Highs school 'Juul rooms'
The companies launched the copycat devices as Juul's market share surged from 13.6 percent of the e-cigarette market in early 2017 to more than 70 percent now, according to a Wells Fargo analysis of Nielsen retail data, which does not include online sales.
The FDA's regulation of e-cigarettes has come under scrutiny in recent months as Juul's popularity has taken off. Anti-smoking advocates complained about the Juul lookalikes in an August letter to the FDA, saying the agency had failed to assert its authority over companies that had "evaded the review process." The FDA said it planned to respond to the letter but declined further comment.
Vaping increased by nearly eightfold between 2011 and 2017 among U.S. high school students, according to the most recent CDC data. Experts say last year's survey likely underestimates the increase because it was conducted before a surge in Juul sales.
Many high schools have resorted to locking bathrooms – jokingly called "Juul rooms" by students. Marcella Bianco, who helps develop school anti-vaping curriculum for the non-profit organization Catch My Breath, said elementary schools have recently started requesting materials.
Educators fear the high-nicotine devices could erode decades of progress in reducing youth tobacco use. Smoking among high school students declined from 15.8 percent to 7.6 percent between 2011 and 2017, according to the CDC, but e-cigarette use grew from 1.5 percent to 11.7 percent over the same period.
"It's like a flashback to 20 years ago," said Kathryn Hensley, a school board member in St. Lucie County, Fla. "Are we starting all over again?"
E-cigarettes have occupied a regulatory gray area in the United States since they emerged a decade ago. Only in 2016 did the FDA finalize rules to regulate e-cigarettes, including the requirement that companies get approval for new products.
Research on the long-term health effects of e-cigarettes is limited. They are widely viewed as safer than tobacco cigarettes because they don't contain the same cocktail of toxic and cancer-causing chemicals.
The U.K. Royal College of Physicians said in a 2016 report that e-cigarettes were 95 percent less harmful than smoking tobacco, citing a reduction in the risk of serious disease and death. The CDC has said e-cigarettes are safer than conventional cigarettes but has not assigned a specific risk reduction because the products can vary widely.
Some health experts are particularly worried about the impact of nicotine from e-cigarettes on adolescents. Research from a 2016 U.S. Surgeon General's report found that such exposure could have "lasting adverse consequences for brain development and cognition" on teenagers. A study released by the National Academy of Sciences this year cited evidence that vaping among young people increases the risk of eventually smoking tobacco.
Banned in other countries
High-nicotine vaping devices and liquids are not allowed in many other parts of the world, including in the European Union and the United Kingdom, which have both set nicotine limits at 20 mg/mL in e-cigarette liquids. Regulators said that level was effective for most smokers trying to quit.
Juul pods are rated at 59 mg/mL, according to the company's marketing. Israeli regulators last month banned Juul out of concern over its high nicotine content, saying the device "posed serious danger to public health."
Davis, the Juul Labs spokeswoman, said in August the company was "incredibly disappointed" with what it called the Israeli government's "misguided decision" to crack down on healthier alternatives to tobacco cigarettes.
Imperial Brands' new myblu product arrived in the United States earlier this year. Matt Kessler, a spokesman for Fontem Ventures, the Imperial Brands unit that owns myblu, said the brand complies with the FDA rules because it is a re-imagination of a similar e-cigarette that was marketed by a company that Imperial brands acquired a year earlier.
The new myblu brand, however, offers 4 percent nicotine strength, meaning at least 40 mg/mL, according to company advertising, higher than any previously offered by the earlier e-cigarette model, called My Von Erl.
Devices that vaporize higher-nicotine liquids fall under the definition of new products subject to FDA review, according to the 2016 regulation. Kessler declined to comment further on nicotine levels in myblu, saying only that the product "is compliant with FDA regulations."
Durante, the CEO of British American Tobacco, acknowledged on the July earnings call that its Vuse Alto device had not been widely available before the August 2016 deadline. He said that's not required under FDA rules.
"To be grandfathered" by the FDA, he said, "you could be in market, in one store, two stores only in the whole country."
The FDA declined to comment on whether myblu and Vuse Alto are compliant or if availability in one or two stores would be considered "on the market." The agency said it would consider "the totality of the evidence" to decide a whether a vaping product had been commercially available before the regulatory deadline.
Struggle to quit
As new high-nicotine Juul competitors arrive, vaping enthusiasts on YouTube are posting reviews of the next "Juul killer" aiming to take a piece of the red-hot market.
Milo Gringlas, a freshman at Cornell University, said Juul has become so ubiquitous on campus that a popular late-night food truck now sells vaping devices and nicotine liquids.
"Everybody either has one or is looking for one," he said.
Austin Tompkins, who lives in Los Angeles, has struggled for the last six months to kick his addiction to Juul, which he started using about three years ago, when he was 19. He realized he needed to stop when he would wake up in the middle of the night needing another hit.
In his latest attempt, he's made it two months without vaping. The urge hasn't gone away.
"I'm telling you, right now, I would love a hit of a Juul," he said.
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