Federal Judge Strikes Down FDA's Postponed PMTA Deadlines

A federal judge has invalidated the FDA’s delayed premarket review deadline for vaping products, and ordered the agency to make plans to begin processing premarket tobacco applications (PMTA’s) soon.

The plaintiffs and the FDA will each have a 14-day period to submit plans for speeding the review process to U.S. District Court Judge Paul Grimm, after which the judge will decide on a timeline. The decision can be appealed by the FDA, which is what many observers expect to happen. It’s unknown if the agency would attempt to appeal before the final ruling, which would be somewhat unusual.

The announcement caused fear and apprehension in the vapor industry. No vaping company has submitted a PMTA, in part because of the extreme cost of the required research and analysis (estimated to be more than $1 million per application), but also because the FDA has still not produced detailed guidance on what would constitute a successful application.

The agency promised in 2017 to issue “foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers” — but those rules still haven’t been published. Because of the uncertainty that any manufacturer could correctly anticipate what the FDA considers “appropriate for the protection of public health,” even the largest, wealthiest e-cigarette companies like JUUL Labs have avoided taking the PMTA plunge. Of course, most vape businesses are not large or wealthy.

That essential backstory seems to have been ignored by Judge Grimm, who explained in his decision that the FDA’s premarket review deadline delay was “so extreme as to amount to an abdication of its statutory responsibilities.” Because the FDA changed the deadline for submission of PMTA’s without going through the rulemaking process mandated by the Administrative Procedure Act, the agency may be forced to follow deadlines imposed by the court.

The decision in large part reads like a political statement on the vaping menace. The judge even prefaced his decision with “facts” about the so-called vaping epidemic that could have been copied and pasted from any anti-tobacco group’s press releases.

“As it turns out, even addiction has become electronic,” wrote Grimm. “And not only among adults, but particularly for teenagers (and younger kids). Especially, as manufactures of e-cigarette products have learned, if they are fruit or dessert flavored, and marketed as cool and alluring.”

The judge then placed the blame for thousands of small vaping businesses potentially being forced to shut their doors squarely on the vape vendors themselves, noting that "manufacturers long have been on notice that they will have to file premarket approval applications...and if they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making."

But vaping manufacturers have begged the FDA to issue guidance that could help the industry navigate the review process. The FDA has been operating without written rules for premarket applications since the Deeming Rule went into effect. The process until now has involved private meetings with manufacturers where the agency has offered informal advice on applications.

The FDA is simply not prepared to review the thousands of applications that could be submitted by vape manufacturers. And it is certainly not ready to enforce its rules on the huge black market that would pop up quickly if every independent vaping manufacturer was forced out of business.

The lawsuit was filed in March 2018 in the U.S. District Court in Maryland. The plaintiffs are five pediatricians and seven organizations, including the American Academy of Pediatrics, Campaign for Tobacco-Free Kids, the American Cancer Society Cancer Action Network, and the heart and lung associations.

The original deadline for vaping manufacturers to submit PMTA’s was Aug. 8, 2018, as specified in the FDA’s 2016 Deeming Rule. But in July 2017, newly appointed FDA Commissioner Scott Gottlieb announced that the agency would postpone the requirement until Aug. 8, 2022. (The date was recently revised again and moved up a year, to 2021, for flavored products other than tobacco, mint and menthol.)

The FDA is likely to appeal the ruling because it is not ready to handle a deluge of applications or to control a black market, but also because it zealously guards its power. No federal agency wants judges stepping in and telling it what to do and when to do it. The implications for the FDA could extend beyond just this case.

If the decision is not appealed, it is likely that the judge will send the FDA back into the rulemaking process, where any court-imposed deadline will still be subject to the usual public comment period, White House review, and revisions. The process could take a year or more.

Whatever happens next, this lawsuit illustrates that the FDA imposed the Deeming Rule without ever expecting to actually have to review a large number of products. The agency never expected the independent vaping industry to survive beyond its shock-and-awe deeming announcement. The FDA was never prepared to actually follow through on the procedures it put in place, and now it's stuck. What will it do next?