Regulatory agency’s “marketing denial order” moves to court.
The U.S. Food and Drug Administration (FDA) has put on hold its ban on JUUL electronic cigarettes and related products.
On July 5, FDA took to Twitter to announce the agency “administratively stayed the marketing denial order” announced June 23 effectively banning the sale and distribution of JUUL products.
“The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review,” FDA said on the official FDA Tobacco Twitter feed. “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 FDA announcement said. “The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products.”
The FDA’s June 23 announcement dealt with the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5% and 3% and menthol flavored pods at nicotine concentrations of 5% and 3%.
The ban made national news, drawing positive reaction from medical organizations. Last month, the American Thoracic Society described the FDA ruling as “based largely on a technical dispute over safety data, rather than JUUL’s appeal among kids,” and not based on “highly addictive levels of nicotine salts,” or long-term health effects.
The American Lung Association said stopping sales of JUUL products “is an important step in ending the youth vaping epidemic,” and the American Medical Association criticized companies peddling e-cigarettes to youths, creating a new generation hooked on tobacco products.
Juul Labs’ website states the company’s mission “is to transition adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products.”
The FDA announcement prompted an online rebuttal from JUUL Chief Regulatory Officer Joe Murillo. He pledged the company would seek a legal stay of the FDA order, and the company did a day later.
On June 24, FDA announced the U.S. Court of Appeals for the D.C. Circuit entered a temporary administrative stay of the marketing denial order for Juul Labs Inc.
“The court notes 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,” FDA said in a statement posted on Twitter.
The ruling about JUUL products marked the third significant FDA action on cigarettes, tobacco or electronic nicotine delivery systems in recent months.
On June 21, the White House published plans for future regulatory actions with FDA plans to establish a maximum nicotine level to reduce the addictiveness of cigarettes.
In April, FDA proposed banning menthol cigarettes and flavored cigars to prevent youths from starting smoking and reduce tobacco-related disease and death. Menthol adds a minty taste and aroma to cigarettes, while adding flavors such as strawberry, grape, cocoa and fruit punch appeal to youths and young adults and make cigars easier to use, according to FDA.
The agency will accept public comments until Aug. 2 for the potential new regulations on menthol and other flavors in tobacco products.