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July 13, 2019

Vape Manufacturers Must Submit PMTAs in 10 Months or Shut Down

Vaping manufacturers must submit premarket tobacco applications (PMTAs) within 10 months or remove their products from the market, according to an order issued today by federal District Court Judge Paul W. Grimm.

The judge struck down the FDA’s 2017 guidance in May, agreeing with plaintiffs that the agency’s 2022 PMTA deadline (which extended the due date for applications from 2018) was issued without following the rulemaking process mandated by the Administrative Procedures Act, and that the four-year delay the FDA granted vaping manufacturers was “so extreme as to amount to an abdication of its statutory responsibilities.”

In his 12-page order, the judge said manufacturers who submit an application within 10 months—by May 11, 2020—will be able to leave products on the market for up to one year while the FDA considers the application. He also said the FDA can exempt products from the application requirements “for good cause,” on a case-by-case basis.

The FDA now has 30 days to file a Notice of Appeal, and to ask the 4th Circuit Court of Appeals to stay (postpone) Grimm’s decision during the appeal. Many industry observers think the FDA and Department of Justice will challenge the ruling, because it usurps powers granted to the executive branch of government.

Others think the FDA will not appeal, because the judge’s decision will accomplish what the agency has sought all along: to reduce the vape industry to a few large companies (primarily tobacco companies).

In a statement, acting FDA Commissioner Ned Sharpless seemed to indicate the FDA may not appeal. “Today’s ruling is an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth,” Sharpless said.

No vape manufacturer has submitted a PMTA, because of the excessive cost of the research and analysis required (estimated at more than $1 million per application). Additionally, FDA had not even published final guidance for manufacturers until last month, when it did so under pressure from Judge Grimm.

Nothing in the FDA guidance document offered any hope for small manufacturers. It would be a fool’s errand to gamble millions of dollars on applications that are unlikely to meet the high bar of proving that products are “appropriate for the protection of public health.”

The lawsuit against the FDA was filed in March 2018 by a group of plaintiffs that includes the American Academy of Pediatrics (AAP), American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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Michael
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Michael

This is just another way to hurt the people we the people have no rights we are all slaves and we will never have a say in anything as long as the government keeps control over everything if the fda really gave a shit they would have banned cigarettes a long time ago but they are steadily making a mint

Sarah Lish
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Sarah Lish

I’m curious as to how the FDA will regulate 0mg vape liquid. It is not a tobacco product. Granted, it is a vaping product but since it has no nicotine how can the FDA deem it a “tobacco product”. I understand that pod devices come with a manufactured pre-filled cartridge that contains nicotine so those devices should be included but strictly vape liquid that does not contain nicotine can not and should not be included. I have yet to see anything either in the 23 pages of guidelines the FDA published or in Judge Grimm’s ruling that takes 0mg vape… Read more »

Ronnie
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Ronnie

If it is sold in a vape shop and the vape shop sells nicotine additives it will be classified as a nicotine product it does not have to contain nic just be sold where they sell the nicotine.

Raymond Schlogel
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Raymond Schlogel

As someone who smoked two packs of Newport for over thirty years I am

Jason Breens
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Jason Breens

Hi all. Im not entirely sure as to how localised to the USA or universal will this ruling effect. By requesting manufacturers withdraw these products from the market, surely can only be enforced to manufacturers and vape shops based in America – and not globally. The FDA has no juristiction in other countries so surely the online/external market will continue as normal, but the localised industry will suffer!?

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