NOTICES OF PROPOSED RULES   
24 UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 internal patient safety processes for specified problems .  The reporting 
under this rule will also help the Department and health care providers 
to understand patterns of system failures in the health care delivery 
system and, where appropriate, to recommend statewide improvements 
to reduce the incidence of pat ient injuries.  It limits access to identifiable 
health information that facilities report to the Department under this rule.  
 (2)  This rule is authorized by Utah Code Subsections 26- 1-
30(2)(a), (b), (d), (e), and (g) and Section 26 -3-8. 
 
R380- 210-2.  Def initions.  
 "Adverse drug event" means any event involving a 
medication that causes or leads to patient harm, while the medication is 
in the control of the facility. Such events may be related to professional 
practice, health care products, procedures, and systems including: 
prescribing; order communication; product labeling, packaging and 
nomenclature; compounding; dispensing; distribution; administration; 
education; monitoring; and use."  
 "Facility" means a general acute hospital, critical access 
hospital,  ambulatory surgical center, psychiatric hospital, orthopedic 
hospital, rehabilitation hospital, chemical dependency/substance abuse 
hospital or chronic disease hospital as those terms are defined in Title 
26, Chapter 21.  
 "Harm" means death or temporary o r permanent impairment 
of body function or structure requiring intervention such as:  
 (1)  a change in monitoring the patient's condition;  
 (2)  a change in therapy; or  
 (3)  active medical or surgical treatment.  
 
R380- 210-3.  Patient Injury Identification . 
 (1)  Each facility shall implement processes to effectively 
identify and report to the Department the incidence of all:  
 (a)  adverse drug events.  
 (2)  Reporting to the Department may occur through 
established, statewide, electronic health care facilit y reporting systems 
managed by the Department.  
 (3)  The report shall include codes applicable to the event 
from the current International Classification of Diseases Clinical 
Modification (ICD -CM) diagnosis coding, including codes for external 
cause of inj ury (E -codes) and codes for place of occurrence.  
 
R380- 210-4.  Patient Injury Reduction.  
 (1)  Each facility shall implement processes that are effective 
in reducing the incidence of:  
 (a)  adverse drug events.  
 
R380- 210-5.  Confidentiality.  
 (1)  Informat ion that the Department holds under this rule is 
confidential under the provisions of Title 26, Chapter 3.  Because of the 
public interest needs to foster health care systems improvements, the 
Department exercises its discretion under Section 26 -3-8 and shall not 
release information collected under this rule to any person pursuant the 
provisions of Subsections 26 -3-7(1) or (8).  
 (2)  Information produced or collected by a facility is 
confidential and privileged under the provisions of Title 26, Chapter 25.  
 
R380- 210-6.  Penalties. 
 As required by Section 63G -3-201(5):  An entity that violates 
any provision of this rule may be assessed a civil money penalty not to 
exceed the sum of $5,000 or be punished for violation of a class B 
misdemeanor for the first violation and for any subsequent similar 
violation within two years for violation of a class A misdemeanor as 
provided in Section 26 -23-6. KEY:  hospital, injury prevention, quality improvement, patient 
safety  
Date of Enactment or  Last Substantive Amendment:  July 26, 2010 
Notice of Continuation:  September 13, 2016 
Authorizing, and Implemented or Interpreted Law:  26 -1-30(2)(a); 
26-1-30(2)(b); 26 -1-30(2)(d); 26 -1-30(2)(e); 26 -1-30(2)(g); 26 -3-8] 
 
 
NOTICE  OF PROPOSED  RULE  
TYPE  OF RULE:   Amendment  
Utah  Admin.  Code  
Ref (R no.):  R384 -415 Filing  No. 
53559  
 
Agency  Information  
1.  Department:  Health  
Agency:  Disease  Control  and Prevention,  
Health  Promotion  
Building:  Cannon  Health  Building  
Street  address:  288 N 1460  W 
City,  state:  Salt Lake  City, UT 84116  
Mailing  address:  PO Box 142106  
City,  state,  zip: Salt Lake  City, UT 84114 -2106  
Contact  person(s):  
Name:  Phone:  Email:  
Braden  Ainsworth  801-
538-
6187  tobaccorulescomments@utah
.gov 
Christy  Cushing  801-
538-
6260  tobaccorulescomments@utah
.gov 
Please  address  questions  regarding  information  on this 
notice  to the agency.  
 
General  Information  
2.  Rule  or section  catchline : 
R384 -415.  Electronic  Cigarette  Substance  Standards  
 
3.  Purpose  of the new rule or reason  for the change:  
The proposed  rule amendment  to Rule R384 -415 revises  
this rule to align  with changes  in Section 26-57 -103,  due 
to the passage of S.B. 1003 during the 2021 First Special  
Session.   In addition,  the Utah  Department  of Health  
(UDOH)  seeks  to incorporate the following  additional  
changes  related to the nicotine  content  in Subsection  
R384-415 -5(1)(b),  and the product  quality  requirements  in 
Section R384 -415-7 to address  public  comment  concerns  
the UDOH received between  March  15, 2021, and April 15, 
2021.  
 
4.  Summary  of the new rule or change:  
The proposed  rule amendment  to Rule R384 -415 revises  
this rule to align with changes  to Section  26-57-103.  
These changes  include  replacing the word  "standards " to 
"requirements  to sell" in Section  R384 -415-1, adding  the   NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 25 new definition  of manufacturer  sealed  electronic  cigarette  
product  to Section  R384- 415-2, and throughout  the rule 
replacing  the term "manufacturer  sealed  electronic  
cigarette  substance" with the new definition  of 
"manufacturer  sealed  electronic  cigarette  product. " 
 
In addition,  regarding  the nicotine content  limit change  in 
Subsection R384 -415- 5(1)(b),  the proposed rule 
amendment  would prohibit  a tobacco  retailer  from selling  
a manufacturer  sealed electronic  cigarette  product  with a 
nicotine  concentration that is greater  than 3% nicotine  by 
weight  per container,  or exceeds  a 36mg/mL  concentration  
of nicotine effective  September  1, 2021,  allowing  retailers  
two and a half months ' time to anticipate  the change,  as it 
is very likely  Utah  tobacco retailers  may avoid  restocking  
their electronic  cigarette product  inventory  by September  
1, 2021, in anticipation  of the U.S. Food and Drug  
Administration's (FDA)  prohibition  of electronic  nicotine  
delivery  systems (ENDS) and other  deemed products  on 
the market  without  premarket  authorization of the sale 
under  21 U.S.C.  387j(c)(1)(A)(i),  21 U.S.C.  
387j(a)(2)(A)(i),  or 21 U.S.C. 387j(a)(2)(A)(ii),  that is 
anticipated to be effective  September  9, 2021.  
 
