Back in 2016, the FDA issued its “deeming rule” which expanded the definition of tobacco products to include e-cigarettes, e-liquids, and other vaping-related products, and gave the agency regulatory power over the U.S. vaping industry. Originally, the FDA’s plan was to require nearly all vaping products to undergo extensive and costly review, with approval for each individual product, effectively crippling the vaping industry as we know it today.
But the most recent FDA announcement may signal a change in the tide of vaping regulation — in particular, the FDA’s plan to make it easier for companies to bring new vaping products to market faster.
The FDA statement details several new initiatives including: developing product standards for e-cigarettes, analysis on the impurity levels in e-liquids, and weighing flavored e-liquids’ effect on adult smokers who are attempting to quit smoking against the appeal of flavored e-liquids to teens.
The FDA vaping regulation announcement also included details on the agency’s plans for efforts that “are aimed at making the pathway for developing nicotine replacement therapy (NRT) products more efficient to promote the development of novel NRT products.” In early August, the FDA released a statement from FDA Commissioner Scott Gottlieb, M.D. on the steps the agency is taking to help smokers to quit.
The communication from Gottleib clarified the FDA’s support for inhaled nicotine replacement therapies:
“With novel forms of nicotine delivery being developed, it’s possible that new kinds of NRTs – with different characteristics or routes of delivery – can offer additional opportunities for smokers to quit combustible tobacco.
We want to explore what new steps we can take using our regulatory policies to enable opportunities for innovation, while making sure these products are demonstrated to be safe and effective for their intended use.”
The FDA plans to hold a public meeting on the topic of premarket review. We’ll keep you posted on the latest developments.
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