VAPOR TECHNOLOGY ASSOCIATION FILES MOTION FOR PRELIMINARY INJUNCTION IN LAWSUIT AGAINST FDA TO DEMAND PMTA RULE AND APPROPRIATE SMALL BUSINESS DEADLINE
September 11, 2019
WASHINGTON D.C. – September 10, 2019 – Today, the Vapor Technology Association (VTA) and Vapor Stockroom (VSR) announced that they filed their motion seeking a preliminary injunction in their lawsuit against the Food & Drug Administration (FDA). The VTA and VSR have requested, and FDA has agreed, to an expedited briefing schedule on the motion.
There are two primary goals to the motion and lawsuit: (1) demand that FDA publish the actual proposed Pre-Market Tobacco Application rule (“PMTA Rule”) that industry has been waiting on for 3 years; and (2) establish a deadline that allows companies, particularly small businesses, the chance to comply with the still unwritten PMTA Rule.
Last month, the VTA and VSR filed a federal lawsuit against FDA over the constantly changing PMTA deadline and process. The industry should never have had to file a lawsuit to demand that FDA engage in the legally required notice and comment period regarding the creation of a PMTA Rule, before imposing the deadline for compliance with the same rule.
The Motion explains through expert testimony that without an injunction, the vapor industry – an industry that is the size of the iron and steel forging and the commercial fishing industries in the U.S. – faces a near-complete shutdown in May of 2020. Scientific expert testimony also explains that there are at least ten reasons why companies cannot conduct and complete the myriad tests, research studies, and surveys that FDA is demanding within the arbitrarily selected ten-month deadline. A link to the preliminary injunction motion and supporting brief can be found here.
Maintaining a May 2020 deadline for filing PMTAs will result in the dangerous scenario that the FDA itself has said “should be avoided if at all possible.” “What makes this motion so compelling is that the FDA already has warned that ‘dramatically and precipitously’ removing vapor products from the market will lead to the ‘mass market exit’ of vapor products which, according to FDA, will lead to an increase in smoking, something that FDA testified is a public health outcome that ‘should be avoided if at all possible,’” explained Tony Abboud, Executive Director of the Vapor Technology Association.
“Our company, and our industry in general, has for the past three years been complying with every regulation and every deadline set by the FDA. As a result, FDA already knows the ingredients that are found in each and every one of our products. But, when FDA has failed to even publish the draft, much less final, PMTA regulation, and is imposing an impossible 10-month deadline for complying with that still unwritten rule, we had to ask the Court to intervene,” said Tony Florence, President of Vapor Stockroom.
Anyone advocating for the ‘mass market” removal of vapor products should heed the FDA’s own sworn testimony. The preliminary injunction motion, if granted, would prevent a mass exit of vapor products from the U.S. market, the closure of thousands of businesses nationwide, and the loss of tens of thousands of jobs. Even worse, the devastating threat of increased smoking if vapor products are removed from the market, is compounded by the very real dangers of the black market activity which public health experts have predicted would follow the removal of vapor products.