AMA Says FDA Policy on Banning Some Vaping Products Doesn’t Go Far Enough

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On January 2, 2020, American Medical Association (“AMA”) President Patrice Harris released a statement saying that the Trump Administration’s new policy limiting flavors in vaping products does not go far enough in combatting the youth vaping epidemic. By leaving some flavors on the market, including the popular menthol flavors, Harris notes that “flavored e-liquids will remain on the market, leaving young people with easy access to alternative flavored e-cigarette products.”

In September 2019, President Trump announced that all flavored vaping products would be removed from the market until they received Food and Drug Administration (“FDA”) clearance. This announcement was lauded by public health advocates as a “an effective proposal that could have a meaningful effect in curbing the youth e-cigarette epidemic,” but was met with criticism by vaping industry groups, who argued that such a policy “may push some adult vapers back to combustible tobacco products, and put jobs and small businesses at risk.”

However, the final Trump Administration enforcement policy, which was also published on January 2, 2020, stopped short of the sweeping ban initially proposed, and settled on “certain, unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors.” Research has shown that underage users mostly use the fruit- and mint-flavored cartridges. Defending the policy compromise, Health and Human Services Secretary Alex Azar noted that “[b]y prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America’s youth grows and evolves ….” FDA Commissioner Steven Hahn added that “this policy balances the urgency with which we must address the public health threat of youth use of e-cigarette products with the potential role that e-cigarettes may play in helping adult smokers transition completely away from combustible tobacco to a potentially less risky form of nicotine delivery.”

However, AMA President Harris noted that such a compromise “is a step in the right direction, but does not go far enough.” Harris added that “[e]-cigarette use among young people continues to spike, creating another generation at risk of nicotine dependence who will face significant health problems as a result,” and argued that “a total ban on all flavored e-cigarettes – in all forms and at all locations – is prudent and urgently needed.”

The FDA also stressed that the enforcement priorities do not constitute a “ban,” but rather a requirement that a manufacturer that wishes to market such a product is required to submit a premarket application to demonstrate that “the product is appropriate for the protection of the public health.” Azar also noted that the Administration “will continue monitoring the situation and take further actions as necessary,” but did not provide any guidance as to what such further actions might be, or what would trigger the Administration to escalate its response.

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