Licensing of Electronic Nicotine-Delivery System Distributors and Dealers (216-RICR-50-15-6)
216-RICR-50-15-6 INACTIVE RULE EMERGENCY RULE
These Rules and Regulations for Licensing of Electronic Nicotine-Delivery System Distributors and Dealers are promulgated pursuant to the authority set forth in R.I. Gen. Laws §§ 23-1-1, 23-1-55 through 23-1-58 for the purpose of establishing the requirements for licensure of electronic nicotine-delivery system distributors and dealers.
A. Wherever used inthis Part, the following terms shall be construed as follows:
1. “Act” means R.I. Gen Laws §§ 23-1-55 through 23-1-58.
2. "Characterizing flavor" means a distinguishable taste or aroma imparted either prior to, or during, consumption of an electronic nicotine-delivery system product or component part thereof, including, but not limited to, tastes or aromas relating to any fruit, mint, menthol, wintergreen, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice. The determination of whether an electronic nicotine-delivery system product has a characterizing flavor shall not be based solely on the use of additives, flavorings, or particular ingredients, but shall instead consider all aspects of a final product including, but not limited to, taste, flavor and aroma, product labeling, and advertising statements. A flavor shall be presumed to be a characterizing flavor if a dealer or distributor has made a statement or claim directed to consumers or the public about such flavor, whether expressed or implied, that it has a distinguishable taste or aroma (other than the taste or aroma of tobacco).
3. "Dealer" means any person, whether located within or outside of the State of Rhode Island, who sells or distributes electronic nicotine-delivery system products to a consumer in the State of Rhode Island.
4. “Department” means the Rhode Island Department of Health.
5. "Director" means the Director of the Rhode Island Department of Health or his or her designee.
6. "Distributor" means any person:
a. Whether located within or outside of the State of Rhode Island, other than a dealer, who sells or distributes electronic nicotine-delivery system products within or into the State of Rhode Island. Such term shall not include any electronic nicotine-delivery system products manufacturer, export warehouse proprietor, or importer with a valid permit, if such person sells or distributes electronic nicotine-delivery system products in the State of Rhode Island only to licensed distributors, or to an export warehouse proprietor or another manufacturer with a valid permit;
b. Selling electronic nicotine-delivery system products directly to consumers in the State of Rhode Island by means of at least twenty-five (25) electronic nicotine-delivery system product vending machines;
c. Engaged in the State of Rhode Island in the business of manufacturing electronic nicotine-delivery system products or any person engaged in the business of selling electronic nicotine-delivery system products to dealers, or to other persons, for the purpose of resale only; provided that seventy-five percent (75%) of all electronic nicotine-delivery system products sold by that person in the State of Rhode Island are sold to dealers or other persons for resale and selling electronic nicotine- delivery system products directly to at least forty (40) dealers or other persons for resale; or
d. Maintaining one or more regular places of business in the State of Rhode Island for that purpose; provided, that seventy-five percent (75%) of the sold electronic nicotine delivery system products are purchased directly from the manufacturer and selling electronic nicotine-delivery system products directly to at least forty (40) dealers or other persons for resale.
7. "Electronic nicotine-delivery system" means an electronic device that may be used to simulate smoking in the delivery of nicotine or other substance to a person inhaling from the device, and includes, but is not limited to, an electronic cigarette, electronic cigar, electronic cigarillo, electronic pipe or electronic hookah and any related device and any cartridge or other component of such device.
8. "Flavored electronic nicotine-delivery system” means any electronic nicotine-delivery system that imparts a characterizing flavor.
6.3 Licensing Requirements and Use of Licensed Entities
A person engaging in business that relates to electronic nicotine-delivery system products in the State of Rhode Island, as set forth in this Part and including any distributor or dealer, shall annually secure a license in accordance with the requirements of R.I. Gen. Laws § 23-1-56 and this Part from the Department before engaging in that business, or continuing to engage in it.
6.4 Eligibility for Licensing
Eligibility of licensees shall be in accordance with R.I. Gen. Laws § 23-1-56(f).
