FDA Guidance to Target Flavored Vape

Will address possible ban on certain e-cigarettes prior to agency authorization
Photograph: Shutterstock

WASHINGTON — During a recent Congressional hearing, the acting commissioner of the U.S. Food and Drug Administration (FDA) said the agency’s upcoming final guidance on e-cigarettes will address enforcement efforts around a proposed ban on all flavored e-cigarettes, except for tobacco, until the agency grants official authorization for certain products to be on the market.

In September, Ned Sharpless, the FDA’s acting commissioner, spoke to the House Energy and Commerce Subcommittee on Oversight of Investigations on concerns over the health effects of e-cigarettes. In an FDA transcript of the hearing, he said the FDA would soon publish its final guidance on e-cigarettes, implementing the administration’s proposed ban on flavored e-cigarettes, except for tobacco, until manufacturers complete their premarket tobacco applications (PMTAs) and the FDA authorizes those applications after agency review.

Fortunately for c-stores, Sharpless said guidance would be enforced across retail channels, while a previous draft of that guidance prioritized enforcement in convenience stores over adult-only stores such as vape stores and tobacco stores, according to officials with NACS.

By May 2020, all e-cigarette manufacturers will have to apply for new product approval through PMTAs, Sharpless said.

Also in September, the U.S. Health and Human Services Secretary Alex Azar made public statements that the FDA and the Centers for Disease Control and Prevention were coordinating multiple studies on deaths and illnesses potentially tied to e-cigarettes. Within the same time frame, three states—Massachusetts, Michigan and New York—took steps to ban certain or all e-cigarettes from the market, at least temporarily. Bentonville, Ark.-based Walmart also made a decision to pull e-cigarettes from its stores during this time.

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