Juul: Dead In The USA?
Last week, the American Food and Drug Administration's Centre for Tobacco Products issued marketing denial orders to JUUL Labs for all its vaping products
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by Dave Cross
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“Currently marketed JUUL products must be removed from the US market,” said the
Food and Drug Administration (FDA). The instruction was immediately put on ice as the U.S. Court of Appeals “entered a temporary administrative stay of the marketing denial order…to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review”.
FDA Commissioner Robert Califf commented: “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”
Some advocates will be short on sympathy for the company they believe acted poorly in removing its flavoured products from sale, encouraging legislators to push harder on banning e-liquid flavours – but all harm reduction campaigners see this as yet another retrograde step by the FDA.
Clive Bates called the move, “an absolutely terrible decision with no basis in ethics, public health, or good regulatory practice.
“FDA’s reasoning does not rely on youth vaping or the usual (unfounded) criticisms of Juul, but on a vague and generalised concern that they do not have enough evidence to do a toxicology assessment. They are not saying there is an actual problem, just that the evidence provided by Juul falls short of an unspecified standard.”
Ultimately, Bates says the FDA has offered “no basis for concern about a real health risk or it would have mentioned it.”
American Vaping Association president Gregory Conley offered up a hopeful insight: “Predictions of doom and gloom for Juul are understandable but may be proven to be premature.”
Conley cited two factors:
- The administrative stay with be issued allowing Juul products to remain on the market while it appeals the FDA's decision
- The fact that Juul still has applications pending at the FDA for its next-generation device that has Bluetooth features to deter youth usage
Conley continued: “With rampant inflation and an economy slipping into a recession, one would think that the Biden Administration would be laser focused on taking steps to improve the lives of Americans. Instead, they are ignoring the science and banning hundreds of thousands of products used by adults to stay off cigarettes. The Biden Administration believes in harm reduction for fentanyl users, but their message to adult smokers and ex-smokers is to drop dead.”
Importantly, while the FDA continues to believe that teen use is an issue to be addressed, Juul usage among youth continues to decline. The 2021 Monitoring the Future Survey found that past-30 day use of Juul among 8th, 10th, and 12th graders fell from 28.3% in 2019 to 4.8% in 2021.
JUUL Labs made the following comment: “We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterised the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health’.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator. 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.”
Photo Credit:
Photo by Jordan Whitfield on Unsplash
Dave Cross
Journalist at POTVDave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous vape companies to develop content for their websites.
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