An investigation by US health authorities about whether electronic cigarettes can cause seizures was prompted by a handful of people who used Juul devices, according to documents from the Food and Drug Administration.
The three seizure reports were made online by the FDA's safety portal and the agency failed to confirm formally whether they were connected to Juul devices. While the company's electronic cigarette dominates the device market, its name is also used as a substitute by some people for any type of vaping.
"There is no evidence of causation, but at least an association with Juul," Mitch Zeller, director of the FDA's Center for Tobacco, sent an email to then FDA commissioner Scott Gottlieb on October 1
The FDA tobacco regulators' plug in reports began as early as October, six months before the agency was issued a broader warning. The agency's regulators use the reporting portal as an early warning system for drug, medical and tobacco problems. A small number of reports can trigger a wider probe to determine if a problem is widespread or serious.
The Juul device is made by Juul Labs Inc. a way for traditional smokers to quit and attract a $ 13 billion investment from Altria Group Inc. on the path to market dominance.
"We will closely monitor all evidence of potential safety issues and work together as we continue to combat youth use and cigarette removal," said Jules Matt spokesman.
San Francisco-based company attracted close scrutiny as the devices also became popular with teens and others who did not start out as smokers.The Wall Street Journal reported today that the US Federal Trade Commission has launched an investigation into marketing Juul has taken steps to try to limit such use by limiting some sales and doing more to check the age of buyers.
Cigarettes are responsible for more than 480,000 deaths annually in the US, according to Centers Disease control and prevention The elimination or restriction of their use would significantly improve public health, even though US regulators are closely monitoring the risks of products that can replace them.
In the case of the seizures described in the FDA documents, the agency was unable to formally confirm that two of the three reports were actually related to Jules, Zeller said in an interview with Bloomberg today. The FDA's online safety reporting portal often does not gather enough information to reach definitive conclusions, and tracking them can be difficult if someone does not save the product in question, take pictures, or leave the investigators to contact them.
But the agency's concern eventually grew to the level it decided to publish. He is publishing updates to the investigation, hoping that the public will provide more detailed information, Zeller said. Earlier this month, the agency said the investigation expanded to 127 reports of seizures or other neurological symptoms related to e-cigarettes between 2010 and 2019. The FDA did not identify a specific product in any of its public communications.
In an email to Gottlieb, Zeller briefly outlined three reports, two by parents of teenagers and one by a 23-year-old man who all say that Jules is associated with seizures or they or their sons survived. The FDA collected 32 more reports before issuing a statement in April that it was investigating a possible link.
Early reports are first-hand accounts that enter the FDA and their contents are not necessarily verified. One, received by the FDA on June 27, 2018, said it was from a mother who said his 16-year-old son had been abused after using a Juul device. Her son told her he saw the aura after inhaling Juul, which she didn't know he was using, and then collapsed.
"From that moment on, I got confused when I heard him bang on the floor in the room above me. I reached him when he was fully clinging, convulsions, blue, eyes rolled up in his head," the mother says in her report . "He was unconscious after the convulsions stopped about a minute after they probably started."
Paramedics discovered a mint scent under a curly teenage girl who later came to the ambulance, she said in a report to the FDA.
The second report of a teenager who was abused that Zeller was a parent at the age of 15, she said. a boy who was addicted to Juul with a year's fruity aroma and also used 5% pods. According to the report, the boy had attention problems and increased compulsiveness.
"While doctors are not yet trained to say with certainty that Yul is behind the problem, obviously the same battle is going on for us and other parents, the high nicotine content in Juul is toxic to our children," wrote the teen's parent .
Juul has been confronted with a number of studies on its sales practices, especially about targeting younger consumers, including the Federal Trade Commission, reported today by the magazine. Juul said in a statement to Bloomberg that he was cooperating with anyone government investigation Altria shares fell 3.8% at 13:26 pm in New York.
Juul sales and marketing practices are also being investigated by the FDA due to the device's popularity with young people.
The Chamber's Committee on Oversight and Reform also investigated Jul. The committee published a report in July detailing vape's efforts to sponsor presentations at schools. Internal emails from Juul published by the commission showed employees discussing how these programs resemble tactics used by cigarette manufacturers in the past. In an email, a Juul employee calls them "terribly similar," according to a committee report.
Juul's school programs are the subject of an "ongoing, ongoing investigation" by the FDA, Zeller said in an interview. He declined to comment on whether the probe was part of a larger study by the company’s marketing practices agency, or a separate investigation.
Documents received from Bloomberg indicate that Juul notified the FDA as early as spring 2018 that it planned to contact schools to work on youth education and prevention of nicotine use. Zeller said that Jules described the programs as those that would target administrators and teachers, not students. The company then told the agency in October that it had rejected the idea, Zeller said.
"We told the FDA that we planned to talk to administrators and teachers and that we met with students to teach youth about the dangers of nicotine addiction," said David, a Yule spokesman. David said the program was "clearly misunderstood" and was intended to warn young people about the dangers of nicotine use.
Not only has worming been associated with seizures, it has also recently been implicated in an outbreak of mysterious lung disease. The Centers for Disease Control and Prevention announced Friday that it is investigating 193 possible cases of serious pulmonary disease related to the use of electronic cigarettes in 22 states. An elderly man in Illinois has died.
Some states say that patients with pulmonary problems report to a large extent that they use vaping products that contain THC, the psychoactive substance in marijuana. The federal authorities have not made such a clear distinction, despite calls from vaping advocates for clarification.
"Much more needs to be known," said Zeller.
The director of the Centers for Disease Control and Prevention Robert Redfield tweeted on Friday that there were "serious risks associated with e-cigarette products."
Former FDA Commissioner Gottlieb, who left the agency in April, said concerns about a possible seizure risk related to e-cigarettes were partly focused on whether high-dose nicotine products were involved. Depending on the strength, the amount of nicotine in a Juul pod is roughly equivalent to a pack of cigarettes.
"You can draw your own conclusions about this, but Juul is a high-dose nicotine product," Gottlieb said in an interview, "It doesn't necessarily mean just Jul. They may be other products, they may be illegal products. ”