August 15, 2019

FDA Sued by Vape Industry Over New PMTA Deadline

The Vapor Technology Association has filed suit in federal court against the FDA and the Department of Health and Human Services. Trade organization VTA and one of its member businesses, Vapor Stockroom, are asking the court to prevent the agency from enforcing its new May 11, 2020 deadline for submission of premarket tobacco applications (PMTAs) by vaping manufacturers.

The legal complaint was filed in the United States District Court for the Eastern District of Kentucky, in Lexington.

VTA is asking the court for “preliminary and permanent injunctive relief,” forcing the FDA to

Propose and finalize a rule governing the submission of PMTAs
Set a reasonable deadline for the filing of PMTAs, after the agency gives notice of a finalized rule, and allows a public comment period
Not take enforcement action against legal vape products until after the new deadline for filing applications
Not take enforcement action based on the recent court-imposed May 2020 deadline

“Absent prompt intervention by the Court, the overwhelming majority of the vaping industry, including over 160,000 jobs at small- and medium-sized businesses, will be destroyed,” the VTA complaint states.

There are more than three million vaping products registered with the FDA by domestic manufacturers. According to the VTA, “the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses.”

“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful,” said VTA executive director Tony Abboud. “The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act.

“Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime,” Abboud added, “but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that 'could adversely affect the public health.’”

According to the lawsuit, there are not enough labs or even enough hours in the day for manufacturers to complete the scientific testing and analysis required by the FDA before the May 2020 deadline. That would be true even if only a small portion of vape manufacturers sought premarket approval.

How did we get here? The history of the PMTA deadline

The May 2020 deadline for PMTA submission was ordered by U.S. District Court Judge Paul W. Grimm on July 12, after the judge ruled in favor of several special interest groups that sued the FDA over its extension of the original PMTA deadline. The FDA told the court that it would be unable to prepare for thousands of PMTA submissions in less than 10 months—and that is the length of time the judge gave the agency, and the vaping industry.

The original deadline for submission of PMTAs, imposed as part of the FDA’s 2016 Deeming Rule, was Aug. 8, 2018. In July 2017, newly appointed FDA Commissioner Scott Gottlieb announced the deadline would be postponed until Aug. 8, 2022 to allow the FDA time to create and finalize what the agency said would be “foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers.”

Then came the moral panic over youth vaping, and Gottlieb shifted from somewhat skeptical supporter of vaping as an alternative for adult smokers to an enthusiastic cheerleader for the widespread public fear and confusion over teen vaping that he called an epidemic. In March 2019 the agency announced it would move up the deadline to submit PMTAs for flavored products from 2022 to 2021.

But before FDA could even finalize that 2021 deadline, the agency’s PMTA deadlines were all invalidated by Judge Grimm’s decision. More than two years after promising “foundational rules” to make the product review process clear, the FDA waited until Judge Grimm forced it to act, and then delivered more confusing guidance on PMTA submissions.

After Grimm issued the 10-month deadline for PMTA submission, FDA Acting Commissioner Ned Sharpless announced the agency would not appeal the decision. “Let me be clear with the tobacco industry: responsible manufacturers certainly don’t need to wait 10 months to act,” Sharpless said.

“Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards,” said Tony Florence, president of Vapor Stockroom LLC, the Lexington, Kentucky e-liquid manufacturer that is VTA’s co-plaintiff on the lawsuit against the FDA.

“We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business,” Florence said. “It’s a devastating one-two punch to small businesses all over the country.”

Jim McDonald

Vaping for: 13 years

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Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

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Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue 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’m a member of 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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