NOTICES OF PROPOSED RULES  
20 UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  process of receiving, investigating and the final disposition of 
complaints.  
 (7)  The department and local health departments shall 
coordinate inspections, complaint investigations, and enforcement 
activities on regulated entities where there is joint responsibility and 
as specified in the Environmental Service Delivery  Plan.  
 
R305- 10-8.  Local Health Department Environmental 
Emergency Response.  
 (1)  Each local health department shall participate in 
environmental emergency preparedness efforts, including:  
 (a)  identifying local health department roles and 
responsibilit ies in emergency response;  
 (b)  establishing partnerships with volunteers, emergency 
response agencies, and other community organizations involved in 
emergency response;  
 (c)  cooperating with the Department of Environmental 
Quality in fulfilling responsi bilities associated with Emergency 
Support Functions;  
 (d)  maintaining an all hazards response plan;  
 (e)  maintaining a continuity of operations plan that shall 
include employee notification, lines of authority and succession, and 
prioritized local healt h department functions; and  
 (f)  testing public health preparedness through participation 
in Department coordinated response drills and exercises.  
 
R305- 10-9.  General Performance Standards for Local Health 
Department Laboratory Services.  
 (1)  Each local  health department shall ensure that 
laboratories used to analyze environmental samples have the 
necessary certification to conduct the applicable tests.  
 
KEY:  administrative procedures, local health departments  
Date of Enactment or Last Substantive Amendment:  2021 
Authorizing, and Implemented or Interpreted Law:  19 -1-201; 26A -
1-106(4)  
 
 
NOTICE  OF PROPOSED  RULE  
TYPE  OF RULE:   Amendment  
Utah  Admin.  Code  
Ref (R no.):  R384 -415 Filing  No. 
53257  
 
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:  
These  changes  revise  this rule to align  with changes  in 
Section 26-57- 103, which became effective 07/01/2020.   
The changes  are needed  due to the passage  of H.B. 23 
during  the 2020  General  Session,  requiring  the 
Department  of Health (Department) to  establish labeling;  
nicotine content;  packaging;  and product  quality  standards  
for manufacturer  sealed electronic  cigarette substances.   
Between July and September  2020,  the Department  
consulted with representatives  from local health  
departments  and members  of the public  to establish the 
language for this rule amendment.  
 
4.  Summary  of the new rule or change:  
This rule amendment  to Rule R384 -415 revises  this rule to 
align  with definition changes  throughout  the Utah  Code.  In 
addition,  the rule amendment  establishes  labeling;  
nicotine content;  packaging;  and product  quality  standards  
and requirements  for retailers  that sell manufacturer  
sealed electronic  cigarette substances.  
 
 
Fiscal  Information  
5.  Aggregate  anticipated  cost or savings  to: 
A) State  budget:  
Enactment  of this 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 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 Utah  Department  of Health  
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   NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  21 electronic  cigarettes  sold in Utah  could  reduce  electronic  
cigarette use among this population and subsequently  
decrease nicotine  dependence treatment  and healthcare  
expenditures  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 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),  offered 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.  
 
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).   To 
offer tobacco cessation services  to 44.5% of Utah  youth  
who vape  (13,350)  would cost Utah  an estimated  
$3,600,000 .  To offer tobacco cessation  services  to 50% of 
young adults  who vape  (ages  18 - 34) (~55,000)  would  
cost Utah  an estimated $16,600,000.  
 
Effective  07/01/ 2021,  this rule amendment  prohibits  a 
tobacco retailer  that sells a manufacturer  sealed electronic  
cigarette substance  from selling  a manufacturer  sealed  
electronic  cigarette  substance  with a nicotine  
concentration higher  than 5% nicotine by weight  per 
container,  or exceeding  a 59mg/mL  concentration  of 
nicotine;  and effective  01/01/ 2022,  this rule amendment  
prohibits  a tobacco retailer  that sells a manufacturer  
sealed electronic  cigarette substance  from selling  a 
manufacturer  sealed electronic  cigarette  substance  with a 
nicotine  concentration  higher  than 3% nicotine by weight  
per container,  or exceeding  a 36mg/mL  concentration of 
nicotine.   An electronic  cigarette substance 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 substances  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 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.  
 A study  of youth  and young  adults  ages  13 - 24 argues  that 
those who have  ever used  e-cigarettes  are five times  more  
likely  to contract  COVID -19 than those  who do not use 
tobacco products.   Dual  users  of cigarettes  and e-
cigarettes  are nearly  seven times  more  likely  to contract  
the respiratory  disease  (Gaiha,  S. M, et al., 2020).  
 
B) Local  governments:  
Enactment  of this 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 this amended rule. 
 
C) Small  businesses  ("small  business " means  a business  
employing  1-49 persons) : 
This 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  
substances.   This 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,  
and 424940.   Other  small  businesses  that sell 
manufacturer  sealed  electronic  cigarette substances  
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 the Department  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  
substances  in Utah,  or approximately  88% of Utah  tobacco  
retailers.   The Department  does  not know  how many  of 
these 1,175 small  businesses  sell manufacturer  sealed  
electronic  cigarette  substances  with nicotine  
concentrations  higher  than either  5% by weight  per 
container  or exceed  59 mg/ml  concentration of nicotine,  or 
the number  of small  businesses  that sell manufacturer  
sealed electronic  cigarette  substances  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  substances  and 
these businesses  will not be affected  by this rule 
amendment.  
 NOTICES OF PROPOSED RULES  
22 UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  The proposed  rule amendment  labeling;  packaging;  and 
product  quality  standards  and requirements  for retailers  
that sell manufacturer  sealed electronic  cigarette  
substances  are effective  07/01/ 2021.   Whereas  regarding  
nicotine  content,  effective 07/01/ 2021,  this rule 
amendment  prohibits  a tobacco retailer  that sells a 
manufacturer  sealed electronic  cigarette substance from 
selling  a manufacturer  sealed  electronic  cigarette  
substance  with a nicotine concentration higher  than 5% 
nicotine  by weight  per container,  or exceeding a 59mg/mL  
concentration of nicotine;  and effective  01/01 /2022,  this 
rule amendment  prohibits  a tobacco retailer  that sells a 
manufacturer  sealed electronic  cigarette substance from 
selling  a manufacturer  sealed  electronic  cigarette  
substance  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  substances  with a higher  
nicotine concentration may experience a direct  fiscal  
impact.   The additional  six 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 additional  six 
months ' time allows  for tobacco retailers  that sell 
manufacturer  sealed electronic  cigarette  substances  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 substance 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 01/01/ 2022.  
 
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.   Utah  tobacco retailers  that sell manufacturer  
sealed electronic  cigarette substances  (or prefilled  pods  or 
cartridges)  will continue  to have the option to sell 
manufacturer  sealed electronic  cigarette  substances  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 01/01/ 2022,  when  Utah  
tobacco retailers  will be required to only sell manufacturer  
sealed electronic  cigarette  substances  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  substances  that 
meet  this 3% nicotine  by weight  per container,  or that do not exceed  a 36mg/mL  concentration  of nicotine  
concentration requirement.  
 
D) Non-small  businesses  ("non-small  business " means  
a business  employing  50 or more  persons) : 
This 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 substances.   The rule amendment  may result  in 
a direct  fiscal  cost to non-small  businesses  that sell 
manufacturer  sealed  electronic  cigarette substances  
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 the 
Department  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  substances  in Utah,  
or approximately  12% of Utah  tobacco  retailers.   The 
Department  does  not know  how many  of these 208 non-
small  businesses  sell manufacturer  sealed  electronic  
cigarette  substances  with nicotine  concentrations  higher  
than either  5% by weight  per container  or exceed 59 mg/ml  
concentration of nicotine,  or the number  of non-small  
businesses  that sell manufacturer  sealed electronic  
cigarette  substances  with nicotine  concentrations  higher  
than 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 substances  and these  
businesses  will not be affected  by this rule amendment . 
 
The proposed  rule amendment  labeling;  packaging;  and 
product  quality  standards  and requirements  for retailers  
that sell manufacturer  sealed electronic  cigarette  
substances  are effective  07/01/ 2021.   Whereas  regarding  
nicotine  content,  effective 07/01/ 2021,  this rule 
amendment  prohibits  a tobacco retailer  that sells a 
manufacturer  sealed electronic  cigarette substance from 
selling  a manufacturer  sealed  electronic  cigarette  
substance  with a nicotine concentration higher  than 5% 
nicotine  by weight  per container,  or exceeding a 59mg/mL  
concentration of nicotine;  and effective  01/01/ 2022,  this 
rule amendment  prohibits  a tobacco retailer  that sells a 
manufacturer  sealed electronic  cigarette substance from 
selling  a manufacturer  sealed  electronic  cigarette  
substance  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  substances  with a higher  
nicotine concentration may experience a direct  fiscal  
impact.   The additional  six 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    NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  23 a 36mg/mL  concentration  of nicotine  may reduce  the direct  
fiscal  cost impact  on tobacco retailers.   The additional  six 
months ' time allows  for tobacco retailers  that sell 
manufacturer  sealed electronic  cigarette  substances  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 substance 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 01/01/ 2022.  
 
