More Appeals Filed Over FDA’s Deeming Rules
Lawyers representing Nicopure Labs and the Right to be Smoke-Free Coalition began the formal process of challenging a recent decision by a US District Court
Just last week, more fire was added to the already hotly contested deeming rules debate. Lawyers representing Nicopure Labs, who makes Halo E-Liquids, and the Right to be Smoke-Free Coalition filed an appeal to the decision made last July by a district court judge from the District of Columbia. It was filed in the U.S. Circuit Court of Appeals in D.C. and aims at stopping the controversial FDA deeming rules once and for all. The attorneys with the Keller and Heckman law firm claim that the FDA had not only violated the First Amendment, but also the Administrative Procedures Act when they decided to extend the existing tobacco regulation on e-cigarettes.
They believe that by “deeming” vaporizers the same as cigarettes, they falsely created an image of vaping as similar in risk to smoking. While this is a complicated and far-reaching problem, their hope to at least relieve the burden created by the Premarket Tobacco Product Application. If they’re unsuccessful, it will be a significant blow to the independent vaping community, while giving a distinct advantage to Big Tobacco companies who are looking to steal some of the vaping market. The FDA has until April 18th to submit a rebuttal, setting up a critical battle in the fight for vaping rights.
The Appeal and Amicus Briefs
The filed appeal makes a note of two significant issues, “(1) the Modified Risk Tobacco Product (MRTP) provision of the TCA [Tobacco Control Act], as well as the ban on free samples of vapor products, violate the First Amendment of the U.S. Constitution, and (2) FDA was obligated to consider a less burdensome Premarket Tobacco Product Application (PMTA) process for vapor products while still protecting the public health.” In an effort to support these claims made by Nicopure and R2BSF, several amicus briefs have been submitted by groups ranging from a US Attorney General to renowned tobacco control experts.
Amicus briefs are official statements of support for one side of a legal fight. Meaning, “friend of the court” in Latin, these briefs are often used to help give context to an important issue or explain the significance of different meanings. In total there were over ten amicus briefs filed by NJoy, the Washington Legal Foundation, Consumers Advocates for Smoke-Free Alternatives, Clive Bates, the Attorney General of Iowa, and Konstantinos Farsalinos, just to name a few. Many of these briefs focus on how flavors are vital to the effectiveness of vaping as a smoking cessation tool, or how vaping and smoking are two entirely different processes. But it’s worth noting that the FDA will probably receive their own amicus briefs to help even things out.
This isn’t the first fight over the controversial FDA deeming rules, in fact, this appeal is only occurring because a previous attempt to get the rules thrown out came up short. Back in July of last year, a District Court Judge in Washington D.C., Amy Berman Jackson denied all the requests made the vaping industry. She said she believed vaping should be subject to the same set of rules put in place by Congress to regulate combustible cigarettes. While this was a significant blow to vapers everywhere, they received a valuable consolation prize the following week when FDA commissioner announced that the implementation of the deeming rules would be delayed until 2022, instead of August of 2018.
It’s not just this new lawsuit either. Earlier this year, the Pacific Legal Foundation filed lawsuits in three different locales to challenge the implementation of the deeming rules. Unfortunately, this delay doesn’t help any devices created after August 8th of 2016, which still require a Pre-Market Tobacco Application to be legally sold, even in spite of the four-year delay. That is unless one of these latest litigations are successful. One such fight is a push by advocates to get the Cole-Bishop predicate approved, which would grandfather in any devices made before August 8th of 2016, even after the 2022 deadline.
The deeming rules are so unpopular in the vaping community for a reason. They unfairly equate vaping with smoking, leading to a large number of people who don’t understand that vaping is much safer. A poll by Action on Smoking and Health found that only 13% of adults think that vaping is much safer than smoking, while 26% believe that vaping is just as, if not more dangerous. These figures simply have to improve if we’re ever going to stop smoking once and for all.
While this particular legal battle may likely end in another defeat, it’s crucial that we keep pushing for our vaping rights. It’s been proven that vaping is one of, if not the best tool we have in the fight against smoking, so treating it as merely an alternative form of tobacco is both short-sighted and factually wrong. We must support legal action like this if we ever hope to live in a world that isn’t mired by tobacco. Tell the FDA that vaping needs to be supported, not regulated.
Do you think a legal battle like this is key to winning the fight for vaping rights? What’s the most critical difference between smoking and vaping in your opinion? How can we work toward a world in which more people understand the real risks of vaping? Let us know in the comments.