The Food and Drug Administration (FDA) has finalized a new regulation that would extend its regulatory authority to cover all tobacco products, including e-cigarettes and vaping products, rather than only traditional combustible cigarettes.
The regulation threatens to upend the still nascent electronic cigarette market by requiring any nicotine delivery devices that were introduced into commerce after Feb. 15, 2007, to go through a lengthy, expensive "premarket review" process. Given that most electronic cigarettes were not marketed until after that date, virtually every product in that space will be subject to premarket review.
Although the true impact of the regulations is unclear, many in the e-cigarette industry have voiced concern that this could effectively prohibit those products from continuing.
For the time being, companies with products on the market today will have two years to submit an application to FDA for "approval" of the product, and would be permitted to stay on the market for another year while FDA reviews this application.
For retailers that sell e-cigarettes, these products will be subject to most of the same FDA restrictions that currently apply to traditional combustible cigarettes, including a minimum purchasing age of 18 and associated customer age identification requirements, as well as marketing and advertisement restrictions and a prohibition of vending machine sales of e-cigarettes. The rules also impose these requirements on hookah, pipe tobacco, and cigars.
Many health experts, who fear that e-cigarettes will eventually hook a new generation of people on traditional cigarettes, were happy with the final rule, though concerned that e-cigarettes will be able to remain on the market for at least another three years. Others worry that a stricter approach to e-cigarettes will make it harder for addicted smokers to access devices that may be their best hope of quitting.
There is expected to be an uptick in e-cigarette companies lobbying Congress to undo components of the new FDA rule.
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