6.5 Application for Licensure and Fee
A. Application for Licensure. Application for licensure shall be made on forms furnished by the Department, which shall be completed, notarized and submitted to the Department.
B. Categories of Licensure.
1. An application for a license to engage in business that relates to electronic nicotine-delivery system products in the State of Rhode Island, as set forth in this Part, shall be submitted for each applicable category of business:
a. Distributor (including manufacturer and importer); or
b. Dealer (retail and vending machine)
2. Each category of business, dealer location and vending machine for electronic nicotine-delivery systems shall require a separate application.
C. Fee.The application fee (not refundable and non-returnable) as set forth in the rules and regulations pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health Part 10-05-2 of this Title) shall accompany the application for registration. Applications received without the required application fee shall be returned to the applicant.
D. Self-certifications. An application for licensure to engage in business that relates to electronic nicotine-delivery system products in the State of Rhode Island, as set forth in this Part, shall include a self-certification as set forth in § 6.9(B) of this Part.
6.6 Issuance of License
A. A license to engage in business that relates to electronic nicotine-delivery system products in the State of Rhode Island, as set forth in this Part, may be issued to an applicant who meets the relevant requirements for licensure as required by the Act and this Part.
B. A dealer’s license shall be issued to a specific licensee for a specific location and shall not be transferable. Each issued license shall be prominently displayed on the premises, if any, covered by the license.
C. If the applicant for a license does not have a place of business in the State of Rhode Island, the license shall be issued for such applicant's principal place of business, wherever located.
6.7 Required Notification to the Department
A licensee must notify the Department, in writing, within thirty (30) days in the event that it changes its principal place of business.
6.8 Expiration Renewal, and Failure to Renew
A. Expiration. The license of every person licensed pursuant to provisions of the Act and this Part shall expire on the thirty-first (31st) day of January of the following year
1. Every licensed person who desires to renew his or her license shall file with the Department, on or before the thirty-first (31st) day of January in each year, an executed renewal application together with a renewal fee as set forth in the rules and regulations Pertaining to the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title) and a self-certification as set forth in § 6.9(B) of this Part. New business licenses are issued throughout the year.
2. Upon receipt of a renewal application and payment of the renewal fee, the accuracy of the application shall be verified and the Department may grant a renewal license effective on the first (1st) day of February and expiring on the thirty-first (31st) day of January of the following year.
C. Failure to Renew. Failure to renew a license on or before the thirty-first (31st) day of January in each year, as required by this Part, shall result in the business becoming an unlicensed business, and subject to the penalties described in § 6.9 of this Part.
6.9 Prohibition on the Sale of Flavored Electronic Nicotine-Delivery System Products
A. The manufacture, distribution, sale, or offer for sale of, or the possession with intent to manufacture, distribute, sell, or offer for sale flavored electronic nicotine-delivery system products to consumers is hereby prohibited in the State of Rhode Island. Compassion centers and licensed cultivators registered with the State of Rhode Island under R.I. Gen. Laws Chapter 21-28.6 are exempt from this provision.
B. Dealers and distributors must self-certify, at the time of initial application and every renewal application under this Part, that none of the electronic nicotine-delivery system products they make, sell, or provide to consumers in Rhode Island are flavored electronic nicotine-delivery system products.
C. A public statement or claim made or disseminated by a dealer or distributor of an electronic nicotine-delivery system product, or by any person authorized or permitted by the dealer or distributor to make or disseminate public statements concerning such electronic nicotine-delivery system product, that such electronic nicotine-delivery system product imparts a characterizing flavor shall constitute presumptive evidence that the electronic nicotine-delivery system product is a flavored electronic nicotine-delivery system product.
6.10 Violations - Enforcement and Penalties
A. Violation of any provision of this Part is subject to all civil and criminal penalties as provided by law.
1. Each flavored electronic nicotine-delivery system product, or any component part thereof, that is manufactured, distributed, sold, or offered for sale, or possessed with intent to manufacture, distribute, sell, or offer for sale (as set forth in § 6.9 of this Part), shall constitute a separate violation.
