A coalition of state and national vapor trade associations[i] has moved to intervene in and appeal the District Court for the District of Maryland’s decision in American Academy of Pediatrics, et al. v. FDA, Case No. 8:18-cv-00883, which drastically accelerated the Premarket Tobacco Product Application (PMTA) deadline for vapor products to May 11, 2020. The trade associations moved to intervene on August 9, 2019 for the purpose of appealing the final judgment, including the May 15, 2019 merits opinion as well as the July 12, 2019 remedy decision, and to participate in any post-judgment proceedings. The trade associations are also seeking to stay the remedy decision, which started the 10-month PMTA clock, pending the outcome of the litigation, and have separately filed a Notice of Appeal of Judge Paul W. Grimm’s May 31, 2019 Letter Order denying their initial attempt to intervene on the remedy issue.[ii] The District Court has ordered briefing of all issues be completed in September, and briefing before the Fourth Circuit is expected to begin soon.
In a separate case, on August 14, 2019, The Vapor Technology Association, along with one of its Kentucky-based members, Vapor Stockroom, filed a lawsuit against FDA in the District Court for the Eastern District of Kentucky. VTA is seeking preliminary and permanent injunctive relief to prevent FDA from enforcing the new May 11, 2020 PMTA deadline. VTA is requesting, among other things, that FDA propose and finalize a long-awaited rule governing the PMTA submission process, comply with the Administrative Procedure Act and notice-and-comment-rulemaking procedures to set a reasonable PMTA deadline, and that it use its discretion not to enforce against companies that have not filed PMTAs until after a new deadline has been finalized. For more information on the VTA lawsuit, see here.
We will keep you updated on these cases as they progress.
[i] The proposed intervenors include the American E-Liquid Manufacturing Standards Association; American Vaping Association; Arizona Smoke-Free Business Alliance; Indiana Smoke-Free Association; Iowans for Alternative to Smoking and Tobacco; Kentucky Smoke-Free Association; Maryland Vapor Alliance; New York State Vapor Association; Ohio Vapor Trade Association; Right to be Smoke-Free Coalition; Smoke-Free Alternatives Trade Association (SFATA) and its state chapters; Tennessee Smoke-Free Association; and Texas Vapor Coalition.
[ii] Also seeking to intervene on the remedy issue with the trade associations were Juul Labs, Inc., NJOY LLC, CASAA, John Middleton, Co., and ITG Brands. In denying intervention (before the parties even filed motions to intervene), Judge Grimm instead permitted the industry stakeholders to file a single consolidated 15-page amicus brief, available here.