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.   Utah  tobacco retailers  that sell manufacturer  
sealed electronic  cigarette substances  (or prefilled  pods  or 
cartridges)  will continue  to have the option to sell 
manufacturer  sealed electronic  cigarette  substances  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 01/01/ 2022,  when  Utah  
tobacco retailers  will be required to only sell manufacturer  
sealed electronic  cigarette  substances  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  substances  that 
meet  this 3% nicotine by weight  per container,  or that do 
not exceed a 36mg/mL  concentration of nicotine  
concentration requirement.  
 
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 ): 
This 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  
substances  and individuals  who work  for small  businesses  
or non-small  businesses  that sell electronic  cigarette  
substances.   The indirect costs or indirect benefits to 
persons is unknows 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 u sing electronic 
cigarettes as a result of enactment of this 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, as a result of 
enactment of this rule amendment.  
 
F) Compliance  costs  for affected  persons:  
This 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  
substances  and individuals  who work  for small  businesses  
or non-small  businesses  that sell electronic  cigarette  
substances.  
 
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 Interim  Executive  Director  of Department  of Health,  
Richard G. Saunders,  has reviewed  and approved this 
fiscal  analysis.  
 NOTICES OF PROPOSED RULES  
24 UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  6. A) Comments  by the department  head  on the fiscal  
impact  this rule may have  on businesses:  
After  conducting  a thorough  analysis,  it was determined  
that this proposed  rule amendment will not result  in a fiscal  
impact  to businesses  is inestimable because  retailers  
have  the option to sell this product.  
 
B) Name  and title of department  head  commenting  on 
the fiscal  impacts:  
Richard  G. Saunders,  Interim  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:  02/15/2021  
 
10. This rule change  MAY  
become  effective  on: 2/22/2021  
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,  Interim   
Executive  Director  Date:  12/17/2020  
 
R384.  Disease Control and Prevention, Health Promotion.  
R384- 415.  Electronic[ -] Cigarette Substance Standards.  
R384- 415-1.  Authority and Purpose.  
 (1)  This rule is authorized by Section 26-57-103[ and 
Subsection 59- 14-803(5) ]. 
 (2)  Th e[is] purpose of this rule is to establish[ es] standards 
for labeling, nicotine content, packaging, and product quality for non-manufacturer sealed electronic[ -] cigarette substances and 
manufacturer sealed electronic cigarette substances for the regulation 
of selling electronic[ -] cigarette[ s] products . 
 (3)  A person may only sell a non -manufacturer sealed 
electronic cigarette substance that is compliant with the established 
standards and requirements set f orth in this rule.  
 (4)  Beginning on July 1, 2021, a person may only sell a 
manufacturer sealed electronic cigarette substance that is compliant 
with the established standards and requirements set forth in this rule.  
[ (3)  This rule does not apply to a m anufacturer -sealed 
electronic-cigarette substance. ] 
 [(4)](5)   A product in compliance with this rule is not 
endorsed as safe.  
 
