Admin. Rule R384-415 Electronic Cigarette Substance Standards Administrative Rules Review Committee May 17, 2021
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Admin. Rule R384-415
Electronic Cigarette Substance Standards
Administrative Rules Review Committee
May 17, 2021
Nicotine Content Limits in Vape Products Can Curb
Utah’s Youth Vaping Epidemic
● Since 2011, Utah’s youth vape product use rate has grown from 1.9%
to 12.4% in 2019, which is a 553% relative increase over eight years.1
● In comparison, Utah’s adult vape product use also rose, from 2% in
2012 to 6.5% in 2019, which is a 225% relative increase.2
1. Prevention Needs Assessment (PNA). Utah SHARP Project. Utah Division of Substance Abuse and Mental Health.
2. Utah BRFSS. Center for Health Data and Informatics. Utah Department of Health
Effects of Nicotine
● Nicotine is one of the most addictive substances, and is as addictive
as heroin.1
● Nicotine adversely affects the heart, reproductive system, lungs,
kidneys, etc, and has carcinogenic potential.2, 3
● Nicotine can be poisonous.3
● An electronic cigarette with a higher concentration of nicotine has a
greater likelihood of being more addictive.3
● Many e-cigarettes have a higher addictive potential than cigarettes.4
1. Jankowski, M., Krzystanek, M., Zejda, J. E., Majek, P., Lubanski, J., Lawson, J. A., & Brozek, G. (2019). E-Cigarettes are More Addictive than Traditional Cigarettes-A Study in Highly Educated Young
People. International journal of environmental research and public health, 16(13), 2279. https://doi.org/10.3390/ijerph16132279
2. Mishra, A., Chaturvedi, P., Datta, S., Sinukumar, S., Joshi, P., & Garg, A. (2015). Harmful effects of nicotine. Indian journal of medical and paediatric oncology : official journal of Indian Society of Medical &
Paediatric Oncology, 36(1), 24–31. https://doi.org/10.4103/0971-5851.151771.
3. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Review of the Health Effects of
Electronic Nicotine Delivery Systems; Eaton DL, Kwan LY, Stratton K, editors. Public Health Consequences of E-Cigarettes. Washington (DC): National Academies Press (US); 2018 Jan 23.
4. HHS. How tobacco smoke causes disease: What it means to you: A report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention,
National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health;
Effects of Nicotine
Nicotine use during adolescence:
● Primes the brain for addiction
● Causes long-term harm to brain
development
● Leads to experimentation with other
substances
Administrative Rulemaking History & Process R384-415
In 2015, HB 415 created Utah Code 26-57, authorizing and
requiring UDOH to establish the following standards for
non-manufacturer sealed electronic cigarette substances (e-liquids):
● labeling; Photo
Source:
● nicotine content; Photo by
Vaporesso
● packaging; and on
Unsplash
● product quality standards. (cropped).
Between Summer-Fall 2015, UDOH convened a stakeholder group
comprised of tobacco retailers, e-liquid manufacturers, and local
health departments. The stakeholder group met four times and
helped draft the original Administrative Rule R384-415 - Electronic
Cigarette Substance Standards.
Administrative Rulemaking History & Process R384-415
The original Administrative Rule R384-415 - Electronic Cigarette Substance
Standards, includes the following requirements for non-manufacturer sealed
electronic cigarette substances:
● labeling requirements mirror FDA labeling requirements and established labeling
requirements for nicotine-free e-liquids;
● nicotine content (open systems) limited to 360 mg nicotine per container,
and does not exceed a 24mg/mL (approx. 2.4%) concentration of nicotine;
● packaging requires e-liquid bottle packaging that is certified as child resistant,
compliant with federal standards concerning child nicotine poisoning prevention;
and
● product quality standards requires retailers to only sell non-manufacturer sealed
electronic-cigarette substances that have been approved for regulatory sale by
the FDA per the PMTA authorization process.
