The FDA has issued 1,300 warning letters and fines to electronic cigarette retailers for illegal sales of vaping devices to minors. The agency called this the largest coordinated enforcement effort in the FDA’s history.
FDA Commissioner Scott Gottlieb, MD, said the agency intends to take new and significant steps to address the challenge of youth vaping, which is reaching “epidemic proportions” according to the FDA.
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The more than 1,300 warning letters and fines to retailers announced today 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% of the US market for e-cigarettes.
In addition, today 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.
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.
Today, the agency has also committed to taking even stronger measures to stem these troubling trends of youth use:
- Looking at, and potentially changing, the FDA’s current compliance policy to determine whether it can better account for manufacturers that are not successfully preventing widespread youth use of their products. This means re-examining all aspects of the enforcement discretion that the FDA exercised when it extended the compliance dates for premarket authorization for certain newly deemed tobacco products. This could also mean revising the overall policy that applies to all manufacturers, which would go beyond the requests that were sent with respect to certain individual products today, and address the entire category of cartridge based e-cigarettes.
- Indefinitely stepping up FDA enforcement actions with a sustained campaign to monitor, penalize and prevent e-cigarette sales in convenience stores and other retail sites.
- Closely evaluating manufacturers’ own internet storefronts and distribution practices and taking appropriate enforcement actions if we find violations of the restrictions on sales to minors. The FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law.
- Investigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of Aug. 8, 2016, thus falling outside of the FDA’s compliance policy, and have not gone through premarket review.
As part of the FDA’s comprehensive plan, the agency also continues to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth.