Juul devices cited in seizure reports that started FDA probe

The US Food and Drug Administration has been investigating reports of seizures caused by e-cigarettes since October.

US e-cigarette maker Juul has faced inquiries into whether it targeted younger users, but the San Francisco-based company says it continues 'to combat youth usage.' [David Paul Morris/Bloomberg]

An investigation by U.S. health authorities into whether e-cigarettes can cause seizures was triggered by a handful of people who reportedly used Juul devices, according to Food and Drug Administration documents.

The three seizure reports came through the FDA’s online safety portal, and the agency wasn’t able to formally verify that they were tied to Juul devices. While the company’s e-cigarette dominates the market for the devices, its name is also used as a substitute by some people for any type of vaping.

“No proof of causality, but at a minimum, an association with Juul,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, emailed then-FDA Commissioner Scott Gottlieb on Oct. 15. The agency’s communications about Juul were obtained by Bloomberg through a public-records request. The FDA hasn’t previously identified any one manufacturer’s device as being tied to the seizures, and Bloomberg’s report is the first confirmation that people specifically said they had used a Juul device.

The probe by FDA tobacco regulators into the reports began as early as October, six months before the agency went public with a wider warning. Regulators at the agency use the reporting portal as an early-warning system for problems with drugs, medical devices and tobacco products. A small number of reports can trigger a wider probe to determine whether a problem is widespread or serious.

Hot startup

Juul’s device is made by Juul Labs Inc. The vaping startup has advertised itself as a way for traditional smokers to quit, and has attracted a $13 billion investment from Altria Group Inc. on its way to dominating the market. Shares of Altria were down 4% to $44.03 at 2:20 p.m. in New York.

“We will vigilantly monitor for any evidence of potential safety issues and work cooperatively as we continue to combat youth usage and eliminate cigarettes,” Juul spokesman Matt David said in a statement.

The San Francisco-based company has attracted scrutiny as the devices have also become popular with teens and others who didn’t start out as cigarette smokers. On Thursday, the Wall Street Journal reported that the U.S. Federal Trade Commission had opened an investigation into the company’s marketing practices. Juul has taken steps to try and curb such use by limiting some sales and doing more to check buyers’ ages.

Cigarettes are responsible for more than 480,000 deaths a year in the U.S., according to the Centers for Disease Control and Prevention. Eliminating or curtailing their use would vastly improve public health, though U.S. regulators are watching carefully to understand the risks of the products that may replace them.

In the case of the seizures described in the FDA documents, the agency wasn’t able to officially confirm two of the three reports were in fact linked to Juul, Zeller said in an interview with Bloomberg Thursday. The FDA’s online safety reporting portal often doesn’t gather enough information to draw final conclusions and follow up can be difficult if someone doesn’t save the product in question, take photos, or doesn’t leave a way for investigators to contact them.

But the agency’s concerns eventually grew to a level where it decided to go public. It released updates on the investigation in hopes the public would bring forward more detailed information, Zeller said. Earlier this month, the agency said the investigation had widened to 127 reports of seizures or other neurological symptoms linked to e-cigarettes between 2010 and 2019. The FDA hasn’t 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 parents of teens and one from a 23-year-old man who all said they thought Juul was linked to seizures either they or their sons experienced. The FDA gathered another 32 reports before issuing a statement in April that it was investigating a possible link.

The early reports are first-hand accounts that come to the FDA, and their contents aren’t necessarily verified. One, received by FDA on June 27, 2018, says it’s from a mother who said her 16-year-old son had a grand mal seizure after using a Juul device. Her son told her he saw an aura after inhaling his Juul, which she didn’t know he was using, and then collapsed.

“From that point I became involved as I heard him crash to the floor in the room above me. I reached him as he was fully seizing, convulsions, turning blue, eyes rolled up in his head,” the mother said in her report. “He was unconscious once the convulsions stopped about a minute after they probably started.”

Paramedics found a mint-flavored Juul under the collapsed teen, who later came to in the ambulance, she said in her report to the FDA. The flavor pod contained 5% nicotine by weight, among the higher amounts on the market, she said.

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

“While doctors are not yet trained to say for certain that the Juul is behind the problem, it is obvious to us and other parents fighting the same battle that the high nicotine content of the Juul is toxic to our children,” the teen’s parent wrote.

Sales scrutiny

Juul has faced a number of inquiries into its sales practices, especially around whether it targeted younger users, including the Federal Trade Commission reported Thursday by the Journal. Juul said in a statement to Bloomberg that it cooperates with any government investigation.

Juul’s sales and marketing practices have also been the target of an FDA investigation because of the device’s popularity among youth. The agency seized documents from Juul’s San Francisco headquarters almost a year ago.

The House Oversight and Reform Committee is also investigating Juul. The committee released a report in July detailing efforts the vape company undertook to sponsor presentations in schools. Internal emails from Juul released by the committee showed employees discussing how these programs resembled tactics used by cigarette makers in the past. In one email, a Juul employee called them “eerily similar,” according to the committee’s report.

Juul’s school programs are the subject of “an active, ongoing investigation” by the FDA, Zeller said in the interview. He declined to comment on whether the active investigation is part of agency’s larger probe into the company’s marketing practices, or a separate inquiry.

Documents obtained by Bloomberg show that Juul informed the FDA as early as the spring of 2018 that it planned to contact schools to work on youth education and nicotine-use prevention efforts. Zeller said Juul described the programs as ones that would target administrators and teachers, not students. The company then told the agency in October it had dropped the idea, Zeller said.

“We told FDA that we were planning on talking with administrators and teachers and that prior to the meeting, we had met with students to educate youth on the dangers of nicotine addiction,” David, the Juul spokesman, said. David said the program was “clearly misconstrued” and had been meant to warn youth about the danger of nicotine use.

More concerns

Vaping has not only been associated with seizures but also recently has been implicated in an outbreak of mystery lung illnesses. The Centers for Disease Control and Prevention said Friday that it was investigating 193 possible cases of severe lung illness linked to e-cigarette use in 22 states. One adult male in Illinois has died.

Some states have said that patients with lung problems largely reported using vaping products that contain THC, the psychoactive substance in marijuana. Federal authorities have not made such a clear distinction, despite calls from vaping advocates for clarification.

“A lot more needs to be known,” Zeller said.

Centers for Disease Control and Prevention Director Robert Redfield tweeted Friday that there are “serious risks associated with e-cigarette products.”

Former FDA Commissioner Gottlieb, who left the agency in April, said concerns surrounding a possible seizure risk linked to e-cigarettes in part 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 that but Juul is a high-dose nicotine product,” Gottlieb said in an interview. “It doesn’t necessarily just implicate Juul. It could be other products, it could be illegal products.”

Source: Bloomberg