The Food and Drug Administration (FDA) revealed via Thursday news release that it would grant approvals for a series of eight tobacco-flavored electronic nicotine delivery system (ENDS) products made by Logic Technology Development LLC. The decision was based on data indicating that youth are less likely to begin using the controversial products because they are tobacco flavored.
The decision comes amid a steady tide of lawsuits aimed at JUUL, a leading manufacturer of ENDS products. Many of these lawsuits are consolidated into a multidistrict litigation captioned In re Juul Labs Marketing, Sales Practices, and Product Liability Litigation.
Per the FDA news release, Logic’s ENDS products were approved because the agency observed that the potential benefit to cigarette smokers who use the product to cease smoking cigarettes outweighs potential risk to youth.
However, this approval is conditioned on “postmarketing requirements to reduce youth access and youth exposure to their marketing,” the release says.
“The FDA will closely monitor how these ENDS products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products,” the agency said.
The agency also relied on data from the National Youth Tobacco Survey, which revealed that “most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors.”