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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  • Robin Lawthers

    Thank you for taking on this Herculean task.

  • Pingback: Linkluster Leo Without Colleague | Hit Coffee()

    • We appreciate the support! Although the FDA’s ruling is unfavorable for all in the vape realm, at Nicopure Labs (the industry leading manufacturer of Halo, eVo & Purity brand premium e-liquids) we have have spent years preparing for the deeming rule and have always placed a strong emphasis on good/responsible manufacturing practices. Our latest webinar may provide you with more insight as to what the future may hold.

  • AllenMcw

    This ruling is just absolutely NUTS! I started vaping just over 4 years ago after (like so many of us ‘ex-smokers’) MANY failed attempts to quit smoking. I had been considering VAPING for well over a year and kept putting it off because I had convinced myself it would not work – just like all my other efforts to quit smoking. But alas like so many others I was getting chronic symptoms of “smokers cough” and my Dr. made clear to me that I had bronchitis which is often a precursor to the KILLER called “Emphysema” and I KNEW I had to do something drastic!

    So finally I made a decision that after my current supply of regular cigarettes ran out I would make the switch to e-ciggs.

    Lo and behold I actually found it EASY to make the switch and not even ONCE was I tempted to go back to regular cigarettes!!

    After only ~4 months I found I could take DEEP breaths and NOT go into a coughing fit for several minutes. I could play sports like Racquetball for 2 1/2 – 3 HOURS and still feel like I could go longer, where before I made the switch 30 MINUTES and I felt like I was going to fall over and faint or something!

    And it has only gotten dramatically better since then! After about a year off of regular cigarettes I told my Dr. about my change and he was so impressed he updated my medical records to say EX-SMOKER (while still mentioning that I am doing e-ciggs). He was SO happy about this change!

    And guess what? Not even the remotest sign of bronchitis anymore!!

    The FDA is messing with people’s lives here! If they get away with this how many won’t make the switch to the FAR LESS DANGEROUS e-ciggs because the cost would ultimately become almost the same as regular cigarettes?

    People like me are LIVING PROOF of how much better e-ciggs are that regular cigarettes!!

    I don’t deny that nicotine is the addicting substance but so what? For lifetime smokers like me, it became a choice of killing myself with THOUSANDS of carcinogens in regular cigarettes vs e-ciggs which has nicotine but NONE of the other harmful substances! Seriously it should be a no-brainer which one simply MUST be the lesser of two “evils”!

    I fully agree that e-ciggs should not be sold to MINORS and I’m blown away that it ever was but it does NOT require FDA over-regulation to outlaw sale to minors!

    We have to fight this ALL THE WAY! It is wrong and it is going to hurt people!

    ***********************
    Is there anything I can do to help in the fight against the FDA? I’m happy to help because I KNOW THAT E-CIGGS SAVED MY LIFE!!!!
    **********************

    Allen

    • Halo BlogMATTster

      We thank you so much for your interest in supporting our challenge of the FDA’s Deeming Rule. We’re looking forward to making sure the voice of all vapers is heard through this challenge. The best way you can join the fight, is through your continued loyalty to Halo, eVo and Nicopure Labs.Thank you again and #VapeOn

  • Fearless4u2nv

    Only goes to show you, our government is the true enemy of freedom.

  • sean

    As a former Halo customer and 30 year smoker, I was able to finally quit smoking 3 years ago (and vaping last year as well) by gradually reducing the nicotine level using a Halo device. Vaping can indeed be a useful cessation tool – I am living proof of that. However, the culprit here, as usual, is fear of the unknown.

    Absent of any long term scientific studies, the public’s imagination runs amok and defaults to the notion that because vaping is associated with nicotine and “smoke” (water vapor in reality), it HAS to be bad for you, which in reality, may or may not be the case (I would be VERY leery of any products from China, for example).

    One of the biggest concerns that I have heard from the anti-vaping community is the lack of transparency, especially in regards to the flavoring used in the e-liquids. What happens when these chemicals are burned? Do they become harmful to us in a vapor form, etc. To illustrate this problem, I have yet to find the chemical ingredients of any e-liquid on this website. To be clear, any substance that comprises the e-liquid is considered a “chemical”, even water.

    So lets get with the program, throw all of our cards on the table, and I firmly believe that the rest will take of itself. If the consumer (and the public for that matter) knows for sure what ingredients are being burned, and studies can then be tailored to analyze specifically these ingredients (including nicotine), proving the risk is minimal, I believe you will start to see public opinion sway, and eventually shift, convincing the FDA to do the same, or at least, the courts.

    Until you sway the masses, you have no hope of persuading the government. And that’s how it should be.