Vaping group sues Trump administration to delay expedited e-cigarette review

Vaping group sues Trump administration to delay expedited e-cigarette review

A vaping industry group on Wednesday filed a lawsuit against the Trump administration in an attempt to delay an upcoming deadline for companies to submit their products for regulatory review. 

The lawsuit from the Vapor Technology Association (VTA) challenged the Food and Drug Administration’s deadline of next May for vaping companies to submit their products for rigorous agency review.

The industry group called the deadline, which was imposed by a federal judge on the agency’s recommendation, “arbitrary” and said it would be “impossible to meet for thousands of small and mid-sized vapor businesses.” 

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“The stark facts set forth in the Complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out … by the May 2020 deadline,” the group said. 

The VTA lawsuit represents the latest salvo in the federal government’s battle to regulate e-cigarettes, which public health officials have blamed for an epidemic of youth addiction to vaping.

The agency gained the authority to regulate tobacco products in 2009, but it wasn’t extended to vaping products until 2016. When the administration changed in 2017, the FDA decided to delay enforcing the laws until 2022.

Former FDA Commissioner Scott Gottlieb moved the deadline up a year to 2021 before stepping down in April, but manufacturers were still allowed to bring their products into the market, even though the FDA knew the public health risks.

Anti-tobacco groups grew increasingly frustrated with the delays, and sued the FDA to speed up the process. A federal judge sided with the groups, and ordered the agency to set a 10-month deadline deadline for all companies to submit their products for federal review through the most intensive regulatory pathway.

The FDA had recommended the 10-month window as a counter to public health groups, which had requested only four months. 

The vaping association represents about 800 companies, including Juul. The group said there are more than 3 million vaping products on the market, and the current deadline means many companies will be forced to stop selling their products. 

The group noted the FDA has now set five different deadlines for companies to meet. 

“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. 

“FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette,” Abboud said.

However, in a July 15 statement in response to the new deadline, acting FDA Commissioner Ned Sharpless said the agency had already made it clear to companies what types of information they will expect in the regulatory submissions.

“Let me be clear with the tobacco industry: responsible manufacturers certainly don’t need to wait 10 months to act,” Sharpless said. 

The Hill has reached out to the FDA for additional comment.