Awareness and Perceptions of US Food and Drug Administration’s JUUL Marketing Denial Order: A National Study of US Adolescents

Abstract

Introduction

We examined awareness and perceptions of the US Food and Drug Administration (FDA) JUUL marketing denial order (MDO) that occurred in June 2022 among a nationally representative sample of US adolescents.

Aims and Methods

Data were collected in August 2022 via an online survey (n = 1603). Adolescents were asked whether they had heard about the JUUL MDO, and, if yes, where they heard the news. Those who had heard were asked about the MDO’s impact on their harm beliefs about JUUL and vape products in general. We examined correlates of awareness of the MDO and of increased JUUL and vape harm perceptions.

Results

Twenty-seven percent of adolescents had heard about the MDO. Older adolescents (adjusted odds ratio [aOR] = 1.13) and LGBTQ+ adolescents (aOR = 2.05) had significantly higher odds of having heard the news, while those who identified as Black or African American had significantly lower odds of having heard (aOR = 0.56). Most participants who were aware of the MDO indicated that they had higher harm perceptions about JUUL itself (77.9%) and vapes in general (79.6%). Youths susceptible to vaping and current users were less likely to report increased harm perceptions about JUUL (B = −0.34 and −0.46, respectively) and vapes in general (B = −0.27 and −0.43) compared with youth not susceptible to vaping.

Conclusions

The results of this nationally representative survey demonstrate that over one-quarter of US youth heard about the JUUL MDO and the vast majority of those indicated increased harm perceptions about vapes. Large-scale news events about vaping can reach youth audiences and may impact what youth think about the harms of vaping.

Implications

Analysis of a nationally representative survey of adolescents aged 13–17 revealed that more than 25% had heard about the marketing denial order issued to JUUL Labs by the FDA in June of 2022. We also found that the vast majority of adolescents reported increased JUUL and vape harm perceptions in response to hearing about the MDO. This indicates that news coverage about vaping—including coverage of regulatory actions—can reach and potentially impact adolescents. It is therefore important to monitor news coverage about vaping, how it is framed and discussed across media platforms, and its reach among priority populations.

Introduction

Adolescent e-cigarette use has become an urgent public health concern in the United States and globally in recent years. In the United States, e-cigarette use (commonly referred to as “vaping”) has become dominated by nicotine-naïve adolescents.¹ In 2021, vaping nicotine had the highest lifetime prevalence of any substance use behavior among 8th, 10th, and 12th graders in the United States.² Globally, the prevalence of past 30-day e-cigarette use among youth aged 12–16 ranges from 1.9% to 33.2%.³ E-cigarettes that contain nicotine are highly addictive, and nicotine may interfere with brain development among adolescents.^4,5 Aerosols emitted by e-cigarettes also contain harmful chemicals and metals, which could lead to lung damage.^4–7 Given this evidence, the US Surgeon General declared adolescent vaping to be an epidemic.⁸

In 2015, JUUL Labs launched their novel JUUL vaping product, which quickly became the most popular e-cigarette brand among youth.⁹ Adolescent vaping increased rapidly from 2017 to 2019, and in 2019, over 59% of high school e-cigarette users reported JUUL as their usual brand, with approximately 600 000 Americans under the age of 21 using JUUL products daily.¹⁰ Following pressure from the US Food and Drug Administration (FDA) to address this unfolding youth vaping epidemic, between 2018 and 2020 JUUL removed all flavored pods from the market, with the exception of menthol.¹¹ While this decreased the product’s overall popularity, recent data reveal that JUUL continues to be used by adolescents in the United States.¹²

The FDA has been reviewing applications from e-cigarette companies for market authorization or denial, weighing the benefits of vape products for adult smokers against the harms to youth.¹³ On June 23, 2022, the FDA issued a marketing denial order (MDO) to JUUL Labs and ordered all JUUL products to be removed from shelves in US stores,¹⁴ an announcement that was covered by several media outlets.^15–17 Within this announcement, the FDA stated that JUUL’s application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”¹⁴ JUUL Labs submitted a same-day appeal to this decision, and on June 24, a US Court of Appeals granted a temporary reprieve that would allow JUUL to keep their products on the market while an additional review was conducted.^14,18 On July 5, 2022, the FDA announced via Twitter that they would be granting a stay on their initial market denial, based on scientific issues that “warranted further review.”¹⁹

While JUUL products currently remain in US stores, research demonstrates that negative news stories about e-cigarettes can increase adolescents’ perceptions of harm.²⁰ For instance, the rise in news coverage of the E-cigarette or Vaping-Associated Lung Injury (EVALI) crisis was associated with increased harm perceptions and decreased interest in vaping among youth, with effects most pronounced in the United States but also observed in both England and Canada.^21,22 Whether news about FDA regulatory decisions about e-cigarettes can reach youth and have an impact on harm perceptions is a topic that has been largely unexplored.

