A vaping industry association and a vaping company filed a suit against the Food and Drug Administration in Kentucky federal court seeking to push back the May 2020 deadline for premarket tobacco applications with the agency.

The Washington, D.C.-based Vapor Technology Association and Lexington, Kentucky-based Vapor Stockroom claim the FDA pushing up the deadline to submit the premarket applications to May 11, 2020, is a violation of the Administrative Procedure Act and the Fifth Amendment’s Due Process Clause. The suit, Vapor Technology Association vs. U.S. Food and Drug Administration, is filed in the U.S. District Court for the Eastern District of Kentucky.

The plaintiffs are also seeking an injunction from the court requiring FDA to establish a proposed and final rule governing the submission of premarket tobacco applications, which would allow in-house counsel to better guide the companies through the process.

Azim Chowdhury, a partner at Keller and Heckman in Washington, D.C., who is not involved with the lawsuit, explained the applications require years of data and expensive testing.

“Companies have relied on these deadlines. So now, you can’t just change that and expect studies to be done in less than 10 months,” Chowdhury said.

Chowdhury explained only two tobacco products have ever been approved after the submission of an application: Snus and IQOS, a Philip Morris product.

He said those products had years of data to submit to the FDA. Meanwhile, those in the vaping industry, which has existed for about 10 years, do not have the thorough data the FDA is seeking for the applications.

In July 2017, according to the suit, the deadline for vaping products was extended to Aug. 8, 2022. In June of this year, the deadline was moved up to May 11, 2020.

“FDA failed to give any notice to the public, including industry stakeholders, or to allow public comment prior to proposing the grossly accelerated deadline,” the plaintiffs said in the complaint.

Beyond tightening up the deadline, the plaintiffs say the FDA has not created final rules for the application submissions.

“Throughout 2016, 2017, 2018 and 2019, FDA publicly and repeatedly told all stakeholders that FDA did not have the rules, guidance, and standards in place for companies to move forward with [premarket tobacco] application submissions,” the plaintiffs said.

In June, the FDA issued nonbinding final guidance for vaping and e-cigarette companies on what should be included in the applications. However, there is not a final rule and that guidance may be subject to change.

“Unfortunately, the final guidance document contains significant changes regarding recommended product testing from the draft version published earlier and fails to definitively specify what evidence is or is not required for an acceptable [premarket tobacco application],” the plaintiffs say in the complaint.

Chowdhury said many companies have been waiting to begin the applications because they have been without final and binding guidance on what an acceptable application looks like.

“The reason companies have waited to initiate testing is because FDA could change something in their non-binding guidance documents,” Chowdhury said. “If they only tested for the original set of chemicals, they would have to redo the testing.”

Should the suit be unsuccessful, Chowdhury said, every e-cigarette and vaping company will have to begin their application process. All vaping products are subject to submitting applications.

However, Chowdhury said FDA does have the discretion of which companies to enforce the deadline.

“What that says to me is that come May 11, 2020, FDA can choose who to come after first or who to come after at all,” Chowdhury explained.

He said it is likely FDA’s enforcement priorities would be on those companies who target their products to minors.

A spokesperson for the FDA said it does not comment on possible, pending or ongoing litigation.

Vapor Technology Association and Vapor Stockroom are represented by Robert P. Johnson of Thompson Hine in Cincinnati; Eric N. Heyer and Joseph A. Smith of Thompson Hine in Washington, D.C.; and Stephanie M. Chmiel of Thompson Hine in Columbus, Ohio. Heyer, who was referred to for comment by another one of the plaintiffs’ attorneys, declined to comment beyond the complaint.