On June 23, 2022, the U.S. Food and Drug Administration (FDA) gave marketing denial orders to JUUL Labs Inc. – a demand to pull all of their products from the shelves in the United States. As a result, JUUL was prohibited from selling and distributing its e-cigarettes and vaping devices in the U.S. The following day, however, the U.S. Court of Appeals passed a temporary administrative stay of the marketing denial order. This means that while JUUL products can still be sold in the U.S. today, their future is uncertain.
As of July 2022, JUUL is legal in the USA. A federal appeals court granted JUUL a temporary emergency hold on the FDA ban while JUUL files an appeal against it. This emergency hold or temporary administrative stay was followed by the FDA taking similar action on July 5, 2022, to stay its own marketing denial order on an administrative level. This action by the FDA does not rescind the original order, however, or constitute authorization to market, sell or ship JUUL products.
The FDA’s original marketing denial orders on June 23 would have forced JUUL to immediately halt its business. The FDA made it clear, however, that its order would not restrict individual consumer possession or use of JUUL products or any tobacco products. Yet the order never went into effect, since the following day JUUL filed an emergency motion with the federal appeals court to block the government ban, calling it an “extraordinary and unlawful action” by the FDA.
A three-judge panel in the District of Columbia Circuit granted JUUL’s emergency request for a stay of the FDA’s order, effectively permitting JUUL to continue selling in the U.S. – for now. The next step will be JUUL filing an appeal against the FDA’s marketing denial orders in an attempt to block the ban permanently. Until further legal action takes place, the stay on the ban approved by the U.S. Court of Appeals will permit JUUL to continue selling and distributing its electronic cigarettes and other products in the United States.
The Food and Drug Administration has stated that it is committed to ensuring that all e-cigarettes and similar products being marketed to consumers meet the administration’s public health standards. Part of this commitment is a recent crackdown on JUUL and hundreds of other nicotine and tobacco companies that required them to submit marketing applications to prove that their products benefit public health – for example, that adult smokers are likely to quit smoking cigarettes in exchange for e-cigarettes.
The FDA’s marketing denial order came after it claimed that JUUL’s application to continue selling its products contained “insufficient and conflicting data.” The FDA stated that the application lacked evidence that the chemicals JUUL uses are “appropriate for the protection of public health.”
While the FDA says it does not have evidence suggesting that JUUL’s products are hazardous, there is not enough evidence to determine their effect on public health one way or the other. This led to the FDA denying the marketing application and immediately ordering JUUL to halt its business in June.
The answer to this question depends on the outcome of JUUL’s pending appeal of the FDA’s order. In its request for a temporary administrative stay, JUUL stated that the FDA was acting on political pressure from Congress and was holding JUUL Labs Inc. to a different standard than other e-cigarette manufacturers.
JUUL also argued that immediately removing its products from the market – as would be required by the FDA’s motion – would harm the general public, as “more than two million adult smokers have switched from cigarette smoking to JUUL products.” The upcoming appeal in the federal courts by JUUL will determine the future of these products in the U.S. market.
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