Lastly,  the proposed amendments  in Section  R384 -415-7 
are consistent  in aligning with federal  law requirements,  
and removes  the 09/09/2021  date,  as the FDA published  
a perspective in February  2021 noting  their progress  
reviewing electronic  cigarette product  Premarket  Tobacco  
Product  Applications  (PMTA),  mentioning  they may need  
additional  time beyond  the 09/09/2021 date to complete  
this process.   On  May 20, 2021,  the FDA published  an 
updated perspective,  posting  lists identifying  over 
6,000,000 products  where a premarket  application was 
submitted to FDA by 09/09/ 2020 via the PMTA  process,  
allowing  Utah 's enforcement  agencies  the ability  to 
research products  with pending PMTA  applications.  
 
 
Fiscal  Information  
5.  Aggregate  anticipated  cost or savings  to: 
A) State  budget:  
Enactment  of this proposed  rule amendment  is not 
expected  to have any fiscal  costs to the state  budget,  as 
existing  allocated  resources  can cover  an increase  for Quit 
Line cessation  services.  
 
There are costs to Utahns  who use electronic  cigarettes,  
especially  to those  who use them  now during the COVID -
19 pandemic.   An electronic  cigarette  product  with a higher  
concentration of nicotine has a greater  likelihood  of being  
more  addictive.   Utahns  who are addicted to nicotine  
products  and want  to quit are more  likely  to need tobacco  
cessation services  to be able to quit successfully.  
 
Currently,  tobacco cessation services  are provided by the 
UDO H through the state  tobacco quit line and through quit 
services covered by health  insurance plans.   The 
continued  sale of addictive  products  results  in higher  cost to the state  tobacco  quit line and health  insurance  
companies  to cover  treatment  for nicotine dependence.  
 
In 2018,  13.3%  of Utah 's Medicaid recipients  used  
electronic  cigarettes.   Reducing the nicotine content  in 
electronic  cigarettes  sold in Utah  could  reduce electronic  
cigarette use among this population and subsequently  
decrease nicotine  dependence treatment  and healthcare  
expendit ures for Medicaid clients,  both in the short  and 
long term.   The Utah  Medicaid program  currently  spends  
an estimated  $125, 900,000 each  year to treat tobacco -
related diseases.  
 
The Utah  state  quit line budget  is approximately  
$1,000,000 annually  and all of the tobacco cessation  
services provided is free and confidential  for users.   The 
average state  cost for treating nicotine  dependence using  
the Utah  quit line ranges  between $273 - $300 per user.   
The Utah  youth  tobacco cessation  program  "My Life My 
Quit" (for both vaping and smoking),  provided  by the Utah  
tobacco  quit line for individuals  between  the ages  of 13 - 
17, cost per user (counseling  calls,  text messaging,  email  
support)  is $273.   The Utah  adult  cessation  program  
provided by the Utah  tobacco  quit line, cost per user 
(counseling  calls,  text messaging,  email  support,  NRT)  is 
$300.  
 
The Utah  Department  of Health Tobacco  Prevention and 
Control  Program 's independent  evaluator,  Research  
Institute  Triangle (RTI),  states:   "Simply  because  5% 
nicotine  makes  up nearly  70% of sales,  it does  not mean  
that removing  5% nicotine  products  would  result  in a 70% 
drop in overall  sales.   Undoubtedly  a very high percentage  
of regular/addicted users  would  either  convert  to the 3% 
(UDOH suspect s this would be the vast majority,  as many  
users  are brand-loyal  and would  likely  stick with their brand  
at the lower  level rather  than switch)  or shop  exclusively  in 
vape  shops  for open  systems  (mods).   Some  percentage  
would possibly  attempt  to quit altogether,  and some  (likely  
a small)  number  might  switch  to cigarettes  or smokeless  
(unintended consequence).  
 
As this change has never  been  made however,  there  is no 
direct  way of estimating that.  There likely  are ways  to use 
simulation models  to predict  indirectly  what  the impact  
might  be, but those  would necessarily  be based on many  
assumptions,  likely  drawn from other  product  types. "  In 
Utah,  an estimated  30,000 youth  currently  use electronic  
cigarette products  (12.4%).   44.5% of U.S. adolescents  
who vape  are seriously  interested  in quitting,  and 24.9%  
tried to quit in the past year (Smith,  2020).   As a result  of 
enactment  of this proposed rule amendment,  to 
hypothetically  provide tobacco cessation  services to 
44.5% of Utah  youth  who vape  (13,350)  would  cost Utah 
an estimated $3,600,000 .  To hypothetically  provide  
tobacco cessation services to 50% of young adults  who 
vape (ages  18-34) (~55,000)  would cost Utah  an 
estimated $16,600,000.  
 NOTICES OF PROPOSED RULES   
26 UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 Effective  09/01/2021 , the proposed  rule amendment  
prohibits  a tobacco retailer  that sells a manufacturer  
sealed electronic  cigarette  product  from selling  a 
manufacturer  sealed electronic  cigarette product  with a 
nicotine  concentration  higher  than 3% nicotine by weight  
per container,  or exceeding  a 36mg/mL  concentration of 
nicotine.   An electronic  cigarette product  with a higher  
concentration of nicotine has a greater  likelihood  of being  
more  addictive,  being that "the amount  of nicotine  
delivered and the way in which  it is delivered  influences  
the addictiveness  of a tobacco  product " (Eaton DL et al., 
2018;  HHS,  2010b).   Reducing the nicotine content  in 
electronic  cigarette  products  sold in Utah  can aid in 
preventing youth  and adult  initiation  of electronic  cigarette  
products  among Utahans  who do not already  smoke  or 
vape.   Electronic  cigarette product  use is more  popular  
among Utah  youth than all other  tobacco products  
combined,  therefore limiting  youth  access  to highly  
addictive electronic  cigarette products  is critical  for 
preventing a new epidemic  of nicotine  addiction.  
 
Lastly,  removing the 09/09/2021 date in Subsection R384 -
415-7(2)  will have  no fiscal  impact  to the state  budget.  
 
B) Local  governments:  
Enactment  of this proposed  rule amendment  is not 
expected  to have any fiscal impact  on local governments,  
as local health departments  will continue to conduct  retail  
observations  and investigations  in accordance with 
respective  state  tobacco control  laws,  state  administrative  
rules , and local health department  regulations  using  
existing  allocated  resources  to enforce the amended rule. 
 
