WASHINGTON, D.C. — Federal action on flavored electronic cigarettes and vapor products could be the next big change coming to the backbar.
On Sept. 11, Health and Human Services Secretary Alex Azar announced the Food and Drug Administration (FDA) would make removing unauthorized non-tobacco flavored e-cigarettes from the market a priority.
According to Azar, the agency FDA intends to finalize a compliance policy in the coming weeks. The policy will include all flavors, including mint and menthol.
"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," Azar said. "We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth."
Following the 2016 deeming rule, which set regulations for e-cigarettes and vapor products among other tobacco products, all electronic nicotine delivery systems (ENDS) must file a Premarket Tobacco Application (PMTA) for FDA approval to remain on the market. To date, the agency has not approved any PMTAs for ENDS.
The move toward a flavor e-cigarette ban comes amid a rising number of reports of vaping-related lung illness, which has led to several deaths, across the United States. Last week, the FDA and Centers for Disease Control and Prevention joined forces with state and local health officials to investigate the cause of the illnesses, as Convenience Store News previously reported.
Bonnie Herzog, managing director of tobacco, beverage and convenience store research at Wells Fargo Securities LLC, said the firm was not "entirely surprised by the FDA's recent full court press on a potential e-cig flavor ban, this time with the very public backing" of the President Donald Trump and his administration.
"The agency, and especially Acting FDA Commissioner Ned Sharpless, have been under significant pressure to 'do something' about the e-cigarette youth crisis and recent spate of respiratory illnesses tied to vaping," she said, noting so far the illnesses have been tied to illicit THC or vitamin E acetate ingredients and not to any major e-cigarette brand.
However, this week's announcement adds new elements to past steps from the FDA, including:
The inclusion of menthol and mint in addition to other non-tobacco flavors; and
Threats of stiffer actions if there youth e-cigarette use does not decrease.
"This could result in a potential ban on all e-cigarettes, regardless of flavor. If so, it would effectively wipe out an entire nicotine product category, which we aren't certain is enforceable under the Tobacco Control Act without congressional approval," Herzog said.
"While we agree kids and e-cigarettes shouldn't mix, we hope cool heads prevail given potential unintended consequences, such as increased black market activity/D.I.Y.— and by kids we think— and a resurgence in combustible cigarette use should smokers move back to the category," she added.
A federal ban on flavored e-cigarettes and vapor products follows numerous measures and proposals taking aim at flavors at the local and state levels.
Notably, on Sept. 4, Michigan Gov. Gretchen Whitmer ordered the Michigan Department of Health and Human Services to issue emergency rules to ban the sale of flavored nicotine vaping products in retail stores and online.
On Sept. 9, New York Gov. Andrew Cuomo announced that he will advance new legislation to ban flavored e-cigarettes.
However, many in the e-cigarette and vapor industry have raised opposition to any flavor bans.
"We're very disappointed that President Trump and N.Y. Gov. Cuomo have fallen for and perpetuated 'fake news.' Evidence shows black market THC tainted with thick oil is causing the lung crisis in the U.S. Nicotine e-liquid has been on the market for 12 years with no issues except health improvement for smokers," the New York State Vapor Association Inc. said in a statement.
Echoing Herzog, the association added these measures will push adult smokers back combustible cigarettes or increase illegal sales of the products.
Yaël Ossowski, deputy director of the Consumer Choice Center, said the Trump administration needs to follow the facts.
"The fact is that the technological revolution that is happening today with vaping is giving people a less harmful alternative to consume nicotine, the stimulant alkaloid that smokers are actually addicted to. That's something to celebrate," Ossowski said.
"Trump needs to know that, as well as the fact that adult smokers are switching en masse to these new reduced-risk products and they've been proven to be 95 percent less harmful than traditional cigarettes. These individuals switch in part due to vaping flavors, and that should be kept in mind. That said, no one wants teens to be vaping, and we should make sure of that," he said, adding "there is more we can do to stop youth vaping, but we must preserve this technology as a tool for adults to consume their nicotine in a less harmful fashion."