When the final Deeming Rule was published back in May 2016, it became immediately clear that FDA had generally ignored the industry’s comments and concerns, and that the vapor industry was, effectively, going to be banned in the United States in two years. Litigation was inevitable. A number of lawsuits were indeed soon filed by individual companies, including Nicopure. But, the importance of this case goes far beyond any one company, which it why it was necessary for the industry to come together, in unprecedented fashion for the vaping community, to join in the lawsuit to make sure the industry’s concerns were heard.
Lead by the Right to be Smoke-Free Coalition, numerous international, national and state trade associations joined forces as named plaintiffs in lawsuit, including the American E-Liquid Manufacturing Standards Association (AEMSA), the American Vaping Association (AVA), the Electronic Vaping Coalition of America (EVCA), the Georgia Smoke Free Association (GSFA), the Kentucky Smoke Free Association (KFSA), the Louisiana Vaping Association (LAVA), Maryland Vape Professionals (MVP), the Ohio Vapor Trade Association (OHVTA), the New Jersey Vapor Retailers Coalition (NJVRC) and the Tennessee Smoke Free Association (TSFA). Also supporting the lawsuit are the Shenzhen E-Vapor Industry Association-USA (SEVIA-USA), the largest single contributor to date, the Smoke-Free Alternatives Trade Association (SFATA), the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) and NOT Blowing Smoke (NBS). This, of course, is in addition to the hundreds of individuals, companies, and vape shops that have contributed to the legal fund to fight this battle.
Since I became involved with the vaping industry in 2009, I have never seen the industry come together like this. But the battle is far from over. We filed the industry lawsuit in June in the District Court in Washington, DC – the leading court for administrative law cases like this – which was consolidated with Nicopure’s lawsuit. For a detailed summary of the industry lawsuit, see here:
In short, we argued that FDA’s Deeming Regulation was itself a violation of several laws specifically designed to keep federal agencies from overreaching, including the Administrative Procedures Act, the Regulatory Flexibility Act and, of course, the U.S. Constitution itself. After our cases were consolidated, Nicopure and the Right to be Smoke-Free Coalition filed separate motions of summary judgment, which are summarized in detail here:
Among other things, we argued that FDA’s decisions to not change the February 15, 2007 Grandfather Date for e-vapor products and to only give the industry a mere two years to prepare Premarket Tobacco Product Applications, which requires numerous non-clinical, clinical and long-term studies, was arbitrary and, because it would result in an effective ban, not what Congress could have intended. Rather, Congress intended FDA to exercise more flexibility authority so that relatively less risky products, like e-vapor products, could remain on the market and be available for adult consumers.
Not surprisingly, FDA hit back hard, filing its own cross motion for summary judgment, which was supported by numerous NGOs including the Campaign for Tobacco-Free Kids. FDA argued that it acted within its authority, and used a lot of outdated and/or debunked science to support its position. Briefing went back and forth until September 8, 2016. Subsequently, the Court held oral arguments on October 11.
At the hearing before Judge Amy B. Jackson, which was well attended by numerous Coalition members, we made our case and answered the Judge’s many tough questions. We cannot speculate as to how she might rule, but she was very knowledgeable and asked good questions of both sides. In fact, a couple of weeks later, the Judge ordered both sides to file a supplemental brief on the question of zero-nicotine e-liquids. She wanted to get our take on whether the issue was “ripe” for review (we believe so!) and how these products could be marketed given the stringent rules for modified risk tobacco products. We filed our joint response with Nicopure on November 1.
We hope the judge will issue a decision in the next few months. Depending on how she rules on each issue, there will almost certainly be an appeal to the DC Circuit Court of Appeals. No matter what happens, the Right to be Smoke-Free Coalition will be prepared – but we need the industry’s continued support. To learn more about the Coalition and how to contribute to the legal fund, please visit www.r2bsmokefree.org.
Companies interested in obtaining additional information on the Right to be Smoke-Free Coalition and the FDA lawsuit should contact:
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For more information on Keller and Heckman’s tobacco and e-vapor regulatory practice visit www.khlaw.com/evapor
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