Just days after the release of the FDA deeming regulations, Nicopure Labs filed a lawsuit claiming that the rules are unconstitutional on so many levels. The foundation of their legal argument stems from an FDA-mandated predicate date requiring all manufacturers of vaping products and electronic cigarettes released to market after February 2007 to adhere to a very costly and time-consuming Pre-Market Tobacco Applications (PMTA) process.
Because the new deeming rules reclassify e-cigs as tobacco products, the American vaping industry is essentially being forced to follow the save FDA approval process as Big Tobacco. The trouble is that the e-liquids used in vaping devices are 100 percent tobacco-free.
Based on these legal assertions, Nicopure Labs claims that the FDA deeming regulations violate the First Amendment to the U.S. Constitution - the right to free expression, freedom of speech, freedom of assembly and freedom of religion. After a series of initial court proceedings, Judge Amy Berman Jackson consolidated the lawsuit to combine with eleven similar filings by other vaping advocates, one of which is the Right to be Smoke-Free Coalition.
Meanwhile, the FDA counter argues that the public health agency already has the federal authority to regulate all “parts” and “components” of tobacco products, which – in theory - legally extends to vaping devices and e-liquids. The agency even posits that it can regulate zero-nicotine vape juices as well as all individual “components” of open-system devices, should it choose to do so. Following this line of thinking, the FDA has the legal authority to regulate coils, wicks, and even batteries, many of which are used in the production of other non-vaping products.
When Judge Jackson finally handed down a ruling last July, she sided with the FDA. In her 93-page summation, she made the following proclamation.
"The Rule requires manufacturers to subject their products to review before marketing them, to tell the truth when making any claims about their health benefits, and to warn consumers about the dangers of nicotine when offering a means to deliver the substance to consumers. In short, the manufacturers of e-cigarettes are now required to tell the 30 million people who use the devices what is actually in the liquid being vaporized and inhaled.”
Nicopure, the Right to Be Smoke Free Coalition, and numerous other plaintiffs immediately filed an appeal. If the appellate court also sides with the FDA, then the case might eventually make its way to the U.S. Supreme Court.
Unfortunately, this years-long court battle is taking a financial toll on the plaintiffs. A Go Fund Me campaign named #FUNDTheSUIT is now in the works where vaping enthusiasts, loyalists, and advocates can contribute small or large financial donations to help keep the appeal process alive.
“In order to pay for the hard work done so far, and to see the appeal all the way through – possibly to the Supreme Court – will conservatively cost $250,000 in legal fees, time, filings, preparations and a variety of other items.”
At the time of this writing, 902 members of the vaping community have donated over $147,000 to the #FUNDTheSUIT campaign in just the first eleven days. The attorneys Keller and Heckman estimate that it will take $250,000 or a quarter of a million dollars to ensure that the appeals process continues all the way to the Supreme Court. The campaign is still about $100,000 short.
All vaping enthusiasts are encouraged to give whatever they can afford to help fund this historic lawsuit. Every donation is welcome, no matter how small. To make donations to the #FUNDTheSUIT campaign, please click the below link. The War on Vaping is real. Please get involved to help save vaping before it’s too late.