In the last 5 years, UDOH has not received a single comment opposing this
established e-liquid nicotine content limit from tobacco retailers, e-liquid
manufacturers, or the public.
Evolution of Electronic Cigarette Products Electronic cigarettes were first introduced to the U.S. market in 2006. The source for this image is the Community Anti-Drug Coalitions of America (CADCA), Research Into Action Webinar: Tobacco Retail Licensing and Youth E-cigarette and Other Tobacco Product Use.
Evolution of Electronic Cigarette Products
● Early electronic cigarettes -
○ Looked like cigarettes
○ Lower levels of free-based nicotine
Image source: Hype Wraps
○ Initially to help people quit smoking (cropped)
● The majority of prefilled cartridges -
○ Contain nicotine salts:
■ Deliver a higher concentration of nicotine
■ Less harsh on the throat - youth initiation tool
■ Makes for easier absorption
■ Available in higher nicotine concentrations
Evolution of Electronic Cigarette Products One 3% or 36 mg/mL JUUL pod = the same amount of nicotine inhaled in a pack of 20 cigarettes. https://truthinitiative.org/research-resources/emerging-tobacco-products/how-m uch-nicotine-juul https://www.healthline.com/health/juul-pod-ingredients#nicotine-content
Evolution of Electronic Cigarette Products https://publichealthlawcenter.org/sites/default/files/Unanswered-Questions-FDA-Blitz-JUUL-Webinar-Slides-Jan2019.pdf
Utah’s Youth Vaping Epidemic
Utah’s Youth Vaping Epidemic
● Utah’s youth vape at nearly twice the rate of Utah’s adults.
● Utah youth who currently use vape products are 50 times more likely to
smoke cigarettes than those who do not use vape products.Evidence Indicators
● The best evidence-based policy interventions to reduce youth use
involve restricting the type of tobacco products sold in the retail
environment.
● Reducing the nicotine content in electronic cigarettes sold in Utah
can aid in preventing youth initiation.
● With electronic cigarette products being the most popular product
for youth, limiting youth access is critical for preventing a new
epidemic of nicotine addiction.
● Decreased nicotine dependence treatment and healthcare
expenditures for Medicaid clients.
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Review of the Health
Effects of Electronic Nicotine Delivery Systems; Eaton DL, Kwan LY, Stratton K, editors. Public Health Consequences of E-Cigarettes. Washington (DC): National Academies Press (US);
2018 Jan 23.
HHS. How tobacco smoke causes disease: What it means to you: A report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2010b.
Disease Prevention and Health Promotion, Office on Smoking and Health, 2014. Retrieved from
https://www.cdc.gov/tobacco/stateandcommunity/tobacco_control_programs/surveillance_evaluation/preventing_initiation/pdfs/preventing_initiation.pdf.
Campaign for Tobacco-Free Kids. The Toll of Tobacco in Utah. Retrieved from https://www.tobaccofreekids.org/problem/toll-us/utah.History of Other States and Countries Limiting Nicotine
Content in Vape Products
● Vape products with 20 mg/mL (approx. 2%) concentration of nicotine
deliver nicotine hit comparable to cigarettes
○ The United Kingdom and 27 countries in the European Union
have limited nicotine concentration in all electronic cigarettes
sold to 20 mg/mL (approx. 2%) in 2016.
○ These countries have not experienced high youth vaping rates.
● In May 2020, Nova Scotia limited the nicotine content of vape
products sold in their state to 20 mg/mL (approx. 2%).
● Dec. 2019, Massachusetts restricts some retailers from selling vape
products with a nicotine content greater than 35 mg/mL (approx. 3%).
