Chris Howard, General Counsel and Vapor Technology Association Board Treasurer, announcing the action by the VTA, said: “Today the Vapor Technology Association filed a lawsuit against FDA for its unreasonable and arbitrary PMTA process - The process is a death knell for the vaping industry, imposes a burden on public health and disregards needs of smokers seeking to quit cigarettes.”
The VTA talks about the accelerated PMTA filing deadline as being gross, its submission to the court asks for it “to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalised.”
Moreover, it demands that the FDA is required “to publish and complete the long-promised ‘foundational rules’ describing the specific requirements for PMTAs”.
“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.”
Tony Abboud, the VTA’s Executive Director, added: “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,’"
“To be clear, no business could rationally have been expected to start conducting complex PMTA testing before FDA finally published its PMTA guidance document on June 11, 2019, the day before it asked the Court to impose a 10-month PMTA deadline,” said Abboud.
The VTA submission highlights that even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out on June 11, 2019, by the May 2020 deadline.
Tony Florence, President of Vapor Stockroom, LLC., said: “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. 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 continued: “It is time for 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. FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette. Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits.”
- Vapor Technology Association - [link]