The U.S. Food and Drug Administration has announced a series of critical and enforcement actions…
The U.S. Food and Drug Administration has announced a series of critical and enforcement actions related to the sale and marketing of e-cigarettes to kids.
In the largest coordinated enforcement effort in the FDA’s history, the agency issued more than 1,300 warning letters and civil money penalty complaints (fines) to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer.
As a result of these violations of the law – and other indications that e-cigarette use among youth has hit epidemic proportions – FDA Commissioner Scott Gottlieb, M.D., signaled that the agency intends to take new and significant steps to address this challenge in a speech at the agency’s headquarters.
FDA targets illegal sales to youth and kid-friendly marketing
As part of the agency’s Youth Tobacco Prevention Plan and ongoing work to protect youth from the dangers of tobacco products, the FDA has taken a series of actions over the past several months to more immediately target the illegal sales of e-cigarettes to youth, as well as the kid-friendly marketing and appeal of these products.
The FDA is stepping up those efforts indefinitely.
Concerning the 1,300 warning letters and fines to retailers: According to FDA, the vast majority of the violations were for the illegal sale of five e-cigarette products – Vuse, Blu, JUUL, MarkTen XL, and Logic.
These five brands currently comprise over 97 percent of the U.S. market for e-cigarettes.
In addition, last week the FDA also issued 12 warning letters to other online retailers that are selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies.
These products were the subject of agency action in May and, subsequently, are no longer being sold with the offending labeling and advertising by the companies that received the May warning letters. However, the retailers receiving the warning letters today are still advertising and selling the violative products.
Several of these retailers were also cited for illegally selling the products to minors.
The agency will continue to monitor and take action against companies that sell tobacco products that might mislead a young child into thinking the product is appropriate for them to consume as food. The FDA has more compliance actions underway.
In addition to these new actions, the FDA had previously issued more than 60 warning letters and fines to businesses that sold JUUL brand products to minors stemming from another enforcement blitz this past spring.
The FDA is conducting checks of retailers
The FDA also continues to conduct checks of retail establishments that sell tobacco products to ensure compliance with federal laws. In total, the FDA has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law and initiated approximately 18,560 civil money penalty cases, as of Sept. 1, 2018.
There is a clear need for strong federal enforcement of youth access restrictions and the FDA will continue to hold retailers accountable by vigorously enforcing the law with the help of the agency’s state partners.
The agency also has issued more than 135 No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from selling tobacco products for specified periods of time.
E-cigarette use by kids has grown dramatically
FDA warns youth use of e-cigarettes is reaching epidemic proportions, signals new, aggressive steps to address challenge, including re-examining FDA’s compliance policy regarding flavored e-cigarettes
Over the past several years, e-cigarettes were the most commonly used tobacco product by youth. In fact, more than 2 million middle and high school students were current users of e-cigarettes in 2017.
This use by children and teens is especially concerning to the FDA because the developing adolescent brain is particularly vulnerable to nicotine addiction. That’s why combating youth use of nicotine-containing products is a core priority and the guiding principle behind the FDA’s Youth Tobacco Prevention Plan.
The FDA now believes that youth use of e-cigarettes is reaching epidemic proportions. This belief is based on not just the results of the agency’s enforcement actions, but also recent sales trends, news coverage, increased concerns among kids, parents and educators, as well as preliminary data that will be finalized and released in the coming months.
To address these trends, and as another part of the agency’s effort, the FDA is re-examining its compliance policy dates for the submission of premarket tobacco applications to the FDA for certain e-cigarettes.
Find out more at www.fda.gov.