Lastly,  removing the 09/09/2021 date in Subsection R384 -
415-7(2)  will have  no fiscal  impact  to the local 
governments,  and the FDA published  a perspective  dated  
05/20/2021 identifies  over 6,000,000 products  where a 
PMTA  application was submitted  to the FDA by 09/09/ 2020  
via the PMTA  process,  allowing  Utah 's enforcement  
agencies  the ability  to research  products  with pending  
PMTA  applications.  
 
C) Small  businesses  ("small  business " means  a business  
employing  1-49 persons) : 
The proposed  rule amendment  may result  in a direct  cost 
to small  businesses  that employ  fewer  than 50 employees  
and choose  to sell manufacturer  sealed electronic  
cigarette  products.   The proposed  rule amendment  may 
result  in a direct  fiscal  cost to small  businesses  that 
primarily  rely on the sale of tobacco products  (retail  
tobacco specialty  businesses)  and operate under  the 
North  American  Industry  Classification System  (NAICS)  
codes  of 453991,  424940.   Other  small  businesses  that 
sell manufacturer  sealed electronic  cigarette  products  
among other  products  they choose to sell include  (445120)  
convenience stores,  (447110)  gas stations  with 
convenience stores,  (445110)  supermarkets  and other  
grocery  stores,  (452319)  general  merchandise  and 
discount  stores,  (447190)  other  gasoline stations,  
(453991)  tobacco  stores,  (424940)  tobacco  product  merchant  wholesalers,  (453220)  gift, novelty,  and souvenir  
stores,  (721110)  hotels,  (813410)  civic and social  
organizations.  
 
A review  of UDOH combined  local health department  
tobacco  retail  compliance check  logs for fiscal  year 2020  
and cross -referenced with Utah  Department  of Workforce  
Services  (DWS) Firm Find Data,  shows  that there  are 
approximately  1,175 small  businesses  that sell some  type 
of electronic  cigarette products  in Utah,  or approximately  
88% of Utah  tobacco retailers.   UDOH does  not know  how 
many  of these  1,175 small  businesses  sell manufacturer  
sealed electronic  cigarette  products  with nicotine  
concentrations  higher  than 3% by weight  per container  or 
exceed 36 mg/mL  concentration  of nicotine.   
Approximately  168 small  business  tobacco retailers,  or 
approximately  12% choose to not sell electronic  cigarette  
products  and these businesses  will not be affected  by this 
rule amendment.  
 
Effective  09/01/ 2021,  the proposed rule amendment  
prohibits  a tobacco retailer  that sells a manufacturer  
sealed electronic  cigarette  product  from selling  a 
manufacturer  sealed electronic  cigarette product  with a 
nicotine  concentration  higher  than 3% nicotine by weight  
per container  or exceeding a 36mg/mL  concentration of 
nicotine.   Only tobacco  retailers  that currently  sell 
manufacturer  sealed electronic  cigarette  products  with a 
higher  nicotine  concentration  may experience a direct  
fiscal  impact.  
 
The two and a half months ' notice  of the nicotine content  
limit from 5% nicotine by weight  per container,  or 59mg/mL  
concentration of nicotine to equal  to or less than 3% 
nicotine  by weight  per container  or that do not exceed a 
36mg/mL  concentration of nicotine  may reduce the direct  
fiscal  cost impact  on tobacco retailers.   The two and a half 
months ' time allows  for tobacco retailers  that sell 
manufacturer  sealed electronic  cigarette  products  with a 
nicotine  concentration  higher  than 3% nicotine by weight  
per container,  or exceeds  a 36mg/mL  concentration  of 
nicotine  to sell their current  inventory  of manufacturer  
sealed  electronic  cigarette  products  with a nicotine  
concentration of 5% nicotine  by weight  per container,  or 
exceeds  a 59mg/mL  concentration  of nicotine  and avoid  
restocking these  products  before 09/01/ 2021.   It is very 
likely  Utah  tobacco retailers  may avoid  restocking their 
electronic  cigarette product  inventory  by 09/01/ 2021 in 
anticipation  of the FDA's prohibition  of ENDS  and other  
deemed  products  on the market  without  premarket  
authorization of the sale of under  21 U.S.C.  
387j(c)(1)(A)(i),  21 U.S.C.  387j(a)(2)(A)(i),  or 21 U.S.C.  
387j(a)(2)(A)(ii),  that is anticipated  to be effective  
09/09/ 2021.  
 
According to Statista 's E-cigarette  market  share in the 
United  States  in 2020,  by brand,  09/04/2020 report,  five 
electronic  cigarette manufacturer  brands  account  for 97% 
of the U.S. market  share:  Juul (42%),  Vuse  (36%),  blu 
(9%),  Logic  (8%)  and Njoy (2%).   Some  of these  electronic  
cigarette brands  sell products  with a nicotine concentration  
that is more  than 3% nicotine  by weight  or 36mg/mL    NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 27 concentration  of nicotine.   Nevertheless,  all these  brands  
also offer electronic  cigarette  products  with less than a 3% 
nicotine  by weight  per container  or 36 mg/mL  
concentration of nicotine.   Since  August  2019,  disposable  
prefilled electronic  cigarettes  that have  risen  in popularity.   
A variety  of disposable prefilled  electronic  cigarettes  
brands  offer their products  with nicotine concentrations  
equal  to or less than 3% nicotine by weight  per container  
or 36 mg/mL  concentration  of nicotine,  including  Puff Bar, 
Dinner  Lady,  Zaero  Vape,  Cali Bar, and Twst Disposable.   
Utah  tobacco retailers  that sell manufacturer  sealed  
electronic  cigarette  products  will continue to have the 
option to sell manufacturer  sealed electronic  cigarette  
products  with a nicotine concentration equal  to or less than 
5% nicotine  by weight  per container,  or that do not exceed  
a 59mg/mL  concentration of nicotine until 09/01/ 2021,  
when Utah  tobacco retailers  will be required to only sell 
manufacturer  sealed electronic  cigarette  products  with a 
nicotine  concentration equal  to or less than 3% nicotine  by 
weight  per container,  or that do not exceed  a 36mg/mL  
concentration of nicotine.  
 
As indicated,  the five electronic  cigarette manufacturer  
brands  listed  above all offer manufacturer  sealed  
electronic  cigarette  products  that meet  this 3% nicotine by 
weight  per container,  or that do not exceed  a 36mg/mL  
concentration of nicotine concentration requirement  and 
there are also several  popular  disposable prefilled  
electronic  cigarette brands  that offer their products  with 
nicotine  concentrations  that meet  this 3% nicotine by 
weight  per container,  or that do not exceed  a 36mg/mL  
concentration of nicotine requirement.  
 
