The Food and Drug Administration released draft guidance on Monday explaining how it plans to evaluate premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems.
The agency said flavored e-cigarettes may appeal to some adult smokers. Research shows that people who smoke menthol cigarettes often prefer menthol-flavored e-cigarettes rather than tobacco-flavored ones, according to the FDA. The agency said it is open to evidence showing that some flavored products could help adult smokers switch from traditional cigarettes by giving them more flavor options.
The FDA said that ENDS flavors such as “menthol, mint, and novel flavors (e.g., spice) —may present a lower risk of youth initiation and use relative to flavors where there is reliable scientific evidence demonstrating greater youth appeal, such as fruit and candy/dessert/other sweet flavored products.”
Because sweet flavors, including fruit and candy attract young people, the FDA said companies seeking to market these flavors must show extra-strong evidence.
“Given the well-established and substantial youth appeal associated with certain flavor categories, particularly fruit and candy/dessert/other sweet flavors that appeal to youth, applicants bear a heightened evidentiary burden to demonstrate that marketing such products would result in a net benefit to the population as a whole,” the FDA said.
Yolonda Richardson, president and CEO at Campaign for Tobacco-Free Kids, called the guidance “troubling in light of the clear scientific evidence, summarized in the guidance itself, that flavors attract youth and play a key role in youth use of e-cigarettes and other tobacco products.”
To date the FDA has authorized 39 e-cigarette products, and the only flavored ones authorized of those are four Njoy LLC menthol-flavored e-cigarette products: Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5% and Njoy Daily Extra Menthol 6%. These 39 products are the only e-cigarettes that currently may be legally marketed and sold in the United States.
In September, FDA Commissioner Mary Makary issued a statement encouraging retailers to stop selling illegal vapes.
“Too often, retailers in communities are selling illegal vaping products marketed to young people with fruit or candy flavors and even marketing gimmicks such as built-in video games and Bluetooth speakers,” Makary said. “The FDA has not authorized any such products, which are mainly illegally imported from China.”
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