U.S. District Judge Karen K. Caldwell rejected vape trade organization Vaping Technology Association (VTA) and its member Vapor Stockroom LLC’s argument to postpone the deadline for when the Food and Drug Administration (FDA) will begin enforcement action over vape companies and devices, Law360 reported.
The issue takes root in a July 2019 order by U.S. District Judge Paul. W. Grimm that set a 10-month deadline of May 12, 2020, for vape manufacturers to apply for FDA review of their products if they want them to remain on the market. Companies that do not submit applications by that date are subject to the FDA removal of them from the marketplace. Those that do apply can remain on the market for up to one year while the FDA considers their applications.
Judge Grimm had set the deadline after finding that the FDA acted illegally when it pushed back the deadline for vape companies to submit applications from 2018 to 2022.
A stricter deadline was championed by the American Lung Association, the American Academy of Pediatrics and several other public health organizations, citing concerns about the growing vape epidemic among youth. The order is on appeal.
On Jan. 2, the FDA announced it would begin restricting sales of vape products without premarket approval beginning May 12 – the same deadline ordered by Judge Grimm. The agency prioritized its focus for enforcement on the following groups – any flavored ENDS (electronic nicotine delivery systems), which includes vape devices and e-liquids; vape products other than tobacco or menthol; all vape products for which the manufacturer failed or is failing to take measures to prevent minors’ access; and any vape product that targets minors or is likely to promote use by minors.
“The guidance also states that, after May 12, 2020, the FDA intends to also prioritize enforcement against any ENDS products that continue to be sold and for which the manufacturers have not submitted a premarket application,” the FDA said in a press statement. “For ENDS products other than those in the three groups described above, if premarket applications are submitted by that date, the FDA intends to continue to exercise enforcement discretion for up to one year pending FDA review of the applications, unless there is a negative action by the FDA on such application or the product is authorized to be marketed by the FDA.”
VTA argued that the FDA took responsibility for the deadline when it issued the guidance. Judge Caldwell found otherwise. “Even if the government had vigorously argued for the 10-month deadline, courts are not ‘motivated’ by parties to rule in a certain way,” she wrote.
VTA’s executive director Tony Abboud said in a statement, “Make no mistake, the FDA’s continued refusal to do anything to alter its accelerated and unreasonable PMTA [premarket tobacco product applications] process threatens to shut down 14,000 small businesses in just a few short months.”
Beasley Allen lawyers Joseph VanZandt and Sydney Everett, together with Mass Torts Section Head Andy Birchfield, are currently representing individuals who are suing the top U.S. vape maker JUUL for the negative impact its products have had on their lives. On Oct. 7 Beasley Allen also filed lawsuits on behalf of school districts in three states that seek to protect students and recover resources spent fighting the vaping epidemic.