Vapor Technology Association sues FDA over PMTA deadline
The Vapor Technology Association (VTA) has filed a lawsuit in response to the FDA’s ‘grossly accelerated’ compliance deadline
The lawsuit challenges the 2020 deadline for vape companies to submit Pre-Market Tobacco Applications [PMTAs].
The plaintiffs demand that the FDA publish the ‘foundational rules’ laying out the specific requirements of the PMTA.
They also call for the FDA to hold back on enforcement actions against non-compliant products ‘until a reasonable period of time after the actual foundational rules are finalized [sic].’
The group fears that thousands of vape businesses will be unable to meet the ‘arbitrary’ deadline:
“With over 3 million vapor products registered with FDA, the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses, particularly in the absence of a draft or final PMTA Rule.
“Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA.”
The FDA was successfully sued by a group of NGOs including the Campaign for Tobacco-Free Kids (CTFK) earlier this year.
The judge agreed to give vape companies just 10 months to meet compliance or face being removed from the US market.
Tony Abboud, Executive Director of the Vapor Technology Association, said:
“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful.
“The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act.
“Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that ‘could adversely affect the public health.”
There are currently no FDA-approved e-cigarettes on the US market.