FDA Official Testifies on E-Cigarette Guidance

Zeller acknowledges the agency does not have the authority to discriminate against c-stores.

December 05, 2019

WASHINGTON—Mitch Zeller, director of the Food and Drug Administration’s (FDA’s) Center for Tobacco Products, testified yesterday before the House Oversight Reform Subcommittee on Economic and Consumer Policy on the status of pending agency guidance that would ban flavored e-cigarette products.

In September, the Trump Administration announced it would ban all flavored e-cigarettes except for tobacco until the FDA grants official approval for certain products to be on the market. Acting FDA Commissioner Ned Sharpless later confirmed that the FDA’s guidance would be enforced across retail channels—banning the products from brick-and-mortar stores and the internet. Reports subsequently indicated, however, that the guidance would exempt vape shops from the flavor ban. NACS has strongly opposed the proposal because it creates an unlevel playing field in the marketplace by allowing one channel of trade to sell legal products while prohibiting another from doing the same.

During Wednesday’s hearing, Rep. Gerry Connolly (D-VA) questioned Zeller about a potential vape shop exemption by leading him through a series of questions about FDA’s authority to regulate tobacco products.

“Is there any legal way for a hypothetical flavor ban to conceivably exempt vape shops?” Rep. Connolly asked Zeller.

Zeller acknowledged that FDA does not have the authority, saying: “I think under the law we would not be able to differentiate between types of retail outlets.”

Rep. Connolly also cited data that indicate underage users are more likely to get e-cigarettes from a vape shop than a convenience store and asked Zeller, “How would that support a hypothetical plan that allows flavors in vape shops but bans them in gas stations when the numbers suggest just the opposite of where the problem is?”

“I think you are making a very good point,” Zeller responded.

Zeller resisted giving specific information on the status of the guidance—including the timing of its release, whether it includes a ban on mint and menthol e-cigarettes, and if any retail channels are currently exempted. Instead, Zeller repeatedly told lawmakers that discussions are ongoing.

As reported in NACS Daily, NACS President and CEO Henry Armour was among the stakeholders invited to the White House for a roundtable last month with President Trump and Health and Human Services Secretary Alex Azar to discuss the Administration’s policy on flavored e-cigarettes. The Trump Administration last month also announced plans to pursue raising the federal minimum age to purchase electronic cigarettes from 18 to 21 as a way to combat youth vaping.