From the Desk of the General Counsel: Thanksgiving and Regulation

From the Desk of the General Counsel: Thanksgiving and Regulation

Good morning from a sunny Thanksgiving week here in Florida!

First of all, please allow me to thank you all for the feedback you provided on the previous blogs. We are interested to hear about your experiences and views and strive to provide you with an honest and objective yet passionate (could those coexist?) perspective on regulatory and other selected factors influencing our industry.

As we share a festive meal with our families and friends, let us first remember that not all—in fact not many!—around the world have the luxury of an abundant meal in peace on any given holiday. My family and I watched in disbelief as the tragedies unfolded in Paris and Lebanon on the same day, as I am sure all of you did, with a mix of fear, anger and sadness. Even as I write this, two of my three children are visiting their grandmother and uncle in France for Thanksgiving—love prevailed over fear when we agreed they should still travel to France in spite of the high alert and only days after the senseless massacre. Allowing fear to interfere with one’s family life would mean handing “them” a win. Sure, we must be extremely vigilant, learn every step of the way, and act as appropriate, but let us enjoy and give thanks for this holiday and appreciate the clarity and relative predictability we enjoy in our society.

Which brings me to the topic of the day: Where are we in this relatively predictable and possibly clear rulemaking process that leads to the issuance of regulation affecting our vaping industry?

Vaping Regulations and Rulemaking Process

As you may recall from my previous blog, at present the final deeming rule that the FDA penned after reviewing all docket comments is at the Office of Management and Budget (OMB)’s Office of Information and Regulatory Affairs (OIRA). For simplicity, I will stick with “OMB”—too many abbreviations!

The OMB has scheduled 34 meetings on the FDA Deeming Regulation, so far, through December 15. The list of meetings (and name of requestors) can be seen at

Now, it seems that the OMB suggested listening sessions from now on rather than individual meetings with interested parties. If your organization has meaningful economic impact data to share with the OMB in connection with the deeming rule, you may still try to schedule meetings (the link to the relevant rule description is here: ), but it does appear that the OMB’s schedule is full. Having scheduled the last meeting on December 15 strongly suggests that the OMB will not avail itself of the full 90 days it may use for rule review, and therefore may wrap up the conclusions of its industry meetings by Christmas.

Let’s remind ourselves of the scope of the OMB/OIRA review of a regulation (also called a rule). Regulations are issued by agencies, boards, and commissions and have the force and effect of law. A good overview of the pathway (or the process known as rulemaking, governed by the Administrative Procedure Act (5 U.S.C. Chapter 5)) a regulation takes from initiative to final publication is here:

As indicated on the OMB’s website, the Office of Information and Regulatory Affairs (OIRA) is a statutory part of the Office of Management and Budget within the Executive Office of the President. The OIRA is the United States Government’s central authority for the review of Executive Branch regulations, approval of Government information collections, establishment of Government statistical practices, and coordination of federal privacy policy.

Executive Order 12866 (1993)—Improving Regulation and Regulatory Review directs agencies to follow certain principles in rulemaking, such as consideration of alternatives and analysis of benefits and costs, and describes OIRA’s role in the rulemaking process. The 2011 Executive Order 13563 reaffirms five principles governing regulatory review:

“… each agency must, among other things: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.”

Now, let us pause and note that with respect to the FDA deeming rule currently under review, it does not appear that the FDA has fully justified in the preamble to the 2014 proposed rule that the rule’s “benefits justify the costs.” Maybe it will do so in the preamble to the final rule, which we have not seen yet—let’s for now give the FDA the benefit of the doubt. It also appears that much more can be done by the FDA “to impose the least burden on society” and to “identify and assess available alternatives to direct regulation.” These are by no means the only comments one could link back to the respective Executive Orders; however, one may start one’s deep dive of this particular rulemaking process surrounding the deeming rule with the very text of the Executive Orders.

So if you are headed to the OMB to discuss the deeming rule, please familiarize yourselves with the OMB’s scope of work and what the OMB can or cannot tell an agency such as the FDA to do—dense legal stuff, for sure, and hard to navigate alone.

Let’s be grateful that we do have all of these online regulatory resources and relative clarity as to the rulemaking process. And never take the rule of law and liberties for granted, it’s a different world out there!

Thank you for your continued interest. Happy Thanksgiving to you all!

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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