FDA misses deadline for deciding which e-cigarette products should be removed from the market

WASHINGTON — The Food and Drug Administration announced Thursday that it has failed to meet a court-ordered deadline for deciding which e-cigarette products can stay on the market. In fact, it has yet to rule on whether any of the largest and most controversial e-cigarette companies, including JUUL, can keep selling their products.

Tobacco control advocates and vaping industry supporters alike are furious, and the delay could land the FDA back in federal court.

A federal judge ordered the agency in April 2020 to decide by Sept. 9, 2021, which e-cigarette products can stay on the market and which must be pulled off the shelves, but the agency has now blown past that deadline.

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In a statement released Thursday afternoon, acting FDA Commissioner Janet Woodcock insisted that the agency has “made significant progress” in reviewing the roughly 6.5 million applications it has received. The FDA has now taken action on applications covering over 6 million products, according to the FDA release. The agency also released Thursday the names of several small vaping shops it decided to shut down over the past week.

Matthew Myers, president of the Campaign for Tobacco Free Kids, which sued the FDA to create the Sept. 9 deadline, applauded that progress but insisted it was not enough.

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“While FDA has said it has ruled on 93% of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic. Every day those products remain on the market, our kids remain in jeopardy,” said Myers. “It is very frustrating that this problem has been allowed to fester for more than a decade. There needs to be a resolution and a resolution quickly.”

Myers added that if the FDA does not decide on the major applications soon, his group will “have no choice but to go back to the court to have the court enforce its order requiring FDA to begin to remove any product not authorized.”

Myers declined to say when the group would go back to court but added that “this can’t be a delay of months, it has to be resolved promptly or else we have to ask a court to intervene.”

The delay also drew ire from Capitol Hill. “FDA’s years-long failure to regulate e-cigarettes has led millions of kids who never would have picked up a tobacco product to begin vaping,” wrote Sen. Dick Durbin (D-Ill.) in a statement. “While I am pleased FDA has rejected all e-cigarette applications to date for failing to show a health benefit, it is unacceptable to delay evaluation of e-cigarettes most responsible for hooking children, like JUUL.”

The FDA’s statement also frustrated vaping industry advocates, who have been angered in recent days by the FDA’s efforts to shut down small vape shops while pushing off decisions on larger vaping companies, like Juul.

“It is absolutely absurd that the same agency that found time to ban over 6 million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares,” said Gregory Conley, president of the American Vaping Association, a vaping advocacy group.

The agency’s statement also provides little clarity for tobacco companies that still have applications pending with the FDA. Vape shops have been requesting extensions from the FDA so they can continue selling their products until the FDA finishes reviewing their applications, but Woodcock’s statement did not address those requests. Instead, it simply reiterated the agency’s previous stance that products with pending applications are “subject to enforcement action at the FDA’s discretion.”

“This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers,” Conley added. “After spending five-plus years peddling false hope to businesses across America, the FDA now can’t even be bothered to grant formal extensions to the remaining pending applicants.”

The agency added, however, that it will prioritize cracking down on companies that do not have applications pending, or which have already been ordered off the market.

Following the publication of this story, an agency spokesperson insisted that it had not missed any court-ordered deadline for reviewing vaping products.

“The court did not order FDA to complete its reviews by Sept. 9, 2021,” wrote FDA spokesperson Michael Felberbaum in a statement to STAT. 

However, advocates and e-cigarette makers alike largely interpreted that Sept. 9 deadline, which a federal judge described as a “deadline for approval,” as the date by which the FDA had to finish reviewing e-cigarette applications. 

The American Cancer Society Cancer Action Network, one of the plaintiffs in the lawsuit that set the deadline, described FDA’s action Thursday as the FDA’s failure “to meet its court-ordered deadline to rule on all e-cigarette and other tobacco product manufacturers’ applications.”

Source: STAT