In the current study, we sought to examine awareness and perceptions of the JUUL MDO issued by the FDA among a nationally representative sample of US adolescents. We also sought to examine correlates of awareness of the MDO and of JUUL and vape harm perceptions.

Materials and Methods

Recruitment

Data for this study were collected from a national sample of adolescents (ages 13–17) from all 50 states. Participants were recruited through Ipsos Public Affairs’ online KnowledgePanel. KnowledgePanel is a probability-based web panel designed to be representative of the United States. For recruitment, Ipsos contacted English-speaking US adults in their KnowledgePanel with children in the household aged 13–17 years. Parents received an email invitation to complete a screener and those with eligible children living in their household were asked to allow this child to take the survey. Assent and parental consent were obtained for all participants. Of 5649 individuals invited to participate in the survey, 2852 individuals completed an initial screener (50.5% screener completion rate). A total of 1249 individuals were ineligible after completing the screener (e.g., outside the age range or parent did not provide consent for youth to complete), resulting in 1603 qualified individuals. All surveys were completed in August 2022, one month after the initial FDA MDO decision was announced. Each participant who completed the survey received a $5 cash equivalent incentive for their participation. The survey took approximately 16 minutes to complete. The study was approved by The University of North Carolina at Chapel Hill Institutional Review Board.

Measures

All survey participants were shown an item assessing their awareness of the FDA MDO: “On June 23, 2022, the Food and Drug Administration (FDA) announced that it would order JUUL to stop selling its vape products in the US. Did you hear about this?” Participants were given the options of Yes, No, and Not sure; only those who answered “Yes” were shown the follow-up items.

Follow-up items first assessed MDO information source (“Where did you first hear this news about JUUL?”), with social media, news websites, TV or radio, someone told you, and other (specify) as response options. The order of these response options was randomized. Then, harm perceptions about JUUL and vapes in general were assessed with two separate items (“Which of the following describes how the news affected what you think about [JUUL OR vapes in general]?”). The 4-point harm perception response scales were (1) [JUUL is OR Vapes are] no more harmful than I thought, (2) a little more harmful than I thought, (3) somewhat more harmful than I thought, and (4) a lot more harmful than I thought.

Participants were also asked about past 30 day use of e-cigarettes. Those who had vaped in the past 30 days were classified as current users. Those who indicated that they had vaped before, but not in the past 30 days, were asked a series of 5 items about their curiosity about (1 item) and openness to vaping (4 items), with responses on 4-point scales (eg, definitely not to definitely yes). An example item is, “Do you think that in the future you might use an e-cigarette or vape?” If they answered anything other than “not at all curious” and “definitely not” to all items, they were classified as susceptible to vaping. Youth who had never vaped before were asked the same series of 5 items and were again classified as susceptible to vaping if they answered anything other than “not at all curious” and “definitely not” to all items. All other adolescents were classified as not susceptible to vaping.²³

At the end of the survey, participants were asked to self-report gender, race, ethnicity, and sexual orientation. The survey also asked about tobacco use in the home. Finally, participants’ parents were asked to report their education level.

Data Analysis

We first descriptively examined awareness of the JUUL MDO, JUUL harm perceptions, and vape harm perceptions by participant characteristics and vaping status. We then computed separate regression models to examine correlates of awareness of the JUUL marketing denial order (logistic regression), increased JUUL harm perceptions (linear regression), and increased vape harm perceptions (linear regression). Results from the regression models included adjusted odds ratios (aORs), unstandardized regression coefficients (B), and 95% confidence intervals (CIs). We interpreted estimates to be statistically significant if the CIs for the aORs did not cross 1 and the CIs for the Bs did not cross 0. We used weights in all analyses to produce estimates that are representative of youth ages 13–17 in the United States. The weighting process accounted for unequal probability of selection and non-response, with final weights aligning with population benchmark demographic distributions for 13-17 year olds in the United States. We conducted analyses using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) and R Studio.

