and other state and local legislation have impacted their business. In particular, it is critical to leverage current findings to inform future regulatory actions and efforts to assess compliance with regulations.

Supplementary Material

A Contributorship Form detailing each author’s specific involvement with this content, as well as any supplementary data, are available online at https://academic.oup.com/ntr.

Funding

This work was supported by the National Cancer Institute (R01CA215155-01A1; PI: Berg). Dr. Berg is also supported by other NCI funding (R01CA179422-01; PI: Berg; R01CA239178-01A1; MPIs: Berg, Levine), the US Fogarty International Center/ National Cancer Institute (1R01TW010664-01; MPIs: Berg, Kegler), and the NIEHS/Fogarty (D43ES030927-01; MPIs: Berg, Marsit, Sturua). The Stanford authors are supported by other NCI funding (5R01CA067850-17; PI: Henriksen; 1R01CA217165; PI: Henriksen; 1P01CA0225597; MPI: Henriksen, Luke, Ribisl). Dr. Wagener is supported by (R01CA204891, PI: Wagener; U01DA045537, PI: Wagener; R21DA046333, MPIs Wagener, Villanti). Steve Sussman’s research activities are supported by a California Tobacco-Related Disease Research Program Award (TRDRP Grant #26IR-0016) and a National Cancer Institute and FDA Center for Tobacco Products (CTP) Award (NCI/FDA Grant #U54CA180905).

Dr. Pulvers is supported by funding from the US National Institutes of Health (SC3GM122628; PI: Pulvers), the California Tobacco Related Disparities Research Program (27IP-0041; PI: Pulvers; 28IP-0022S; PI: Oren), and the US Department of Health and Human Services (3GM1226290FK0105-01-00; PI: Fernando Sañudo).

Declaration of Interests

None declared.

Acknowledgements

The authors would like to acknowledge the following people for their efforts in developing assessment tools and/or collecting data: Nina Schleicher, PhD, Trent Johnson, MPH, Sarah Dorvil, MPH, Robert Fairman, MPH, Christina Meyers, MPH, Amy Park, MPH, Akilah Patterson, MPH, and Amber Weber, MPH.