Licensing of Electronic Nicotine-Delivery System Distributors and Dealers (216-RICR-50-15-6)


216-RICR-50-15-6 ACTIVE RULE EMERGENCY RULE

Title 216 Department of Health
Chapter 50 Environmental Health
Subchapter 15 Healthy Environment
Part 6 Licensing of Electronic Nicotine-Delivery System Distributors and Dealers (216-RICR-50-15-6)
Type of Filing Amendment
Regulation Status Active
Effective 10/04/2019 to 01/31/2020

Regulation Authority :

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