The review’s date has been repeatedly moved around, something e-cigarette manufacturers say could shut down small businesses.
A coalition of e-cigarette merchants and manufacturers is suing the U.S. government to stop an upcoming product review by the Food and Drug Administration.
Filed by the Vapor Technology Association, the lawsuit claims that rapid-paced regulation could jeopardize a rapidly-growing and quickly changing industry. The vape lobby claims that the product submission deadline of May could wipe out small companies with limited resources.
The deadline, notes The Hill¸ was imposed by a federal judge on the FDA’s recommendation. But the Vapor Technology Association has damned the chosen date as “arbitrary,” warning that it’d be “impossible to meet for thousands of small and mid-sized vapor businesses.”
“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 the FDA only just laid out […] by the May 2020 deadline,” the lawsuit says.
According to The Hill, the VTA’s complaint is but the ‘latest salvo’ in a years-long battle between the federal government and e-cigarette companies. The FDA didn’t gain regulatory authority over tobacco products until 2009. And it wasn’t ‘til 2016 that the agency expanded its purview to vapes, too.
Under the Trump administration, product reviews for electronic cigarettes have been continuously moved around, shifted and delayed. It took a judge’s order to set a 2020 deadline, following litigation by anti-tobacco groups demanding a four-month window for review.
A judge approved the anti-tobacco coalition’s request for an expedited review but sided with the EPA in extending the window to ten months.
The Vapor Technology Association says that dates and deadlines have shifted so often that it’s difficult to ensure both compliance and preparedness.
“It is time for the 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.
Abboud and the VTA noted that the Food and Drug Administration has set five different deadlines for companies to meet. The last scheduled product review wasn’t until 2022.
“FDA’s actions, if left unchecked, will down an entire industry that has developed to challenge the combustible cigarette,” Abboud added.
However, acting FDA Commissioner Ned Sharpless hasn’t been short on criticism.
“Let me be clear with the tobacco industry,” Sharpless said, “responsible manufacturers certainly don’t need to wait 10 moths to act.”