2. Any violation by a clerk, cashier, or other employee or staff shall be imputed to the person's employer for assessment of violations and penalties.
B. Pursuant to R.I. Gen. Laws § 23-1-57, any distributor or dealer who sells, offers for sale, or possesses with intent to sell, electronic nicotine-delivery system products in the State of Rhode Island without the appropriate license shall be fined in amounts set forth in R.I. Gen. Laws § 23-1-58. Compassion centers and licensed cultivators registered with the State of Rhode Island under R.I. Gen. Laws Chapter 21-28.6 are exempt from this provision.
1. The person receiving a citation under the Act may elect to pay the fine(s) through the mail within ten (10) days or appear in court to answer to the citation.
2. All recipients of third and subsequent citations under the Act within any thirty-six (36) month period (measured from the date on which the license holder received the first citation) shall appear in court for a hearing on the citations.
3. The failure of a person receiving a citation under the Act to either pay the citation through the mail within ten (10) days (where permitted under this Part) or to appear in court on the date specified shall be cause for the court, to hold the person in contempt of court with the penalty assessed a suspension of license issued under this Part for six (6) months and a five hundred dollar ($500) fine.
4. The court may impose court costs and any other court fee(s) on anyone convicted in court of a violation of this Part.
If any provisions of this Part, or the application thereof, to any person or entity or circumstance is adjudged invalid by a court of competent jurisdiction, such judgment shall not affect or impair the validity of the other provisions of this Part, or the application thereof, to other persons, entities, and circumstances.
|Title||216||Department of Health|
|Part||6||Licensing of Electronic Nicotine-Delivery System Distributors and Dealers (216-RICR-50-15-6)|
|Type of Filing||Amendment|
|Effective||10/04/2019 to 03/26/2020|
R.I. Gen. Laws § 23-1-1
R.I. Gen. Laws § 23-1-55 through 23-1-58
Executive Order 19-09
Purpose and Reason:
The Rhode Island Department of Health (RIDOH) is promulgating emergency regulations in order to prohibit manufacture, distribution, sale, or offer for sale of, or the possession with intent to manufacture, distribute, sell, or offer for sale flavored electronic nicotine-delivery system products to consumers in Rhode Island.
Brief statement of Reason for Finding Imminent Peril:
The Rhode Island Department of Health (RIDOH) finds that the State is facing a youth vaping crisis. Per the Governor’s Executive Order 19-09 entitled “Protecting Rhode Island Youth Against the Harms of Vaping,” the RIDOH Director authorized the promulgation of emergency regulations to address this crisis. Issue: In 2018, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and United States Surgeon General all declared youth e-cigarette use a national epidemic, pervasive in every state; the data available on the subject clearly support such a characterization. Since 2014, electronic nicotine-delivery system (ENDS)products have been the most commonly used tobacco products among U.S. youth, overtaking traditional cigarettes (1). ENDS product sales virtually doubled in 2018, having risen 97% from 2017. Nationwide, ENDS use among middle and high school students collectively increased 900% between 2011-2015, with increases in usage of 78% among high school students and 48% among middle school students measured from 2017 to 2018 alone (2)(3). Two out of five Rhode Island high school students reported trying e-cigarettes in 2017. The total number of children who are currently using ENDS rose to 3.6 million in 2018, which represents a 1.5 million jump in usage over a single year (4). Cause: Rhode Island and the nation had been making progress to reduce nicotine addiction and cigarette smoking among youth; however, the rate at which ENDS products—including e-cigarettes—are being adopted and used by youth stands to derail this progress. The aggressive marketing and promotion of flavored e-cigarette products toward youth by the vaping industry has had a measurable and deleterious effect on downward trends on youth nicotine addiction and cigarette smoking. Remarkably, 81% of youth e-cigarette users reported their first use of an ENDS product was a flavored ENDS product (5). Youth and young adults report using ENDS products because