The Utah  Department  of Health Tobacco  Prevention and 
Control  Program 's independent  evaluator,  Research  
Institute  Triangle (RTI),  states:  "Simply  because 5% 
nicotine  makes  up nearly  70% of sales,  it does  not mean  
that removing  5% nicotine  products  would  result  in a 70% 
drop in overall  sales.   Undoubtedly  a very high percentage  
of regular/addicted users  would  either  convert  to the 3% 
(UDOH suspect s this would be the vast majority,  as many  
users  are brand-loyal  and would  likely  stick with their brand  
at the lower  level rather  than switch)  or shop  exclusively  in 
vape  shops  for open  systems  (mods).   Some  percentage  
would possibly  attempt  to quit altogether,  and some  (likely  
a small)  number  might  switch  to cigarettes  or smokeless  
(unintended consequence).   As this change has never  
been  made  however,  there is no direct  way of estimating  
that.  There likely  are ways  to use simulation models  to 
predict  indirectly  what  the impact  might  be, but those  
would necessarily  be based  on many  assumptions,  likely  
drawn from other  product  types. " 
 
Lastly,  removing the 09/09/2021 date in Subsection R384 -
415-7(2)  will have  a positive  direct  fiscal  impact  on small  
businesses  that sell manufacturer -sealed electronic  
cigarette  products,  as these  retailers  may be allowed  to 
continue to sell electronic  cigarette  products  that comply  
with other  sections  of the proposed rule amendment  and 
are pending review  by the FDA under  their PMTA  process,  
should it take longer  than 09/09/2021 to complete.   FDA 
published  a perspective  dated  05/20/ 2021,  that identifies  over 6,000,000 products  where  a PMTA  application  was 
submitted to FDA by 09/09/ 2020 via the PMTA  process,  
allowing  Utah 's enforcement  agencies  the ability  to 
research products  with pending PMTA  applications.  
 
The indirect  costs  to small  businesses  are unknown  and 
difficult  to determine,  as the potential  impact  is unknown.   
UDOH does  not know  how many  of these 1,175 small  
businesses  choose to sell manufacturer  sealed electronic  
cigarette products  with nicotine  concentrations  higher  than 
3% by weight  per container  or exceed 36 mg/mL  
concentration of nicotine.  
 
Similarly  removing the 09/09/2021  date in Subsection  
R384-415 -7(2)  will have  a positive  direct  fiscal  impact  to 
small  businesses,  as these retailers  may be allowed to 
continue to sell electronic  cigarette  products  that comply  
with other  sections  of the proposed  rule pending  review  by 
the FDA under  their PMTA  process,  should it take longer  
than 09/09/2021 to complete.  
 
D) Non-small  businesses  ("non-small  business " means  
a business  employing  50 or more  persons) : 
The rule amendment  may result  in a direct  cost to non-
small  businesses  that employ  more  than 50 employees  
and choose  to sell manufacturer  sealed electronic  
cigarette products.   The rule amendment  may result  in a 
direct  fiscal  cost to non-small  businesses  that sell 
manufacturer  sealed electronic  cigarette products  among  
other  products  they choose  to sell include  (445120)  
convenience stores,  (447110)  gas stations  with 
convenience stores,  (445110)  supermarkets  and other  
grocery  stores,  (452319)  general  merchandise  and 
discount  stores,  (447190)  other  gasoline stations , and 
(453220)  gift, novelty,  and souvenir  stores.  
 
A review  of UDOH combined  local health department  
tobacco  retail  compliance check  logs for fiscal  year 2020  
and cross -referenced  with DWS  Firm Find Data,  shows  
that there  are approximately  208 non-small  businesses  
that sell some  type of electronic  cigarette products  in Utah,  
or approximately  12% of Utah  tobacco retailers.   UDOH  
does  not know  how many  of these 208 non-small  
businesses  sell manufacturer  sealed electronic  cigarette  
products  with nicotine concentrations  higher  3% by weight  
per container  or exceed  36 mg/mL  concentration of 
nicotine.   Approximately  164 non-small  business  tobacco  
retailers,  or approximately  9.6%,  choose to not sell any 
electronic  cigarette  products  and these  businesses  will not 
be affected by this rule amendment.  
 
Effective  09/01/ 2021,  the proposed rule amendment  
prohibits  a tobacco retailer  that sells a manufacturer  
sealed electronic  cigarette  product  from selling  a 
manufacturer  sealed electronic  cigarette product  with a 
nicotine  concentration  higher  than 3% nicotine by weight  
per container  or exceeding a 36mg/mL  concentration of 
nicotine.   Only tobacco  retailers  that currently  sell 
manufacturer  sealed electronic  cigarette  products  with a 
higher  nicotine  concentration  may experience a direct  
fiscal  impact.  NOTICES OF PROPOSED RULES   
28 UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 The two and a half months ' notice  of the nicotine  content  
limit from 5% nicotine by weight  per container,  or 59mg/mL  
concentration of nicotine to equal  to or less than 3% 
nicotine by weight  per container,  or that do not exceed a 
36mg/mL  concentration of nicotine  may reduce the direct  
fiscal  cost impact  on tobacco retailers.   The two and a half 
months ' time allows  for tobacco retailers  that sell 
manufacturer  sealed electronic  cigarette  products  with a 
nicotine  concentration  higher  than 3% nicotine by weight  
per container,  or exceeds  a 36mg/mL  concentration  of 
nicotine  to sell their current  inventory  of manufacturer  
sealed  electronic  cigarette  products  with a nicotine  
concentration of 5% nicotine  by weight  per container,  or 
exceeds  a 59mg/mL  concentration  of nicot ine and avoid  
restocking these  products  before 09/01/ 2021.   It is very 
likely  Utah  tobacco retailers  may avoid  restocking their 
electronic  cigarette product  inventory  by 09/01/ 2021 in 
anticipation  of the FDA's prohibition  of ENDS  and other  
deemed  products  on the market  without  premarket  
authorization of the sale of un under  21 U.S.C.  
387j(c)(1)(A)(i),  21 U.S.C.  387j(a)(2)(A)(i),  or 21 U.S.C.  
387j(a)(2)(A)(ii),  that is anticipated  to be effective  
09/09/ 2021.  
 
