From the Desk of the General Counsel: FDA Regulation

From the Desk of the General Counsel: FDA Regulation

Hello again, I am writing you from our headquarters in the beautiful and sunny state of Florida. Today, I’m going to share some exciting recent news and answer some of your questions and concerns regarding upcoming regulatory developments. Thank you all very much for taking the time to read the blog and for the feedback—praise must be earned and is never taken for granted!

Deeming Rule Progress

First, the news: the much expected FDA rule on vaping products is a step closer to publication. As of October 19, 2015, the final rule is under review by the Office of Management and Budget (OMB).

That is a necessary step in the regulatory process, one that is likely to take a couple of months to complete. OMB does take meetings with industry, provided those meetings are substantive and informative of the economic impact on the rule. Now, you may have heard that some in the vaping industry have received an actual copy of the final rule. Neither FDA nor OMB are allowed to share the rule before publication in the Federal Register, and one should not believe messages that are intended to raise panic.

Besides, we KNOW that the final rule will be substantially similar to the proposed rule published in 2014, which already imposes rather onerous requirements on the industry. We also know that any bans or caps on ingredients or emissions require a separate rulemaking process under Section 907 of the Tobacco Control Act, which has not been initiated by the FDA to date.

We all hold diverse views about this rule, which range from “E-cigarettes are not tobacco products, they are the anti-tobacco product” to “the FDA should never have authority over electronic cigarettes and other vaping products” to “reasonable implementation of the Tobacco Control Act is appropriate, provided it takes into account the comparative risk profile of the product.”

Well, the Tobacco Control act does not differentiate much among tobacco products in terms of the applicability of its main provisions, including premarket review. Also, the Tobacco Control Act does not address the taxation of E-cigarettes and other vaping products, nor does it address vaping bans—those are not within the purview of the FDA.

E-cig Premarket Applications

The FDA has, however, great latitude to request vast amounts of information in support of product premarket applications such as substantial equivalence reports and premarket tobacco product applications, and in my experience, it surely does request such information—and it takes its time reviewing it. There is no “playbook” or exhaustive list of the type of information FDA will look at in reviewing premarket applications for newly deemed tobacco products although previous successful premarket applications for cigarettes created a substantial body of knowledge and experience in that respect.

There is also, of course, the controversy surrounding the so-called February 15, 2007 “grandfather date” which is an important date in the TCA because only products that were demonstrably on the market on that very date—not before nor after—may continue to stay on the market only if entirely unchanged since, without requiring a premarket review by the FDA. All tobacco products modified or launched after that date, depending on the timing of such launch, will have to follow one of the three premarket review pathways available in the statute. And a comparison with a February 15, 2007 product may be required. Needless to say, it is highly speculative and, to my knowledge, impossible to prove that any particular electronic cigarette would have been on the U.S. market as of that date. And even if it were – well, that product is long gone and obsolete, its parts cannot be manufactured identically, and the same goes for its ingredients. And who would even want to use such product today, anyway, when we have much better performing devices and liquids?

More importantly, why would FDA want anyone to use a 2007 product?

During a recent meeting I attended, Mitch Zeller, the FDA’s Director of the Center for Tobacco Products, briefly discussed a bill introduced in Congress earlier in the year that he did not seem to believe had great chances at success. That bill intended to change the grandfather date for newly regulated products such as E-cigarettes and liquids. Director Zeller conveyed that changing the grandfather date would substantially limit the goals of the Tobacco Control Act. It’s anyone’s guess, therefore, if FDA will consider changing that date.

Effects on the Industry

It is safe to assume that some manufacturers and importers will consider a range of judicial and other options to counter the effect the deeming rule would have on the industry over the next few years after its adoption. I get asked all the time: “What will happen the day after the deeming rule becomes effective? Will FDA ban ecigs?” And my short answer is, “no” although there will be a series of deadlines for compliance with various provisions of the Tobacco Control Act for manufacturers, importers and retailers of E-cigarettes. These provisions include: facility registration—so that FDA knows where to inspect—listing of all relevant SKUs, providing FDA with copies of the packaging and marketing materials for products on the market, filing a list of all ingredients with the FDA, and other requirements as well. And, within a reasonably short period of time FDA will announce manufacturing facility inspections, likely starting with domestic manufacturers—but FDA certainly has the manpower and capacity to inspect foreign manufacturing facilities such as those located in China. The FDA even has an office in China!

The Sunny Side
Irrespective of how you feel about the upcoming regulation, the good news is the wait will soon be over and we will all step back and decide whether there are any grounds to challenge that rule or how shall we go about complying with it or even both. Understandably, we will not discuss possible litigation strategies and outcomes here, as each interested party should find their own favorite lawyer to work with, if needed.

Over the past two weeks I also had the great pleasure to meet some of you, our loyal consumers and followers, at the recent Vapor Dynasty show in Phoenix, AZ, as well at the international Tabexpo London show. We will post the presentation recordings online, hoping that you will find the information useful. We had an amazing public of consumers, business partners and competitors, and we listened and learned from all of you, too. This October, I also had the privilege to share our views on reduced risk products at the Food and Drug Law Institute FDA Regulation of Tobacco Products Conference in DC, joining distinguished speakers such as Director Zeller, Dr. Aruni Bhatnagar from the University of Louisville, KY, Professor David Sweanor from the University of Ottawa, and Ella Yeargin, FDA CTP Ombudsman. The focus was tobacco harm reduction, where vaping plays a clear leading role.

To be sure, and it was reiterated during that conference, the FDA duly recognizes that nicotine-containing products are ranked on a continuum of risk, with nicotine replacement therapies and then vaping products at the lowest end of the risk spectrum and combustible cigarettes at the highest, most dangerous end. As early as 2014 CTP Center Director Mitch Zeller clearly and wisely stated before the Senate Health, Education, Labor and Pensions Committee that there is relative risk in nicotine containing products, and stated his view of the FDA’s regulatory goals. You can watch that excerpt here:

But don’t get too aggravated, please, while watching! Remember that he speaks from a Big Government angle, that’s his job, and he is very good at it. As our job is to make a good, reliable product, to stay ahead of regulatory developments and, most importantly, to make a difference in smokers’ lives by offering a better alternative.

Stay tuned for updates in the coming weeks!


The opinions and other information contained in these blog posts and comments do not necessarily reflect the opinions or positions of Nicopure Labs LLC, owner of the Halo and HaloCigs marks.

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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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