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.