As we reported last July, District Court Judge Amy Berman Jackson denied all of the vaping industry’s arguments in her decision, and even added a bizarre message to vapers, assuring us the Deeming Rule only meant that e-cigs “would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.”
Judge Jackson delivered her decision on July 21, just one week before FDA commissioner Scott Gottlieb announced that the final deadline of the agency’s Deeming Rule — the August 8, 2018 deadline to submit PMTA’s, or exit the market — would be postponed for four years, giving vape manufacturers a much-needed legal reprieve.
However, the four-year delay by the FDA doesn’t change the Deeming Rule’s predicate date. Products made after February 15, 2007 still face extinction after August 8, 2022. And there is still no way for manufacturers to introduce products made after August 8, 2016 without first receiving a marketing order from the agency. A marketing order requires submission of a PMTA, which could cost millions of dollars, and in no way guarantees approval.
There are several other lawsuits challenging the Deeming Rule. In addition to multiple pending actions filed in 2016, several small vaping businesses filed lawsuits in three separate jurisdictions last month, supported by the Pacific Legal Foundation.
But lawsuits take a long time, and even if one or more of them is successful, the FDA and Justice Department would likely appeal themselves, leaving thousands of small vaping businesses with an uncertain future, possibly for many years. That uncertainty itself may be deadly to the small vapor industry.
Meanwhile, vaping advocates are making a final push for support for inclusion of the Cole-Bishop predicate date change in the budget bill that will be finalized in the coming weeks. If the language is included in the budget, all vaping products that were on the market before August 8, 2016 would be grandfathered. They wouldn’t have to go through the crushing PMTA process, and wouldn’t have to depend on judges and the legal system.
There are two ways to send messages to your elected officials now. You cansupported by the Pacific Legal Foundation visit www.August8th.org or message CASAA AUG8 to 52886 on your phone. Please take one minute today to help save vaping.