According to Statista 's E-cigarette  market  share in the 
United  States  in 2020,  by brand,  09/04/2020 report,  five 
electronic  cigarette manufacturer  brands  account  for 97% 
of the U.S. market  share:  Juul (42%),  Vuse  (36%),  blu 
(9%),  Logic  (8%)  and Njoy (2%).   Some  of these  electronic  
cigarette brands  sell products  with a nicotine concentration  
that is more  than 3% nicotine by weight  or 36mg/mL  
concentration of nicotine.   Nevertheless,  all these  brands  
also offer electronic  cigarette  products  with less than a 3% 
nicotine  by weight  per container  or 36 mg/mL  
concentration of nicotine.   Since  August  2019,  disposable  
prefilled electronic  cigarettes  have risen  in popularity.   A 
variety  of disposable prefilled  electronic  cigarettes  brands  
offer their products  with nicotine  concentrations  equal  to or 
less than 3% nicotine by weight  per container  or 36 mg/mL  
concentration of nicotine,  including  Puff Bar, Dinner  Lady,  
Zaero Vape,  Cali Bar, and Twst Disposable.   Utah  tobacco  
retailers  that sell manufacturer  sealed electronic  cigarette  
products  will continue to have the option to sell 
manufacturer  sealed electronic  cigarette  products  with a 
nicotine  concentration equal  to or less than 5% nicotine  by 
weight  per container,  or that do not exceed  a 59mg/mL  
concentration of nicotine  until 09/01/ 2021,  when  Utah  
tobacco retailers  will be required to only sell manufacturer  
sealed  electronic  cigarette  products  with a nicotine  
concentration equal  to or less than 3% nicotine by weight  
per container,  or that do not exceed  a 36mg/mL  
concentration of nicotine.  
 
As indicated,  the five electronic  cigarette manufacturer  
brands  listed  above all offer manufacturer  sealed  
electronic  cigarette  products  that meet  this 3% nicotine by 
weight  per container,  or that do not exceed  a 36mg/mL  
concentration of nicotine concentration requirement  and 
there are also several  popular  disposable prefilled  
electronic  cigarette brands  that offer their products  with 
nicotine  concentrations  that meet  this 3% nicotine  by weight  per container,  or that do not exceed  a 36mg/mL  
concentration of nicotine requirement.  
 
The Utah  Department  of Health Tobacco  Prevention and 
Control  Program 's independent  evaluator,  Research  
Institute  Triangle (RTI),  states:  "Simply  because 5% 
nicotine  makes  up nearly  70% of sales,  it does  not mean  
that removing  5% nicotine  products  would  result  in a 70% 
drop in overall  sales.   Undoubtedly  a very high percentage  
of regular/addicted users  would  either  convert  to the 3% 
(we suspect  this would  be the vast majority,  as many  users  
are brand-loyal  and would  likely  stick with their brand at 
the lower  level rather  than switch)  or shop  exclusively  in 
vape  shops  for open  systems  (mods).   Some  percentage  
would possibly  attempt  to quit altogether,  and some  (likely  
a small)  number  might  switch  to cigarettes  or smokeless  
(unintended consequence).   As this change has never  
been  made  however,  there is no direct  way of estimating  
that.  There likely  are ways  to use simulation models  to 
predict  indirectly  what  the impact  might  be, but those  
would necessarily  be based  on many  assumptions,  likely  
drawn from other  product  types. " 
 
Lastly,  removing the 09/09/2021 date in Subsection R384 -
415-7(2)  will have  a positive  direct  fiscal  impact  on small  
businesses  that sell manufacturer -sealed electronic  
cigarette  products,  as these  retailers  may be allowed  to 
continue to sell product  pending review  by the FDA under  
their PMTA  process,  should it take longer  than 09/09/2021  
to complete.   FDA published a perspective  dated  
05/20/2021,  that identifies  over 6,000,000 products  where  
a PMTA  application was submitted to FDA by 09/09/ 2020  
via the PMTA  process,  allowing  Utah 's enforcement  
agencies  the ability  to research  products  with pending  
PMTA  applications.  
 
The indirect  costs to non-small  businesses  are unknown  
and difficult  to determine,  as the potential  impact  is 
unknown.   UDOH does  not know  how many  of these  208 
non-small  businesses  choose to sell manufacturer  sealed  
electronic  cigarette products  with nicotine  concentrations  
higher  3% by weight  per container  or exceed 36 mg/mL  
concentration of nicotine.   Similarly  removing  the 
09/09/2021 date in Subsection R384-415 -7(2)  will have  a 
positive direct  fiscal  impact  to non-small  businesses,  as 
these retailers  may be allowed  to continue to sell electronic  
cigarette  products  that comply  with other  sections  of the 
proposed  rule pending review  by the FDA under  their 
PMTA  process,  should it take longer  than 09/09/2021 to 
complete.  
 
E) Persons  other  than  small  businesses,  non-small  
businesses,  state,  or local  government  entities  
("person" means  any individual,  partnership,  corporation,  
association,  governmental  entity, or public  or private  
organization  of any character  other  than an agency ): 
The proposed  rule amendment  to Rule R384 -415 may 
result  in an indirect  cost or indirect  benefit  to persons,  
which  can include  both consumers  who buy electronic  
cigarette  products  and individuals  who work  for small  
businesses  or non-small  businesses  that sell electronic    NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 29 cigarette  products.   The indirect  costs  or indirect  benefits  
to persons  is unknown and difficult  to determine,  as the 
potential  impact  on consumers  is unknown  as they could 
choose  to vape  electronic  cigarettes  with a lower  nicotine  
concentration,  or they may choose  to quit using electronic  
cigarettes  as a result  of enactment  of this proposed rule 
amendment.  
 
Likewise,  the indirect  costs  or indirect  benefits  to persons  
employed at tobacco retail  businesses  is unknown  and it 
is difficult  to determine the impact  on individual  tobacco  
retail  employees,  who may be employed  at either  small  
businesses  or non-small  businesses  which  could be 
impacted as already  indicated in 5C and 5D above,  as a 
result  of enactment  of this proposed rule amendment.  
 
Lastly,  removing the 09/09/2021 date in Subsection R384 -
415-7(2)  will have  a positive  direct  fiscal  impact  to persons,  
as these retailers  may be allowed  to continue  to sell 
electronic  cigarette products  that comply  with other  
sections  of the proposed rule pending  review  by the FDA 
under  their PMTA  process,  should  it take longer  than 
09/09/2021 to complete.  
 
F) Compliance  costs  for affected  persons:  
The rule amendment  to Rule R384 -415 may result  in an 
indirect  cost or indirect  benefit  to persons,  which  can 
include both consumers  who buy electronic  cigarette  
products  and individuals  who work  for small  businesses  or 
non-small businesses  that sell electronic  cigarette  
products.  
 
