FDA rescinds ban on Juul Labs e-cigarettes

The FDA is providing an update on the status of the agency’s review of the premarket tobacco product applications, or PMTAs, submitted by JUUL Labs, noting that on June 23, 2022, the FDA issued marketing denial orders, or MDOs, to JUUL Labs, Inc. for all of their products marketed in the United States at the time. “Today, the FDA rescinded the MDOs issued in June 2022 to JUUL Labs, Inc. This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant. Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications… The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed,” the FDA stated. Publicly traded companies in the tobacco products space include Altria Group (MO), British American Tobacco (BTI), Imperial Brands (IMBBY) and Philip Morris (PM).