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Helena public health officials react to FDA JUUL ban

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Posted at 3:21 PM, Jun 23, 2022
and last updated 2022-06-23 17:25:29-04

HELENA - JUULS, are little electronic cigarettes or vapes that have been in the news in the past for allegedly marketing to teens, now with a marketing denial order from the Food and Drug Administration (FDA) , they are no longer available for sale or distribution in the United States.

"The flavors, we know that the look and the design is really appealing to youth and the biggest issue with this is addiction," said Sarah Sandau, Lewis and Clark Public Health Prevention Program Coordinator.

Lewis and Clark County Public Health officials say teens in the county have turned to vapes like JUULs because of their sleek look.

Sandau says that in 2017, 44% of Lewis and Clark County high schoolers reported using a vape or electronic cigarette at least once, by 2021 that number had risen to 50%, and 1-in-3 Montana teens report using an e-cigarette regularly.

"We have found that teens that use e-cigarettes are four times more likely to start smoking cigarettes in the future compared to their peers," said Sandau.

In the past JUUL Labs has been accused of targeting teens with their flavors of JUULpods like mint, mango, creme, and cucumber.

In their decision to have JUUL labs e-cigarettes pulled from shelves, the FDA cited a lack of evidence that the devices would be appropriate for public health and the company's failure to complete a full toxicological risk assessment in their premarket product applications regarding potentially harmful chemicals that could leak from the nicotine pods.

However, the FDA noted that it has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods.

The FDA also determined that there is no way of knowing the potential risk that comes from using nicotine pods in general.

But Sandau says that the removal of the highly popular vaping product from stores will hopefully reduce the number of youth tempted to try the product

"We know youth use of any use of nicotine in any form is unsafe and since nicotine is so highly addictive it can harm a young brain, we support all efforts, locally, statewide and nationally to stop youth initiation," said Sandau.

JUUL labs issued a statement saying they disagree with the FDA’s decision and believe they have provided sufficient data and information to the FDA.

The company says it plans to seek a stay of the order and says that the FDA findings are incorrect their statement states:

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.
Joe Murillo, Chief Regulatory Officer at Juul Labs