ALEXANDRIA, Va.—The Food and Drug Administration (FDA) is suspending its ban on JUUL vaping products while the company appeals the agency’s decision, reports the Wall Street Journal.
“On July 5, 2022, FDA administratively stayed the marketing denial order. The agency has determined that there are scientific issues unique to the Juul application that warrant additional review. This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it. 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 stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products,” the FDA said via Twitter.
In late June, the FDA issued marketing denial orders (MDOs) for all JUUL products currently sold in the U.S., and the notice called for the removal of JUUL products from the U.S. market.
Shortly after, a federal appeals court granted Juul Labs Inc. an emergency administrative stay of the FDA’s MDOs of JUUL products, pending further order from the court. JUUL products were able to continue to be marketed for retail sale while Juul Labs pursues legal remedies.
Juul asked the FDA for a longer stay to continue selling its e-cigarettes for the duration of the appeal process. Juul separately asked the FDA to stay its own order pending the appeal, reports the Journal.
Initially, the FDA denied Juul’s request for a stay, which led Juul to seek a stay of the ban in court.
"FDA's extraordinary and unlawful action, which demands that JLI immediately halt essentially all of its business operations, warrants the emergency interim relief requested," Juul Labs said in its filing with the U.S. Court of Appeals for the D.C. Circuit. "FDA's decision is arbitrary and capricious and lacks substantial evidence, and an immediate administrative stay is critical to protect JLI, its commercial partners, and its customers," the company said in its motion.
A statement from the FDA said that Juul’s premarket tobacco product applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
In court filings, Juul alleged the FDA mishandled its applications. Juul said the agency overlooked more than 6,000 pages of data that the company submitted to the FDA on the aerosols that users inhale.
Last week, NACS filed an amicus brief in the U.S. Court of Appeals for the D.C. Circuit in support of Juul’s petition for a stay.
“If allowed to take effect, the Order threatens NACS members with harm independent of the harm Juul describes in its stay application,” wrote NACS in the brief. “The order saddles retailers and distributors with inventory they cannot sell and contracts they cannot fulfill, waylaying a substantial portion of their business practically overnight.”
NACS argued that the immediate removal of JUUL products would “wreak havoc” on the entire industry, upend an important segment of the economy, endanger countless jobs and impede small businesses’ ability to operate.
The FDA said that it remains focused on its regulatory oversight of e-cigarettes and other ENDS products. So far, the agency made decisions on about 99% of the nearly 6.7 million products for which applications were received by the Sept. 9, 2020 deadline. This included issuing marketing denial orders for more than one million ENDS products.
To date, the FDA has authorized 23 ENDS products.
Last week, the Biden Administration published plans for future potential regulatory actions, including a proposed standard by the FDA that would establish a maximum nicotine level in cigarettes and certain other combusted tobacco products.
The FDA recently released two proposed tobacco product standards. One bans menthol as a characterizing flavor in cigarettes, and the second bans all characterizing flavors, including menthol, in cigars.