Due to the impacts of the COVID-19 pandemic, a Maryland federal judge granted a 120-day extension to the Premarket Tobacco Product Application (PMTA) deadline for nicotine vapor products.
This comes in response to an FDA letter sent March 31 to the United States Court of Appeals for the Fourth Circuit Counsel, stating that the agency did not have the staff available to review applications after many of them were tapped to help the U.S. Publish Health Service in their coronavirus response.
While the 120-day delay moves this deadline to September 9, 2020, the FDA did receive 15 letters from groups representing the manufacturers of these products requesting a 180-day suspension. The agency denied that length of time was needed given their “countervailing critical public health priority in promptly requiring submission of applications.”
According to Law360, members of the nicotine vapor product industry are challenging the deadline in both the Fourth and Sixth circuit courts, claiming that the FDA “flouted the formal rulemaking process and imposed a one-size-fits-all application process, contrary to the case-by-case approach called for by the Tobacco Control Act.”
What is the PMTA?
The Premarket Tobacco Application (PMTA) was initially designed to give the FDA a way to review any new tobacco product before it hits the shelves in U.S. stores. Initially, this applied only to products like cigarettes and smokeless tobacco, but in May of 2016, the FDA finalized a “deeming” rule stating that the PMTA guidelines would also cover nicotine vapor technology. Under this deeming, any product produced after August 8, 2016, would need to file a PMTA before it was available for sale, but it also included products already on the market before that date.
When that “deeming” rule was passed in 2016, the FDA set a deadline for companies to file their PMTA applications, and for a multitude of reasons, that date was pushed back a few times. Anti-vaping groups argued that the FDA had not allowed a sufficient comment period before extending those previous deadlines, and they filed a lawsuit hoping not only to force the FDA to demand PMTAs for vaping products to be sold but any product without an application in process should be taken off the market immediately. Ultimately the judge decided on the now delayed May 12 date.
What does this mean?
Manufacturers of these alternative products welcome the delay, but it was not seen as a victory. The FDA has estimated that “conducting the necessary scientific investigations and preparing a premarket tobacco application would take 5,000 hours.” This includes the time to conduct a chemical analysis and any necessary nonclinical or clinical studies, but according to Mitch Zeller of the FDA’s Center for Tobacco Products, this entire process will cost manufacturers “several thousand dollars” per application.
That is where things get complicated for those producing these products. According to the guidelines laid out by the FDA, each e-liquid flavor and varying nicotine level will require its own application, which would end up costing millions. Most producers of alternative nicotine technology are not large organizations with millions of dollars in reserves and will not be able to take this burden. While the FDA has said to be looking for alternative options (applicants relying on previously published research on similar products), these applications will undoubtedly lead to the need to pass the cost onto consumers, if the companies can stay in business at all.
We will continue to monitor these appeals as the September 9 deadline approaches.