DAR File No. 44114

Health, Disease Control and Prevention, Health Promotion

Rule R384-415

Electronic-Cigarette Substance Standards

Notice of Proposed Rule

(Amendment)

DAR File No.: 44114
Filed: 10/01/2019 08:22:13 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

Outdated dates in Sections R384-415-7 and R384-415-8 that reference requirements for tobacco retailers to comply with as of 08/08/2019 that need to align better with the FDA's changed timeline on regulating electronic cigarettes. When this rule was originally written, the FDA published timeline to approve electronic cigarette substance standards was planned to be on or before 08/08/2019. However the FDA's original timeline was delayed until August 2022 and then changed to May 2021 by court ruling. This timeline could change again. As a result, this administrative rule is out of date and should be updated so it no longer states a specific date in both Sections R384-415-7 and R384-415-8.

Summary of the rule or change:

In Section R384-415-7, the change modifies the date language and adds language that will better align with the FDA's electronic cigarette pre-market product process which has changed multiple times and is not a set date and eliminating the 08/08/2019 date from this administrative rule. In Section R384-415-8, the change modifies the date language for consistency in Subsection R384-415-8(1)(c) and instead adds language that will better align with the FDA's electronic cigarette pre-market product process which has changed multiple times and is not a set date and eliminating the 08/08/2019 date from this administrative rule.

Statutory or constitutional authorization for this rule:

• Section 26-57-103

Anticipated cost or savings to:

the state budget:

These proposed rule changes are not expected to have any fiscal impact on the state budget because these changes do not affect the implementation of this rule; they simply clarify the process.

local governments:

These proposed rule changes are not expected to have any fiscal impact on local governments because these changes do not affect the implementation of this rule; they simply clarify the process.

small businesses:

These proposed rule changes are not expected to have any fiscal impact on small businesses because these changes do not affect the implementation of this rule; they simply clarify the process.

persons other than small businesses, businesses, or local governmental entities:

These proposed rule changes are not expected to have any fiscal impact on other persons because these changes do not affect the implementation of this rule; they simply clarify the process.

Compliance costs for affected persons:

There are no potential costs for updating this rule because these changes do not affect the implementation of this rule; they simply clarify the process.

Comments by the department head on the fiscal impact the rule may have on businesses:

There is no fiscal impact on businesses because these rule changes do not change requirements for businesses.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Health Promotion
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Heather Borski at the above address, by phone at 801-538-9998, by FAX at 801-538-9495, or by Internet E-mail at hborski@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:

11/14/2019

Interested persons may attend a public hearing regarding this rule:

• 11/07/2019 01:00 PM, UDOH Cannon Building, 288 N 1460 W, Room 125, Salt Lake City, UT

This rule may become effective on:

11/22/2019

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2020	FY 2021	FY 2022
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$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

 

*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 for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

As of January 1, 2019, according to the Utah Department of Health's (UDOH) combined local health department tobacco retail compliance check logs, there are approximately 835 non-small businesses tobacco retailers operating in Utah under the NAICS codes of 453991 and 424940. These businesses will likely not experience a direct cost or benefit because these rule changes will allow them to continue to sell non-manufacturer sealed electronic cigarette substances until the United States Food and Drug Administration (FDA) institutes its process to regulate standards for electronic cigarette substances.

 

The head of the Department of Health, Joseph Miner, MD, has reviewed and approved this fiscal analysis.

 

 

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 substances 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) "Business" means any sole proprietorship, partnership, joint venture, corporation, association, or other entity formed for profit or non-profit purposes.

(2) "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) "Department" means the Utah Department of Health.

(4) "Electronic-cigarette" means the same as the term is defined in Subsections 26-38-2(1) and 59-14-802(2).

(5) "Electronic-cigarette Product" means the same as the term is defined in Subsection 59-14-802(3).

(6) "Electronic-cigarette substance" means the same as the term is defined in Subsection 59-14-802(4).

(7) "Local health department" means the same as the term is defined in Subsection 26A-1-102(5).

(8) "Manufacture" means the same as the term is defined in Subsection 26-57-102(5).

(9) "Manufacturer" means the same as the term is defined in Subsection 26-57-102(6).

(10) "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.

(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) "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 is offered for sale, sold, or otherwise distributed to consumers.

(14) "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 for sale, exchanged, or offered for exchange.

(15) "Retailing" means involvement 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) "Transaction statement" means a statement, in paper or electronic form, which the manufacturer transferring ownership of the product certifies that the electronic-cigarette substance is in compliance with the standards in this rule.

 

R384-415-3. Labeling.

(1) The retailer shall ensure that nicotine containing 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) The retailer shall ensure that an 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."

(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 least 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 either 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 information on the principal display panel have the same orientation.

(4) A retailer of an electronic-cigarette substance will not be in violation of this Section when packaging:

(a) contains a health warning;

(b) is supplied to the retailer by a 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.

(5) An electronic-cigarette substance package that would be required to bear the warning in Subsection (1) or (2) of this Section but is too small or otherwise unable to accommodate a warning label with sufficient space to bear such information is exempt from compliance with the requirement provided:

(a) the information and specifications required in Subsection (1) and (2) 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 firmly and permanently affixed to the packaged electronic-cigarette substance.

(c) In the case of Subsection (5)(a) or (b), the carton, outer container, wrapper, or tag will serve as the location of the principal display panels.

 

R384-415-4. Prohibited Sales.

(1) The retailer shall be prohibited from selling an electronic-cigarette substance to the public that is labeled to the public as containing:

(a) additives that create the impression that an 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.

 

R384-415-5. Nicotine Content.

The retailer shall sell an electronic-cigarette substance to the consumer that is limited to 360 mg nicotine per container, and does not exceed a 24mg/mL concentration of nicotine.

 

R384-415-6. Packaging.

The retailer shall ensure that the packaging of an electronic-cigarette substance intended for sale to a consumer is certified as child resistant, and compliant with federal standards and law concerning child nicotine poisoning prevention.

 

R384-415-7. Product Quality.

[As of August 8, 2019,]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.

 

R384-415-8. Record Keeping and Testing.

(1) The retailer shall provide the electronic-cigarette substances transaction statement to the Department or the local health department within five working days of a request. The retailer shall ensure that the transaction statement includes manufacturer certifications that:

(a) the nicotine content of an electronic-cigarette substance is compliant with Section R384-415-5;

(b) the packaging of an electronic cigarette-substance is child-resistant; and

(c) [United States Food and Drug Administration Approval after August 8, 2019.]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 evidence that supports the documents described in Subsection R384-415-8(1) to the Department or the local health department within 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 electronic-cigarette substance.

 

R384-415-9. 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 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 criminal offense under state law.

 

KEY: electronic cigarettes, nicotine, standards, Electronic Cigarette Regulation Act

Date of Enactment or Last Substantive Amendment: [December 29, 2016]2019

Authorizing, and Implemented or Interpreted Law: 26-57-103; 59-14-803(5)