Results

Participant Characteristics

A total of 1603 adolescents completed the survey. Participants’ mean age was 15, and about half were male (49.3%). Most identified as white (71.1%), and 24% identified as Latino/a. In terms of vaping status, 7.1% were current users, while 39.8% were susceptible to vaping, and 53.2% were not susceptible to vaping. All participant characteristics can be found in Table 1.

Table 1.

Study Participant Characteristics (N = 1603)

Variable	n	Unweighted (%)	Weighted (%)
Age, years M (SD) [age range]	15.07 (1.37) 13–17
Race
White	1188	74.1	71.1
Black or African American	178	11.1	14.7
American Indian or Alaskan Native	21	1.3	2.3
Asian	54	3.4	4.9
Native Hawaiian or other Pacific Islander	2	0.1	0.2
More than one race	133	8.3	5.0
Other race	19	1.2	1.7
No response	8	0.5	0
Hispanic
Yes	285	17.8	24.4
No	1316	82.1	75.6
No response	2	0.1	0
Gender
Female	712	44.4	47.2
Male	829	51.7	49.3
Other response1	58	3.6	3.5
No response	4	0.3	0.3
Sexual orientation
Straight or heterosexual	1363	85.0	90.0
LGBTQ+2	210	13.1	12.9
Don’t know what question means	22	1.4	1.1
No response	8	0.5	0.8
Year in school
5th grade	3	0.2	0.1
6th–8th grade	539	33.6	33.8
9th–10th grade	692	43.2	41.8
11th–12th grade	338	21.1	22.2
High school graduate or in college	31	1.9	2.0
Highest educated parent
High school (or equivalent) or less	288	18.0	24.4
Some college or associate’s	407	25.4	21.7
Bachelor’s degree	473	29.5	27.1
Graduate degree	434	27.1	26.8
No response	1	0.1	0.1
Household income
US $0–$24 999	187	11.7	11.2
US $25 000-$49 999	229	14.3	15.8
US $50 000-$74 999	263	16.4	15.0
US $75 000-$99 999	274	17.1	13.1
US $100 000+	650	40.5	44.9
Vaping status
Not susceptible to vaping	840	52.4	53.2
Susceptible to vaping	656	40.9	39.8
Current user	107	6.7	7.1
Other tobacco product use (past 30 days)
Cigarettes	47	3.0	3.6
Traditional cigars	11	0.7	2.0
Little cigars and cigarillos	16	1.0	3.2
Pipe filled with tobacco	1	0.1	0.7
Hookah	11	0.7	2.6
Smokeless tobacco	5	0.3	1.3
Tobacco product use in the home	406	25.3	24.3
Ever vaped
Nicotine	247	15.4	15.2
THC	85	5.3	5.4
CBD	73	4.6	4.7
Other substances3	86	5.4	5.6
Don’t know	77	4.8	4.9

M = mean; SD = standard deviation.

¹Non-binary or gender queer, n = 24; transgender, n = 9; questioning, n = 8; prefer not to say, n = 17.

²Lesbian or gay, n = 32; bisexual, n = 64; something else, n = 28; I’m not sure yet, n = 86.

³Melatonin, caffeine, essential oil, tea, vitamin B or C.

Awareness of the JUUL Marketing Denial Order

More than one-quarter of youth (27.4%, 95% CI: 24.8%, 30.0%) reported hearing about the JUUL MDO (Table 2). In adjusted logistic regression models, higher age (aOR: 1.13, 95% CI: 1.03, 1.25) and identifying as LGTBQ+ (aOR: 2.05, 95% CI: 1.35, 3.12) were associated with higher odds of awareness of the MDO (Table 3). Identifying as Black or African American was associated with lower odds of awareness (aOR: 0.56, 95% CI: 0.35, 0.90). No other variables were significantly associated with awareness of the MDO.

Table 2.

