US FDA Rejects JUUL's Premarket Tobacco Product Application

Shopify API - 27 June 2022

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A well-known vape brand, JUUL, has officially withdrawn all its products from the American vape market. After months of pressure and much speculation, the US Food and Drug Administration (FDA) rejected JUUL's Premarket Tobacco Product Application (PMTA), forcing the brand to exit the US vape market.

Not only that, but it turns out that many health and anti-vape groups have been pressuring the FDA for months to reject all applications from JUUL. And actually, earlier this year, several anti-tobacco groups urged the FDA by sending a letter to take action and push the FDA to ban flavored vaping products.

Meanwhile, the ALA (American Lung Association) and the Campaign for Tobacco-Free Kids said they were very disappointed that the FDA was still reviewing application presentations, including JUUL's. ECigIntelligence revealed that the Campaign for Tobacco-Free Kids intends to take the agency to court if there is no clarification on the reasons for the timeline and delay of this matter.

“We are writing to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on still-pending premarket tobacco product applications (PMTAs) before the agency involving flavored e-cigarette products, including those with menthol flavor and, based on the best available scientific evidence, reject pending applications for all non-tobacco e-cigarettes to protect the nation’s youth from the health harms of these products,” said the letter signed by the American Academy of Pediatrics, the American Heart Association, and the Campaign for Tobacco-Free Kids.

JUUL's Potential to Help People Quit Smoking Should Not Be Ignored

Recently, The Wall Street Journal reported that the FDA plans to withdraw JUUL from the US market and reject JUUL's PMTA application. Matt Culley, a content creator on the board of the Consumer Advocates for Smoke-free Alternatives Association (CASAA), discussed this report in Filter, saying the FDA should take into account the fact that JUUL has successfully helped millions of people quit smoking.

“Juul products have helped millions of smokers switch to a harm reduction alternative,” he said. “That alone should be enough for FDA authorization. That said, Juul has made some mistakes along the way, and they’ve been forced into a group full of small businesses that are on the outside looking in.”

JUUL to Be Pulled From US Market

The FDA has just issued a marketing denial order (MDO) on JUUL. The decision applies to all JUUL products currently being marketed in the US and forces its manufacturer to fully exit the US market.

“We recognize these are a significant portion of the available products and many have played a disproportionate role in the rise of youth vaping,” said FDA Commissioner Robert M. Califf.

Quoted from NPR, Joe Murillo, head of regulatory at JUUL Labs, responded by disagreeing with the FDA's statement and intending to appeal.

"We respectfully disagree with the FDA's findings and decision,"

“We intend to stay and explore all our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator.” Murillo added.

Source: Vapingpost

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