they like the flavorings/taste, they perceive the product as less harmful/less toxic, and they find the marketing and advertisement campaigns alluring. Nationally, 63.6% of middle and high school students have used a flavored tobacco product in the past month. Further, 31% of teenagers said they started vaping because of the flavor availability. Flavored ENDS products appeal to the tastes of young people because they come in fruit, candy, and minty flavors . Fruity flavors account for more than 80% of sales for Juul, the nation’s largest ENDS producer with 76% of the market share in 2018. The American Thoracic Society further suggests that tobacco companies use minty flavors as a way to target new smokers, like youth, because “[t]he soothing taste [of menthol cigarettes] makes a cigarette more appealing, especially to teens between 12 and 17 years of age, and is frequently the ‘starter’ product for people who become chronic cigarette users.” (6) Negative Impacts: Cigarettes cause deadly health consequences, like lung cancer and heart disease. Most adult lifelong smokers started using tobacco in their youth; therefore, successful prevention efforts must begin by curbing tobacco and nicotine consumption at an early phase in youth development. Recent research found that children who used ENDS were four times more likely to try smoking tobacco cigarettes, and nearly three times more likely to become regular smokers within two years (7). Nearly nine out of 10 current adult cigarette smokers first started using tobacco products by age 18, and 99% having first started by age 26. Approximately 16,000 children now under 18 and alive in Rhode Island will ultimately die prematurely from smoking, given currents rates of morbidity and mortality. The common carcinogenic ingredient between cigarettes and e-cigarettes, when sold as intended, is nicotine. Most e-cigarettes contain nicotine, the highly addictive drug found in regular cigarettes and other tobacco products. Nicotine is found to alter the brain development of youth, which may have negative long-term health effects on attention, learning, and memory; usage has also been shown to increase the propensity for lower impulse control, mood disorders, and addiction to other substances like alcohol and drugs (8). In addition, most ENDS products contain and emit numerous potentially toxic substances other than nicotine, for which long-term studies have not been conducted; some of these toxins have already been banned by FDA for human ingestion, and many have not been tested by FDA for inhalation. The severe harms caused by the national rise in ENDS product use, particularly with respect to the impacts on youth, are currently being investigated by CDC and FDA. Solution: In 2019, the Federal government issued recommendations that youth and young adults, women who are pregnant, and adults who do not currently use tobacco products should not use or start using ENDS products. Simply put, CDC states that “[t]he use of e-cigarettes is unsafe for kids, teens, and young adults” because they contain nicotine, a highly addictive substance which can damage the developing brain (9). CDC has also indicated that ENDS products, including flavored ENDS products, can contain other harmful substances in addiction to nicotine. As a result, CDC endorses evidence-based strategies that include limiting youth access to tobacco and nicotine products. Banning the sale of all flavored ENDS products throughout Rhode Island is a reasonable and effective first step to address this problem. (1) U.S. Surgeon General’s Advisory on E-Cigarette Use among Youth, available at https://www.cdc.gov/tobacco/basic_information/e-cigarettes/surgeon-general-advisory/index.html (2) FDA Proposes Regulations as Teen E-Cigarette Use Skyrockets 78% in 1 Year, available at https://www.cancer.org/latest-news/fda-proposes-regulations-as-teen-e-cigarette-use-skyrockets-78-percent-in-1-year.html (3) Id. (4) Id. (5) See Michigan Emergency Rules https://www.michigan.gov/documents/mdhhs/Emergency_vaping_rules_-_signed_by_Gov-Director_9.18.19_666139_7.pdf. (6) What Is Menthol? available at https://www.thoracic.org/patients/patient-resources/resources/menthol.pdf. (7) https://content.govdelivery.com/attachments/MIEOG/2019/06/04/file_attachments/1224015/Signing%20Statement%20SB%20106,%20155.pdf (8) Id. (9) https://www.cdc.gov/tobacco/basic_information/e-cigarettes/Quick-Facts-on-the-Risks-of-E-cigarettes-for-Kids-Teens-and-Young-Adults.html