● Other states have introduced bills to limit electronic cigarette
nicotine content to 20 mg/mL (approx. 2%).Administrative Rulemaking History & Process R384-415
In 2020, HB 23 (which incorporated HB 118) amended Utah
Code 26-57 authorizing and requiring UDOH to establish similar
standards for previously excluded manufacturer sealed electronic
cigarette substances (pods or cartridges):
● labeling; Photo
Source:
● nicotine content; Photo by
Fallon
● packaging; and Michael on
Unsplash
● product quality standards. (cropped).Administrative Rulemaking History & Process R384-415
Balancing Statutes Guiding Administrative Rulemaking
● HB 23 (26-57-103(2))
○ “In consultation with a local health department”
○ “With input from members of the public”
● Utah Administrative Rulemaking Act
○ “Administrative record” or “information an agency relies
upon when making a rule...including” agency analysis,
public comment, and analysis of public comment
(63G-3-102)
○ “Involve persons affected by the agency’s rules”
(63G-3-301(3))
○ “Analysis of the fiscal impact a rule may have on
businesses” (63G-3-301(5))Administrative Rulemaking History & Process R384-415
In the Summer-Fall 2020, UDOH held five stakeholder meetings to discuss
the rule amendments.
Participants included:
● Utah Academy of Family Physicians ● Utah Medical Association
● Utah Department of Health ● Local Health Departments
● Utah Retail Merchants Association ● Utah Vapor Business Association
● Utah Tobacco Specialty Business ● Utah E-juice Manufacturer
Owners
The Department also held two public hearings and received written comments
(three comment periods) from other interested partiesAdministrative Rulemaking History & Process R384-415 ● During the course of the stakeholder meetings, participants were asked to provide evidence to support or oppose limits on nicotine concentrations. ● The stakeholder group reviewed 20 pieces of evidence consisting primarily of peer-reviewed research and other data. ● Stakeholders took turns presenting on the shared research and the group discussed the findings. ● On Sept. 22, 2020, the stakeholder group voted to recommend that the nicotine concentration be limited to 3% or equal to or less than 36 mg/mL. Citations for reviewed research can be found here: https://docs.google.com/document/d/1fzmzr2_r97NMHpTC1WBfvpnWi-GqxCz-5IBcVbTE5l0/edit
Market Considerations
The five top-selling vape pod and cartridge manufacturers brands (97% of market)1
offer vape pods or cartridges that meet the nicotine content limit of 3% or 36 mg/mL
nicotine concentrations.
Juul pods contain either 3% nicotine by
weight (35mg/ml) or a 5% nicotine by
weight (59 mg/ml);
Vuse cartridges contain 1.8%, 2.4%, and
5%, all their cartridges are nicotine by
weight;
blu cartridges contain 0%, 1.2% or
2.4% nicotine by weight;
Logic cartridges contain 0, 20 mg/ml,
27 mg/ml, or 39 mg/ml; and
Njoy pods contain 2.4% nicotine by
weight (28 mg/ml) or 5% nicotine by
weight (58mg/ml). Photo Source: Statista’s E-cigarette market
share in the United States in 2020, (cropped).
1. Statista’s E-cigarette market share in the United States in 2020, by brand, 9/4/2020, retrieved from https://www.statista.com/statistics/1097004/e-cigarette-market-share-us-by-brand/.Market Considerations
● Research Triangle Institute (RTI) predicts that users will most likely
switch to lower concentrations instead of quitting altogether, mitigating
the impact on the market.
○ A very high percentage of regular/addicted users would convert to the 3%
(brand loyalty)
○ A very small percentage would possibly attempt to quit altogether
○ A very small number might switch to cigarettes or smokeless (unintended
consequence)
○ No direct way to estimate the impact
○ Predictions are based on assumptions from other product typesAdministrative Rulemaking History & Process R384-415
Between Nov. 1, 2020-April 15, 2021, UDOH submitted three proposed rule
filings. For every rule filing, UDOH proactively notified possible impacted
parties, including:
● UDOH mailed a letter notifying all Utah tobacco retailers that sell
electronic cigarette products with each rule filling.
