You have probably seen this as it has even made all the UK news outlets – but the vape brand JUUL has been removed from the US market.
The FDA (Food and Drug Administration) issued a MDO (Marketing Denial Order) to JUUL labs Inc meaning the company must stop selling and distributing their products in the US.
Affected are the JUUL device and the Virginia Tobacco and Menthol pods with 3 and 5mg nicotine strength.
Why Has This Happened?
Well back in 2019 our late great Neil H wrote about the PMTA process – this stands for “Pre Market Tobacco Application”. All tobacco products have to be approved by the FDA before they can be legally sold in the US.
So far very few vapes have been approved for sale you can see a list of those here – PMTA 2022 Granted Orders.
The application process is full of red tape and seems to be taking forever.
As you can imagine being one of the largest vape companies in the US, JUUL applied and waited like all the other companies and has now received the MDO.
What Is The Impact?
At the moment customers who use JUUL are fine – they won’t get any legal issues.
However the company JUUL must not distribute, import or sell the offending products.
The FDA stated that the JUUL application…
“lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings 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 and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications. “
The FDA statement does say that there is no immediate hazard to vapers using the devices but there is insufficient evidence to approve the marketing of these products.
According to an article in the UK Daily Mail – shop owners in the US have said people are rushing to buy their JUUL products in bulk of up to 40 packages at once.
As for UK vapers there is no restriction on the sale of these – but whether the company will continue in business with losing a huge chunk of its market is another matter.
JUUL Responds
The firm’s chief regulatory officer Joe Murillo said in the official statement from JUUL…
“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 characterized 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.”
Read the full announcement from the FDA here – FDA Denies Authorization to Market JUUL Products.
I think this Tweet sums up my opinion…
So you’re telling me you can’t buy a juul pod but you can purchase rifles and enough ammo to kill a community….. am I reading this shit right?
— monroe (@mmonrroee) June 24, 2022
