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Possible Juul link to seizures initiates FDA investigation



An ongoing investigation by the Food and Drug Administration into a possible association between seizures and the use of e-cigarettes was initiated by three cases allegedly involving the use of Juul. Bloomberg reported today.

Bloomberg received communications between FDA officials in mid-October 2018 detailing the three cases. The FDA noted that "there is no causal link, but at least a connection with Juul." Mitch Zeller, director of the FDA's Tobacco Products Center, wrote to Scott Gottlieb, the then FDA commissioner. In an interview, Zeller said that, according to Bloomberg (1

9459003), the FDA failed to confirm that Juul use was associated with seizures in two of the three cases originally reported.

"We are aware of the first report in which 32 cases over a 10-year period have been linked to steam products, some of which referenced JUUL products from the submitter," a Juul spokesperson said in an email at The Verge. "Although the FDA has not contacted us on this matter, we will vigilantly seek clues about potential safety issues and work cooperatively as we continue to combat adolescent consumption and eliminate cigarettes, the leading cause of preventable death in the US , "

Over the next few months, the agency uncovered another 32 reports on the use of e-cigarettes that had been linked to seizures between 2010 and 2019. In April, she publicly announced her investigation. Since then, the total number of reports to the FDA regarding the use of seizure e-cigarettes has increased to 127. The FDA continues to investigate reports of seizures through its safety reporting portal.

Separately, the Centers for Disease Control and Prevention are investigating an unknown lung disease, which also appears to be related to the use of e-cigarettes. More than 190 people have the unknown disease. One person died last week after being hospitalized with the disease.

Yesterday USA Today published an article that focused on marijuana vapes for lung disease. Juul is quoted in it. "Many patients vapourized both nicotine and THC," Juul said in a statement to USA Today . "We also need to make sure that illegal products such as counterfeits, counterfeit products and those that supply controlled substances are not on the market."


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