A flurry of Amicus briefs was filed this week from multiple organizations in support of the plaintiffs in the historic NJOY and Right to be Smoke-Free Coalition legal appeal over the FDA deeming regulations. The Amicus briefs should not be confused with the recently filed opening briefs by the plaintiffs’ lawyers last week. The legal term amicus curiae literally means “friend of the court,” and these types of documents are often filed in court cases by third parties who feel that they have information which might be pertinent to the case.
This week, the U.S. Court of Appeals in Washington DC received separate briefs from such reputable institutions as the Washington Legal Foundation (WLF), the Consumer Advocates for Smoke Free Alternatives Association (CASAA), and even the Attorney General from the state of Iowa. Co-plaintiff NJOY and former Director General of Wales Clive Bates also offered additional briefs.
The NJOY/Right to be Smoke-Free Coalition lawsuit is historic. Just days after the FDA deeming regulations were announced in May of 2016, NJOY filed a lawsuit claiming that the rules were unconstitutional. Among their many assertions, the plaintiffs state that the new regulations violate retailers’ first amendment rights of free speech. The Right to be Smoke-Free Coalition and several other organizations filed similar lawsuits shortly thereafter, and the presiding Judge Amy Berman-Jackson eventually consolidated many of them into a single case in July 2016.
Almost a year later, that same judge issued a 93-page decision which essentially sides with the FDA. The ruling is considered a blow to the American vaping industry, but not totally unexpected. The case is heading into appeal with lawyers for the plaintiffs recently filing opening briefs in early February.
Overview of the Amicus filings
The Washington Legal Foundation is a non-profit that tends to focus on legal issues involving free enterprise, free speech rights of individuals and businesses, limited government, and the rule of law. The WLF amicus brief alleges that the requirement for retailers to obtain FDA approval for “modified risk” claims essentially violates their rights of protected speech. The WLF further claims that the FDA has no legal authority to forbid retailers from marketing or advertising their products as smoking cessation aids or tobacco harm reduction tools. Moreover, the deeming rule is harmful to public health by limiting the amount of truthful information available regarding the health benefits of vaping for smokers who are trying to quit.
The NJOY brief contains language that is somewhat more expressive. While also taking aim at first amendment rights, the NJOY document also takes issue with the Pre-Market Tobacco Application (PMTA) process, claiming that it is essentially “a government-imposed gag order” that simultaneously perpetuates the spreading of misinformation about vaping.
The State of Iowa brief also supports the first amendment and PMTA arguments while also calling into question why the FDA is regulating e-cigs in the very same way as combustible tobacco products. The amicus brief clearly states that the Iowa lawmakers felt “compelled to defend its strong interest in reducing the number of Iowans who smoke combustible tobacco products” and that Iowans should know that “the difference between combustible cigarettes and non-combustibles, like e-cigarettes, is dramatic”.
The CASAA brief also mentions many of the same points and arguments of the other amicus filings while also offering important information about the health benefits of e-liquid sampling in local vape shops and the wide variety of available e-liquid flavors currently on the market. CASAA may be planning ahead for what many believe is a coming attack on the vaping community that may take the form of a FDA flavor ban nationwide.
Related Article: FDA Chief may have just threatened vaping a 42-word tweet
The Clive Bates brief was particularly noteworthy in that the document was signed by multiple leaders of the international vaping community including many of the world’s leading physicians and scientists. Pro-vaping advocates like Konstantinos Farsalinos, Riccardo Polosa, Michael B. Siegel, David Sweanor and many others collectively assert that the FDA deeming regulations will backfire. By making the sales of electronic cigarettes more burdensome for retailers, the FDA is essentially driving millions of Americans back into the arms of Big Tobacco. Because the FDA deemings lump e-cigs and combustible tobacco products into the same category, they are sending a subliminal message to the general public that both are equally as deadly.