FDA bans Juul vape products; court orders a temporary stay
The U.S. Food and Drug Administration (FDA) on June 23 banned the sale and distribution of Juul Labs Inc. vaping products, and further ordered that Juul products already in stores must be removed.
Juul immediately went to court and received a temporary stay on the ban the next day from the U.S. Court of Appeals for the District of Columbia. However, the court was clear that the order was made only to give judges time to consider Juul’s motion to overturn the ban, and the delay “should not be construed in any way as a ruling on the merits of that motion.”
The judges gave Juul until June 27 to file a full motion with the court and gave the FDA until July 7 to respond to that. The court said it would respond to Juul’s request to have the ban overturned by July 12.
The FDA ban on Juul — one of the best-selling vaping brands in the United States — is widely seen as bad news for the vaping industry, and for Big Tobacco as a whole. Altria Group, the parent company of Philip Morris International, holds a 35% stake in Juul.
The situation also leaves vape retailers in an awkward position of not knowing if, or for how long, they’ll be able to keep selling one of their most-popular brands.
FDA reviewing millions of vape products
If you haven’t been following the FDA’s attempts to regulate the vaping industry, here’s the backstory:
In 2009, Congress approved the Family Smoking Prevention and Tobacco Control Act, which gave the FDA, for the first time, authority to regulate tobacco products for public health. In 2016, the FDA approved a rule to regulate all tobacco products, including vape products with nicotine derived from tobacco.
As part of the regulatory process, vape product manufacturers were required by September 2020 to submit applications with clinical trial data about the health effects of their products, showing that they met regulatory standards. More than 6 million different vape products were allowed to stay on the market while they were under FDA review.
So far, the FDA has approved applications for 23 electronic nicotine delivery systems (or “ENDS”), but it has rejected about a million other applications. Many of the rejected applications were for flavored vape products, which researchers claim are leading to a rise in teen vaping.
Vape industry advocates point out that some adults successfully use their products to wean themselves away from cigarettes as part of efforts to quit smoking.
No clinical data to suggest immediate hazard from Juul
In announcing its intent to ban Juul products, the FDA acknowledged that it “has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or JUULpods.”
However, the FDA also said that the information it had received from Juul was “insufficient” for the agency to “assess the potential toxicological risks of using the Juul products.”
In the Juul case, the FDA said some of the research findings the company had submitted “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.”
The agency also said there’s no way for it to determine “the potential harms” of using third-party vape juice with Juul devices, or of using Juul vape-juice pods with a non-Juul device.
Juul: We’re exploring all of our options
Juul issued a statement saying it feels the clinical trial data it submitted was complete and met FDA requirements.
The statement was attributed to Juul Labs Chief Regulatory Officer Joe Murillo, who asserted “We have provided sufficient information and data based on high-quality research to address all issues raised by the agency.”
The company is “exploring all of our options under the FDA’s regulations and the law,” according to the statement from Murillo, who added that Juul might appeal.
“We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” Murillo’s statement concluded.
Other industry figures were more aggressive in criticizing the FDA decision.
“The agency is hellbent on rigging the process to fulfill its prohibitionist agenda,” said American Vapor Manufacturers Association President Amanda Wheeler.
What do vape shops do about Juul?
News of the ban prompted a run on Juul products in some places. Other stores saw a more low key response, with shop owners predicting that vapers would switch to other approved brands. Some stores had already pulled Juul products from their shelves in anticipation of the move.
The FDA itself recommends that vape shop operators contact their suppliers and manufacturers for up-to-date guidance.
Vape products on the market without FDA authorization are “marketed unlawfully and are subject to enforcement action,” the agency said, adding that sales of unauthorized vape products are “among our highest enforcement priorities.”
The action against Juul is the latest round in the federal government’s attempts to get tighter control over the vaping industry. We discussed a related issue — the new law giving the FDA oversight of synthetic nicotine — back in May.
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