From the Desk of the General Counsel: Response to the FDA’s Deeming Rule

From the Desk of the General Counsel: Response to the FDA’s Deeming Rule

D-Day is here! The Food and Drug Administration (FDA) issued its long awaited rule, which now brings vapor products under the umbrella of the Tobacco Control Act. The following are some thoughts and information in the wake of what quite possibly one of the most devastating decisions affecting public health in the United States:

Although many in the vaping industry were surprised by the outcome of the ruling, Nicopure Labs has been preparing for months. As most lawyers will tell you, the FDA is rather limited in what it can, and cannot do under the Tobacco Control Act. Rather than thinking in “good” or “bad” terms – and, to be clear, this is very “bad” – let us pause and place it context, as a prerequisite of our next steps.

Simply put, the timing of this rule is outrageous. Days after the Royal College of Physicians report unequivocally stated that, from a health perspective, that not only is vaping is 95% less risky than smoking, vaping is also an important harm reduction tool. In addition, only a matter of days away from a stern scolding by the Appropriations Committee, the FDA chose to issue its rule drowned in a verbose preamble, while sitting on it all winter. It’s clear as day, the FDA felt vulnerable and backed into a corner; as this document is peppered with a multitude of references from past litigation. Yes, we all know and agree: vaping products must be regulated somehow, but not by neglecting scientific evidence, fairness and proper authority. Again, the timing of FDA’s rule shows an almost callous disregard to the direction the world is going, in effect turning their backs on what health-concerned smokers want to know, and to the economics of an entire supply chain and the potential black market.

On that note, should legitimate manufacturers be put out of business by staggering compliance costs, for the FDA to say there is no risk of a black market, is to deliberately ignore tangible evidence from Canada, where many vape happily and illegally ( and probably unsafely for that reason), and from just about any other country that banned the product.
In all reality, the rule shouldn’t be a major surprise to us; after all, we all saw and commented on the 2014 proposed rule. The voluminous preamble serves to reinforce why the FDA has decided it got the rule right the first time around, in 2014. The ability to admit one’s mistakes and to rectify the issue is one of the marks of a brilliant mind. Instead, some individuals remain stubborn and just can’t bring themselves to do it.

Last, but not least, “IT ain’t over yet”, as we will continue to fight for what is right. Essentially, IT has only started. Now, more than ever, we must stand tall and united to pursue those just, but narrow avenues that are still available to us as stakeholders in public health. The availability and affordability of nicotine consumer products, which are unquestionably far less dangerous than cigarettes, is vital for sustainable tobacco harm reduction. However, no matter how much one tries to be logical about IT, one still feels disappointed and let down by the presumed custodian of public health in the greatest country on Earth.

Now, for a more practical matter, there will be a barrage of opinions and “advice” on the FDA rule from various sources. Choose your sources carefully – many have an opinion, but few have the expertise. At Nicopure Labs, we will share a professional, objective, unembellished and non-speculative information about the deeming rule. In effort to properly educate on the regulatory scope of vaping, we will offer webinars beginning next week, as well as Q&A for different audiences (retailers and consumers in particular). So visit our blog in the coming days and week, and thank you for your continuous support.

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About author

Patricia Kovacevic 10 posts

Patricia I. Kovacevic, Esq. is the general counsel and chief compliance officer of Nicopure Labs LLC, the leading E-liquid and vaping device manufacturer of American-made Halo and eVo E-liquids and Reactor, Tracer, Triton and G6 devices. With extensive U.S. and international industry experience, Ms. Kovacevic held senior legal and compliance positions at, among others, Philip Morris International and Lorillard. Her expertise includes global E-cigarette and tobacco regulation and compliance. Ms. Kovacevic serves on the advisory board of the Global Tobacco and Nicotine Forum. In the past, she served on the UN’s Public-Private Partnership Commission. Ms. Kovacevic is admitted to practice in New York. She holds a Juris Doctor degree from Columbia Law School (NY) and has completed the Harvard Business School “Corporate Leader” course. She is fluent in seven European languages.

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