The FDA has backed down from its decision to order all Juul products off the market, issuing an administrative stay last night that puts the previous order on hold. The agency announced on Twitter it “has determined that there are scientific issues unique to the JUUL application that warrant additional review.”
The FDA had issued a Marketing Denial Order (MDO) for all current Juul products on June 23, claiming Juul had not addressed certain toxicological concerns in its Premarket Tobacco Application (PMTA), which the FDA has been reviewing for nearly two years. Juul Labs reportedly spent over $100 million preparing its PMTA.
The FDA stay suspends Juul’s MDO while the agency re-reviews Juul’s application. In some previous FDA MDO reversals—most notably Turning Point Brands’—the agency rescinded the marketing denial and placed the products back into full scientific review. In the TPB case, the FDA claimed it had “overlooked” relevant scientific data.
Juul said in its court filings that the FDA had simply ignored thousands of pages of evidence submitted in the company’s PMTA that addressed the issues the agency claimed as reasons for the MDO. The FDA decision was influenced by political considerations, said Juul.
Juul Labs had already filed motions in federal court asking for a full review of the FDA’s MDO and for a stay allowing the company to sell products during the review. The court immediately granted a temporary stay pending its decision whether to give Juul a longer stay. The company had originally sought and been denied an administrative stay from the FDA, forcing Juul to seek relief in court.
Today, Juul Labs and the FDA filed a joint motion in the D.C. Circuit Court of Appeals to “hold the case in abeyance pending completion of agency proceedings”—to put Juul’s petition for review on hold while the FDA completes its “additional review” of Juul’s PMTA. Juul also withdrew its pending emergency motion for a stay.
According to the court filing by Juul Labs, the FDA has agreed not to enforce against Juul while the agency re-reviews Juul’s PMTA. Juul also told the court that the FDA has agreed to leave the administrative stay in place for an additional 30 days if the agency decides to “maintain or re-issue” the Juul MDO, in order to “afford [Juul Labs] an opportunity to seek further judicial relief if necessary.”
In other words, Juul intends to refile its motions with the court if FDA ends its stay and re-orders Juul products off the market. Meanwhile the company will continue to sell its JUUL device and tobacco and menthol pods, depending on the same FDA enforcement discretion currently protecting other vape products on the market without FDA authorization.
The FDA Center for Tobacco Products (CTP) is supposed to approve or deny marketing authorizations based on analysis of the scientific evidence provided by each manufacturer in its PMTAs. But the Juul decision was clearly tilted by pressure from members of Congress and the Biden administration, who apparently think improperly influencing supposedly scientific agency decisions is justified when it gets the results they want.
Soon after the FDA announced Juul’s MDO, members of Parents Against Vaping (PAVe) held a celebratory webinar with what they described as their “Congressional Champions.” During that event, U.S. Rep. Raja Krishnamoorthi (D-IL) and a member of Senator Dick Durbin’s (D-IL) staff bragged about influencing the FDA’s decision to deny Juul’s application.
“So I am so heartened that the FDA—after I and my office actually had a long conversation with the FDA commissioner about this—finally decided to stop JUUL from [selling products],” Krishnamoorthi told the anti-vaping group. The Illinois congressman went on to say he is “so glad” to have “an ally” in FDA Commissioner Robert Califf.
On June 22—the day before the Juul MDO was issued—Sen. Durbin said in a press release that Commissioner Califf should immediately remove all vaping products without an FDA authorization from the market. “It’s time for Commissioner Califf to do his job to protect our children or step aside,” said Durbin.
Durbin, Krishnamoorthi, and other (mostly Democratic) members of Congress, have promoted a Campaign for Tobacco-Free Kids-sponsored pressure campaign on the FDA for years, attempting to swing agency actions on vaping products toward the prohibition they want. The justification for harsh regulation is always “the children.” The health of 30 million Americans who smoke is never a consideration, nor are the wishes of millions of vapers.
Tuesday was the first day on the job for new FDA Center for Tobacco Products Director Brian King, but it wasn’t a good one for the agency. In addition to being forced to reverse the Juul MDO, the FDA also learned a federal district court ruled against the agency in a long-running challenge to the FDA’s authority to regulate premium cigars under the Deeming Rule.
The CTP doesn’t seem to know if it’s a scientific agency or a political one, and is now caught in the crosswinds between its stated regulatory mission, pleasing its political bosses, and its fear of congressional oversight. The FDA tobacco office doesn’t know what it’s doing, and is rapidly becoming a joke.
The way the agency chose to announce the Juul stay illustrates the current chaos at the FDA. Rather than a normal announcement in a press release issued during business hours, the news yesterday arrived at 7:53 p.m. in a weird series of tweets, as though the agency leaders had huddled for hours arguing with lawyers over what could and should be done.
It was reminiscent of the first news of the Juul MDO, which came in a leak to the Wall Street Journal. When the formal announcement arrived the next day, the news had already exploded. “Juul” trended on Twitter both days, and panicked Juul users cleaned out convenience stores’ inventory nationwide.
The FDA still hasn’t issued a full explanation of its stay, but has simply taken the text of its tweets and added it in a note to the top of its June 23 MDO announcement.
Meanwhile, the FDA is almost a week late issuing decisions on PMTAs for about 109 other mass-market vaping products, based on estimates in a federal court filing by the agency.
On April 15, U.S. District Court Judge Paul Grimm ordered the FDA to issue progress reports on the agency’s reviews of Premarket Tobacco Applications (PMTAs) submitted by the 10 largest manufacturers of vaping products sold primarily in the convenience store/gas station segment of the vaping market. Judge Grimm’s revised remedial order specifically named vaping products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” It also covers any other product with two percent or more market share according to market research by Nielson.
The FDA estimated in its first progress report, delivered May 13, that there were 240 PMTAs fitting Judge Grimm’s criteria remaining to be acted upon. The agency provided a timeline for completion, estimating that 51 percent of the PMTA reviews (about 122 applications) would either be authorized or denied by June 30, and additional five percent (12 more applications) completed by Dec. 31, and the remaining PMTAs (about 106) finished by June 30, 2023.
Since those estimates were provided to the judge, the FDA has authorized products by two manufacturers: two NJOY Daily disposable e-cigarettes, and the Vuse Vibe and Vuse Ciro devices and refills (total six SKUs). Those plus Juul’s five denied products equals 13 of the 122 the FDA expected to have completed by June 30.