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Juul devices mentioned in seizure reports that triggered an FDA probe

A US health department investigation into whether e-cigarettes can cause seizures was triggered by a handful of people who used Juul devices, according to the Food and Drug Administration documents.

The three seizure reports went through the FDA's internet security portal, and the agency was unable to formally verify that they were bound to Juul devices. While the company's e-cigarette dominates the device market, its name is also used by some people as a substitute for any kind of vapors.

"No evidence of causality, but at least an association with Juul" Mitch Zeller, director of the FDA's Tobacco Products Center, sent an e-mail to former FDA commissioner Scott Gottlieb on October 1

5. The FDA has not yet identified a manufacturer's device as being tied to seizures, and Bloomberg's report is the first confirmation that individuals explicitly stated that they had used a Juul device.

FDA Tobacco Regulatory Review in Reports Begins Already in October, six months before the agency's IPO, a broader warning was issued. The agency's regulators use the reporting portal as an early-warning system for drug, medical device and tobacco issues. A small number of reports can trigger a broader investigation to determine if a problem is widespread or serious.

Hot Startup

Juuls Gadget is manufactured by Juul Labs Inc. The vaping startup has self-promoted itself This is a way for traditional smokers to quit smoking and has attracted $ 13 billion of investment from Altria Group Inc. towards market leadership.

"We will closely monitor all indications of potential safety issues and continue to work cooperatively to combat adolescent consumption and eliminate cigarettes," said Juul spokesman Matt David in a statement.

The San Francisco-based company has caught the eye as devices have become popular with teenagers and others who have not started out as cigarette smokers. The Wall Street Journal reported today that the US Federal Trade Commission had initiated an investigation into the company's marketing practices. Juul has taken steps to curb such use by restricting some sales and doing more to check the buyer's age.

In the US, cigarettes are responsible for more than 480,000 deaths each year, according to Centers for Disease Control and Prevention. Eliminating or restricting their use would significantly improve public health, although US regulators are careful to understand the risks of the products they could replace.

In the case of the seizures described in the FDA documents, the agency was unable to formally confirm that two of the three reports are actually related to Juul, Zeller said in an interview with Bloomberg today. Often, the FDA's online safety reporting portal does not collect enough information to draw final conclusions, and tracking can be difficult if someone does not save the product in question, takes no pictures, or gives investigators no way to contact them.

However, the agency's concerns rose to the point where it decided to go public. She published updates of the investigation in the hope that the public would provide more detailed information, Zeller said. Earlier this month, the agency said the investigation had expanded to 127 reports of seizures or other neurological symptoms related to e-cigarettes between 2010 and 2019. The FDA has not identified a specific product in any of its public communications.

Early Reports

In his October email to Gottlieb, Zeller briefly outlined the three reports, two from teenage parents and one from a 23-year-old man, all of whom said Juul associated with seizures she or her sons were experienced. The FDA collected another 32 reports before issuing a statement in April that a possible link was being investigated.

The early reports are first-hand reports received by the FDA, and their content does not necessarily need to be reviewed. A study received by the FDA on June 27, 2018, said it was from a mother who said her 16-year-old son had a grand mal seizure after using a Juul device. Her son told her that he had seen an aura after inhaling his Juul, which she did not know had used it, and then collapsed.

"From that moment on, I got involved when I heard him crash into the floor above me. I reached him when he was fully gripped, convulsions that turned blue and turned his eyes in his head, "the mother said in her report. "He was unconscious when the cramping stopped about a minute after it started."

Paramedics found a mint-flavored juul under the collapsed teen who later appeared in the ambulance, she said in her report to the FDA. The flavoring agent contained 5% by weight of nicotine, among the higher levels on the market, she said.

The second report of a teenager who had a grand mal seizure that Zeller reported came from a parent of a 15-year-old boy who had been addicted to fruit-flavored Juul for the past year and who also used the 5% pads , The boy had developed attention problems and increased compulsiveness according to the report.

"Although the doctors are not yet sure that the Juul is behind the problem, it is obvious to us and other parents that they are fighting the same fight. Juul's high nicotine content is toxic to our children," wrote the parent of the teenager.

Sales Analysis

Juul has conducted a series of investigations into his selling practices, particularly with regard to whether they are targeted by younger users, including the Federal Trade Commission, which today reports on the Journal has been. Juul said in a statement to Bloomberg that it cooperates in all government investigations. Altria shares fell 3.8% at 13:26. in New York.

Juul's sales and marketing practices were also the target of an FDA investigation because of the adolescent's popularity with adolescents. The agency seized documents from Juule's headquarters in San Francisco nearly a year ago.

The House Oversight and Reform Committee is also investigating Juul. The committee issued a report in July detailing the efforts of the Vape company to sponsor presentations in schools. Internal e-mails from Juul published by the committee showed employees how these programs resembled the tactics used by cigarette manufacturers in the past. In an e-mail, a Juul employee called her "incredibly similar" according to the committee's report.

Juuls school programs are the subject of an "active, ongoing investigation" by the FDA, Zeller said in an interview. He declined to comment on whether the active investigation is part of a larger investigation of the company's marketing practices or a separate investigation.

Documents Received from Bloomberg Show That Juul Already Informed the FDA in the Spring of 2018 That This Was Scheduled Contact Schools to help educate young people and prevent smoking. Zeller said Juul described the programs as such to administrators and teachers, not to students. The company then informed the agency in October that the idea had been dropped, said Zeller.

"We informed the FDA that we were planning a meeting with administrators and teachers and met with students before meeting with them to teach the dangers of nicotine addiction," said David Juul's spokesman. David said the program was "clearly misinterpreted" and warned teens of the danger of nicotine use.

Other Concerns

Vaping has not only been associated with seizures, but has also recently been involved in an outbreak of mysterious lung disease. The Centers for Disease Control and Prevention announced Friday that they are investigating 193 possible cases of severe lung disease related to the use of e-cigarettes in 22 states. An adult man in Illinois has died.

Some states have reported that patients with lung problems have reported extensively on the use of steam containing THC, the psychoactive substance in marijuana. The federal authorities have made no clear distinction despite requests from vaping advocates for clarification.

"Much more has to be known," Zeller said.

Robert Redfield, director of disease control and prevention, tweeted on Friday are "serious risks associated with e-cigarette products".

Former FDA Commissioner Gottlieb, who left the agency in April, expressed concerns over a potential seizure risk associated with e-cigarettes. Depending on the strength, the amount of nicotine in a Juul pod is about one pack of cigarettes.

"You can draw your own conclusions from that, but Juul is a high-dose nicotine product," Gottlieb said in an interview. "It's not just about Juul, it could be other products, it could be illegal products."

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