Academy Reacts to Latest FDA E-cigarette Policy Delay

The U.S. District Court for the District of Maryland ruled last July that the FDA had exceeded its authority in allowing the ongoing sale of e-cigarettes before their manufacturers had applied for regulatory approval. Finding for the plaintiffs in a lawsuit brought by public health groups objecting to the FDA's slow-walking of e-cigarette safety review, the court ordered that manufacturers such as JUUL had until May 12, 2020, to submit their premarket tobacco applications to the agency.

U.S. District Judge Paul Grimm wrote in that ruling that e-cigarettes and their appeal to youth presented "a clear public health emergency."

But on April 23, the FDA announced that it had sought and received a court-approved extension of that cutoff to Sept. 9, citing the pandemic.

The pandemic, countered the Academy and its co-signatories -- including the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and the National Center for Health Research -- should instead be cause for swift action.

"In light of the skyrocketing youth e-cigarette epidemic, and concerns that smoking and vaping may increase the risk of severe complications from COVID-19, it is more critical than ever that new tobacco products be subject to statutorily required public health review by the FDA," the groups wrote to FDA Commissioner Stephen Hahn, M.D., in their April 23 letter.

Under the court order, the products under review will be allowed to stay on the market for up to one year while the FDA reviews their applications. This latest delay, then, means that products likely to be removed from store shelves will remain available that much longer, even as COVID-19 ups the stakes for smokers.

In an April 24 Kaiser Health News interview, National Institute on Drug Abuse Director Nora Volkow, M.D., predicted that data would eventually verify a deadly connection between e-cigarette use and COVID-19.

"We already know for COVID that, with comorbid conditions -- particularly those that affect the lungs, the heart, the immune system -- (patients) are more likely to have negative outcomes," she said. "One can predict an association. In the meantime, because of the data that already exist, we should be very cautious. The prudent thing is to strongly advise individuals who are vaping to stop."

In their letter, the Academy and its co-signatories called on the FDA not to be idle in the interim. Specifically, they wrote, as soon as possible after Sept. 9, the agency should disclose

• all new tobacco products, and their manufacturers, for which marketing applications were filed by that date;
• all products exempted from the premarket application requirement, with a statement explaining the exemption;
• all tobacco products, including e-cigarettes and cigars, that are already on the market for which applications to remain on the market are owed; and
• in the event that a list of such products has not been compiled, an explanation why that has not occurred.

"This information is necessary to allow the public to determine the extent of industry compliance with the court-ordered deadline for filing premarket applications, as well as to monitor the FDA's enforcement of the Sept. 9 deadline going forward," the letter said.

"Because the disclosures we seek involve new tobacco products that are already on the market, releasing this information to the public could not possibly result in disclosure of trade secrets or confidential commercial information," the groups added.