● Tobacco Retailers, Manufacturers, Associations representing tobacco
retailers/manufacturers: Dyer Law Group, Retail Merchants Association, Utah
Vapor Business Association, Vapor Technology Association, RJ Reynolds, Maverik.
● Public Health and Prevention: Utah Tobacco Free Alliance Executive Committee,
Utah Association of Local Health Departments, Utah Local Association of Community
Health Education Specialists, Mothers Against Drunk Drivers, Local Health Dept.
Tobacco Leads, Utah Academy of Family Physicians, Utah Medical Association, the
Utah State Board of Education, and Utah Substance Use and Mental Health Advisory
(USAAV+) Council.Administrative Rulemaking History & Process R384-415
Between Nov. 1, 2020-April 15, 2021, three proposed rule filings:
1. Nov. 1-30, 2020: Rule filing #53115
a. Nicotine level at 3% or 36 mg/mL
b. Held public hearing on November 19, 2020.
c. In Dec. 2020 after evaluating public comments, UDOH chose to not make
rule filing #53115 effective.
2. Jan. 15-Feb. 15, 2021: Rule filing #53257
a. Based on analysis of public comments, the Department proposed a new
rule including technical changes and phased approach for nicotine
concentration limits.
b. Nicotine level at 5% or 59 mg/mL (until Dec. 31, 2020) phased approach
to 3% or 36 mg/mL
3. Mar. 15-Apr. 15, 2021: Change to Proposed Rule (CPR) to filing #53257
a. Based on analysis of public comments, the CPR includes some technical
revisions.
b. The 3% or 36 mg/mL nicotine content limit was removed, limiting retailers
to sell products containing 5% or 59 mg/mL of nicotine.
c. Held public hearing on April 6, 2021.Administrative Rulemaking History & Process R384-415
Administrative Rulemaking History & Process R384-415
Between November 1, 2020-April 15, 2021, three amendments to
Administrative Rule R384-415 - Electronic Cigarette Substance Standards
have been submitted and have included the following for manufacturer sealed
electronic cigarette substances:
● labeling requirements mirror FDA labeling requirements and established labeling
requirements for CBD nicotine-free e-liquids;
● nicotine content (closed systems) nicotine content has changed from:
○ 3% / 36 mg/mL to
○ phased timeline of 5% / 59 mg/mL to 3% / 36 mg/ml
○ current version only limited to 5% / 59 mg/mL;
● packaging requires retailers sell products in their original packaging and do not repackage
products offered for sale, including CBD e-cigarettes.
● product quality standards requires retailers to only sell electronic cigarette products approved
for regulatory sale by the FDA per the PMTA authorization process.Administrative Rulemaking History & Process R384-415
Side by Side Comparison of Rules
“Open Systems - E-liquids” “Closed Systems” - cartridges/pods
● labeling requirements mirror FDA labeling ● labeling requirements mirror FDA labeling
requirements and established labeling requirements and established labeling
requirements for nicotine-free e-liquids; requirements for CBD nicotine-free e-liquids;
● nicotine content (open systems) limited to ● nicotine content (closed systems) nicotine
360 mg nicotine per container, and does content has changed from 3% / 36 mg/mL,
not exceed a 24mg/mL concentration of to staggered timeline of both 5% / 59
nicotine; mg/mL to 3% / 36 mg/ml, and current
version to only limited to 5% / 59 mg/mL;
● packaging requires e-liquid bottle packaging ● packaging requires retailers sell products in
that is certified as child resistant, compliant their original packaging and do not repackage
with federal standards concerning child products offered for sale, including CBD
nicotine poisoning prevention; and e-cigarettes.
● product quality standards requires retailers to ● product quality standards requires retailers to
only sell non-manufacturer sealed only sell electronic cigarette products
electronic-cigarette substances that have been approved for regulatory sale by the FDA per
approved for regulatory sale by the FDA per the PMTA authorization process.
the PMTA authorization process.R384-415
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