DAR File No. 44113

Health, Disease Control and Prevention, Health Promotion

Rule R384-418

Electronic-Cigarette Mandatory Warning Signage and Sale Restrictions

Notice of 120-Day (Emergency) Rule

DAR File No.: 44113
Filed: 10/01/2019 08:11:12 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

Cases of vaping-related lung/pneumonitis injury initially spiked during the end of July 2019 and beginning of August 2019, both in Utah and nationally. As of 9/27/2019, nationally there have been 805 confirmed and probable cases of severe lung/pneumonitis injuries due to vaping in 46 states and 1 US territory. Nationally there have been 12 confirmed deaths in 10 states (California (2), Florida, Georgia, Illinois, Indiana, Kansas (2), Minnesota, Mississippi, Missouri and Oregon). Of those 46 states and 1 US territory, Utah is experiencing the highest number of cases per capita. In Utah, as of 9/30/2019, a total of 81 reports of potential illness have been received by the Utah Department of Health (UDOH) and local health departments, of which 71 are confirmed or probable cases of severe lung/pneumonitis injuries due to vaping, and 10 of the reports are under review. The purpose of this rule is to protect the immediate health, safety, and welfare of Utah youth and adults. UDOH has consistently received reports of approximately 10 new cases per week since August 2019. The lower case counts in September, both in Utah and nationally, are attributed to a reporting lag rather than an actual downturn in cases. UDOH plans to continue active surveillance of the vaping-related lung/pneumonitis injury outbreak by counting and classifying cases, as well as identifying exposures, not knowing how long the caseload will continue in the coming weeks or months.

Summary of the rule or change:

The emergency rule continues to allow Utah tobacco retailers to sell electronic-cigarette products and electronic-cigarette substances. However, as a condition to selling any electronic-cigarette products, this rule requires all tobacco retailers to display mandatory warning signs that warn consumers not to vape unregulated tetrahydrocannabinol (THC) obtained from the black market. This mandatory warning signage is effective direct prevention communication to tobacco consumers. Utah tobacco consumers cannot legally purchase electronic-cigarette products online and so they must purchase these products at physical tobacco retailers. Only tobacco retailers displaying the mandatory warning signs will be allowed to sell electronic-cigarette products and electronic-cigarette substances in Utah. In addition, this emergency rule restricts the sale of all flavored electronic-cigarette substances (both manufacturer sealed and non-manufacturer sealed electronic-cigarette substances) to existing age-restricted retail tobacco specialty businesses, which are tobacco retailers that must abide by stricter state regulations, including zoning proximity requirements. General tobacco retailers do not rely on electronic-cigarette products to maintain their business operations, and therefore, are not required to abide by these stricter standards. General tobacco retailers will be allowed to continue to sell non-flavored electronic-cigarette substances (both manufacturer sealed and non-manufacturer sealed electronic-cigarette substances). The sale of THC electronic-cigarette products and THC electronic-cigarette substances is illegal in the state of Utah unless the sale is made in compliance with Title 26, Chapter 61a, Utah Medical Cannabis Act, or Title 4, Chapter 41A, the Cannabis Production Establishments.

Emergency rule reason and justification:

Regular rulemaking procedures would cause an imminent peril to the public health, safety, or welfare.

Justification: Ongoing investigatory findings, both by the Centers for Disease Control and Prevention (CDC) nationally, and UDOH in Utah, related to the outbreak of cases of severe lung/pneumonitis injuries due to vaping have identified that patients are using unregulated electronic-cigarette products to vape THC obtained from the black market. Neither the national nor the Utah-specific investigation has identified any specific electronic-cigarette product, vaping product (devices, liquids, refill pods, and/or cartridges), substance that is linked to all cases. The majority of patients experiencing severe lung/pneumonitis injuries due to vaping both nationally (77%) and in Utah (94%; n=36 patients) self-reported using electronic-cigarette products to vape THC cartridges. Utah Public Health Laboratory testing of Utah case-associated THC electronic-cigarette substances identify that 89% of THC samples contain Vitamin E acetate. Some Utah patients also self-reported using electronic-cigarette products to vape nicotine substances (64%; n=36 patients). Pulmonologists treating the patients experiencing severe lung/pneumonitis injuries associated with vaping have stated the patients' medical imaging shows acute damage to their lungs. It is unknown what future medical costs these individuals will incur over the rest of their lives. In Utah, 14% of cases are between the ages of 10-19, 47% of these cases are between the ages of 20-29 and 31% of these cases are between the ages of 30-39 (n=71 patients).

