Vaping Companies, Including Juul, Sue FDA To Delay E-Cigarette Review

Source from:  Forbes 08/16/2019

An industry group representing 800 vaping companies—including heavyweight Juul—filed suit against the Food and Drug Administration (FDA) Wednesday to delay May’s deadline to submit e-cigarettes for approval.

The Vapor Technology Association (VTA) claimed in its lawsuit that the deadline would put smaller e-cigarette companies out of business.

The fight over when vaping companies will submit products to the FDA for review has been going on since 2016, when the agency gained authority over e-cigarettes.

According to the lawsuit, the FDA pushed back 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,” said VTA executive director Tony Abboud in a statement.
Anti-tobacco groups were frustrated by the FDA’s delays and sued to speed up the product review process.

In June, a federal judge ruled in favor of the anti-tobacco groups and set the new deadline for May of next year—which in turn caused the VTA to file Wednesday’s suit.

Vaping companies claim smaller firms cannot afford the expensive FDA review process, while health advocates argue the companies need to prove e-cigarettes’ public health benefit.

What to watch for: The outcome of this lawsuit. It was filed in Kentucky’s U.S. District Court, where major tobacco cases have been heard.

Tangent: The FDA is investigating nearly 130 reports of seizures in e-cigarette users. No link between the two has been established, and scientists do not yet understand the long-term health effects of vaping.

Key background: A patent for the first modern e-cigarette was registered in 2003. Since then, e-cigarette use has exploded, particularly among teenagers, with 2018 sales generating over $2.3 billion in revenue. Juul, the San Francisco-based vape-pen maker, was responsible for over half of that 2018 revenue. (San Francisco banned e-cigarettes this year.) In December 2018, the U.S. surgeon general said that vaping among America’s youth had reached epidemic levels. Juul CEO Kevin Burns issued a public apology for youth vaping addiction in July.  Enditem