R384- 415-2.  Definitions.  
 As used in this rule:  
[ (1)  "Business" means any sole proprietorship, partnership, 
joint venture, corporation, association, or other entity formed for 
profit or non-profit purposes. ] 
 [(2)](1)   "Child resistant" means the same as the term 
"special packaging" is defined in 16 C.F.R 1700.1(a)(4) [ (January 1, 
2015) ]and is tested in accordance with the method described in 16 
C.F.R. 1700.20[  (January 1, 2015) ]. 
 [(3)](2)  "Department" means the Utah Department of 
Health.  
 [(4)](3)   "Electronic[ -] cigarette" means the same as 
that[the] term is defined in [ Subs ]Section[ s 26-38-2(1) and 59 -14-
802(2) ] 76-10-101. 
 [(5)](4)  "Electronic[ -] cigarette [ P]product" means the 
same as that [the] term is defined in [ Subs ]Section [ 59-14-802(3) ]76-
10-101. 
 [(6)](5)  "Electronic[ -] cigarette substance" means the same 
as that[the] term is defined in [ Subs]Section [ 59-14-802(4) ]76-10-
101. 
 [(7)](6)   "Local health department" means the same as 
that[the] term is defined in Subsection 26A -1-102(5).  
 (7)  "Industrial hemp product" means the same as that term 
defined is in Section 4 -41-102. 
 (8)  "Manufacture" means the same as that [the] term is 
defined in [ Subs ]Section 26 -57-102[ (5)]. 
 (9)  "Manufacturer" means the same as that [the] term is 
defined in [ Subs ]Section 26 -57-102[ (6)]. 
 (10)  "Manufacturer sealed electronic cigarette substance" 
means the same as that term defined is in Section 26 -57-102.  
 [(10) ](11)   "Mg/mL" means milligrams per milliliter, a 
ratio for measuring an ingredient, in liquid form, where accuracy is 
measured in milligrams per milliliter, or a percentage equivalent.  
 (12)  "Nicotine" means the same as that term is defined in 
Section 76- 10-101. 
[ (11)  "Nicotine" means the same as the term is defined in 
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec. 387(12) 
(2013). ] 
[ (12)  "Manufacturer -sealed electronic-cigarette substance" 
means the same as the term defined is in Subsection 26 -57-102(6). ] 
 (13)  "Non -manufacturer sealed electronic cigarette 
substance" means:  
 (a)  an electronic cigarette substance that is not a 
manufacturer sealed electronic cigarette substance; and  
 (b)  an el ectronic cigarette substance container the 
electronic cigarette manufacturer does intend for a consumer to open 
or refill.    NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  25  [(13) ](14)   "Package[  ]" or "packaging" means a pack, box, 
carton, or container of any kind, or if no other container, any 
wrapping,  in which an electronic cigarette substance or a 
manufacturer sealed electronic cigarette substance is offered for sale, 
sold, or otherwise distributed to consumers.  
 (15)  "Permit" means the same as that term is defined in 
Section 26- 62-101. 
 [(14) ](16)   "Retailer" means any person who sells, offers 
for sale,  exchanges,  or offers to exchange for any form of 
consideration, an non-manufacturer sealed electronic[ -] cigarette 
substance or a manufacturer sealed electronic cigarette substance to 
a consumer. This  definition is without regard to the quantity of an 
non-manufacturer sealed electronic[ -] cigarette substance or a 
manufacturer sealed electronic cigarette substance sold, offered for 
sale, exchanged, or offered for exchange.  
[ (15)  "Retailing" means invo lvement in any of the activities 
listed in Subsection R384 -415-2(14). This definition is without 
regard to the quantity of an electronic -cigarette substance sold, 
offered for sale, exchanged, or offered for exchange. ] 
 [(16) ](17)   "Transaction statement" m eans 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 substance is in compliance with the standards in 
this rule.  
 
