Vapor Technology Association Files Lawsuit Against FDA over PMTA Process

Vapor Technology Association Files Lawsuit Against FDA over PMTA Process

The Vapor Technology Association (VTA), a leading U.S. non-profit industry trade association representing the industry-leading manufacturers of vapor devices, e-liquids, flavorings and components and retailers of these products, has filed a lawsuit against the U.S. Food and Drug Administration over its premarket tobacco application (PMTA) process.

The VTA teamed up with Vapor Stockroom (VSR) to file the lawsuit against the FDA in federal court. In question is the PMTA process and what exactly will be required of vapor manufacturers to file these applications. Recently, the PMTA deadline was moved up to May 2020 [read more here] and while the lawsuit was filed by the VTA in regards to its potential negative impact on the vapor industry, the PMTA process and deadline will also impact other covered tobacco products, including the premium cigar industry.

The VTA wants the FDA to clearly define and publish guidance on the specific requirements of the PMTA process. The lawsuit also is seeking to stop the FDA from enforcing its May 2020 deadline for PMTAs and from actions to be taken against those companies that do not file an application in time to meet this deadline. The VTA reports that there are the May 2020 deadline makes it nearly impossible for many small and mid-sized vapor businesses to file an PMTA in time, especially with the process being unclear and without proper guidance from the FDA. The organization is calling for a more reasonable deadline to be set for PMTAs after proper guidance has been published for more time to be provided for the many tests and studies to be conducted that are required by the FDA.

“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful,” commented Tony Abboud, executive director of the VTA. “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.’”