Vaping regulation in US: the FDA steps under the Gottlieb guidance

2019-05-21T11:51:17+00:00 March 14th, 2019|Authorities, US|0 Comments
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Scott Gottlieb, FDA Commissioner from March 2017, has announced his resignation: let’s retrace the steps taken by the FDA in the regulation of vaping under his guidance. For vaping world…a rough road.

Gottlieb ‘has been active and aggressive on many issues as commissioner..’, as Politico observed; he focused his activity, among others, on facilitation of registration for generic pharma, on widespread addiction of opioid (<opioid crisis) and on regulations of tobacco products and related, with a particular attention to vaping.

In July 2017, the first FDA move against tobacco under Gottlieb’s guide is announced: ‘a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death’. As Gottlieb himself declared later, the central principle of the FDA plan is  that ‘primarily causes death and disease from tobacco use isn’t the nicotine in these products. It’s the act of lighting tobacco on fire to free that drug for inhalation’. But since nicotine is the addictive substance that makes so difficult to quit smoking, FDA started its plan pointing attention on nicotine levels in traditional cigarettes, to make them less addictive. Levels of nicotine in noncombustible products such as e-cig would not be altered.

At the same time, Gottlieb delayed PMTA submission deadlinefor new tobacco products from 2018 to 2022; in these four years, products could be marketed indefinitely (previously there were a oneyear transition period). This extra-period would allow the FDA to issue transparent guidelines and standards for vaping manufacturers, in order to have efficient and predictable premarket review process.

In the same speech, Gottlieb faced a long-standing theme, the use in e-liquids of ‘obviously kid-appealing flavors‘, announcing the beginning of the regulatory process. Vaping producers always feared a flavor ban that could cause the collapse of the industry.

In fall 2018, the problem of the spread of vaping among youth broke out: initial results from the National Youth Tobacco Survey came at the FDA attention, giving the alarm  on the increasing percentage of vapers among students. These data caused a strong reaction by Gottlieb, which stated “The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.” Flavors ban became a priority to reduce e-cigs appeal to youth. On November 2018 the beginning of a regulation that will ban the sale of flavored e-liquids (other than tobacco, menthol and mint) except in adult-only stores, like vape or tobacco shops, was announced by Gottlieb.

In February 2019, commenting additional data of the National Youth Tobacco Survey published by the CDC (Centers for Disease Control and Prevention), Gottlieb announced tough actions to regulate e-cigs to stop what he labeled as ‘epidemic’ use among youth.

On March 5, Gottlieb announced his resignation, telling he will remain in office the time needed to carry on the flavors ban and the other regulatory activities that were planned.

An uncertain time is going on for vaping, that has been waiting for a long time to know clear details about the premarket review process and the fate of its flavored products.