Cautious relief after US court grants four-month PMTA deadline extension

Vape businesses have generally welcomed the decision by the Maryland US District Court to grant a four-month extension to the premarket tobacco product application (PMTA) deadline. However, some have warned that the US Food and Drug Administration (FDA) could use the extra time to make changes to the current guideline, and that anti-vaping groups might take advantage of it to renew pressure.

The court granted the extension request made by the FDA last week to move the deadline back from 11th May to 9th September. It could be crucial extra time for the industry, given the sweeping measures to control the coronavirus pandemic and the difficulties companies across the sector are facing.

“The novel coronavirus outbreak has given rise to a number of challenges for businesses nationwide, our members and the businesses our members depend upon to complete the PMTA process included,” April Meyers, president of the Smoke-Free Alternatives Trade Association (SFATA), said.

She added that “there is simply no way to complete the process on schedule,” especially at a time when facilities had to shut down indefinitely.

According to Mitch Zeller, director of the FDA’s Center for Tobacco Products (CTP), 30 PMTAs for e-cigarette products are pending. “I understand that many manufacturers intend to file applications by May 12, 2020, for a large number of products but are now facing unforeseen obstacles,” Zeller told the Maryland court last week.

 

A double-edged sword

 

However, Ryan Stump, chief operating officer at vaping manufacturer Charlie’s Chalk Dust, is worried that a prolonged delay might open the door to changes in the PMTA process and renewed lobbying by opponents of vaping.

He told ECigIntelligence he viewed the FDA’s request as a double-edged sword “because it allows us more time to increase the number of submissions, but with that comes additional cost and the potential for more FDA scrutiny”.

He added: “We have done everything asked by the FDA up to this point and I would hate to see these requirements change to become less favourable for our products to be approved.”

Stump, whose company has presented PMTA applications for a number of e-liquids, said the 120-day extension “grants the FDA and anti-vape lobbyists the ability to manipulate the current guidelines set forth by the FDA”.

At the same time, the possibility of the PMTA deadline being repeatedly delayed without a clear plan could itself be a drag for companies that have spent months preparing to apply in May.

 

Longer delay called for

 

Many companies, however, had pushed for a longer delay, in part because of the uncertainty surrounding COVID-19 and its extended impact on the global economy.

The Vapor Technology Association (VTA) had requested a delay of at least 180 days for large companies and 270 days for small manufacturers.

Tony Abboud, the trade group’s executive director, set the four-month delay was “a step in the right direction” but that it “likely would not go far enough under the circumstances”.

He said: “We hope that the FDA will revisit the appropriateness of a 9th September 2020 deadline in the coming months and, during this time, seek ways to implement process modifications that will ensure the survival of small businesses and a diverse array of the vapour products on which former smokers now rely.”

 

What This Means: As expected, district judge Paul Grimm gave a green light to the FDA request. It remains to be seen how beneficial the extra time will be for a vaping industry already experiencing hard times since last year’s lung illness outbreak.

The evolution and duration of the current coronavirus pandemic in the US will also determine whether the extension is long enough for manufacturers and if the FDA decides to tighten the current application requirements further.

Julian Hattem ECigIntelligence US correspondent

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