HOME / PUBLICA TIONS / UTAH STA TE BULLETIN / 03/01/2016 CONTENTS / FILE NO. 40210
DAR FILE NO. 40210
This rule was published in the March 1, 2016, issue (Vol. 2016, No. 5) of the Utah State Bulletin.
Health, Disease Control and Prevention, Health Promotion
Electronic-Cigarette Substance Standards
NOTICE OF PROPOSED RULE
(Amendment)
DAR File No.: 40210
Filed: 02/16/2016 10:57:38 AM
RULE ANALYSIS
PURPOSE OF THE RULE OR REASON FOR THE CHANGE:
The amendments are intended to clarify requirements of the rule and also to alleviate some of the fiscal burden the rule could impose on Utah
small businesses.
SUMMARY OF THE RULE OR CHANGE:
Under Section R384-415-10, a provision has been clarified to read that retailers will be expected to have access to the documen ts in that section
for a period of two years after the retailer purchases the electronic-cigarette substance. The required size of the safety warn ing statement has
been reduced from 30 percent of the principle display panel to 20 percent. Also, the maximum allowed nicotine content for these  products have
been increased from 240mg per container to 360mg. However, the maximum nicotine concentration has stayed that same at 24mg/mL. Language
has been added to the provision requiring child resistant packaging on all electronic-cigarette substance containers. The new l anguage makes
reference to any federal standards that might be put into place. This addition has been made to recognize the recently signed " Child Nicotine
Poisoning Prevention Act" at the federal level. Finally, nonsubstantive grammatical changes have been made.
STATE STATUTORY OR CONSTITUTIONAL AUTHORIZATION FOR THIS RULE:
Subsection 59-14-803(5)
Section 26-57-103
ANTICIPATED COST OR SAVINGS TO:
the state budget:
The amendments to the rule will not change the implementation of enforcement by the Utah Department of Health (UDOH). The same enforcement
apparatus and cost that was to be used for the original rule will accommodate these amendments. As such, UDOH expects to experi ence no
additional costs or savings. The original rule anticipated that there would be savings to the state by reducing the number of c alls to the Utah
Poison Control Center. In 2014, there were 131 poison control calls in Utah associated with electronic-cigarette substances. Ea ch of these calls
cost the state approximately $65. However, amendments to the rule that increase the allowed nicotine per container and reduce t he size of the
safety warning statement could reduce the positive effects of this rule. Therefore, compared to original rule, this amendment m ay reduce the
savings to the state due to an increase in poison control calls. However it is difficult to provide a specific amount. Also, be cause the amendments
may increase the number of poisonings (compared to the original rule) there may also be a reduced savings to the Utah Medicaid Program.
Poisonings among Medicaid-covered individuals would increase medical bills. It has been estimated that the medical costs associ ated with a
single poisoning is $15,000 for in-hospital treatment and $3,000 for an emergency room visit. Tho ugh UDOH cannot determine the number of
electronic-cigarette related poisoning among Medicaid patients (and thus the total savings), it is expected that by increasing the allowed nicotine
content and reducing the size of the warning statement that there would be reduced savings to Medicaid. Since the amendments wi ll be made
before enforcement of the rule, there will be no noticeable cost to state agencies and the overall net effect will likely be sa vings. However, the
amended rule does reflect a potential opportunity cost when compared to the original language in the rule. (DAR NOTE: The origi nal proposed new
Rule R384-415 was published in the October 15, 2015, Bulletin under DAR No. 39 797 and is effective as of 12/29/2015.)
local governments:
The amendments to the rule will not change the implementation of enforcement by UDOH. The same enforcement apparatus and cost t hat was to
be used for the original rule will accommodate these amendments. As such, no additional costs or savings are anticipated.
