An order mandating e-cigarette company Juul to immediately pull its product from the market has been temporarily suspended by the Food and Drug Administration.
Citing a desire to protect public health, the agency had said Juul provided sufficient information regarding its products’ toxicological profile in its premarket tobacco product application. Its suspension required products currently being sold to be pulled from shelves.
Then, on July 5th, the FDA issued a temporary stay to its marketing denial order.
“The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review,” the agency stated on Twitter, noting the order was not currently being rescinded.
“All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed,” the agency added. “The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products.”
Juul Labs Inc.’s chief regulatory officer Joe Murillo told Engadget that the company had “provided sufficient information and data based on high-quality research to address all issues raised by the agency.”
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being appropriate for the protection of the public health,” Murrillo said.
The FDA’s ban on Juul products had already been blocked. After the ban was issued on June 23, the company filed a legal challenge in court.
“FDA’s decision is arbitrary and capricious and lacks substantial evidence,” the company argued in its court filings. The company said it would suffer irreparable harm if the FDA’s ban was allowed to take effect and it would lose the majority of its domestic revenue.
The United States Court of Appeals for the D.C. Circuit blocked the FDA’s ban, prohibiting the ban from being enforced while prior to the presentation of argument from both parties’ legal representation.
Juul has been blamed for an increase in nicotine use among teens and young adults because its product is consumer-friendly, producing no smoke and virtually no smell.
FDA Commissioner Dr. Robert M. Califf said Juul products “make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping” when the agency announced the marketing ban in June.
“E-cigarettes have been the most commonly used tobacco product among youth since 2014,” reports the Centers for Disease Control and Prevention. “In 2021, about 1 out of every 35 middle school students (2.8%) reported that they had used electronic cigarettes in the past 30 days.”
The company stopped selling popular fruit or sweet flavors in 2019 after some anti-smoking groups argue the products entice teens.
“Vaping remains popular among teens, with nearly 10.7 million youths aged 12-17 admitting they have tried or would try e-cigarettes,” noted Forbes.
The FDA began regulating nicotine products, like e-cigarettes, hookahs and cigars, in 2016. The agency has argued the billion-dollar industry needed to be scientifically evaluated.
E-cigarette makers have to prove their products ultimately support public health by helping smokers quit, for example, and are not likely to encourage teens to smoke.
The FDA’s ban paralleled President Joe Biden’s ongoing effort to reduce and restrict Americans’ use of nicotine.
The day before the Juul ban became official, the FDA announced its plan to reduce the amount of permitted nicotine in cigarettes to “minimally addictive or non-addictive levels” to prevent young people from becoming addicted. The agency also said establishing a maximum nicotine level would help current smokers quit.
Conservative television personality Tucker Carlson called the move the Biden administration’s “new drug war.”
“Nicotine is not the thing that gives you cancer. Nicotine is the thing, it’s addictive, but it also increases mental acuity,” Carlson said during his show on June 21. Carlson said the federal government wanted Americans to go through nicotine withdrawal so they would be “more passive and easier to control.”
