Secretary of Health and Human Services (HHS) Alex Azar announced on September 11 that Food and Drug Administration (FDA) will finalize a compliance policy that would effectively ban all flavored e-cigarettes. In a press release accompanying the announcement, HHS explained that FDA will begin enforcing the premarket authorization requirements for non-tobacco flavored electronic nicotine delivery system (ENDS) products. Of note to NATSO members, the compliance policy will reportedly impact all businesses that sell flavored e-cigarettes rather that targeting convenience stores and other smaller format retail establishments that sell tobacco and e-cigarette products, including truckstops and travel centers.
“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” said HHS Secretary Alex Azar. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
A 2016 FDA regulation required all ENDS product manufacturers file premarket tobacco authorization applications with FDA within two years from the rule’s effective date. FDA, however, delayed the premarket authorization requirement until 2022 in a compliance policy. Subsequently, the FDA issued a proposal on March 13 to restrict sales of flavored e-cigarettes and require that retailers establish adult-only areas or take other steps to limit access to flavored e-cigarettes to anyone under age 18. In the coming weeks, FDA will finalize a new compliance policy that will outline FDA’s enforcement policy for non-tobacco flavored ENDS products that lack premarket authorization across all channels of distribution.
NATSO will continue to monitor this issue and provide an analysis once the compliance policy has been issued.
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