small businesses:
UDOH anticipates that small businesses will experience reduced costs because of the amendments to the rule. Industry representa tives have
estimated that the amended rule will cost small specialty-businesses $12,500 to $1,600,000 during the first year of enforcement  due to either a
loss in sales or required improvements to their operations. However, representatives have also estimated that these amendments have reduced
the cost of compliance by $1,500 to $160,000. UDOH cannot estimate cost or savings to the i ndustry as a whole because the number of small
specialty-businesses is unknown. The wide range in the cost estimate perhaps reflects the large variability in product quality that exists in the
industry. Much of the responsibility to comply with the rule will fall on manufacturers who sell to Utah retailers. Industry re presentatives estimate
that the amended rule will cost a Utah small-manufacturer approximately $15,500 to $266,000 over the first year of enforcement.  However,DAR File No. 40210 (Rule R384-415), 2016-5 Utah Bull. (03/01/2016) http://www.rules.utah.gov/publicat/bulletin/2016/20160301/402 10.ht m
1 of 5 5/4/2016 3:42 P Mrepresentatives also have estimated that the amendments to increase the allowed nicotine content and decrease the size of the s afety warning
statement have reduced the cost to comply by $17,000 to $35,000. UDOH cannot estimate the cost or savings to the industry as a whole
because the number of small manufacturers is unknown. The manufacturer could also face non-fiscal costs. Prescribing manufactur er labeling
requirements may be perceived as an infringement of the manufacturer's freedom of speech. Also, the manufacturer may face a per ceived
infringement on their intellectual property if product information is requested by the enforcing agency. These perceived non-fi scal costs may be
somewhat alleviated by the amendments. The small specialty-retailer will also face costs and savings because of the rule. Indus try
representatives estimate that the amended rule will cost a small specialty-retailer approximately $46,350 to $1,600,000 during the first year of
enforcement due largely to a loss in sales. This cost estimate is based on the assumption that consumers would not purchase an alternative
product if their selection of products was limited. The small specialty-retailer may incur come small costs to educate staff on  compliance with the
rule. It is not possible to predict these costs due to varying circumstances, but to reduce this burden the state and local hea lth department will
provide support. However, representatives also estimate that the amendments allowing for a higher nicotine content and smaller warning
statements have reduced the cost to comply by $1,500 to $160,000. The amendments will allow retailers to keep more of their cur rent products on
the market, hence reducing the potential loss in sales and the potential of local fines. UDOH cannot estimate the cost and savi ngs to the industry
as a whole because the number of small specialty-businesses is unknown. It is expected that small general-retailers will incur little cost through the
enforcement of the rule. General retailers typically sell manufacturer-sealed electronic-cigarette substances, which are exempt  from the rule.
General retailers may experience some cost through educating staff on the rule or through incurring local enforcement fines. Ho wever, because
the number of small general-retailers who sell these products is unknown, UDOH cannot estimate the total cost they will incur.
persons other than small businesses, businesses, or local governmental entities:
These amendments will decrease the cost of compliance to businesses in the state. Those savings can be passed on to consumers i n the price of
electronic cigarette products. UDOH cannot estimate the total savings to the consumer due to varying circumstances of the indiv idual retailers.
However, the amendment to increase the allowed amount of nicotine and decrease the required warning statement may impose costs on other
members of the public. The average medical bill associated with a poisoning is approximately $15,000 for inpatient treatment an d $3,000 in
emergency room fees. The cost of a poisoning in terms of lost productivity is approximately $2,600 per poisoning if the victim is hospitalized. It is
difficult to estimate a population level cost. There is evidence that suggests that electronic-cigarettes among youth may be co nnected to using
traditional tobacco. If this is the case, the amendments of the rule may increase future tobacco-related medical costs. The Cen ters for Disease
Control and Prevention has estimated that in Utah, residents as a whole experience $542,000,000 a nnually because of tobacco products.
General retailers may experience some cost through educating staff on the rule or through incurring local enforcement fines. Ho wever, because
the number of general retailers who sell these products is unknown, UDOH cannot estimate the total cost they will incur.
COMPLIANCE COSTS FOR AFFECTED PERSONS:
UDOH has sought comment from representatives in the electronic-cigarette industry. It is estimated that an individual small-man ufacturer will incur
approximately $15,500 to $266,000 in compliance costs during the first year of rule enforcement. It is expected that the majori ty of these costs
will come from redesigning labels, and sales lost through limiting nicotine content. Therefore, this industry estimate is based  on the assumption that
the consumer would not purchase an alternate product if their selection was restricted. The small-specialty retailer will also incur compliance
costs. It is estimated that a single, small specialty-retailer will need to pay approximately $46,400 to $1,600,000 to comply w ith the rule. It is
expected that the majority of these costs will come from sales lost through not being able to sell products from out-of-state t hat don?t comply with
the rule. However, this industry cost estimate is based on the assumption that the consumer would not purchase an alternate pro duct if their
selection was restricted. It is expected that general retailers will incur little compliance cost because the majority of the p roducts they sell are
exempt from the rule. The small portion of general retailers that will come under regulation may experience: 1) a negligible lo ss in sales; 2) some
cost through educating staff; and 3) potential fines through local enforcement. However, because the number of general retailer s who sell these
products is unknown, UDOH cannot estimate what individual compliance cost they will incur.
