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FDA takes new steps to address epidemic of youth e-cigarette use
Warning letters and civil money penalty complaints to retailers are largest coordinated enforcement effort in agency history; FDA requests manufacturers provide plan for mitigating youth sales within 60 days; warns it may restrict flavored e-cigarettes to address youth epidemic.
The U.S. Food and Drug Administration announced a series of critical and historic 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. “We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year. But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this 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 FDA Commissioner Scott Gottlieb, M.D. in a speech at the agency’s headquarters. "While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine. In the coming weeks, we’ll take additional action under our Youth Tobacco Prevention Plan to immediately address the youth access to, and the appeal of, these products,” said FDA Commissioner Gottlieb and added, "We’re also fully committed to the concept that products that deliver nicotine exist on a continuum of risk, with combustible products representing the highest risk, and electronic nicotine delivery systems perhaps presenting an alternative for adult smokers who still seek access to satisfying levels of nicotine, but without all of the harmful effects that come from combustion. But in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products.”
Aggressive enforcement strategy
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.
One aspect of the agency’s plan will entail increased enforcement. The more than 1,300 warning letters and fines to retailers announced were part of a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors at both brick-and-mortar and online retailers, which was conducted from June through the end of August. 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, 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 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 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 currently 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.
Source: FDA
13.09.2018
