Many health and anti-vape groups have been pressuring the FDA to flat out reject any applications by Juul for months. In fact earlier this year, several anti-tobacco groups sent a letter to the FDA urging it to take action on the outstanding PMTAs and encouraging the agency to deny applications for flavoured vaping products.
While entities such as the American Lung Association (ALA) and the Campaign for Tobacco-Free Kids said they are “deeply disappointed” that the FDA was still studying a percentage of the applications, including Juul’s. ECigIntelligence revealed that the Campaign for Tobacco-Free Kids has gone as far as saying that it intends to take the agency to court if it did not “immediately clarify” the timeline and reason for these delays.
“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all non-tobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” said the letter, which was signed by the American Academy of Pediatrics, the American Heart Association, and the Campaign for Tobacco-Free Kids among others.
Juul’s smoking cessation potential should not be ignored
The Wall Street Journal has recently reported that the FDA was planning to reject Juul’s PMTAs and pull the brand off the US market. Discussing these reports on Filter, Matt Culley, a content creator on the board of the Smoke Free Alternatives Consumer Advocacy (CASAA) said that the FDA should take account the fact that Juul has helped millions quit smoking.
“The Juul product has helped millions of smokers switch to a reduced risk alternative,” he said. “That alone should be enough for an FDA authorization. That being said, Juul has made some mistakes along the way, and they’re being forced into a group full of small businesses who are on the outside looking in.”
Juul to be pulled out of the US market
Of course, this was not the case! The FDA has just issued a marketing denial order (MDO) to Juul. The decision applies to “all of their products currently marketed in the United States,” forcing the manufacturer to completely exit the US market.
“We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” stated FDA Commissioner Robert M. Califf.
In response to the FDA decision, a Juul representative said that the brand intends to fight back. “We respectfully disagree with the FDA’s findings and decision,” said Joe Murillo, Juul Labs’ chief regulatory officer, as quoted by NPR.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law,” added Murillo “including appealing the decision and engaging with our regulator.”