Awareness of the JUUL Marketing Denial Order and Harm Perceptions by Demographic and Tobacco Characteristics

Variable	Awareness of the JUUL marketing denial order, N = 1603			JUUL harm perceptions, n = 449		Vape harm perceptions, n = 447
	n	Weighted %	95% CI	Weighted M	95% CI	Weighted M	95% CI
Overall	451	27.4%	24.8, 30.0	2.82	2.69, 2.95	2.88	2.76, 3.00
Race
White	349	29.5%	26.5, 32.6	2.78	2.64, 2.92	2.85	2.72, 2.99
Black or African American	37	19.2%	12.8, 25.5	2.97	2.53, 3.41	3.02	2.58, 3.46
More than one race	40	30.0%	20.6, 39.3	3.07	2.69, 3.45	3.04	2.63, 3.44
Other race	23	23.1%	13.8, 32.5	2.74	2.20, 3.28	2.78	2.26, 3.31
Latino/a
No	378	28.8%	25.9, 31.6	2.77	2.63, 2.91	2.81	2.67, 2.94
Yes	72	23.1%	17.7, 28.5	3.03	2.74, 3.31	3.18	2.95, 3.42
Gender
Female	197	26.6%	22.8, 30.3	2.80	2.61, 2.99	2.97	2.79, 3.15
Male	238	28.3%	24.6, 31.9	2.85	2.67, 3.02	2.83	2.66, 3.00
Other response	15	27.7%	15.3, 40.1	2.63	1.93, 3.34	2.43	1.75, 3.12
Sexual orientation
Straight or heterosexual	367	26.2%	23.5, 28.9	2.83	2.69, 2.97	2.91	2.78, 3.04
LGBTQ+	80	37.7%	30.0, 45.5	2.72	2.40, 3.03	2.69	2.39, 2.99
Highest educated parent
High school (or equivalent) or less	71	22.2%	16.8, 27.7	2.76	2.46, 3.07	2.97	2.69, 3.24
Some college or associate’s	122	29.3%	24.1, 34.5	2.94	2.69, 3.19	3.00	2.75, 3.25
Bachelor’s degree	136	28.8%	24.1, 33.5	2.61	2.38, 2.84	2.58	2.35, 2.81
Graduate degree	122	29.2%	24.3, 34.2	2.97	2.74, 3.20	3.03	2.82, 3.23
Household income
US $0–$24 999	51	23.0%	16.0, 29.9	2.71	2.24, 3.18	2.91	2.46, 3.36
US $25 000–$49 999	56	24.2%	17.6, 30.8	2.86	2.52, 3.21	2.94	2.61, 3.28
US $50 000–$74 999	68	23.8%	17.8, 29.8	2.86	2.52, 3.21	2.97	2.63, 3.30
US $75 000–$99 999	87	30.8%	24.5, 37.2	3.02	2.76, 3.27	2.93	2.67, 3.18
US $100 000+	189	29.8%	25.8, 33.8	2.76	2.57, 2.94	2.82	2.65, 3.00
Vaping status
Not susceptible to vaping	224	26.2%	22.7, 29.6	2.95	2.77, 3.14	3.02	2.84, 3.20
Susceptible to vaping	189	28.0%	24.0, 32.0	2.69	2.49, 2.88	2.76	2.58, 2.94
Current user	38	33.5%	22.6, 44.3	2.66	2.29, 3.03	2.63	2.32, 2.94
Tobacco product use in the home	132	33.0%	27.4, 38.5	2.93	2.70, 31.6	2.82	2.60, 3.04

M = mean; CI = confidence interval.

Table 3.

Correlates of Awareness of the JUUL Marketing Denial Order, JUUL Harm Perceptions, and Vape Harm Perceptions

