From the Desk of the General Counsel: The Deeming Rule

From the Desk of the General Counsel: The Deeming Rule

Hello, again, this time from a plane ride from rainy Washington DC back to Tampa. I hope you all had a good Thanksgiving week.  Sadly, the news brought yet another tragic set of events, this time in California. To honor those lost, let us look forward to the last month of 2015 with hope and optimism.

This may also be the last month before our industry becomes regulated. Nobody knows the precise timing of the deeming rule, however, let’s remind ourselves where do we stand in the rule-making process and where can we go from here.

Deeming Rule Progress

As I was writing you all last week, the deeming rule is now at the Office of Management and Budget (OMB) for economic impact review. The OMB has conducted several individual meetings with stakeholders, including with us, Nicopure Labs LLC, makers of Halo. Because of increasing requests for meetings and to what appears to be a self-imposed December 15th deadline, the OMB is no longer granting individual meetings. Instead, it has grouped stakeholders into three listening sessions on December 4th, 7th and 11th.

If you are headed to the OMB, or are simply interested to learn more about the identity of the stakeholders having met with the OMB or about the content of the meetings, here is a good starting point:

http://www.reginfo.gov/public/do/eom12866Search

To date, however, no meeting materials seem to have been posted on the respective website in connection with completed stakeholder meetings.

In brief, if you are still meeting with the OMB or attending one of the three listening sessions, please make sure to be concise, concrete, and focus on the following type of data: vaping industry size and segmentation, market shares, economic footprint of the industry (number of employees, turnover, contributions to state and federal budget), cost of compliance with various provisions of the deeming rule, and suggestions as to alternative regulatory solutions for the FDA’s deeming rule that will accomplish the FDA’s goals while at the same time having a less onerous impact on the regulated industry.

As to other forms of engagement, while you may still have comments on the final deeming rule, once the rule is published in the Federal Register and its effective date is announced (usually 30 days after publication), comments filed at that time will not impact the rule’s implementation. At that stage one may consider judicial review. And now for the big money question:

When Will the Rule Be Published, and What Will It Comprise?

My personal estimate is—not before January 1st. It’s not a bet, though! In the meantime, read the Tobacco Control Act carefully, as all provisions referencing tobacco products will apply to vaping products. Relevant FDA links here:

http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm

And here for the searchable text of the Tobacco Control Act:

http://www.accessdata.fda.gov/scripts/tobaccocontrol/

Until soon!

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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