- The Washington Times - Thursday, August 15, 2019

The vaping industry is suing the Food and Drug Administration over the agency’s accelerated timeline to submit applications to keep tobacco and nicotine products on the market.

The trade group Vapor Technology Association and Vapor Stockroom, a vape-product manufacturer, filed a lawsuit Wednesday over the FDA’s “unreasonable and arbitrary” premarket tobacco application (PMTA) process and the “recently grossly accelerated” filing deadline of May 2020.

“Since 2016, the FDA has provided five different PMTA submission deadlines: Aug. 8, 2018; Nov. 8, 2018; Aug. 8, 2022; Aug. 8, 2021; and now May 12, 2020,” the lawsuit reads. “The most recent deadline was only just established on July 12, 2019 — leaving a scant 10 months for vapor industry manufacturers to attempt to comply, which is now 27 months earlier than previously set by FDA.”

The plaintiffs said they are asking the court to stop the FDA from enforcing the May application deadline and from taking enforcement actions against companies that do not have a premarket application on file until a “reasonable period of time” after the application rules are finalized.

The FDA would not comment on the lawsuit, the agency told The Washington Times. The agency published its final guidelines for manufacturers submitting product applications June 11.



Gregory Conley, president of the American Vaping Association, said he is thrilled to see the lawsuit filed this week.

“It is simply impossible for a vapor company to comply with the rushed and sloppy guidance that the FDA issued in June,” Mr. Conley said. “Make no mistake about it, if the FDA sticks to its arbitrary May 2020 application date, thousands of small businesses will close and millions of ex-smokers will be at risk of relapse back to combustible cigarettes.”

The lawsuit follows a federal judge’s decision in July to have makers of e-cigarettes and other nicotine products to submit applications to the FDA within 10 months.

The Campaign for Tobacco-Free Kids, the American Academy of Pediatrics and other advocacy groups had filed a federal lawsuit last year against the FDA after the agency delayed its premarket review for tobacco and nicotine products until 2021 and 2022.

The FDA’s postponement of application reviews, which would have allowed products under consideration to stay on the market, prompted advocacy groups to take legal action against the agency, citing a youth e-cigarette epidemic.

In 2018, 3.6 million middle and high school students nationwide had used e-cigarettes, up from 1.5 million from the previous year, according to the FDA.

Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, said the lawsuit filed by the vaping companies this week demonstrates a lack of dedication to keeping their products away from youth.

“This lawsuit shows that e-cigarette companies, including Juul, are not serious about preventing youth use and will do everything they can to avoid FDA review of the public health impact of their products, including whether they appeal to kids,” Mr. Willmore said. “These companies have no one to blame but themselves if they are not ready to submit their products for FDA review as they have been on notice for years that they will have to do so.”

U.S. District Judge Paul Grimm, who set the 10-month deadline and ordered the FDA to speed up its review of applications, pointed out in his ruling that e-cigarette manufacturers have introduced sweet-flavored, high-nicotine products like Juul without review of their public health impact or appeal to children, contributing to a rise in e-cigarette use last year.

Mr. Grimm also said the industry has purposefully avoided complying with premarket product requirements to keep products on the market without FDA approval.

The plaintiffs filed the lawsuit in the U.S. District Court for the Eastern District of Kentucky.

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