Despite the coronavirus (COVID-19) pandemic, there have been questions surrounding the looming PMTA deadline of May 12, 2020. The eJuices.co team sat down with general counsel Rob Solomon to clarify some questions that vape shops and others in the vape industry may have regarding PMTA.
Do you believe that the PMTA submittal deadline will remain as May 12, 2020 (as judicially established in July 2019), or rather that the deadline will be extended?
On April 3, 2020, the federal court in Maryland which originally set the May 12, 2020 PMTA submittal date said that, as requested by the FDA, it would extend the date for 120 days, from May 12, 2020, to September 9, 2020. The FDA was clear in its request that it was seeking the extension only because of substantial disruptions caused by the novel coronavirus pandemic. Due to some technical legal issues the extension is not final yet (as of April 10, 2020), but I have no doubt that we will have the final ruling within the coming days. Depending upon how quickly business normalizes as the economic effects of the pandemic lessen, there could be a move in our industry to lobby for an additional PMTA extension. I would expect the public health lobby to strongly resist that move.
If the PMTA submission date is delayed, do you believe that the PMTA requirements will be changed prior to final implementation?
Based upon their public announcements, a number of the major manufacturers in our industry, at the time of the economic crisis, were well on their way to completing their PMTA filings in order to meet the May 12 submission deadline. These companies have spent large sums of money and devoted significant human resources in that effort, and I suspect would resist any industry move to dilute the PMTA requirements. However, as the economy opens up, I do believe that there generally will be a focus on overly burdensome regulations that create barriers to medium and small businesses. As we approach the September 9th PMTA submittal date, if a significant number of small and medium-sized producers have not prepared or completed their PMTA filings there may be an opportunity to persuasively press for changes in the PMTA regime within the context of saving businesses and jobs.
If there are changes to the PMTA requirements what might they be, and what should vape shop owners know about the changes?
Changes to the PMTA could fall into two buckets. First, an extended deadline for product submissions could be granted to smaller producers. Second, some of the technical components of the PMTA requirements could be relaxed for smaller producers. The challenge for vape shop owners will be to stay current on which of their manufacturers are making timely PMTA submissions to the FDA so they are not caught with illegal products on their shelves. As they make submissions, manufacturers should provide their retailers with proof and advise of any FDA action on the submittals. Retailers should demand a right to return unsold products at the point that the product becomes illegal unless the retailer is prepared to accept that risk.
Did the FDA request a delay of the PMTA submittal date solely because of the coronavirus or was the FDA willing to adjust the submittal date regardless of the pandemic?
The FDA was very clear that it was requesting a delay solely because of the coronavirus. Prior to the economic disruption resulting from the virus and the government ’s response to it the vaping industry was seeking relief from the harsh requirements of PMTA. However, there was no public indication that those efforts were going to be successful.
With respect to the Administration’s proposal that tobacco products be removed from FDA jurisdiction and transferred to a new stand-alone division within the Department of Health and Human Services, could that reorganization happen within the 120- day PMTA extension?
I do not foresee that significant change happening by September 9, 2020. There is a great deal of process that would be required to effect such a reorganization, and the government is currently preoccupied with the economic and medical welfare of the country. Moreover, we are moving into election season, and I would not expect such a major politically- charged action at this time.