The agency is set to enforce the marketing and sale of materials to the country’s youngest consumers.
Those aiming to reduce or quit their vaping as one of their New Year’s resolutions recently got a bit of an assist from the U.S. Food and Drug Administration (FDA). As of Jan. 2, FDA officials announced a decision to enforce a ban on fruit- and mint-flavored products that are used in e-cigarettes. Enforcement is expected to begin by early February. Although the ban does not apply to menthol and tobacco-flavored products and will not impact the sale of tank-based vaping systems sold within vaping shops, the regulation is expected to target the sale and distribution of vaping products to young people. According to FDA officials, companies that do not cease the manufacture, distribution, and/or sale of the unauthorized flavored cartridge-based e-cigarettes within the specified 30 days will risk “enforcement actions.” Additionally, the FDA has issued a guidance document that describes how officials intend to prioritize enforcement resources with regard to the marketing of certain products that do not receive premarket authorization.1
The announcement comes during a time of what the FDA and organizations such as the Centers for Disease Control and Prevention (CDC) have identified as epidemic levels of e-cigarette use among youth as well as a national outbreak of those who have experienced vaping-related lung injuries,2 including nearly 3,000 people who have required hospitalization and/or other healthcare treatment and nearly 60 people who have since died. The move to place the ban also comes while many health and government officials state-by-state are grappling with how to best regulate e-cigarettes and various vaping-related products.
BIG, YOUNG PROBLEM
“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes,” said Alex Azar, secretary of the U.S. Department of Health & Human Services (HHS), in a recently prepared statement to the press. According to Azar, HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally. “By prioritizing enforcement against the products that are most widely used by children, our action seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” Azar said. “We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary.”
The final guidance outlining the FDA’s enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, comes on the heels of the annual National Youth Tobacco Survey’s results on e-cigarette use, which show that more than 5 million middle and high school students in the country had used e-cigarettes within the previous 30 days.2 The survey, a joint effort of the FDA and CDC, also reports that approximately 1.6 million of current youth e-cigarette users are using the product frequently (defined as use on 20 days or more in a 30-day period), with nearly 1 million using e-cigarettes daily. Additional research has also found that youth are particularly attracted to e-cigarette flavors such as fruit and mint, much more so than tobacco or menthol flavored e-cigarettes.3 According to the FDA, these overall levels of youth e-cigarette use are particularly concerning because using e-cigarettes puts them at risk for nicotine addiction and other health consequences. Officials say evidence shows that youth exposure to nicotine can adversely affect the developing adolescent brain and that, compared with non-users, youth who use e-cigarettes are more likely to try conventional cigarettes in the future.
Janice Selekman, DNSc, RN, NCSN, FNASN, a professor at the University of Delaware who has written on the aspect of vaping among youth populations,4 says that regulations are “moving in the right direction,” but that more diligence is needed.
“We don’t know all of the long-term effects yet of vaping, but, in addition to the chemicals that are in the pod, there is what I consider to be an ignored component — in that when you heat up the coil so that the juice that’s in the pod can be inhaled into a vapor — you are actually inhaling the chemicals that are in those heating coils, which are lead, chromium, nickel, manganese, and others.”
RUN ON REGULATIONS
All e-cigarettes and other ENDS products became subject to the FDA’s tobacco authorities, including the premarket authorization requirements in the Federal Food, Drug, and Cosmetic Act as of Aug. 8, 2016. According to the FDA, all e-cigarettes and other ENDS products on the market at that time required authorization to be legally marketed. However, as an exercise of its enforcement discretion, the agency had deferred enforcement of the premarket authorization requirements. To date, no ENDS products have been authorized by the FDA, which means that all ENDS products currently on the market are considered illegally marketed and are subject to enforcement, at any time, in the FDA’s discretion, according to FDA officials.
The FDA intends to prioritize enforcement against illegally marketed ENDS products as of 30 days from the publication of its notice of availability of the recent guidance (dated Jen. 2, 2020) in the Federal Register, by focusing on the following groups of products that do not have premarket authorization, according to a prepared statement released to the press:1
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent access to minors; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
Cartridge-based ENDS products are described by the FDA as those that consist of, include, or involve a cartridge or pod that holds liquid that is to be aerosolized when the product is used. For purposes of the recent FDA policy, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS product, the FDA stated.
In addition to data showing that cartridge-based ENDS products are most commonly used among youth, findings from the 2019 Monitoring the Future survey by the National Institute on Drug Abuse indicate that youth preference for menthol- and tobacco-flavored e-cigarettes is much lower than that for mint- and fruit-flavored e-cigarettes,5 and so these products are not among the FDA’s current enforcement priority focus, according to the FDA. This could reportedly change if an increase in the use of these products by youth is realized, according to the FDA, which also claims it will prioritize enforcement whenever manufacturers fail to take adequate measures to prevent youth access to such products. The agency also will consider whether manufacturers use adequate age-verification technology (or require that retailers who sell products use such technology) to prevent underage access to its website and to prevent underage sales through the internet, officials said. In addition, consideration will be given to whether the manufacturer limits (or requires retailers who sell its products to limit) the quantity of ENDS products that a customer may purchase within a given period of time.
ENDS products that are targeted to youth or likely to promote the use of ENDS by youth, such as products marketed with labeling and/or advertising that resemble kid-friendly foods and drinks, products marketed directly to minors by promoting ease of concealing the product or disguising it as another product, and products marketed with characters designed to appeal to youth, will also be subject to the FDA’s priority enforcement list, officials said. The guidance also states that, after May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application.
- Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization. FDA. 2020. Accessed online: www.fda.gov/media/133880/download
- Cullen KA, Gentzke AS, Sawdey MD, et al. E-Cigarette Use Among Youth in the United States, 2019. JAMA. 2019;322(21):2095-2103.
- Leventhal AM, Miech R, Barrington-Trimis J, et al. Flavors of e-Cigarettes Used by Youths in the United States. JAMA. 2019;322(21):2132-4.
- Selekman J. Vaping: It’s All a Smokescreen. Pediatric Nursing. 2019;45(1):12-15.5. 5. Monitoring the Future 2019 Survey Results: Overall Findings. National Institute on Drug Abuse. 2019. Accessed online: www.drugabuse.gov/related-topics/trends-statistics/infographics/monitoring-future-2019-survey-results-overall-findings