As anticipated, the FDA has proposed a new rule detailing the steps tobacco companies will be required to take in order to sell electronic cigarettes and similar vaping products. The FDA will evaluate applications for marketing approval across a variety of categories, including the product’s potential impact on public health. The agency aims to ‘clear the market’ of all unauthorized flavored electronic cigarettes.
Earlier this summer, manufacturers were ordered to submit premarket applications for their vaping products by May 12, 2020. The requirement applies for tobacco products that were introduced on the market starting on August 8, 2016, with the goal of ensuring that unsafe products aren’t being marketed and sold to the public, particularly kids and teenagers.
The newly proposed rule will solidify the procedures the FDA will use when evaluating premarket tobacco product applications (PMTAs) from these manufacturers, among other things. The FDA will require manufacturers or anyone attempting to import electronic cigarettes into the United States to, first and foremost, ‘demonstrate … that marketing of the new tobacco product(s) would be appropriate for the protection of public health.’
The agency will consider many things when evaluating an application, including ‘the risks and benefits to the population as a whole,’ including people who don’t use tobacco-related products. Among other things, officials will look at a proposed product’s ingredients — including additives and toxicological profile — and any other constituents and components, plus its potential health impact.
In a statement today, Acting FDA Commissioner Ned Sharpless said:
This proposed rule follows our announcement last week that we intend to finalize a compliance policy in the coming weeks that would prioritize enforcement to clear the market of unauthorized, non-tobacco-flavored e-cigarette products. These important regulatory actions are part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death.