G) Regulatory  Impact  Summary  Table  (This  table  only 
includes  fiscal  impacts  that could  be measured.   If there  
are inestimable fiscal  impacts,  they will not be included  in 
this table.  Inestimable  impacts  will be included in 
narratives  above.)  
Regulatory  Impact  Table  
Fiscal  Cost  FY2021  FY2022  FY2023  
State  
Government  $0 $0 $0 
Local  
Governments  $0 $0 $0 
Small  
Businesses  $0 $0 $0 
Non-Small  
Businesses  $0 $0 $0 
Other  
Persons  $0 $0 $0 
Total  Fiscal  
Cost  $0 $0 $0 
Fiscal  
Benefits     
State  
Government  $0 $0 $0 Local  
Governments  $0 $0 $0 
Small  
Businesses  $0 $0 $0 
Non-Small  
Businesses  $0 $0 $0 
Other  
Persons  $0 $0 $0 
Total  Fiscal  
Benefits  $0 $0 $0 
Net Fiscal  
Benefits  $0 $0 $0 
H) Department  head  approval  of regulatory  impact  
analysis:  
The Executive Director of the Department  of Health,  
Richard G. Saunders,  has reviewed  and approved this 
fiscal  analysis.  
 
6. A) Comments  by the department  head  on the fiscal  
impact  this rule may have  on businesses:  
The proposed  rule amendment  may result  in a direct  cost 
to businesses  that sell manufacturer  sealed  electronic  
cigarette products  and to businesses  that primarily  rely on 
the sale of tobacco  products.  
 
B) Name  and title of department  head  commenting  on 
the fiscal  impacts:  
Richard  G. Saunders,  Executive  Director  
 
 
Citation  Information  
7.  This rule change  is authorized  or mandated  by state  
law, and implements or interprets  the following  state  
and federal  laws.   State  code  or constitution  citations  
(required ): 
Subsection  
26-57-103(2)    
 Public  Notice  Information  
9.  The public  may submit  written  or oral comments  to 
the agency  identified  in box 1.  (The public  may also 
request  a hearing  by submitting a written  request  to the 
agency.   The agency  is required to hold a hearing  if it 
receives  requests  from ten interested persons  or from an 
association having not fewer  than ten members.   
Additionally,  the request  must  be received by the agency  
not more  than 15 days  after the publication of this rule in 
the Utah  State  Bulletin.   See  Section 63G-3-302 and Rule 
R15-1 for more  information.)  
A) Comments  will be accepted  
until:  07/15/2021  
 
10. This rule change  MAY  
become  effective  on: 07/22/2021  NOTICES OF PROPOSED RULES   
30 UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 NOTE:  The date above  is the date on which  this rule MAY 
become effective.   It is NOT the effective date.   After  the 
date designated  in Box 10, the agency  must  submit  a 
Notice  of Effective  Date  to the Office  of Administrative  
Rules  to make  this rule effective.  Failure  to submit  a 
Notice  of Effective  Date  will result  in this rule lapsing and 
will require  the agency  to start the rulemaking  process  
over.   
 
Agency  Authorization  Information  
Agency  head  
or designee,   
and title:  Richard  G. 
Saunders,  
Executive  Director  Date:  06/01/2021  
 R384.  Disease Control and Prevention, Health Promotion.  
R384- 415.  Requirements to Sell Electronic Cigarette Products  
[Substance Standards ]. 
R384- 415-1.  Authority and Purpose.  
 (1)  This rule is authorized by Section 26 -57-103.  
 (2)  The purpose of this rule is to establish requirements to 
sell an electronic cigarette product regarding [standards for ] labeling, 
nicotine content, packaging, and product quality for non -
manufacturer sealed electronic cigarette substances and manufactu rer 
sealed electronic cigarette [ substances for the regulation of selling 
electronic cigarette ]products.  
 (3)  A person may only sell a n [non-manufacturer sealed 
]electronic cigarette substance, that is not a manufacturer sealed 
electronic cigarette subst ance,  that is compliant with the established 
[standards and ]requirements set forth in this rule.  
 (4)  Beginning on July 1, 2021, a person may only sell a 
manufacturer sealed electronic cigarette product [substance] that is 
compliant with the established [ standards and ]requirements set forth 
in this rule.  
 (5)  A product in compliance with this rule is not endorsed 
as safe.  
 R384- 415-2.  Definitions.  
 As used in this rule:  
 (1)  "Child resistant" means the same as the term "special 
packaging" is defined in 16 C.F.R 1700.1(a)(4) and is tested in 
accordance with the method described in 16 C.F.R. 1700.20.  
 (2)  "Department" means the Utah Department of Health.  
 (3)  "Electronic cigarette" means the same as that term is 
defined in Section 76-10 -101.  
 (4)  "Electronic cigarette product" means the same as that 
term is defined in Section 76 -10-101. 
 (5)  "Electronic cigarette substance" means the same as that 
term is defined in Section 76 -10-101. 
 (6)  "Local health department" means the same as that term 
is defined in Subsection 26A -1-102(5).  
 (7)  "Industrial hemp product" means the same as that term 
is defined is in Section 4 -41-102. 
 (8)  "Manufacture" means the same as that term is defined 
in Section 26 -57-102. 
 (9)  "Manufacturer" means the same as that t erm is defined 
in Section 26 -57-102. 
 (10)  "Manufacturer sealed electronic cigarette substance" 
means the same as that term is defined [ is ]in Section 26 -57-102.  
 (11)  "Mg/mL" means milligrams per milliliter, a ratio for 
measuring an ingredient, in liqui d form, where accuracy is measured 
in milligrams per milliliter, or a percentage equivalent.   (12)  "Manufacturer sealed electronic cigarette product" 
means the same as that term is defined in Section 26 -57-102. 
 [(12) ](13)   "Nicotine" means the same as th at term is 
defined in Section 76-10 -101.  
 [(13) ](14)   "Non -manufacturer sealed electronic cigarette 
substance" means:  
 (a)  an electronic cigarette substance that is not a 
manufacturer sealed electronic cigarette substance; and  
 (b)  an electronic cigarett e substance container the 
electronic cigarette manufacturer does intend for a consumer to open 
or refill.  
 [(14) ](15)   "Package" or "packaging" means a pack, box, 
carton, or container of any kind, or if no other container, any 
wrapping, in which an electro nic cigarette substance or a 
manufacturer sealed electronic cigarette product [substance ] is 
offered for sale, sold, or otherwise distributed to consumers.  
 [(15) ](16)   "Permit" means the same as that term is defined 
in Section 26 -62-101. 
 [(16) ](17)   "Retailer" means any person who sells, offers 
for sale, exchanges, or offers to exchange for any form of consideration, a[ n] non -manufacturer sealed electronic cigarette 
substance or a manufacturer sealed electronic cigarette 
product [substance] to a consumer. T his definition is without regard 
to the quantity of a[ n] non -manufacturer sealed electronic cigarette 
substance or a manufacturer sealed electronic cigarette 
product [substance] sold, offered for sale, exchanged, or offered for 
exchange.  
 [(17) ](18)   "Trans action statement" means a statement, in 
paper or electronic form, which the manufacturer transferring ownership of the product certifies that the non-manufacturer sealed electronic cigarette substance or the manufacturer sealed electronic 
cigarette product [substance ] is in compliance with the 
requirements [standards ] in this rule.  
 
