Today, the Vapor Technology Association (VTA) and Vapor Stockroom (VSR) filed a lawsuit in federal court against the U.S. Food & Drug Administration (FDA), amongst others, over its unreasonable and arbitrary Pre-Market Tobacco Application (“PMTA”) process and the recently grossly accelerated PMTA filing deadline. Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs. In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized.
With over 3 million vapor products registered with FDA, 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, particularly in the absence of a draft or final PMTA Rule. Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA.
Since 2016, FDA has provided five different PMTA submission deadlines: August 8, 2018; November 8, 2018; August 8, 2022; August 8, 2021; and now May 12, 2020. The most recent deadline was only just established on July 12, 2019 – leaving a scant ten months for vapor industry manufacturers to attempt to comply, which is now 27 months earlier than previously set by FDA.
“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful. 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, 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,'” said Tony Abboud, Executive Director of the Vapor Technology Association.
The PMTA application is by far the most arduous of the many regulatory requirements governing ENDS products, and requires a complex, multi-year, multi-million-dollar process that FDA has still failed to fully articulate despite its repeated promises to do so. “To be clear, no business could rationally have been expected to start conducting complex PMTA testing before FDA finally published its PMTA guidance document on June 11, 2019, the day before it asked the Court to impose a 10-month PMTA deadline,” said Abboud.
The stark facts set forth in the Complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out on June 11, 2019, by the May 2020 deadline.
“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. 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,” said Tony Florence, President of Vapor Stockroom, LLC. “It’s a devastating one-two punch to small businesses all over the country,” he added.
“It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses,” said Abboud. “FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette. Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits,” he added.
The plaintiffs in the case are Vapor Technology Association and Vapor Stockroom, LLC. The plaintiffs are represented by Thompson Hine LLP as counsel. The case, titled Vapor Technology Association, et al. vs. Food & Drug Administration, et al. has been filed in the United States District Court for the Eastern District of Kentucky. The case number is not yet assigned but a link to the filing can be found here.
The Vapor Technology Association is the leading U.S. non-profit industry trade association whose 800+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hard-working American brick-and mortar retail store owners throughout the United States.
Vapor Stockroom is a Lexington, Kentucky manufacturer of nicotine-containing e-liquids and currently manufactures 40 distinct lines. It employs thirteen people and sells its products in local retail stores, online, and through distribution to vape shops and tobacco specialty stores nationwide.