FDA calls youth e-cigarette use a 'clear and present danger'
The U.S. Food and Drug Administration is cracking down on the sale and marketing of e-cigarettes to kids. I
WASHINGTON - The U.S. Food and Drug Administration is cracking down on the sale and marketing of e-cigarettes to kids.
In what it calls the largest coordinated enforcement effort in the FDA’s history, the agency issued more than 1,300 warning letters and 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.
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.
As a result of the violations – and other indications that e-cigarette use among youth has hit epidemic proportions – FDA Commissioner Scott Gottlieb, M.D., said there was a need to stem what he called a “clear and present danger”.
“This starts with the actions we’re taking today to crack down on retail sales of e-cigarettes to minors,” said Gottlieb. “We will also revisit our compliance policy that extended the dates for manufacturers of certain flavored e-cigarettes to submit applications for premarket authorization.”
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 has asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse the trends, or face a possible extension of compliance dates for submission of pre-market applications.
The FDA also issued 12 warning letters to other online retailers that are selling misleadingly labeled or advertised e-liquids resembling kid-friendly food products such as candy and cookies.
The 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 are still advertising and selling the products, according to the FDA.
Several of these retailers were also cited for illegally selling the products to minors.
The FDA says it 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 says more compliance actions are underway.
In addition to the recent actions, the FDA says it 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 agency also recently sent letters to JUUL Labs and several other companies requiring them to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of their products.
The FDA is investigating whether manufacturers introduced certain e-cigarette products to the market after Aug. 8, 2016, and may be subject to enforcement for marketing those products without premarket authorization.
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.
A spokesperson for JUUL issued the following statement:
"JUUL Labs will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.
"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes. Appropriate flavors play an important role in helping adult smokers switch. By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission."