R384- 415-3.  Labeling.  
 (1)  The retailer shall ensure that a nicotine containing non-
manufacturer sealed electronic cigarette substance or a manufacturer 
sealed electronic cigarette product [substance ] offered for sale to the 
consumer features on the product package label the required safety warning stating "WARNING:   This product contains nicotine.  
Nicotine is an addictive chemical."  
 (2)  Consistent with 21 C.F.R. 1143.3, the safety warning 
statements required in Subsection (1), the required safety warning statement must appear directly on the package and must be clearly 
visible underneath any cellophane or other clear wrapping as follows:  
 (a)  be located in a conspicuous and prominent place on the 
two principal display panels of the package and the warning area 
must comprise at least 30 percent of each of the prin cipal display 
panels;  
 (b)  be printed in at least 12 -point font size and ensures that 
the required warning statement occupies the greatest possible 
proportion of the warning area set aside for the required text;  
 (c)  be printed in conspicuous and legible  Helvetica bold or 
Arial bold type, or other sans serif fonts, and in black text on a white background or white text on a black background in a manner that 
contrasts by typography, layout, or color, with all other printed 
material on the package;  
 (d)  be capitalized and punctuated as indicated in 
Subsection (1); and  
 (e)  be centered in the warning area in which the text is 
required to be printed and positioned such that the text of the required   NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12 31 warning statement and the other information on the principal display 
panel have the same orientation.  
 (3)  The retailer shall ensure that a non -manufacturer sealed 
electronic cigarette substance marketed as nicotine-free and offered 
for sale to the consumer features a safety warning stating 
"WARNING:  Keep away fro m children and pets."  
 (4)  The safety warning statements required in Subsection 
(3), the required safety warning statement must appear directly on the 
package and must be clearly visible underneath any cellophane or 
other clear wrapping as follows:  
 (a)  be located in a conspicuous and prominent place on the 
two principal display panels of the package and the warning area 
must comprise at least 30 percent of each of the principal display panels;  
 (b)  be printed in at least 12 -point font size and ensures that 
the required warning statement occupies the greatest possible proportion of the warning area set aside for the required text;  
 (c)  be printed in conspicuous and legible Helvetica bold or 
Arial bold type, or other sans serif fonts, and in black te xt on a white 
background or white text on a black background in a manner that contrasts by typography, layout, or color, consistent with the other printed material on the package;  
 (d)  be capitalized and punctuated as indicated in 
Subsection (3); and  
 (e)  be centered in the warning area in which the text is 
required to be printed and positioned such that the text of the required warning statement and the other information on the principal display 
panel have the same orientation.  
 (5)  A retailer will not be in violation of this section for 
packaging that:  
 (a)  contains a health warning;  
 (b)  is supplied to the retailer by the electronic cigarette 
product [substance] manufacturer, importer, or distributor, who has 
the required state, local, or tobacco tax license or permit, if 
applicable; and  
 (c)  is not altered by the retailer in a way that is material to 
the requirements of  this section.  
 (6)  A non -manufacturer sealed electronic cigarette 
substance or a manufacturer sealed electronic cigarette product [substance] package that would otherwise be required to bear 
the safety warning in Subsection (1) or (3) but is too small or 
otherwise unable to accommodate a safety warning label with 
sufficient space to bear such information is exempt from compliance with the requirement provided that:  
 (a)  the information and specifications required in 
Subsection (1) and (3) appear on the carton or other outer container or wrapper if the carton, outer container, or wrapper has sufficient 
space to bear the information; o r 
 (b)  appear on a tag otherwise firmly and permanently 
affixed to the non-manufacturer sealed electronic- cigarette substance 
package or the manufacturer sealed electronic cigarette product [substance] package.  
 (7)  In the case of Subsection (6)(a) or (b ), the carton, outer 
container, wrapper, or tag will serve as the location of the principal 
display panels.  
 (8)  The retailer shall ensure that an industrial hemp product 
that is a non -manufacturer sealed electronic cigarette substance or an 
industrial hemp product that is a manufacturer sealed electronic 
cigarette product [substance ] is compliant with Title 4, Chapter 41, 
Part 1, Industrial Hemp and Section R68- 26-5, unless:  
 (a)  an industrial hemp product that is a non-manufacturer 
sealed electronic ci garette substance marketed as containing nicotine and offered for sale or an industrial hemp product that is a manufacturer sealed electronic cigarette product [substance] 
marketed as containing nicotine and offered for sale is in compliance 
with the safety  warning requirements in Subsection (1) and (2); or  
 (b)  an industrial hemp product that is a non-manufacturer 
sealed electronic cigarette substance marketed as nicotine-free and 
offered for sale is exempt from the safety warning requirements in 
Subsectio n (3) and (4); if the product is compliant with Title 4, 
Chapter 41, Part 1, Industrial Hemp and Section R68-26 -5. 
 
R384- 415-4.  Prohibited Sales.  
 (1)  The retailer shall be prohibited from selling a non-
manufacturer sealed electronic cigarette substance or a manufacturer sealed electronic cigarette product [substance ] that is labeled as 
containing:  
 (a)  additives that create the impression that a non -
manufacturer sealed electronic cigarette substance or a manufacturer sealed electronic cigarette product [substance ] has a health benefit;  
 (b)  additives that are associated with energy and vitality;  
 (c)  illegal or controlled substances as identified in Section 
58-37-3; and 
 (d)  additives having coloring properties for emissions.  
 (2)  The retailer shall be prohibited from selling an 
industrial hemp product that is a non -manufacturer sealed electronic 
cigarette substance or an industrial hemp product that is a manufacturer sealed electronic cigarette product [substance] unless it 
is compliant with Title 4, Ch apter 41, Part 1, Industrial Hemp; 
Section R68- 26-5; and Section R68- 33-5. 
 R384- 415-5.  Nicotine Content.  
 (1)  The retailer shall be prohibited from selling a non-
manufacturer sealed electronic cigarette substance or a manufacturer 
sealed electronic cigarette product [substance ] to the consumer if the 
product is not compliant with the following:  
 (a)  the nicotine concentration for a non-manufacturer 
sealed electronic cigarette substance is limited to 360 mg nicotine per 
container, or does not exceed a 24m g/mL concentration of nicotine; 
and 
 (b)  the nicotine concentration for a manufacturer sealed 
electronic cigarette product [substance ] is limited : 
 (i)  to 5% nicotine by weight per container, or does not 
exceed a 59mg/mL concentration of nicotine, effective July 1, 2021 ; 
and 
 (ii)  to 3% nicotine by weight per container, or does not 
exceed a 36mg/mL concentration of nicotine, effective September 1, 
2021.  
 