R384- 415-3.  Labeling.  
 (1)  The retailer shall ensure that nicotine containing non -
manufacturer sealed electronic[ -] cigarette substance or manufacturer 
sealed electronic cigarette 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 Sub section (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 disp lay 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 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 punctu ated 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 
warning statement and the other information on the principal display 
panel have the  same orientation.  
 [(2)](3)   The retailer shall ensure that a[ n] non-
manufacturer sealed electronic[ -] cigarette substance or a 
manufacturer sealed electronic cigarette substance marketed as 
nicotine -free and offered for sale to the consumer features a safety 
warning stating "WARNING:  Keep away from 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 text 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.  
[ (3)  The retailer shall ensure that the required safety 
warning appear directly on the package and must be visible 
underneath any cellophane or other clear wrapping as follows:  
 (a)  be located in a conspicuous and prominent place on the 
two principle display panels of the package and the warning area 
must comprise at least 30 percent of each of the principal display 
panels;  
 (b)  is capitalized and punctuated as indicated in Subsection 
(1) or (2) of this Section;  
 (c)  be printed in at leas t 12-point font size and ensure that 
the required warning statement occupies the greatest possible 
proportion of the warning area set aside for the required text;  
 (d)  uses a conspicuous and legible Helvetica, Arial, or 
other san serif font;  
 (e)  uses ei ther a black font on a white background or a 
white font on a black background; and  
 (f)  is centered in the warning area in which the text is 
required to be printed and positions such that the text of the required 
warning statement and the other informatio n on the principal display 
panel have the same orientation. ] 
 [(4)](5)  A retailer [ of an electronic-cigarette substance 
]will not be in violation of this [ S]section [ when ]for packaging  that: 
 (a)  contains a health warning;  
 (b)  is supplied to the retail er by [ a]the electronic cigarette 
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 o f this [ S]section.  
 [(5)](6)  A[n] non-manufacturer sealed electronic[ -] 
cigarette substance or a manufacturer sealed electronic cigarette 
substance package that would otherwise be required to bear the safety 
warning in Subsection (1) or (2) [ of this Section ]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 
Subse ction (1) and [ (2)](3)  [of this Section ]appear on the carton or 
other outer container or wrapper if the carton, outer container, or wrapper has sufficient space to bear the information; or  
 (b)  appear on a tag otherwise firmly and permanently 
affixed to the non-manufacturer sealed [ packaged ]electronic[ -] NOTICES OF PROPOSED RULES  
26 UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  cigarette substance package or the manufacturer sealed electronic 
cigarette substance package.  
 [(c)](7)  In the case of Subsection [ (5)](6)(a) or (b), the 
carton, outer container, wrapper, or tag will s erve 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 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 cigarette substance marketed as containing nicotine 
and offered f or sale or an industrial hemp product that is a 
manufacturer sealed electronic cigarette 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 or an industrial hemp product that is a manufacturer 
sealed electronic cigarette substance marketed as nicotine-free and  
offered for sale is exempt from the safety warning requirements in 
Subsection (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 proh ibited from selling a[ n] non-
manufacturer sealed electronic[ -] cigarette substance or a 
manufacturer sealed electronic cigarette substance[to the public ] that 
is labeled [ to the public ]as containing:  
 (a)  additives that create the impression that a[ n] non-
manufacturer sealed electronic[ -] cigarette substance or a 
manufacturer sealed electronic cigarette 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 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 substance is compliant with Title 4, Chapter 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 sell ing a[n] non-
manufacturer sealed electronic[ -] cigarette substance or a 
manufacturer sealed electronic cigarette substance to the consumer 
[that]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[and] does not exceed a 24mg/mL concentration of 
nicotine ; and 
 (b)  the nicotine concentration for a manufacturer sealed 
electronic cigarette 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 January 1, 
2022.  
 R384- 415-6.  Packag ing. 
 (1)  The retailer shall ensure that the packaging of a[ n] non-
manufacturer sealed electronic[ -] cigarette substance intended for 
sale to a consumer is certified as child resistant, and compliant with federal standards and law concerning child nicotin e poisoning 
prevention.  
 (2)  The retailer shall sell non -manufacturer sealed 
electronic cigarette substances and manufacturer sealed electronic 
cigarette substances in the product's original packaging.  
 (3)  The retailer shall be prohibited from repackagi ng or 
dispensing any non-manufacturer sealed electronic cigarette 
substance or any manufacturer sealed electronic cigarette substance 
for retail sale.  
 (4)  The retailer shall be prohibited from refilling a 
manufacturer sealed electronic cigarette 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 el ectronic 
cigarette substance is compliant with Title 4, Chapter 41, Part 1, 
Industrial Hemp; and Rule R68- 26. 
 
R384- 415-7.  Product Quality.  
[ When the United States Food and Drug Administration 
instituting its process to approve electronic cigarettes, the  retailer 
shall only sell an electronic -cigarette substance that has been 
approved for regulatory sale by the United States Food and Drug 
Administration through a Pre -Market Tobacco application or 
Substantial Equivalent application. ] 
 (1)  No 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)  Notwithstanding Subsection (3), after September 9, 
2021, no 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).  
 (3)  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 
effect ive date of this section.  
 