Statutory or constitutional authorization for this rule:

• Subsection 26-1-30(4)

Anticipated cost or savings to:

the state budget:

UDOH plans to create and distribute the required mandatory warning signs electronically through a digital download, and by mail or through local health departments using existing allocated resources.

local governments:

Local health departments will continue to conduct permitting and compliance checks at tobacco retailers and use existing allocated resources to enforce this emergency rule.

small businesses:

Emergency Rule R384-418 may result in a direct cost or benefit to businesses. The costs or benefits to businesses are unquantifiable and depend on the business designation and whether the business chooses to display the mandatory warning signs. Approximately 50% of Utah tobacco retailers are considered small businesses. Twenty percent (20%) of these small businesses (or approximately 170 retailers) are designated as age-restricted retail tobacco specialty businesses. As long as these retail tobacco specialty businesses display the mandatory warning signs, these businesses will be allowed to continue to sell flavored electronic-cigarette products and flavored electronic-cigarette substances. The small businesses designated as general tobacco retailers do not primarily rely on electronic-cigarette products to maintain their business operations. General tobacco retailers will no longer be allowed to sell flavored electronic-cigarette products and flavored electronic-cigarette substances. General tobacco retailers can continue to sell non-flavored electronic-cigarette products and non-flavored electronic-cigarette substances upon the condition they display the mandatory warning signs.

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

Emergency Rule R384-418 may result in a direct cost or benefit to persons. The costs or benefits to persons are unquantifiable and depend on whether they consume flavored electronic-cigarette or electronic-cigarette substances at retail tobacco specialty businesses that display the mandatory warning signs. These individuals will now only be able to purchase these products at retail tobacco specialty businesses. These individuals may continue to purchase non-flavored electronic-cigarette products and non-flavored electronic-cigarette substances at general tobacco retailers that display the mandatory warning signs.

Compliance costs for affected persons:

UDOH plans to create and distribute the required mandatory warning signs electronically through a digital download and by mail or through local health departments to both general tobacco retailers and retail tobacco specialty businesses; these businesses do not have to pay for these required warning signs, unless individual retail tobacco retailers choose to create and use their own warning signs in accordance with this rule's guidelines. General tobacco retailers will no longer be able to sell flavored electronic-cigarette products and flavored electronic-cigarette substance during the time frame that this emergency rule is in effect. Some of the non-small businesses classified as general tobacco retailers may choose to redistribute these flavored electronic-cigarette products and flavored electronic-cigarette substance products to other retail locations outside of Utah.

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

The current public health emergency regarding lung injuries which are associated with the use of electronic-cigarettes outweighs any negative fiscal impact on general tobacco retailers.

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 [email protected]

This rule is effective on:

10/01/2019

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 business tobacco retailers operating in Utah under the NAICS codes of 453991 and 424940. These businesses may experience a direct cost or benefit because of this emergency rule. The cost or benefit to businesses are unquantifiable and depend on whether the business chooses to display the mandatory warning signs. In addition, the cost or benefit to these businesses depend on whether they can or cannot sell flavored electronic-cigarette products and flavored electronic-cigarette substances. All tobacco retailers will be allowed to continue to sell non-flavored electronic-cigarette products and non-flavored electronic-cigarette substances; upon the condition the retailers display the mandatory warning signs.

 

The majority of these non-small businesses are designated as general tobacco retailers that do not rely on electronic-cigarette products to maintain their business operations. General tobacco retailers will no longer be allowed to sell flavored electronic-cigarette products and flavored electronic-cigarette substances. General tobacco retailers can continue to sell non-flavored electronic-cigarette products and non-flavored electronic-cigarette substances upon the condition they display the mandatory warning signs.

 

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

 

 

R384. Disease Control and Prevention, Health Promotion.

R384-418. Electronic-Cigarette Mandatory Warning Signage and Sale Restrictions.

R384-418-1. Authority and Purpose.

(1) This rule is authorized by Section 26-1-30(4).

(2) The purpose of this rule is to protect health, safety and welfare of the Utah youth, by requiring mandatory warning signs that warn consumers not to use electronic-cigarette products to consume unregulated t etrahydrocannabinol (THC) substances and by restricting the sale of flavored electronic-cigarette products and electronic-cigarette substances in retail tobacco specialty businesses.

 

R384-418-2. 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) "Department" means the Utah Department of Health.

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

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

(5) "General tobacco retailer" means a tobacco retailer that is not a retail tobacco specialty business.

(6) "Flavored electronic-cigarette product" means an electronic-cigarette product that has a taste or a smell distinguishable by an ordinary consumer either before or during use or consumption of the electronic-cigarette product, including but not limited to a taste or smell of any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb, spice, menthol or mint.

(7) "Flavored electronic-cigarette substance" means an electronic-cigarette substance that has a taste or a smell distinguishable by an ordinary consumer either before or during use or consumption of the electronic-cigarette product, including but not limited to a taste or smell of any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb, spice, menthol or mint.

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

(9) "Non-flavored electronic-cigarette substance" means an electronic-cigarette substance that has a taste or a smell of tobacco that is distinguishable by an ordinary consumer either before or during use or consumption of the electronic-cigarette product.

