From the Desk of the General Counsel: Society for Research on Nicotine and Tobacco Meeting

From the Desk of the General Counsel: Society for Research on Nicotine and Tobacco Meeting

Greetings from the Society for Research on Nicotine and Tobacco annual meeting in Chicago.  The reason for my visit to the Arctic, or what seems like it, is for the most up-to-date vaping and nicotine science discussion. Colleagues from the Vapor Technology Association are also in attendance, tweeting up a storm and keeping our followers updated.  This enlightening event presents an opportunity to interact with the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) leadership in anticipation of the FDA deeming rule on vaping products.

The Director of the CTP, Mitch Zeller provided an in-depth perspective on nicotine policy, and examined the FDA’s regulatory science. Mr. Zeller’s first presentation, which I will summarize below, was extremely informative for all in attendance as it outlined the FDA’s expectations and concerns with respect to vaping products.

Mr. Zeller began with a brief overview of the Tobacco Control Act while affirming he would not address or give any updates regarding the upcoming deeming rule (And everyone in the audience was hoping he would spill the beans!).

However, Mr. Zeller did unexpectedly emphasize the need for innovation, a subject very dear to all of us in the industry, who feel obligated to lead the way in new product development. Thus, the FDA’s regulatory policy must encourage all manufacturers to apply the latest technology to create tobacco products proven to reduce risk and exposure to harmful constituents.

Mr. Zeller then turned to his favorite topic – the FDA’s comprehensive Nicotine Regulatory Policy, which includes:

– Developing jurisdictional boundaries ( i.e, classifying Drugs vs. Tobacco products)

– Working with CDER and CDRH (other FDA centers)

– Exploring expedited pre-market review of tobacco products based on relative toxicity and risk

Turning his focus to another important issue, Mr. Zeller clearly explained that there absolutely is a continuum of nicotine containing products and the FDA “understands that people smoke for the nicotine, but die from the tar.” He conceded that there is a public health opportunity to shift smokers to much cleaner, less harmful nicotine delivery products. He also proceeded to point out that kids and pregnant women should abstain from nicotine use.

Mr. Zeller also proposed a very provocative question, “Are we – public health and public opinion – having the right debate?”

The current point of contention has solely been about E-cigarettes, while failing to cover some of the broader, tougher questions. The controversy surrounding vaping products, in his words, is, “emotional, very divisive in tobacco control and filled with misconceptions about nicotine safety,” – such as people mistakenly believing that nicotine causes cancer.

Some of the concerns Mr. Zeller, and his comrades at the FDA would like addressed involve the long-term usage of nicotine without actually smoking conventional cigarettes. Another area is dual use (smoking and vaping), and the appropriate period of transition to the use of only “clean” nicotine. The dilemma is, what if there are differences in opinion between public health officials and the general public? Furthermore, what are the consequences of youth initiation and diminishing interest to quit resulting from dual use?

Mr. Zeller’s final thoughts were very encouraging to all of us who fight for reasonable regulation, commensurate with the harm reduction potential of our products.

He stresses, “We should not be striving for consensus among industry, public health and tobacco, but we should seek some common ground to go forward.”

All I can add is that vapers, too, should have a voice and take an active role in this building consensus. As this is, after all, about people and their health!

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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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