
From the Associate editor
FDA has been quite active in the tobacco industry these past few months…
A seismic shift occurred in the US Food & Drug Administration (FDA) regarding e-cigarettes and other electronic nicotine delivery systems (ENDS). FDA pushed back by five years (until August 2022) the deadline for an approval process required by current regulations. The previous deadline would have been costly and time-consuming and could have easily wiped out virtually all e-cigarette brands. FDA also extended the approval process for “newly regulated” combustible products such as cigars, pipe tobacco, hookah tobacco, etc, until August 2021.
This suggests FDA is willing to allow more time to study pros, cons, and scientific research of e-cigarettes more thoroughly, rather than simply painting e-cigarettes with the broad brushstroke of impossible regulations and manufacturing requirements. With research data both for and against e-cigarettes growing steadily, the debate on e-cigarettes as a good alternative to conventional combustion cigarettes continues. Hopefully, with the extra extension in the approval processes, more objective scientific research studies can be done and help clarify the situation, possibly ensuring that a product which is potentially much less harmful is available to those who want it and that it is not legislated out of existence.
FDA’s more (can you say?) “relaxed” approach to e-cigarettes has been met with relief from the e-cigarette and vaping industry, but it has also met with objections from anti-vaping circles. FDA Commissioner Scott Gottlieb, M.D. took some political heat, with 13 US Senate Democrats accusing him of granting e-cigarettes a “free pass” to launch their products without regulation. In reality, this process gives these mostly small-to medium-sized companies a few more years to provide required.
That heat might have had some effect. Shortly after that FDA announced plans to regulate of nicotine in cigarettes, attempting to bring deliveries down to “non-addictive” levels, even though it is still unclear what a “non-addictive” level of nicotine is. Then, FDA announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other ENDS by kids. According to an agency press release, “The agency plans to expand its ‘The Real Cost’ public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018.” This would be the first time FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.
Nevertheless, these policies can still be seen in a positive light. They are not a strike against simply part of FDA’s comprehensive plan to address the role of the industry; they are tobacco and nicotine, help move those who cannot quit nicotine altogether onto less harmful products, and keep tobacco products out of the hands of youth. This is an opportunity for all involved, whether it be legislators, manufacturers, and naysayers to work together towards finding a solution that all can agree on.