The Vapor Technology Association (VTA), a vaping industry group, is suing the FDA to delay the new PMTA deadline. If successful, the review of thousands of e-cigarettes will be on hold.
The lawsuit is the latest challenge the FDA faces in its attempt to regulate the vaping industry, which is now a multi-billion-dollar market. The lawsuit was filed in the U.S. District Court in Kentucky.
The industry group has argued that the latest deadline, which is next May, to submit products for review could cause many smaller companies to close up shop. Online shops like Vape4Ever would also be affected, and it would ultimately impact the sale of vape juice both online and in stores.
The VTA is seeking “preliminary and permanent injunctive relief,” which would force the FDA to set a reasonable deadline for filing PMTAs after giving notice of the finalized rule and allowing for a public comment period.
The FDA would also be required to propose and finalize a rule that governs the submission of PMTAs and not take enforcement actions against legal vape products until after the new deadline for applications has been finalized.
According to the VTA’s complaint, “Absent prompt intervention by the Court, the overwhelming majority of the vaping industry, including over 160,000 jobs at small- and medium-sized businesses, will be destroyed.”
The VTA argues that the May 2020 PMTA deadline is “impossible to meet for thousands of small and mid-sized vapor businesses.”
Tony Abboud, VTA executive director, said that the FDA has failed to “provide advanced notice” or a chance for public comment, which is required under the Administrative Procedure Act.
The lawsuit claims that there is not enough time or labs to complete the testing and analysis required by the FDA by the May 2020 deadline.
U.S. District Court Judge Paul W. Grimm ordered the PMTA deadline on July 12 after ruling in factor of special interest groups that sued the FDA over its original PMTA extension.
After Grimm’s decision, the FDA Acting Commissioner, Ned Sharpless, said that the agency would not be appealing the decision.
“It’s 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 Abboud.
Vaping executives have long argued that companies will not be able to afford to conduct the studies needed for the FDA review. Only products that meet FDA standards would be permitted to be sold.