https://sputnikglobe.com/20220625/juul-gets-a-temporary-stay-on-fda-ban-1096646486.html
Juul Gets a Temporary Stay on FDA Ban
Juul Gets a Temporary Stay on FDA Ban
Sputnik International
On Thursday, the Food and Drug Administration (FDA) announced a nationwide ban on Juul vaping devices and flavors. It previously banned flavors from all “small... 25.06.2022, Sputnik International
2022-06-25T01:31+0000
2022-06-25T01:31+0000
2022-06-25T01:31+0000
tobacco
e-cigarettes
food and drug administration (fda)
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A federal appeals court has issued a temporary stay on the FDA ban of Juul vaping products, allowing them to continue to be sold in stores, for a while at least.The court stressed that the stay “should not be construed in any way as a ruling on the merits” of Juul’s larger case against the FDA ban.Juul asked for an administrative stay of the order on Friday, arguing that the ban would cause significant and irreparable harm to the company. The short stay is to give Juul time to file for an emergency review of the FDA order.On Thursday, the FDA said Juul must stop selling their nicotine vaping devices and flavors in the United States. The ban would be disastrous for the company, which sells most of its products in America. The Wall Street Journal reported on Friday that Juul is considering bankruptcy if they cannot get the FDA order overturned. Juul’s Chief Regulatory Officer Joe Murillo told Engadget on Thursday that the company would fight the order and was exploring “all options.”In 2020, the FDA ordered makers of e-cigarettes to submit their products for review. The FDA says it wants to evaluate the potential health benefits for adult smokers switching to the products and weigh that against the health concerns caused by their rising popularity among teenagers.The FDA says that Juul’s application did not provide enough information on the potential health risks of their products. Juul countered by pointing out that their application was over 125,000 pages long. A press release at the time of its submission also touted data from 110 scientific studies.26 other “electronic nicotine delivery systems” have been approved by the FDA, including products from fellow start-up NJOY and from a company owned by tobacco industry giant R.J. Reynolds.The American Vapor Manufacturers Association predictably disagreed. “[The FDA] is hellbent on rigging the process to fulfill its prohibitionist agenda. Their analysis seems completely arbitrary and no amount of data or evidence will sway the FDA off its destructive path,” said president Amanda Wheeler in a statement posted on the association’s Twitter account. “A responsible FDA would emphasize harm reduction, which experts agree will save lives by helping adults quit combustible cigarettes.” Wheeler also stated that the products approved by the FDA are “obsolete” and that adult vape users have “little enthusiasm” for them.The FDA previously slammed Juul for claiming their products are a safer alternative to smoking without FDA approval. Juul has also spent at least $87 million settling lawsuits with various states over their alleged marketing to underaged smokers.It is unclear at this time how long the temporary order will last, but the next step will be for Juul to file for an emergency review of the order. If that is granted, a protracted court case is possible.
https://sputnikglobe.com/20210628/e-cig-company-juul-to-pay-40-million-in-settlement-of-underage-marketing-lawsuit-1083260839.html
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tobacco, e-cigarettes, food and drug administration (fda)
tobacco, e-cigarettes, food and drug administration (fda)
Juul Gets a Temporary Stay on FDA Ban
On Thursday, the Food and Drug Administration (FDA) announced a nationwide ban on Juul vaping devices and flavors. It previously banned flavors from all “small vaping devices” except for Tobacco and Menthol.
A federal appeals court has issued a temporary stay on the FDA ban of Juul vaping products, allowing them to continue to be sold in stores, for a while at least.
The
court stressed that the stay “should not be construed in any way as a ruling on the merits” of Juul’s larger case against the FDA ban.
Juul asked for an administrative stay of the order on Friday, arguing that the ban would cause significant and irreparable harm to the company. The short stay is to give Juul time to file for an emergency review of the FDA order.
On Thursday, the FDA said Juul must stop selling their nicotine vaping devices and flavors in the United States. The ban would be disastrous for the company, which sells most of its products in America. The
Wall Street Journal reported on Friday that Juul is considering bankruptcy if they cannot get the FDA order overturned. Juul’s Chief Regulatory Officer Joe Murillo
told Engadget on Thursday that the company would fight the order and was exploring “all options.”
In 2020, the FDA ordered makers of e-cigarettes to submit their products for review. The FDA says it wants to evaluate the potential health benefits for adult smokers switching to the products and weigh that against the health concerns caused by their rising popularity among teenagers.
The FDA says that Juul’s application did not provide enough information on the potential health risks of their products. Juul countered
by pointing out that their application was over 125,000 pages long. A press release at the time of its submission also
touted data from 110 scientific studies.
26 other “electronic nicotine delivery systems” have been approved by the FDA, including products from fellow start-up NJOY and from a company owned by tobacco industry giant R.J. Reynolds.
The decision from the FDA brought both praise and condemnation. “JUUL will finally be held accountable for creating the youth vaping epidemic, and igniting a new industry of highly-addictive flavored products that are harming millions of American kids,” Meredith Berkman and Dorian Fuhrman, the founders of Parents Against Vaping e-cigarettes (PAVe) told NPR in a joint email.
The American Vapor Manufacturers Association
predictably disagreed. “[The FDA] is hellbent on rigging the process to fulfill its prohibitionist agenda. Their analysis seems completely arbitrary and no amount of data or evidence will sway the FDA off its destructive path,” said president Amanda Wheeler in a statement posted on the association’s Twitter account. “A responsible FDA would emphasize harm reduction, which experts agree will save lives by helping adults quit combustible cigarettes.” Wheeler also stated that the products approved by the FDA are “obsolete” and that adult vape users have “little enthusiasm” for them.
The FDA
previously slammed Juul for claiming their products are a safer alternative to smoking without FDA approval. Juul has also spent at least $87 million settling lawsuits with various states over their alleged marketing to underaged smokers.
It is unclear at this time how long the temporary order will last, but the next step will be for Juul to file for an emergency review of the order. If that is granted, a protracted court case is possible.