COMMENTS BY THE DEPARTMENT HEAD ON THE FISCAL IMPACT THE RULE MAY HAVE ON BUSINESSES:
The proposed amendment clarifies Subsection R384-415-10(a) that retailers will be expected to retain the records required in th at section for two
years after the purchase of the e-cigarette substance. It also reduces the size of the safety warning statement from 30 percent  of the display
panel to 20 percent and increase the maximum allowed nicotine content from 240mg per container to 360mg per container. Business  will see a
positive fiscal impact because the proposed amendment reduces a business's cost of compliance to this rule.
Joseph Miner, MD, Executive Director
THE FULL TEXT OF THIS RULE MAY BE INSPECTED, DURING REGULAR BUSINESS HOURS, AT THE DIVISION OF
ADMINISTRATIVE RULES, OR AT:
Health
Disease Control and Prevention, Health PromotionCANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY , UT 84116-3231
DIRECT QUESTIONS REGARDING THIS RULE TO:
Luke Chalmers at the above address, by phone at 801-538-6260, by FAX at , or by Internet E-mail at tpcprules@utah.gov
INTERESTED PERSONS MAY PRESENT THEIR VIEWS ON THIS RULE BY SUBMITTING WRITTEN COMMENTS TO THE
ADDRESS ABOVE NO LATER THAN 5:00 P.M. ON:
03/31/2016
THIS RULE MAY BECOME EFFECTIVE ON:
04/07/2016DAR File No. 40210 (Rule R384-415), 2016-5 Utah Bull. (03/01/2016) http://www.rules.utah.gov/publicat/bulletin/2016/20160301/402 10.ht m
2 of 5 5/4/2016 3:42 P MAUTHORIZED BY:
Joseph Miner, Executive Director
RULE TEXT
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) This rule establishes standards for labeling, nicotine content, packaging, and product quality for electronic-cigarette sub stances for the
regulation of electronic-cigarettes.
(3) This rule does not apply to a manufacturer-sealed electronic-cigarette substance.(4) A product in compliance with this rule is not endorsed as safe.
R384-415-2. Definitions.
As used in this rule:(1) "Artificial coloring" means the same as the term is defined in 21 C.F.R. 101.22(a)(4) (April 1, 2015) and as the term "colo r additive" is
defined in 21 C.F.R 70.3(f) (April 1, 2015).
(2) "Artificial flavoring" means the same as the term is defined in 21 C.F.R 101.22(a)(1) (April 1, 2015).(3) "Batch number" means the same as the term "lot number, control number, or batch number" is defined in 21 C.F.R. 210.3(b)(11 ) (April 1,
2015).
(4) "Business" means any sole proprietorship, partnership, joint venture, corporation, association, or other entity formed for profit or
non-profit purposes.
(5) "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).
(6) "Department" means the Utah Department of Health.
(7) "Electronic-cigarette" means the same as the term is defined in Subsections 26-38-2(1) and 59-14-802(2).
(8) "Electronic-cigarette Product" means the same as the term is defined in Subsection 59-14-802(3).(9) "Electronic-cigarette substance" means the same as the term is defined in Subsection 59-14-802(4).(10) "EP standards" means the standards established for medicines by the European Pharmacopeia, the European equivalent of the United
States Pharmacopeia. The EP standards define requirements for the qualitative and quantitative composition of medicines, and th e tests that are
to be used on medicines, substances, an d materials used in their production.
(11) "Generally Recognized As Safe" means an United States Food and Drug Administration designation that a substance added to f ood is
generally recognized, by qualified experts, as having been adequately shown to be safe under the conditions of its intended use , as found in 21
C.F.R. 170.30 (April 1, 2015). Such a substance is exempted from the usual Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sec.  301 et sq.
(2013).
(12) "Local health department" means the same as the term is defined in Subsection 26A-1-102(5).(13) "Manufacture" means the same as the term is defined in Subsection 26-57-102(5).
(14) "Manufacturer" means the same as the term is defined in Subsection 26-57-102(6).
(15) "Mg/mL" means milligrams per milliliter, a ratio for measuring an ingredient, in liquid form, where accuracy is measured i n milligrams
per milliliter, or a percentage equivalent.
(16) "Natural flavoring" means the same as the term is defined in 21 C.F.R 101.22(a)(3) (April 1, 2015).(17) "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 ).
(18) "Manufacturer-sealed electronic-cigarette substance" means the same as the term defined is in Subsection 26-57-102(6).
(19) "Pharmaceutical" means a compound manufactured for use as a medicinal drug.(20) "Retailer" means any person who sells, offers for sale, or offers to exchange for any form of consideration, an electronic -cigarette
substance to a consumer. This definition is without regard to the quantity of an electronic-cigarette substance sold, offered f or sale, exchanged, or
offered for exchange.