R384- 415-6.  Packaging.  
 (1)  The retailer shall ensure that the packaging of a non -
manufacturer sealed electronic cigarette substance intended for sale 
to a consumer is certified as child resistant, and compliant with 
federal standards and law concernin g child nicotine poisoning 
prevention.  
 (2)  The retailer shall sell non -manufacturer sealed 
electronic cigarette substances and manufacturer sealed electronic cigarette products [substances ] in the product's original packaging.  
 (3)  The retailer shall be prohibited from repackaging or 
dispensing any non-manufacturer sealed electronic cigarette substance or any manufacturer sealed electronic cigarette 
product [substance] for retail sale.  NOTICES OF PROPOSED RULES   
32 UTAH STATE BULLETIN , June 15, 2021, V ol. 2021 , No. 12  (4)  The retailer shall be prohibited from refilling a 
manufacturer sealed electronic cigarette product [substance] that is 
not intended to be opened by a retailer or a consumer.  
 (5)  The retailer shall ensure that an industrial hemp product 
that is a non -manufacturer sealed electronic cigarette substance or an 
industrial hemp product that is a manufacturer sealed electronic 
cigarette product [substance ] is compliant with Title 4, Chapter 41, 
Part 1, Industrial Hemp; and Rule R68- 26. 
 R384- 415-7.  Product Qu ality.  
 (1)  Consistent with 21 U.S.C 387j, n [N]o manufacturer or 
retailer shall sell, offer for sale, or distribute an electronic cigarette, an electronic cigarette product, or an electronic cigarette substance unless the product complies with each of the  relevant electronic 
cigarette product standards established by the U.S. Food and Drug 
Administration under 21 U.S.C. 387g(3).  
 (2)  N[otwithstanding Subsection (3), after September 9, 
2021, n]o manufacturer or retailer shall sell, offer for sale, or 
distribute an electronic cigarette, an electronic cigarette product, or 
an electronic cigarette substance unless the product has received 
marketing authorization from the U.S. Food and Drug Administration (FDA) under 21 U.S.C. 387j(c)(1)(A)(i), 21 U.S.C. 387j(a )(2)(A)(i), 
or 21 U.S.C. 387j(a)(2)(A)(ii) and related FDA regulations, policies, 
or actions . 
 (3)  A manufacturer or retailer will not be in violation of 
Subsection (2) and may continue to sell, offer for sale, or distribute 
an electronic cigarette, an el ectronic cigarette product, or an 
electronic cigarette substance if:  
 (a)  the manufacturer or retailer only sells, offers for sale, 
or distributes an electronic cigarette, an electronic cigarette product, 
or an electronic cigarette substance that is compl iant with the 
requirements set forth in this rule;  
 (b)  the manufacturer submitted a timely Pre-Market 
Tobacco application or Substantial Equivalent application to the FDA 
by September 9, 2020, verified by being listed on the FDA's website 
as a deemed new  tobacco product with timely application; and  
 (c)  the FDA has not issued a written marketing order and 
therefore the product's Pre -Market Tobacco application or Substantial 
Equivalent application is pending review by the FDA.  
 [(3)](4)   This section will  take effect on the date that 
manufacturers are required to secure marketing orders from the FDA  
to continue marketing their products in the United States.[   Any 
delays in enforcement efforts by FDA due to litigation will not impact 
the effective date of  this section. ] 
 R384- 415-8.  Record Keeping and Testing.  
 (1)  The retailer shall provide the non -manufacturer sealed 
electronic cigarette substance transaction statements or manufacturer 
sealed electronic cigarette product [substance ] transaction statemen ts 
to the Department or the local health department within 14 calendar 
days of a request. The retailer shall ensure that the transaction statement includes manufacturer certifications that:  
 (a)  the labeling requirements [standards ] are compliant 
with Sect ion R384 -415-3; 
 (b)  the nicotine content of a non -manufacturer sealed 
electronic cigarette substance is compliant with Subsection R384 -
415-5(1)(a) and the nicotine content of a manufacturer sealed 
electronic cigarette product [substance ] is compliant with  Subsection 
R384- 415-5(1)(b);  
 (c)  the packaging requirements [standards ] are compliant 
with Section R384 -415-6; and  (d)  the product quality requirements [standards ] are 
compliant with Section R384-415-7.  
 (2)  The retailer shall provide evidence that sup ports the 
documents described in Subsection R384 -415-8(1) to the Department 
or the local health department within 14 calendar days of a request.  
 (3)  The retailer shall have access to the documents 
described in Subsections R384- 415-8(1) and R384- 415-8(2) for a 
period of two years after the retailer purchases the non -manufacturer 
sealed electronic cigarette substance or the manufacturer sealed 
electronic cigarette product [substance ]. 
 
R384- 415-9.  Enforcement.  
 (1)  In enforcing or seeking penalties of any violation as set 
forth in this rule or Section 26- 57-103, the Department and local 
health departments shall comply with the enforcement requirement in Title 26, Chapter 62, Part 3, Enforcement.  
 
KEY:  electronic cigarettes, nicotine, [ standards, ]Electronic 
Cigarette Product and Nicotine Product Regulation Act  
Date of Enactment or Last Substantive Amendment:  [June 1, ] 
2021  
Notice of Continuation:  December 8, 2020  
Authorizing, and Implemented or Interpreted Law:  26 -57-103 
 
 
NOTICE  OF PROPOSED  RULE  
TYPE  OF RULE:   New 
Utah  Admin.  Code  
Ref (R no.):  R429 -1 Filing  No. 
53439  
 
Agency  Information  
1.  Department:  Health  
Agency:  Patient  Safety  Program  
Room  no.: 106 
Building:  Cannon  
Street  address:  288 N 1460  W 
City,  state:  Salt Lake City, UT 84116  
Mailing  address:  PO 144004  
City,  state,  zip: Salt Lake City , UT 8411 4-4004  
Contact  person(s):  
Name:  Phone:  Email:  
Carl Letamendi  801-
538-
7072  cletamendi@utah.gov  
Stephanie  
Saperstein  801-
538-
6430  stephaniesaperstein@utah.go
v 
Mike  Martin  801-
538-
9205  mikemartin@utah.gov  
Please  address  questions  regarding  information  on this 
notice  to the agency.