FDA Chief Clarifies Approach to Tackling Flavored E-Cigarettes (2)

Sept. 25, 2019, 3:03 PMUpdated: Sept. 25, 2019, 5:48 PM

The head of the Food and Drug Administration says the agency doesn’t actually intend to ban entirely flavored e-cigarette products produced by companies like JUUL and Blu, as President Donald Trump directed the agency to do earlier this month.

Head of the Health and Human Services Department Alex Azar said earlier this month the Trump administration intends “to clear the market of flavored e-cigarettes.” Some interpreted that to mean the FDA would ban the flavors outright, but Ned Sharpless made it clear Sept. 25 that isn’t the case.

The FDA will be “enforcing existing law,” which “would not mean flavored products will never be marketed,” Sharpless said at a vaping hearing before the House Energy and Commerce Subcommittee on Oversight and Investigations.

“Flavored e-cigarettes will be expected to exit the market unless and until manufacturers of these products provide scientific evidence demonstrating marketing their products is appropriate to the protection of public health,” he said.

Manufacturers have until May 2020 to apply to the FDA for marketing applications. If companies don’t have an approved application by then, they will be required to pull their products from the market.

Before that deadline, the FDA will release a regulatory guidance about flavored e-cigarettes, and upon finalization of that guidance it will send out warning letters to companies to pull flavors from the market, Sharpless said at the hearing.

“Anyone who thought their product was good for public health can file an application at any time” even before the May deadline, he said. If the product can demonstrate a public health use, then it would be authorized for sale, Sharpless said.

Manufacturers have until May 2020 to apply to the FDA for marketing applications, and if companies don’t have an approved application by then, they will required to pull their products from the market.

Detailed Records Required

The FDA released a proposed rule this month outlining what manufacturers should put in their marketing applications. Companies would need to show that the product’s labeling isn’t misleading or false, among other things. The agency would also require manufacturers to keep detailed records about their marketing practices.

Lawmakers at the hearing also expressed frustration with counterfeit e-cigarettes. Most people who’ve reported a lung illness related to vaping have used e-cigarettes to vape THC, a compound in marijuana that gets the user high, according to the Centers for Disease Control and Prevention. E-cigarettes are regulated by the FDA, but THC vapes aren’t an approved product.

Rep. Yvette Clarke (D-N.Y.) asked Sharpless whether the FDA has authority to tackle counterfeit products that contain THC.

“THC and other things that might be vaped that are not nicotine, our justification is more challenging,” Sharpless said, adding that the FDA is working with the Drug Enforcement Administration on that problem.

Michael R. Bloomberg, the founder and majority owner of Bloomberg Law parent Bloomberg LP, has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco.

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To contact the reporters on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Peggy Aulino at maulino@bloomberglaw.com

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