Juul Wins Temporary Stay of FDA Marketing Denial Order

Retailers can continue to sell JUUL products while the stay issued by the U.S. Court of Appeals for the D.C. Circuit is in force.

June 24, 2022

ALEXANDRIA, Va.—A federal appeals court Friday granted Juul Labs Inc. an emergency administrative stay of the U.S. Food and Drug Administration's marketing denial order (MDO) of JUUL products, pending further order of the court. JUUL products can continue to be marketed for retail sale while Juul Labs pursues legal remedies.
Some retail stores have received a “cease and desist” letter purporting to be from the FDA regarding JUUL products. The FDA Center for Tobacco Products issued a statement Friday evening noting, “FDA did not create or distribute this letter and is not collecting JUUL products from retailers.”

Earlier Friday, Juul asked the U.S. Court of Appeals for the D.C. Circuit to grant it emergency interim relief from the FDA’s order.

The D.C. Circuit Appeals Court panel ordered the FDA’s “marketing denial order be administratively stayed pending further order of the court. The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion.”
In a statement Friday following the appeals court action, Gregg Augustine, senior vice president, U.S. Commercial, Juul Labs, said, “As a result of the Court’s action, we will continue to responsibly market our products as we have up to this point pending the Court’s ruling on our forthcoming motion to stay.
“While a stay is in effect, all of our products remain available for sale and there is no legal prohibition against continuing to market JUUL products. Additionally, we have every intention to honor our current contractual obligations and pay valid invoices,” Augustine said.

“As we previously said, we strongly disagree with the FDA’s decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency. We continue to believe our application provided robust data showing JUUL products meet the statutory standard of being ‘appropriate for the protection of the public health.’ This order allows us to continue engaging with our regulators in pursuit of a science and evidence-based determination for our products.”

On Thursday, the FDA issued MDOs for all JUUL products currently sold in the U.S., and the notice called for removal of JUUL products from the U.S. market. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.

"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 Friday 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.

The FDA’s decision on JUUL appears to be part of a sweeping crackdown on tobacco products in the U.S.

The FDA said that it remains focused on its regulatory oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS). So far, the agency has made decisions on about 99% of the nearly 6.7 million products for which applications were received by the Sept. 9, 2020, deadline, including issuing marketing denial orders for more than one million ENDS products.

To date, the FDA has authorized 23 ENDS products.

This week, the Biden Administration published plans for future potential regulatory actions, including a proposed standard by the Food and Drug Administration (FDA) that would establish a maximum nicotine level in cigarettes and certain other combusted tobacco products. The administration said the goal is to reduce youth use, addiction and death.

NACS has expressed concerns that a standard on very low nicotine would push current users to seek out illicit sources for the products. Tobacco companies say that forced reduction of nicotine would cause people to smoke more, not less, and would expand the illicit market for cigarettes.

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.

The menthol market accounts for roughly 34% of cigarette sales, and flavored cigars account for 51% of cigar sales. Given the existing market and current user base, NACS believes a ban on these products will push sales to the illicit market, which undermines the efforts of responsible retailers and poses a greater risk to communities. The rulemaking process includes a comment period in which the agency will consider input from the public before finalizing the rule.

NACS will be filing comments on behalf of the industry, but the FDA also needs to hear from individual retailers. Here’s how to help stop the FDA menthol ban and file comments by August 2.