PMTA Confusion Update: FDA Clarifies One-Year Sales Extension
FDA personnel were misleading some small vaping manufacturers about the final date on which they can lawfully sell their products. Although the misunderstanding does not appear to entail intentional dishonesty, it may nonetheless result in unpleasant surprises for many people when the current one-year grace period expires in September.
According to a lawyer who represents numerous vaping sector clients, many small company owners believe they have been advised by the FDA that they have an additional year to market their goods. That, however, is not the case.
What exactly is going on? Let's start with the PMTA deadline from last year.
The PMTA deadline in 2020 and the flood of submissions
Manufacturers had until Sept. 9, 2020, to submit Premarket Tobacco Applications (PMTAs) to the FDA. Manufacturers who submitted their goods on time were given a one-year extension to market them while the FDA's Center for Tobacco Products (CTP) examined their applications. The product must have been on the market for at least six months to be eligible to stay on the market during that grace period.
To be qualified for the review period, a product must have been on the market before August 8, 2016, when the FDA's Deeming Rule took full effect and the market was frozen.
As part of a judgement against the FDA in a lawsuit filed by the American Academy of Pediatrics (AAP) and many other tobacco control groups, a federal judge issued the 2020 PMTA deadline (which was eventually postponed from May to September).
Judge Paul Grimm concurred in his finding that manufacturers who submitted their products on time might get a one-year extension to sell them while they were being reviewed, and that the FDA could offer additional extensions to the one-year grace period for "good cause" on a "case-by-case basis."
“CTP Director Mitch Zeller said that FDA anticipated getting about 6,000 applications, and they wound up getting literally millions,” says attorney Azim Chowdhury. “But when Judge Grimm set the deadline, he was basing it on the FDA estimate that there would be just a few thousand applications.”
The FDA CTP planned for the avalanche of submissions based on the assumption that just a few thousand would be filed. The FDA, on the other hand, was uninformed that small vaping companies had developed a system that allowed almost any e-liquid company to submit a nearly perfect application for a few thousand dollars, and that the applications were being coordinated in a private Facebook group.
As a result, hundreds of companies submitted applications for millions of goods, and the FDA had no choice but to follow the formal procedures of the PMTA procedure for each one.
Every PMTA is accepted first, then filed, followed by preliminary scientific review, full scientific evaluation, and acceptance or rejection. Following the preliminary scientific evaluation, the FDA may send a deficiency notice to the application, requesting additional information or modifications to address specific concerns.
For manufacturers who aren't far along in the scientific review process, the FDA simply doesn't have the authority to extend the procedure.
“For companies who are in scientific review, have responded to deficiency letters, and have studies or testing ongoing—that’s within the discretion of the FDA to grant extensions without going to Judge Grimm,” says Chowdhury. “But any blanket extension would be immediately challenged [by the plaintiffs in the AAP lawsuit].”
In the PMTA review process, the FDA favors mass-market products.
As the PMTA deadline loomed last year, anti-vaping groups urged that the FDA establish a public list of goods that would be permitted to remain on the market lawfully during the one-year grace period beginning Sept. 9, 2020. Director of the CTP, Zeller, agreed to do so.
In February, five months after the PMTA submission deadline, Zeller said that the list was still incomplete since the FDA had been swamped with applications and was still working on the first stages of processing for the majority of them.
According to Zeller, the FDA will devote its resources to completing assessments of the most popular goods first, which means that small manufacturers' applications will be unlikely to be examined before the one-year extension expires.
He additionally tried to appease anti-vaping activists by enforcing laws against companies that sell products that haven't been subjected to premarket review.
As a result of FDA's drowning in a tidal wave of small-business applications, the agency is still processing those applications, while the CTP scientific team is analyzing applications for products filed by mass-market vape manufacturers such as Juul, Vuse, Blu, Logic, and NJOY.
So because FDA prioritizes PMTA reviews based on market share, many small manufacturers' goods will likely be taken off the market on Sept. 9—before they even reach scientific review (which could gain them a further extension)—simply because the FDA can't get to them in time.
Due to the court's prohibition on the FDA giving a blanket extension for all products, only a few small firms will likely be able to acquire one.
The FDA hired temporary contractors to supplement CTP staff for processing applications because it was overwhelmed with millions of applications.
On the phone, small manufacturers frequently deal with folks like these. At least one contact from the CTP was received (or will be received) by every manufacturer who filed a PMTA, asking for verification of information in their applications.
Employees and contractors at the FDA are following a script that was written for calls that were supposed to be made just after the deadline last year—if the agency hadn't been inundated with applications.
Last October, guaranteeing “another year” on the market or “a one-year extension” would have been easy for manufacturers to understand; it would have meant adding another year to the years since the market was frozen on August 8, 2016.
It's possible that FDA staff are intentionally misleading the business, but it's more likely that the majority of these callers are temporary contractors who are unfamiliar with the process.
However, hearing the words "another year" or "a one-year extension" today, seven months after the PMTA submission deadline, might cause confusion, and some in the vape business have undoubtedly misinterpreted what they were informed.
Most micro e-liquid companies lack the financial means to either conduct the costly testing required to avoid punishment or to remain open for several months (or longer).
That is why the FDA's deceptive phone calls are so cruel, even if the cruelty is usually unintended and stems from ineptitude rather than malice. Some business owners say they have been told they have an extra year to sell products without PMTA clearance after September 9, 2021.
Making it all extremely confusing and damaging, as companies rely on this information to conduct their business as usual. Information that is being purposefully misleading.
Even if the future is uncertain, we will continue to keep our doors open for as long as we can legally speaking. Thank you for being patient and sticking with us during these troubled times.
Leave a comment