(21) "Retailing" means involvement in any of the activities listed  in Subsection R384-415-2(20). This definition is without reg ard to the
quantity of an electronic-cigarette substance sold, offered for sale, exchanged, or offered for exchange.
(22) "Straight color" means a color additive approved for human consumption in food and drugs as listed in 21 C.F.R. 73.1 throu gh 21 C.F.R.
73.1991 (April 1, 2015), 21 C.F.R. 74.101 through 21 C.F.R. 74.1 711 (April 1, 2015), and 21 C.F.R. 81.1 (April 1, 2015), and in cludes substances as
are permitted by the specifications for such color.
(23) "Tamper-evident" means the packaging uses an indicator or barrier to entry that is distinctive by design, or must employ a n identifying
characteristic.
(24) "Transaction statement" means a statement, in paper or electronic form, which the manufacturer transferring ownership of t he product
certifies that the electronic-cigarette substance is  in compliance with the standards in this rule.
(25) "USFDA Food Standards" means the United States Food and Drug Administration's common designation for standards of identity ,
standards of quality, and standards of fill of container promulgated under the Federal Food, Drug & Cosmetics Act, 21 U.S.C. Se c. 301 et seq.
(2013)and as contained in 21 C.F.R. 130 through 21 C.F.R. 169 (April 1, 2015).
(26) "USP-NF standards" means the standards for drug products es tablished by the United States Pharmacopeia and National Formul ary.
The USP-NF standards include standards for chemical and biological drug substances, dosage forms, compounded preparations, exci pients,
medical devices, and dietary supplements.
R384-415-3. General Labeling.
(1) The retailer shall ensure that a container holding an electronic-cigarette substance offered for sale to the consumer confo rms to theDAR File No. 40210 (Rule R384-415), 2016-5 Utah Bull. (03/01/2016) http://www.rules.utah.gov/publicat/bulletin/2016/20160301/402 10.ht m
3 of 5 5/4/2016 3:42 P Mfollowing labeling standards:
(a) the label is smear resistant; and
(b) the label clearly displays:
(i) the nicotine content in mg/mL or percent by volume;(ii) the manufacturer name;
(iii) the batch number;
(iv) the ingredients, as required in Section R384-415-4;(v) a tamper-evident warning, which meets the requirements of Section R384-415-5; and(vi) a safety warning, which meets the requirements of Section R384-415-6.
R384-415-4. Labeling of Ingredients.
(1) The retailer shall ensure that:
(a) an ingredient of an electronic-cigarette substance is listed on the label of the container holding an electronic-cigarette substance, except as
provided for in Subsection R384-415-4(1)(c)(i).
(b) An artificial coloring ingredient is listed on the label using the classification system that best applies. Classification systems include:
(i) Food, Drug, and Cosmetic color designation and number;
(ii) Drug and Cosmetic color designation and number; or(iii) the generic straight color name, if the artificial color is not classified under the systems found in Subsection R384-415 -4(1)(b)(i) or
Subsection R384-415-4(1)(b)(ii).
(c)(i) An ingredient included in the manufacturer's proprietary mixture of flavorings is exempt from being listed on the label by name.
(ii) An ingredient included in the manufacturer's proprietary mixture of flavorings is listed on the label under the generic te rm of artificial
flavoring, natural flavoring, or both.
R384-415-5. Labeling of Tamper-Evident Warning.
(1) The retailer shall ensure that the label of an electronic-cigarette substance displays a tamper-evident warning alerting th e consumer to the
tamper-evident feature of the packaging
(2) The retailer shall ensure that the tamper-evident warning:(a) is prominently displayed to consumers;(b) is placed on the label so that it would be unaffected if the tamper-evidence feature is removed; and
(c) lists the type of tamper-evident feature used with the product.
R384-415-6. Labeling of Safety Warning.
(1) The retailer shall ensure that an electronic-cigarette substance offered for sale to the consumer features a safety warning  stating "nicotine
is addictive and poisonous. Keep away from children and pets".
(2) The retailer shall ensure that the safety warning:
(a) occupies at least [ 30
]20percent of the largest panel of the container and any additional immediate packaging;
(b) is in capitalized letters;(c) has a font size that occupies the maximum amount of the area described in Subsection R384-415-6(2)(a);
(d) uses the Helvetica, Arial, or Univers font; and
(e) uses either a black font on a white background or a white font on a black background.
R384-415-7. Nicotine Content.
(1) The retailer shall comply with the following nicotine content standards regarding an electronic-cigarette substance sold to  the consumer:
(a) The nicotine content for an electronic-cigarette substance is limited to [ 240
]360 mg per container, and does not exceed a 24mg/mL
concentration.
