Comer and committee grill FDA chief about handling of vapes

U.S. Rep. James Comer, R-Ky.
(AP photo by Alex Brandon)

Kentucky Health News

Rep. James Comer of Kentucky and other House members "grilled FDA Commissioner Robert Califf about why the agency has failed to swiftly assess product applications for e-cigarettes while illicit products from China flood store shelves," Luke Zarzecki reports for Inside Health Policy. "Califf defended FDA's approach by saying the agency is not resourced to deal with the flood of millions of applications for vaping products."

Califf appeared Thursday at a hearing of the Comer-chaired House Committee on Oversight & Accountability that last almost five hours. "We covered topics from seafood inspection, all the way to every other topic that I think could be imaginable," Comer told Zoey Becker of FiercePharma.

"Multiple lawmakers blamed FDA’s failure to quickly approve e-cigarette and vaping products from the United States for the proliferation of illegal imports, Zarzecki reports, quoting Comer: “FDA’s failure to regulate has allowed unsafe and illicit products to proliferate.”

"Califf said FDA would be more equipped to deal with illicit products if Congress approved the agency’s request to require e-cigarette manufacturers to pay user fees," Zarzecki reports. "He said FDA will not approve applications for vaping products unless they demonstrate the product will not contribute to nicotine addiction among children and youth." He said no one expected 26 million applications, and FDA has requested more staff to address the backlog.

The agency has asked the Supreme Court to review an appeals court’s ruling that it consider every marketing application for flavored e-cigarette products individually, "rather than rejecting them en masse because of their impact on youth smoking," Zarzecki notes.

"Public health groups have also sued the FDA and HHS over delaying a ban on menthol cigarettes and flavored cigars, and a spokesperson for FDA noted the rule is pending at the White House Office of Management and Budget."

FDA Commissioner Robert Califf (AP photo)

Califf said that in 2023, FDA “issued warning letters to more than 120 manufacturers and distributors and more than 400 retailers; filed over 40 civil money penalty complaints against manufacturers and over 65 against retailers; and collaborated with our federal partners at the U.S. Customs and Border Protection to seize approximately 1.4 million units of unauthorized e-cigarette products with an estimated retail value of more than $18 million; among other actions.”

"Comer criticized FDA for not seizing more illegal products from retailers," Zarzecki reports, and said the agency's approach to e-cigarettes is not what Congress had in mind. Comer said, “Those seeking to play by the rules don’t even know what the rules are because FDA won’t tell them, or FDA won’t put information out, or they will put information out, but they change it.”

Califf said vaping and electronic cigarettes came along after Congress passed the Tiobacco Control Act, under which the FDA operates.

Comer, who represents the state's First Congressional Distict, also criticized FDA for “failing to do the bare minimum to carry out its core mission” under the Biden administration. He said “a pattern of issues” show the agency “appears consistently unprepared for crises.”

He noted that FDA inspections of foreign manufacturing plants, where many drugs sold in the U.S. are made, haven't returned to pre-pandemic levels. He said the agency inspected 79 percent fewer foreign plants in 2022 than it did in 2019.

Califf conceded, “We need to pick up the pace.” He said the FDA recently “completely" reworked its inspection system in India to address problems there. The agency is converting its Office of Regulatory Affairs into an Office of Inspections and Investigations, "reassigning some 1,500 staffers to related roles."