LAKEVILLE, Minn. —The Vapor Technology Association (VTA), along with one of its members, filed suit Aug. 14 against the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (DHHS) in federal court seeking preliminary and permanent injunctive relief to prevent the FDA from enforcing its new deadline of May 11, 2020, for manufacturers to submit premarket tobacco product applications (PMTAs) for nicotine vapor products.
VTA alleges that the FDA’s proposed new PMTA process and deadline are “unreasonable and arbitrary” and compliance would be impossible for many manufacturers, particularly medium and small businesses affected by the decision.
The FDA published its PMTA guidance document that lays out the process June 11, one day before a ruling in a lawsuit from the Federal District Court for the District of Maryland. That litigation, American Academy of Pediatrics, et al, v. FDA, is a lawsuit brought by health-related tobacco control groups who argued against FDA’s extension of product application deadlines for vapor products to August 2022. Following the decision by Judge Paul Grimm, FDA indicated it would move forward with the new application deadline of May 11, 2020. In addition, a coalition of trade associations are seeking to intervene in the Maryland case both to appeal the final judgment and participate in any post-judgment proceedings.
This new case against the FDA was filed by VTA and one of its Kentucky members, Vapor Stockroom, in the Federal District Court for the Eastern District of Kentucky.
“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful,” said Tony Abboud, executive director of the VTA, Washington, D.C. “The agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedures Act.” According to the VTA, since the FDA began regulating vapor products as of August 2016 under the Family Smoking Prevention and Tobacco Control Act, the FDA has provided five different PMTA submission deadlines.
More than 3 million new vapor products have been registered with the FDA. With the June 2019 final guidance still leaving some questions unanswered about the requirements for a complete PMTA to be filed, many manufacturers are not likely to have the necessary time and financial resources needed to complete any tests required by the FDA. Even if the process proves to be more affordable than many expect, manufacturers have indicated that there simply are not enough laboratories or experts to complete all the work necessary for the large number of likely applications within the abbreviated deadlines.
Thomas Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at firstname.lastname@example.org.