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The FDA on Vaporizer & ECig Regulation

Filed in News & Politics by on August 7, 2015

The vaporizer community is conflicted about the progress of the U.S. government’s decision-making regarding regulation of e-cigarettes. Some are cynical about the process. Maybe they didn’t study the public comments sent to the FDA by vapers and vaporizer companies, fda on vaporizer regulation v2 cigsor pay close attention to what Mitch Zeller, director of the FDA’s Center for Tobacco Products, has said publicly about the industry.

We at V2 feel very differently. Naturally, there’s a great deal at stake for us as an independent player in the vaporizer and e-cig business. But we encourage all vapers to tune in to the public conversation because we’re also hopeful that the FDA has listened to our comments and those of thousands of vapers all over the country.

At a recent conference, Zeller spoke about regulation as it applies to e-cigarettes and the FDA’s lengthy process. His comments were interpreted by some as more encouraging than expected. In a summary note, Wells Fargo analyst Bonnie Herzog said “Director Zeller underscored the importance of ‘opening up the dialogue’ across various stakeholders in the nicotine space, suggesting to us that he and the agency remain committed to using science and data to shape regulation while recognizing the nicotine continuum of risk which is consistent with his previous comments.”

Zeller’s remarks framed the conversation about nicotine and the vaporizer industry using a “continuum of risk,” and acknowledged the debate needed to focus on “issues that matter.”

The “continuum of risk” is a topic Zeller has discussed earlier, pointing out that there are different products containing nicotine that pose different levels of risk to people. “Right now the overwhelming majority of people seeking nicotine are getting it from the deadliest and most toxic delivery system, and that’s the conventional cigarette,” Zeller says in an interview from 2013. “But if there is a continuum of risk and there are less harmful ways to get nicotine, and FDA is in the business of regulating virtually all of those products, then I think there’s an extraordinary public health opportunity for the agency to embrace some of these principles and to figure out how to incorporate it into regulatory policies.

Zeller expanded on earlier remarks he made at the NATO Show about the FDA exploring the role of “therapeutic nicotine” with other FDA “centers” (specifically the Center for Drug Evaluation and Research and Center for Devices and Radiological Health.) If this progresses, it could open some fascinating avenues, and we’re eager to know more.

The FDA is expected this summer to complete rules that would require FDA approval for a range of ecig and vaporizer products, including e-liquid and most devices.

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Comments (1)

  1. Morgan says:

    Correct – Nicotine delivery is fundamental to all quit smoking systems. And in my opinion, vaping is the most efficient method of quitting smoking.