Judge sets 10-month deadline for e-cig makers to apply for federal approval

A federal judge has set a 10-month deadline, ending in May 2020, for e-cigarette and cigar makers to apply for FDA authorization to keep their products on the market.

The July 12 ruling was issued by U.S. District Judge Paul W. Grimm, the same judge who ruled two months ago that the FDA acted illegally by allowing e-cigarettes to remain on the commercial market until August 2020 without having been authorized by the FDA. At the time, e-cigs—including flavored tobacco and brands marketed directly to kids and teens—were somewhat unregulated.

“The record before me shows a purposeful avoidance by the industry of complying  with the premarket requirements despite entreaties from the FDA that it can do so,” Grimm wrote in this week’s ruling. “The record offers little assurance that, in the absence of a deadline for filing, the industry will do anything other than raise every roadblock it can and take every available dilatory measure to keep its products on the market without approval.”

Grimm’s latest order allows e-cigarette manufacturers to apply to the FDA and submit their products for public health review by May 12, 2020, exactly 10 months after he issued the ruling. At that point, companies who haven’t submitted applications will be subject to FDA enforcement and removal from the market; companies who did submit applications will be permitted to keep their products on the commercial market for a year while the agency reviews applications.

In a statement, the American Heart Association said it’s critical the FDA “use this legally required review process to remove from the market products that appeal to kids and have fueled the youth e-cigarette epidemic.” Data revealed that in 2018, more than one-fifth of high school students were using e-cigarettes, due in large part to major marketing campaigns by companies like Juul.

The AHA, alongside five other American medical societies and five individual pediatricians, had filed a lawsuit March 27, 2018, challenging the FDA’s decision to allow e-cigarettes and cigars on the market without federal approval.

“While our organizations had urged an even shorter application deadline of 120 days from the judge’s order, the new deadline is a dramatic improvement of more than two years from the current deadline of August 2022 set by the FDA,” The AHA wrote in its July 12 statement. “It is also an improvement that the judge set a one-year deadline for the FDA to consider product applications, compared to current FDA policy of allowing products to stay on the market indefinitely during review.”

Grimm’s order also imposed the May 2020 deadline for cigar manufacturers, who were previously told they had until 2021 to file for approval with the FDA.