A group representing Juul and 800 other vaping companies is suing the Food and Drug Administration (FDA) to delay May’s deadline to submit e-cigarettes for approval, as the agency struggles to regulate the multibillion-dollar e-cigarette industry.
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In the Kentucky lawsuit, the Vapor Technology Association claimed the deadline would put smaller e-cigarette companies out of business.
According to the suit, the FDA delayed its deadline at least five times. “It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses,” VTA executive director Tony Abboud said in a statement.
Smaller vaping groups say they can’t afford the expensive FDA review process, while health advocates maintain the companies should be required to prove e-cigarettes’ public health benefit.
Since the emergence of e-cigarettes in 2003, little longitudinal research has been done about the long-term effects of the popular products. Pushback from the vaping company started in 2016, when the FDA began reviewing the products. They became increasingly popular with claims that they were a healthier alternative for traditional cigarette smokers.
Health experts also warn of the growing epidemic of underage vaping, which they say can be harmful to teens' brain development.
In the past several months, the FDA also launched an investigation into the possibility of vaping linking to seizures, after more than 130 incidents were reported.
A federal judge set the new deadline for the hearing for May 2020 in Kentucky, where other major tobacco cases have been heard. The date favors the anti-tobacco groups, which catalyzed Wednesday’s filing.
The FDA declined to comment on the new lawsuit, but acting FDA Commissioner Ned Sharpless said earlier this summer that the investigation into e-cigarette products is part of a commitment to public safety.
"The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health,” Sharpless said.
In 2018, sales for e-cigarettes generated over $2.3 billion in revenue, per Forbes. Juul forecasted $3.4 billion in revenue for 2019 – triple what is made last year, according to Bloomberg. Shortly after these projections, the company’s home base of San Francisco banned e-cigarettes in June.