	Awareness of the JUUL marketing denial order, N = 1603	Increased JUUL harm perceptions, n = 449	Increased vape harm perceptions, n = 447
Variable	aOR (95% CI)	Adjusted B (95% CI)	Adjusted B (95% CI)
Age	1.13 (1.03, 1.25)	0.02 (-0.07, 0.11)	0.02 (−0.07, 0.11)
Race
White	Ref.	Ref.	Ref.
Black or African American	0.56 (0.35, 0.90)	0.24 (-0.24, 0.71)	0.17 (−0.32, 0.67)
More than one race	0.98 (0.62, 1.56)	0.20 (-0.19, 0.58)	0.11 (−0.29, 0.52)
Other race	0.69 (0.38, 1.25)	-0.17 (-0.72, 0.38)
Latino
No	Ref.	Ref.	Ref.
Yes	0.75 (0.52, 1.08)	0.26 (−0.05, 0.57)	0.34 (0.04, 0.63)
Gender
Female	Ref.	Ref.	Ref.
Male	1.15 (0.87, 1.52)	0.05 (−0.21, 0.32)	−0.12 (−0.38, 0.13)
Other response	0.59 (0.28, 1.22)	−0.08 (−0.91, 0.75)	−0.37 (−1.19, 0.44)
Sexual orientation
Straight or heterosexual	Ref.	Ref.	Ref.
LGBTQ+	2.05 (1.35, 3.12)	−0.13 (−0.51, 0.25)	−0.21 (−0.57, 0.15)
Highest educated parent
High school (or equivalent) or less	Ref.	Ref.	Ref.
Some college or associate’s	1.32 (0.86, 2.04)	0.18 (−0.24, 0.59)	0.05 (−0.70, 0.15)
Bachelor’s degree	1.26 (0.80, 1.99)	−0.03 (−0.46, 0.41)	−0.27 (−0.70, 0.15)
Graduate degree	1.30 (0.79, 2.12)	0.30 (−0.13, 0.74)	0.10 (−0.31, 0.52)
Household income
US $0–$24 999	Ref.	Ref.	Ref.
US $25 000–$49 999	1.02 (0.58, 1.81)	0.31 (−0.28, 0.89)	0.21 (−0.34, 0.76)
US $50 000–$74 999	0.94 (0.54, 1.63)	0.30 (−0.29, 0.89)	0.21 (−0.36, 0.79)
US $75 000–$99 999	1.29 (0.74, 2.26)	0.44 (−0.12, 1.00)	0.21 (−0.33, 0.76)
US $100 000+	1.22 (0.71, 2.10)	0.13 (−0.41, 0.68)	0.06 (−0.48, 0.60)
Vaping status
Not susceptible to vaping	Ref.	Ref.	Ref.
Susceptible to vaping	0.97 (0.73, 1.28)	−0.34 (−0.61, −0.07)	−0.27 (−0.52, −0.006)
Current user	1.14 (0.67, 1.96)	−0.46 (−0.89, −0.03)	−0.43 (−0.82, −0.04)
Tobacco product use in the home	1.34 (0.97, 1.85)	0.33 (0.04, 0.63)	0.05 (−0.24, 0.35)

aOR = adjusted odds ratio; B = beta coefficient; CI = confidence interval; table reports adjusted results from regression models. Boldface indicates statistically significant results.

Source of Information About JUUL Marketing Denial Order

Adolescents reported having heard about the JUUL MDO most commonly through social media (32.1%, 95% CI: 27.1%, 37.1%). Other primary sources of information were TV or radio (29.7% CI: 24.5%, 34.9%), other people (27.5%, 95% CI: 22.9%, 32.2%), and online news (9.2%, 6.0%, 12.5%).

Harm Perceptions

Mean JUUL and vape harm perceptions were 2.82 and 2.88, respectively, on a scale from 1 to 4 where 1 indicates no increased harm and a 2, 3, or 4 indicates increasing levels of perceived harm after hearing about the MDO (Table 2). The majority of participants selected a 2, 3, or 4, meaning that the news made most participants think that JUUL itself (77.9%, 95% CI: 73.4%, 82.3%) and vapes in general (79.6%, 95% CI: 75.4%, 83.8%) were more harmful than they had previously thought.

Among individuals who had heard about the JUUL MDO, youth who were susceptible to vaping (B = −0.34, 95% CI: −0.61, −0.07) and current users (B = −0.46, 95% CI: −0.89, −0.03) were less likely to report increased harm perceptions about JUUL because of the news compared with youth who were not susceptible to vaping (Table 3). The same was true for general vape harm perceptions; youth who were susceptible to vaping (B = −0.27, 95% CI: −0.52, −0.006) and current users (B = −0.43, 95% CI: −0.82, −0.04) were less likely to report increased harm perceptions about JUUL because of the news compared with youth who were not susceptible to vaping. In addition, Latino/a youth (B = 0.34, 95% CI: 0.04, 0.63) had higher vape harm perceptions because of the news compared with non-Latino/a youth. No other variables were significantly associated with JUUL or vape harm perceptions.

Discussion

The results of this nationally representative survey show that many adolescents were aware of the MDO issued to JUUL Labs by the FDA. More than one in four adolescent participants (27.4%) heard the news, and the most common sources of information were social media, TV or radio, and other people (eg, peers). Differences in awareness of the MDO were observed by age, sexual orientation, and race; older adolescents and LGBTQ+ youth were more likely to have heard the news, while Black adolescents were less likely to have heard the news. Of note, vaping is higher among older adolescents and people who identify as LGBTQ+,^24,25 indicating that this news reached some population segments who are at higher risk of vaping. Current users themselves trended towards higher odds of having heard the news (compared to non-users), but this difference was not statistically significant.

Of the participants who heard the MDO news, the vast majority reported that their harm beliefs about JUUL had increased. While those participants who were not susceptible to vaping had the greatest increase in harm perception, as compared to current users and those susceptible to vaping, this finding may be because non-users are predisposed to higher harm perceptions,²⁶ and so may be more easily convinced of additional harm. These results suggest that a regulatory action by the FDA—in this case to deny market authorization of JUUL—may have increased youth harm perceptions about JUUL. Additionally, the majority of adolescents also reported that the news increased their harm perceptions about vapes in general, despite the MDO having been issued specifically to JUUL. This supports findings previously seen during the EVALI news coverage,²⁷ namely, that media coverage about potential harms of specific vape products may impact perceptions of vapes in general and contribute to the increasing harm perceptions around e-cigarettes and vaping that have been observed.^28,29

More broadly, this study indicates that news coverage about vaping may reach a large number of adolescents. Indeed, population estimates of US adolescents suggest that the FDA MDO news may have reached more than 7 million adolescents (27.4% of adolescents aged 13–17).³⁰ It is therefore important to monitor news coverage about vaping and how it is framed in the news media, as this may have implications for e-cigarette harm perceptions among both youth and adult audiences.

Limitations

Strengths of the study include a nationally representative survey of youth, specific questions about the FDA MDO, and survey administration within two months of the FDA announcement. This study also had some limitations. The survey was administered following the initial MDO, the subsequent court action, and a further FDA announcement, but the survey only asked about perceptions of the initial MDO announcement. Adolescent harm perceptions were also assessed at a single timepoint, and thus we were unable to examine changes in harm perceptions over time. Additionally, we were unable to examine whether the news had an impact on vaping behaviors. Future work could examine the long-term impact of news coverage on vaping behaviors, and qualitative work could help us further understand why youth may view e-cigarettes and vaping as more harmful in the wake of news coverage about regulatory actions or other events on the topic of vaping harms.

Conclusion

We found that news of the FDA’s MDO of JUUL reached more than a quarter of US adolescents and may have contributed to increased harm perceptions about JUUL and vapes in general. This indicates that large-scale news events about vaping can reach youth audiences, and that these events may impact the way that youth perceive the harms of e-cigarettes and vaping. While this MDO itself would only have an impact in the US market, the news was covered internationally, and further research could examine the impact of news coverage of regulatory actions on youth in other countries. Additionally, while this study was limited to adolescents, future work could also examine how the news was perceived by adult vapers and smokers.

Funding

This work was supported the National Institute on Drug Abuse and the FDA Center for Tobacco Products (CTP), R01DA049155. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.

Declaration of Interests

SMN has served as a paid expert witness in litigation against tobacco and e-cigarette companies.

Author Contributions

Alissa Rams (Conceptualization [Equal], Formal analysis [Supporting], Methodology [Equal], Writing—original draft [Equal], Writing—review & editing [Equal]), Sarah Kowitt (Conceptualization [Equal], Formal analysis [Equal], Methodology [Equal], Writing—original draft [Equal], Writing—review & editing [Equal]), Caroline Ritchie (Conceptualization [Equal], Formal analysis [Equal], Methodology [Equal], Project administration [Equal], Writing—review & editing [Equal]), Erin Sutfin (Formal analysis [Equal], Methodology [Equal], Writing—review & editing [Equal]), Paschal Sheeran (Formal analysis [Equal], Methodology [Equal], Writing—review & editing [Equal]), and Seth Noar (Conceptualization [Equal], Formal analysis [Equal], Funding acquisition [Equal], Methodology [Equal], Project administration [Equal], Supervision [Equal], Writing—original draft [Equal]).

Patient Consent for Publication

Not applicable.

Ethics Approval

All procedures were approved by the UNC Institutional Review Board (#20-1245). Participants’ parents or legal guardians gave informed consent and participants gave assent to participate in the study before taking part.

Data Availability

Data are available upon reasonable request and upon approval of the study guarantors.