Nicopure et al. File Appeal After Loss Against FDA Regs

Posted by Mitch Clarke on 14th Sep 2017

Following the news of their initial defeat in the U.S. District Courts at the hands of the FDA and Judge Amy Jackson on July 21st, Nicopure Labs and Right to be Smoke-Free Coalition is filing an appeal to once again challenge the FDA's 2016 "deeming" regulations.

On May 10, 2016, we saw the official battle between the regulators and the regulated begin with fresh fervor in the form of a courtroom standoff between Nicopure LLC—a Trinity, Florida manufacturer behind e-liquid brands such as Halo—and the Federal Drug Administration a mere two days after the FDA announced their incoming regulations for the e-cigarette industry.

The Looming Threat

The FDA's "Deeming" Regulations flagged e-cigarettes and their components (e.g. batteries, chargers, and mouthpieces) as tobacco products—despite a distinct lack of actual tobacco present in these devices—making them subject to the PreMarket Tobacco Application requirements already in place for the tobacco industry. 

We believe the FDA is doing a massive disservice to public health," said Jeff Stamler, CEO and co-founder of Nicopure Labs, "and we will keep fighting for the vaping industry to ensure these products will continue to help a growing number of people quit tobacco and start a new, smoke-free life.

These applications have a ridiculous range of required data going far beyond simply stating the company of origin, product labeling, ingredients, and other such traditionally supplied information.

In fact, after paying for the nonclinical and clinical laboratory studies needed to determine ecological, environmental, toxicological, public health, and behavioral impacts, the cost to supply each application with the necessary information can quickly skyrocket out of control.

While the cost to compile a single PMTA is difficult to pin down with exact certainty, estimates can be as modest as the FDA's predicted $300,000/500 man-hours per product application or reach as high as the $5m/1700 man-hours witnessed by news sources across the country. 

This astronomical price tag may be affordable for the major tobacco companies who handle hundreds of billions of dollars in gross revenue annual, but for the independent small-medium e-cigarette businesses composing 99% of the e-cigarette industry (who feel giddy after breaking a mere $1 million in sales), this veritable tax applied to each and every product will force them out of business faster than a grocery store in Houston. 

While many vapers, manufacturers, and retailers alike have taken to the message boards and airwaves to proclaim their disapproval of the looming threat against the modern e-cigarette industry, the case brought before Judge Amy Jackson was the first time a formal argument against the FDA's regulations has been brought forward in a court of law. 

Following the announcement of the upcoming iconoclastic clash, other manufacturers and vaping advocacy groups—including the Right to be Smoke-Free Coalition, the Consumer Advocates for Smoke-free Alternatives Association (CASAA), and many more—emerged from the fog to follow suit, throwing their hat in the ring for Judge Amy Jackson to consider their side of the argument. 

Judge Jackson's Decision

Yet sadly, just last month on July 21st, the honorable Judge Jackson ruled unequivocally in favor of the FDA's decision to continue applying these stringent regulations in such a thoroughly damaging way, reinforcing the justice system's recurring philosophy that although a law may be inadvisable, it's not necessarily unlawful. 

...[B]anning the manufacture or sale of the devices,” wrote Judge Jackson, “ not what the Deeming Rule does or what it was intended to accomplish. In the Deeming Rule, the FDA simply announced that electronic cigarettes, or electronic nicotine delivery systems (“ENDS”) would be subject to the same set of rules and regulations that Congress had already put in place for conventional cigarettes.

Indeed, the reasonings outlined in Judge Jackson's decision reiterate this well-meaning point. 

But it's important to keep in mind that for traditional tobacco products, this PMTA process can easily be postponed for years or waived entirely for any tobacco products already on the market prior to 2007, which would include the vast majority of the harmful products you see behind gas station cashiers or in the pockets of your elderly relatives. 

But for e-cigarettes, a technological trend less than a decade old, such an easy out is simply unobtainable.

Judge Jackson's initial ruling was released a mere week before Dr. Scott Gottlieb, newest head honcho of the FDA, announced the FDA's latest plan of action in dealing with the threat against public health that is tobacco. 

This plan includes many points, such as lowering the nicotine content in cigarettes, educating the nation's youth on the dangers of tobacco, and most importantly, a four-year delay in enforcing the "Deeming" Regulations at all, pushing the time limit back to 2022.

Nicopure's Continued Push

In the wake of this news, Nicopure and R2B Smoke-Free have filed a follow-up appeal with U.S. Court of Appeals in the D.C. Circuit, still confident that a continued legal push will reveal the FDA's "Deeming Rule" to be created in violation of the Administrative Procedure Act as well as infringing upon the First Amendment rights of vapers and manufacturers alike. 

I'm disappointed in the judge's decisions to deny us on every motion, but at the same time, this is just one step in a longer legal battle. We always knew this would end in an appeal, either by the FDA or the industry, said Stefan Didak, Founder & President at

Whether their attempt to retain an objective decision on the matter will succeed, it remains to be seen. 

But vapers and advocates both remain hopeful that the facts of the case will be immediately apparent to a second pair of judging eyes.

With such a daunting threat to a burgeoning industry, it would fly in the face of our free market economy to extinguish a rightful member on merely moral beliefs rather than ineffable fact.