FDA Targets E-Cigarette Makers

Pointing to Juul specifically, the agency mandates top-selling brands have 60 days to provide plans for how they will mitigate sales to minors.

The U.S. Food and Drug Administration (FDA) is considering a ban on flavored e-cigarettes from Juul Labs and other companies as it grapples with an “epidemic” of youth e-cigarette use that threatens to create a new generation of nicotine addicts, the agency’s head official said on Wednesday, Sept. 12.

In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit a policy that extended the dates for some manufacturers of flavored e-cigarettes to get FDA approval before selling their products. That could lead to removal of some major flavored e-cigarette brands, including the popular products made by Juul Labs Inc., if they do not address the issue to the agency’s satisfaction.

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The FDA is giving the five top-selling e-cigarette brands – Juul, Vuse, MarkTen XL, Blu and Logic—60 days to provide plans for how they will mitigate sales to minors.

A company 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.”

Various healthcare groups and policymakers have voiced concerns over e-cigarettes used by middle and high school-aged youth. This September, the agency announced more than 1,300 warning letters and fines were sent to both brick-and-mortar and online retailers for selling e-cigarette products to minors discovered during a nationwide undercover campaign from June through August.

MANUFACTURERS RULE

Gottlieb mandated manufacturers of JUUL, Vuse, MarkTen XL, blu and Logic submit details on how each will confront and prohibit youth access to and use of their products. The companies have 60 days to comply or face the possibility of the FDA removing their items from store shelves.

According to a FDA press release, “This could mean requiring these brands to remove some or all of their flavored products that may be contributing to the rise in youth use from the market until they receive premarket authorization and otherwise meet all of their obligations under the law.”

Anti-smoking groups and some local politicians have long argued that fruit, dessert, tropical and candy e-liquid and nicotine salt flavors encourage underage vaping. Consequently, numerous cities and states have proposed and/or passed bans on flavored tobacco products, San Francisco being one of the most recent.

The FDA charges that more than 2 million middle school and high school students used e-cigarettes in 2017.