No. 40632 (Amendment): Rule R384-415. Electronic-Cigarette Substance Standards

(Amendment)

DAR File No.: 40632
Filed: 08/02/2016 08:55:41 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The changes are intended to clarify the rule in light of the FDA's Tobacco Control Act Deeming Rule.

Summary of the rule or change:

The majority of the provisions for labeling have been removed from Rule R384-415, including the manufacturer's name, batch number, ingredients, tamper-evident warning, and the nicotine content. The rule's requirement for a safety warning on the label is amended to coincide with the requirements of the FDA Tobacco Control Act Deeming Rule. A separate safety warning specific to nicotine-free products has been added. The amended rule simplifies the restrictions on the retail sale of products that give the impression of a potential health benefit stimulant or are labeled as having colorants for emissions. The requirements limiting the variation of nicotine in a product have been removed. The provisions requiring products to feature tamper-evident packaging have been removed. The requirement that ingredients of electronic-cigarette substances meet certain manufacturing standards have been removed and replaced by a requirement that, by August 2019, the retailers can only sell products approved for sale by the FDA through their pre-market review or substantial equivalent application process. Record-keeping requirements that relate to deleted sections of the rule have been removed. This includes the requirement that retailers have a batch tracing system.

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 State Health Department. The same enforcement apparatus and cost that was used for the original rule will accommodate these amendments. As such, the State Health Department expects to experience no additional costs or savings.

local governments:

Since the State funds these enforcement efforts the amendments to the rule will not change the implementation of enforcement. The same enforcement apparatus and cost that was used for the original rule will accommodate these amendments. As such, no additional costs or savings are anticipated.

small businesses:

The State Health Department anticipates that small businesses will experience reduced costs because of the amendments to the rule. Savings will occur because of amendments that remove the requirement that products must have tamper-evident packaging, leak-resistant packaging, and certain labeling provisions. Also, the retailer will no longer be expected to maintain a batch tracing system. The State Health Department estimates that a Utah e-liquid seller would experience savings of $0 to $73,000 during the first year of enforcement. The Department cannot estimate the savings to the industry as a whole because the number of sellers is unknown. The Department expects that additions to the rule will not increase costs above what was estimated in previous iterations of the rule. It is expected that, because of the rule, a Utah e-liquid seller would experience costs of $10,000 to $450,000 during the first year of enforcement. Costs are most likely to result from lost sales due to non-compliant product. However, the majority of the rule requirements are based on federal regulations that businesses would already be expected to follow. The only exception is that the Utah rule places a restriction on the sale of high nicotine products and those that market themselves as containing healthful additives. The Department cannot estimate the cost to the industry as a whole because the number of sellers 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. However, because the number of small general retailers who sell these products is unknown, the Department cannot estimate the total cost they will incur. The e-liquid seller could also face non-fiscal costs and benefits. The requirement of a safety warning may be perceived as an infringement of free speech. Also, sellers may feel wrongfully deprived of property if a local health department exercises its authority to seize goods it has determined to be a danger to public health. With the amendments to the rule this event is less likely to occur. However, the use of federal regulations in the state rule will decrease any perceived sense of inequality between what is expected in Utah and the regulations of other states.

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 in the price of electronic cigarette products. The Department cannot estimate the total savings to the consumer due to varying circumstances of the individual retailers. However, the amendment to loosen the requirements on labeling and packaging may impose costs on other members of the public. Provisions have been removed from the rule that may have prevented nicotine poisonings. As such, the public may experience medical costs they would not have had if certain labeling and packaging requirements had not been removed. It is difficult to estimate what this cost would be due to a wide range of potential medical circumstances. General retailers may experience some cost through educating staff on the rule or through incurring local enforcement fines. However, because the number of general retailers who sell these products is unknown, the Department cannot estimate the total cost they will incur.

Compliance costs for affected persons:

The department expects that additions to the rule will not increase costs above what was estimated in previous iterations of the rule. Amendments to the rule are based on federal regulations that businesses are expected to follow. The only change in the rule that would cause a business to change its practices would be the amended requirements to the safety warning. Not only is this based on a federal standard, but also the amendment will not cost more than what has been estimated in previous iterations of this rule. The rule retains the restrictions on the sale of high nicotine products and those that market themselves as containing healthful additives. These provisions were present in previous iterations of the rule and will not add a cost to business above what has been estimated before. The majority of amendments remove requirements and thus will reduce the cost to business. As such, the department estimates that a Utah e-liquid seller would experience costs of $10,000 to $450,000 during the first year of compliance. Again, rule amendments have not added to compliance costs. Provisions that already existed in the rule contribute to the provided cost estimate and largely result from lost sales from non-compliance product. It is expected that general retailers will incur little compliance cost because the majority of the products they sell are exempt from the rule. The small portion of general retailers that will come under regulation may experience: 1) a negligible loss in sales; 2) some cost through educating staff; and 3) potential fines through local enforcement.

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

The purpose of the amendment is to bring the rule into conformance with the FDA's Tobacco Control Act Deeming Rule. The majority of the provisions for labeling have been removed since they are now superceded by the Deeming Rule. The amendment simplifies retail sale restrictions and removes any limits addressing variations of nicotine in a product. It also removes the requirements addressing tamper-evident packaging and requirements addressing ingredients of electronic-cigarette substances. It also removes any related record keeping requirements. The amendment will fiscally impact business by decreasing the cost of compliance with the deleted rule requirements.

Joseph 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:

• Janae Duncan at the above address, by phone at 801-538-9273, by FAX at , or by Internet E-mail at [e-mail]

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:

10/03/2016

This rule may become effective on:

10/10/2016

Authorized 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 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) "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 "color 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]1) "Business" means any sole proprietorship, partnership, joint venture, corporation, association, or other entity formed for profit or non-profit purposes.

([5]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).

([6]3) "Department" means the Utah Department of Health.

([7]4) "Electronic-cigarette" means the same as the term is defined in Subsections 26-38-2(1) and 59-14-802(2).

([8]5) "Electronic-cigarette Product" means the same as the term is defined in Subsection 59-14-802(3).

([9]6) "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 the tests that are to be used on medicines, substances, and materials used in their production.

(11) "Generally Recognized As Safe" means an United States Food and Drug Administration designation that a substance added to food 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]7) "Local health department" means the same as the term is defined in Subsection 26A-1-102(5).

([13]8) "Manufacture" means the same as the term is defined in Subsection 26-57-102(5).

([14]9) "Manufacturer" means the same as the term is defined in Subsection 26-57-102(6).

([15]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.

[(16) "Natural flavoring" means the same as the term is defined in 21 C.F.R 101.22(a)(3) (April 1, 2015).]

([17]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).

([18]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.

[(19) "Pharmaceutical" means a compound manufactured for use as a medicinal drug.]

([20]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.

([21]15) "Retailing" means involvement in any of the activities listed in Subsection R384-415-2([20]14). This definition is without regard 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 through 21 C.F.R. 73.1991 (April 1, 2015), 21 C.F.R. 74.101 through 21 C.F.R. 74.1711 (April 1, 2015), and 21 C.F.R. 81.1 (April 1, 2015), and includes 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 an identifying characteristic.]

([24]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.

[(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 and Cosmetics Act, 21 U.S.C. Sec. 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 established by the United States Pharmacopeia and National Formulary. The USP-NF standards include standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, 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 conforms to the following 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 term 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 the 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]3 . Labeling[of Safety Warning].

(1) The retailer shall ensure that [an]nicotine containing electronic-cigarette substance offered for sale to the consumer features on the product package label the required[a] safety warning stating ["nicotine is addictive and poisonous. Keep away from children and pets".]"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."

([2]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) [occupies at least 20 percent of the largest panel of the container and any additional immediate packaging]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 [in ]capitalized [letters]and punctuated as indicated in Subsection (1) or (2) of this Section;

(c) [has a font size that occupies the maximum amount of the area described in Subsection R384-415-6(2)(a)]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 [the]a conspicuous and legible Helvetica, Arial, or [Univers]other san serif font;[and]

(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-[7]5 . Nicotine Content.

[(1) ]The retailer shall [comply with the following nicotine content standards regarding an]sell an electronic-cigarette substance [sold ]to the consumer[:

(a) The nicotine content for an electronic-cigarette substance is]that is limited to 360 mg nicotine per container, and does not exceed a 24mg/mL concentration of nicotine.

[(b) The nicotine level for an electronic-cigarette substance is limited to a 10% variation in mg/mL above the content level indicated on the label.

(c) An electronic-cigarette substance labeled 0 mg/mL or 0% by volume contains no nicotine.]

 

R384-415-[8]6 . 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]7 . 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 presents reduced health risks;

(b) pharmaceuticals;

(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.]

As of August 8, 2019, the retailer shall sell an electronic-cigarette substance that has been approved by the United States Food and Drug Administration through a Pre-Market Tobacco application or Substantial Equivalent application.

 

R384-415-[10]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-[7]5;

(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.]

(c) United States Food and Drug Administration Approval after August 8, 2019.

[(2)(a) The retailer shall have a system in place to trace production of an electronic-cigarette substance through the labeled batch 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 request.

(c) The retailer shall ensure that documents produced through batch tracing provide evidence in support of the electronic-cigarette substances transaction statement.]

(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)[(a)] The retailer shall have access to the documents described in Subsections R384-415-[10]8(1) and R384-415-[10]8(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 the local health department within 5 working days of a request.]

 

R384-415-[11]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: [ April 15, ]2016

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

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