(b) The nicotine level for an electronic-cigarette substance is limited to a 10% variation in mg/mL above the content level ind icated on the
label.
(c) An electronic-cigarette substance labeled 0 mg/mL or 0% by volume contains no nicotine.
R384-415-8. Packaging.
(1) The retailer shall ensure that the packaging of an electronic-cigarette substance intended for sale to a consumer;
(a) is certified as child resistant , and compliant with federal standards and law concerning child nicotine poisoning prevention ;
(b) does not leak at the time of sale; and
(c) utilizes a tamper-evident feature by means of one or more of the following:
(i) a bubble pack;(ii) a heat shrink band;(iii) a breakable cap; or
(iv) an inner-seal.
R384-415-9. Product Quality.
(1) The retailer shall ensure that an ingredient in an electronic-cigarette substance is compliant with either USP-NF standards , EP standards,
USFDA Food Standards, or is Generally Recognized As Safe at the time of sale.
(2) The retailer shall be prohibited from selling an electronic-cigarette substance that contains:
(a) vitamins or other additives that create the impression that an electronic-cigarette substance has a health benefit or prese nts reduced health
risks;DAR File No. 40210 (Rule R384-415), 2016-5 Utah Bull. (03/01/2016) http://www.rules.utah.gov/publicat/bulletin/2016/20160301/402 10.ht m
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(c) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality;
(d) illegal or controlled substances as identified in Section 58-37-3; and
(e) additives having coloring properties for emissions.
R384-415-10. Record Keeping and Testing.
(1) The retailer shall provide the electronic-cigarette substances transaction statement to the [ department ]Department  or the local health
department within five working days of a request. The retailer shall ensure that the transaction statement includes manufacture r certifications
that:
(a) the nicotine content of an electronic-cigarette substance is compliant with Section R384-415-7;
(b) the packaging of an electronic cigarette-substance is child-resistant; and
(c) an ingredient used in an electronic-cigarette substance meets the appropriate standard found in Section R384-415-9.(2)(a) The retailer shall have a system in place to trace production of an electronic-cigarette substance through the labeled b atch number to
the ingredients used in manufacturing.
(b) The retailer shall provide documents produced from batch tracing to the enforcing agency within five working days of a requ est.
(c) The retailer shall ensure that documents produced through batch tracing provide evidence in support of the electronic-cigar ette substances
transaction statement.
(3) 
(a) The retailer shall [ maintain ]have access to  the documents described in Subsections R384-415-10(1) and R384-415-10(2) for a period of
two years after the retailer purchases the electronic-cigarette substance.
(b) the retailer shall provide the documents described in Subsections R384-415-10(1) and R384-415-10-(2) to the Department or t he local
health department within 5 working days of a request.
R384-415-11. Enforcement.
(1) The [ department ]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 fo r the violation of the standards for electronic cigarettes set f orth in this rule. A
local health department shall have authority to enforce and seek penalties for violations of public health law including this r ule 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 ]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 ]Department  or local health department
makes such a determination it shall notify the Utah State Tax Co mmission to revoke the person's license as provided in Subsecti on 59-14-803(5).
(4) Administrative or civil enforcement of this rule by the [ department ]Department  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 cr iminal offense
under state law.
KEY: electronic cigarettes, nicotine, standards, Electronic Cigarette Regulation Act
Date of Last Substantive Amendment: [ December 29, 2015 ]2016
Authorizing, and Implemented of Interpreted Law: 26-57-103; 59-14-803(5)
ADDITIONAL INFORMATION
More information about a Notice of Proposed Rule  is available online .
The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at
http://www.rules.utah.gov/publicat/bull-pdf/2016/b20160301.pdf . The HTML edition of the Bulletin is a convenience copy. Any discrepancy between
the PDF version and HTML version is resolved in favor of the PDF version.
Text to be deleted is struck through and surrounded by brackets ([ example ]). Text to be added is underlined ( example ).  Older browsers may not
depict some or any of these attributes on the screen or when the document is printed.
For questions regarding the content  or application  of this rule, please contact Luke Chalmers at the above address, by phone at 801-538-6260, by
FAX at , or by Internet E-mail at tpcprules@utah.gov.  For questions about the rulemaking process , please contact  the Division of Administrative
Rules.
Home  / Publications  / Utah State Bulletin  / 03/01/2016 Contents  / File No. 40210DAR File No. 40210 (Rule R384-415), 2016-5 Utah Bull. (03/01/2016) http://www.rules.utah.gov/publicat/bulletin/2016/20160301/402 10.ht m
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