R384- 415-8.  Record Keeping and Testing.  
 (1)  The retailer shall provide the non-manufacturer sealed 
electronic[ -] cigarette substance[ s] transaction statement s or 
manufacturer sealed electronic cigarette substance transaction 
statements  to the Department or the local health department within 
14 calendar [five working] days of a request. The retailer shall ensure 
that the transaction statement includes manufacturer certifications that: 
 (a)  the labeling standards are  compliant with Section 
R384- 415-3; 
 [(a)](b)  the nicotine content of a[ n] non-manufacturer 
sealed electronic[ -] cigarette substance is compliant with S ubsection 
R384- 415-5(1)(a) and the nicotine content of a manufacturer sealed 
electronic cigarette subst ance is compliant with Subsection R384 -
415-5(1)(b) ;   NOTICES OF PROPOSED RULES  
UTAH STATE BULLETIN , January 15, 2021, V ol. 2021, No. 02  27  [(b)](c)   the packaging standards are compliant with 
Section R384-415 -6[of an electronic cigarette-substance is child -
resistant ]; and  
 [(c)](d)  the product quality standards are compliant with 
Section R 384-415-7[An electronic cigarette substance that has been 
approved for regulatory sale by the United States Food and Drug 
Administration through a Pre -Market Tobacco application or 
Substantial Equivalent application ]. 
 (2)  The retailer shall provide evide nce that supports the 
documents described in Subsection R384 -415-8(1) to the Department 
or the local health department within 14 calendar [5 working ] 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 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.  
[ (1)  The Department may enforce and seek penalties for the 
violation of public health rules including, the standards for electronic 
cigarettes set forth in this rule as prescribed in Sections 26 -23-1 
through 26 -23-10. 
 (2)  A local health department may enforce and seek 
penalties for the violation of the standards for electronic cigarettes set 
forth in this rule.  A local health department shall have authority to 
enforce and seek penalties for violations of public health law 
including this rule as is found in Sections 26- 23-1 through 26- 23-10, 
26A-1-108, 26A -1-114(1) and 26A -1-123.  
 (3)  The Department or local health department is 
responsible to make a determination as to if a person holding a Utah 
State Tax Commission license to sell electronic cigarettes has 
violated the standards of this rule. If  the Department or local health 
department makes such a determination it shall notify the Utah State 
Tax Commission to revoke the person's license as provided in 
Subsection 59- 14-803(5).  
 (4)  Administrative or civil enforcement of this rule by the 
Departm ent or local health departments does not preclude criminal 
enforcement by a law enforcement agency and prosecution of any 
violation of the standards in this rule that can constitute a criminal 
offense under state law. ] 
 KEY:  electronic cigarettes, nicotin e, standards, Electronic 
Cigarette Regulation Act  
Date of Enactment or Last Substantive Amendment:  [December 
1, 2019 ]2021 
Authorizing, and Implemented or Interpreted Law:  26 -57-103[; 
59-14-803(5) ] 
 
 
NOTICE  OF PROPOSED  RULE  
TYPE  OF RULE:   Amendment   
Utah  Admin.  Code  
Ref (R no.):  R414 -505-6 Filing  No. 
53270  
 Agency  Information  
1.  Department:  Health  
Agency:  Health Care Financing, Coverage and 
Reimbursement Policy  
Building:  Cannon  Health  Building  
Street  address:  288 N 1460  W 
Mailing  address:  PO Box 143102  
City,  state,  zip: Salt Lake  City, UT 84114 -3102  
Contact  person(s):  
Name:  Phone:  Email:  
Craig  
Devashrayee  801-
538-
6641  cdevashrayee@utah.gov  
Please  address  questions  regarding  information  on this 
notice  to the agency.  
 
General  Information  
2.  Rule  or section  catchline : 
R414 -505-6.  Intergovernmental  Transfer  (IGT)  Certification  
 
3.  Purpose  of the new rule or reason  for the change:  
The purpose  of this change  is to implement  a submission  
requirement  for non-state  governmental  entities  (NSGEs)  
to obtain annual  IGT certification.  
 
4.  Summary  of the new rule or change:  
This amendment  includes  a deadline  for NSGEs  to submit  
their annual  IGT certification,  using the annual  IGT 
certification  form.  
 
Fiscal  Information  
5.  Aggregate  anticipated  cost or savings  to: 
A) State  budget:  
There  is no impact  to the state  budget  as this change  only 
specifies  a time requirement  for NSGEs  to obtain  IGT 
certification.   It neither  affects  member  services nor 
provider  reimbursement.  
 
B) Local  governments:  
There  is no impact  on local governments  as this change  
only specifies  a time requirement  for NSGEs  to obtain  IGT 
certification.   It neither  affects  member  services nor 
provider  reimbursement.  
 
C) Small  businesses  ("small  business " means  a business  
employing  1-49 persons) : 
There  is no impact  on small  businesses  as this change  
only specifies  a time requirement  for NSGEs  to obtain  IGT 
certification.   It neither  affects  member  services nor 
provider  reimbursement.