E-cig company Juul has had a black cloud above its head thanks to federal regulators’ efforts to squash the brand, but recent court and agency decisions might mean executive efforts to hamper vape companies could potentially go up in smoke.
The U.S. Food and Drug Administration said on Twitter that they stayed Juul’s marketing denial order late Tuesday. The agency wrote they “determined that there are scientific issues unique to the Juul application that warrant additional review.”
It’s been a real roller coaster ride for the e-cig manufacturer. In late June, the FDA under President Joe Biden announced that Juul’s menthol and tobacco-flavored products were no longer authorized to be sold in stores. Vaping companies are required to show that their products help smokers quit while also not harming non-smokers such as young teens. FDA Commissioner Robert M. Califf had said that Juul “played a disproportionate role” in the rise of teen vaping.
Juul had become a poster child for the negative impacts of vaping on teens, especially with regulators long-alleging the company was actively trying to push its products toward young people through its fruity, “fun” flavored pods. In its original review, feds wrote that Juul did not provide enough solid information to show the toxicological impacts of their devices on users, something the company firmly denied after the ruling was handed down.
The company apparently welcomed the day’s developments, with Chief Regulatory Officer Joe Murillo writing in an email statement “With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the Agency’s internal review process.”
Does this mean Juul can stay on store shelves, at least for a little while longer? According to a FDA spokesperson, since Juul’s products “do not have marketing authorization, Juul cannot legally market, ship or sell their products. The stay does not change this.” Still, e-cig makers have been selling their products on store shelves without “authorization” before while they awaited FDA review, and apparently Juul will keep operating the same as it had before its marketing order was denied.
In a further update, Juul provided a copy of the company’s and agency’s dual motion to the U.S. appeals court in Washington D.C. to hold the case until after the agency finishes its review. A section of the appeal reads: “FDA does not intend to take enforcement action against the products subject to JLI’s marketing denial order while the administrative stay is in place.”
Juul had originally asked the courts for a hold on the FDA’s decision, and a panel of three judges on the U.S. Court of Appeals granted that request June 27, according to the Associated Press. The FDA further wrote in Tuesday’s Twitter post that the hold doesn’t rescind its earlier order pulling the product off store shelves, and “does not constitute authorization to market, sell, or ship Juul products.”
The FDA spokesperson said that the need to review the scientific materials came up “in the course of reviewing litigation briefing materials” though the agency rep did not expand more on what “scientific issues” are being re-reviewed.
Juul has previously claimed it provided the FDA with over 125,000 pages of data showing the “substantial public health benefits” of its products. The company claims it provided data measuring the toxicological impact of chemicals contained in its products. Representatives further claimed the FDA did not message them with requests for more info than the company already provided. They called the FDA’s decision “arbitrary.”
“We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health,” Murillo added.
The FDA has approved some vape companies’ marketing orders and denied others both in 2021 and 2022. Though those other examples don’t account for the dizzying number of times Juul has been cited for shady tactics trying to convince lawmakers and customers of the benefits of its vaping products.
The timing is also interesting considering scrutiny of the FDA’s other decisions related to tobacco products. The agency caught flak from a federal judge Tuesday based on 2016 rules holding premium cigars to the same standards and laws as cigarettes. Reuters reported that the judge in this case, Washington D.C. District Judge Amit Mehta, told the FDA it had ignored relevant data about the risks of premium cigars, and asked both the agency and industry groups to submit briefs to whether the court should vacate the agency’s mandates.
The FDA spokesperson declined to talk about that case, saying they do not comment on litigation.
Update 07/06/22 at 2:30 p.m. and 5:30 p.m. ET: This article was amended to include comments from a FDA spokesperson and a Juul executive. It was also updated to include a copy of the FDA and Juul’s dual motion to federal appeals court.