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.’”
Abboud went on to say that no business should be expected to have conducted the tests required by the PMTA requirement without proper guidance. While the FDA did publish a guidance document for vapor manufacturers to follow for the PMTA process back in June 2019 [read more here], the earlier deadline leaves many companies scrambling to conduct all the necessary tests necessary to file the PMTA. Many questions about the process and its requirements, however, have gone left unanswered and to comply will require more resources than some companies have available to them. This is why Vapor Stockroom, a manufacturer based in Lexington, Kentucky, also joined in on the lawsuit.
“Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards,” commented Tony Florence, President of Vapor Stockroom, LLC. “We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business. It’s a devastating one-two punch to small businesses all over the country.”
Abboud warns of the devastating impact the PMTA process could have on many businesses if the FDA isn’t challenged. The VTA an VSR are being represented by Thompson Hine LLP and the case is titled Vapor Technology Association, et al. vs. Food & Drug Administration. The filing can be viewed here.
For all the latest news from the Vapor Technology Association, visit vaportechnology.org.