(10) "Public retail floor space" means the total floor square feet of the business where a customer can see, retrieve, or purchase any item that is offered for sale by the general tobacco retailer, including all areas behind the purchase counter, and including appurtenant areas used for storage.

(11) "Retail tobacco specialty business" means a commercial establishment in which:

(a) The sale of tobacco products accounts for more than 35% of the total quarterly gross receipts for the establishment;

(b) 20% or more of the public retail floor space is allocated to the offer, display, or storage of tobacco products;

(c) 20% or more of the total shelf space is allocated to the offer, display, or storage of tobacco products;

(d) The retail space features a self-service display for tobacco products; or

(e) Any flavored electronic-cigarette product is sold.

(12) "Self-service display" means the same as that term is defined in Section 76-10-105.1.

(13) "Shelf space" means the total cubic feet (length x depth x height) of shelf space contained within the retail space that is used for the offer, display, or storage of items for sale by the tobacco retailer. The shelf height is measured from the top of the tallest item on the top of the shelf. The shelf length is measured from the end of the longest item at the end of the shelf. Empty shelf space is not included in the total shelf space calculation.

(14) "Tetrahydrocannabinol" (THC) means the same as that term defined in Subsection 58-37-4(2)(a)(iii)(AA).

(15) "Tobacco product" means the same as that term is defined in Section 59-14-102.

(16) "Tobacco retail permit" means the permit issued by the local health department to general tobacco retailers and retail tobacco specialty businesses for the sale, marketing, or distribution of tobacco products.

 

R384-418-3. Responsibility for Compliance.

(1) Each business that must comply with this rule is independently responsible to assure compliance and each may be held liable for noncompliance.

(2) General tobacco retailers and retail tobacco specialty businesses shall not endorse or represent an electronic-cigarette product as safe.

(3) General tobacco retailers and retail tobacco specialty businesses shall comply with the mandatory warning signs required by this rule within 6 calendar days after the effective date of this rule or by Monday October 7, 2019, whichever is later.

(4) General tobacco retailers shall comply with the prohibited sale of flavored electronic-cigarette products requirements of this rule within 6 calendar days after the effective date of this rule or by Monday October 7, 2019, whichever is later.

 

R384-418-4. Mandatory Warning Signs.

(1) As a condition to sell electronic-cigarette products, general tobacco retailers and retail tobacco specialty businesses shall display a mandatory warning sign, warning consumers not to use electronic-cigarette products to consume unregulated THC electronic-cigarette substances.

(2) Mandatory warning signs shall be posted at all entrances or in a position clearly visible on entry into the retail location and at each register inside the retailer location where the electronic-cigarette product transaction or sale occurs.

(3) Mandatory warning signs will be created by the Department. Local health departments may distribute the mandatory warning signs for general tobacco retailers and retail tobacco specialty businesses upon request. Retailers may use the Department issued mandatory warning signs or display a warning sign that complies with the signage requirements in this rule.

(4) Mandatory warning signs required in this section must be easily readable and must not be obscured in any way. The mandatory warning sign must state "Vaping unregulated THC is dangerous to your health. A lung disease related to vaping unregulated THC has recently hospitalized dozens of Utahns and caused several deaths nationwide." The words "Vaping unregulated THC is dangerous to your health" must be no less than 0.75 inches in height and the words "A lung disease related to vaping unregulated THC has recently hospitalized dozens of Utahns and caused several deaths nationwide" must be no less than 0.25 inches in height.

 

R384-418-5. Allowed and Prohibited Sale of Flavored Electronic-Cigarette Products.

(1) Only retail tobacco specialty businesses with a valid retail tobacco specialty permit issued by a local health department may sell flavored electronic-cigarette products and flavored electronic-cigarette substances.

(2) General tobacco retailers shall not sell flavored electronic-cigarette products or flavored electronic-cigarette substances.

(3) General tobacco retailers may sell non-flavored electronic-cigarette products and non-flavored electronic-cigarette substances.

(4) The sale of THC electronic-cigarette products and THC electronic-cigarette substances is illegal in the State of Utah unless the sale is made in compliance with Title 26, Chapter 61a, Utah Medical Cannabis Act, or Title 4, Chapter 41a, Cannabis Production Establishments.

 

R384-418-6. Local Authority to Promulgate Laws.

Nothing in this rule shall be construed to limit local health departments or other local governmental entities with authority, from promulgating ordinances and laws that are in addition to or stricter than this rule so long as such laws do not conflict with or impede the provisions of this rule.

 

R384-418-7. Enforcement.

(1) The Department may enforce and seek penalties for the violation of 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, Sections 26-62-301, 26A-1-108, 26A-1-114(1) and 26A-1-123.

(3) 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-cigarette products, electronic-cigarettes substances, general tobacco retailers, retail tobacco specialty businesses

Date of Enactment or Last Substantive Amendment: October 1, 2019

Authorizing, and Implemented or Interpreted Law: 26-1-30