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New restrictions on e-cigarette flavors FDA plans to launch

Taking on epidemic levels of teen e-cigarette use, the US Food and Drug Administration is expected to announce new restrictions on the sale of e-cigarette products.

FDA Commissioner Scott Gottlieb is expected to announce a ban on the sale of most flavored e-cigarettes in convenience stores and gas stations as early as next week, The Washington Post first reported on Thursday. The agency will impose age-verification requirements for online sales. Flavored e-cigarette products would be available in vape and tobacco shops.
Gottlieb is also expected to propose a ban on menthol in regular cigarettes.
e-cigarette flavors FDA
The convenience store ban on flavored e-cigarette sales would not include menthol. Because the FDA will continue to allow the sale of menthol in regular cigarettes, the agency doesn't want to give cigarettes an advantage over e-cigarettes.

E-cigarette makers argue the devices help adult smokers give up cigarettes -- potentially saving them from related illnesses -- by giving a nicotine fix without the smoke and smell of combustible cigarettes. The scientific consensus is still out on the long-term health effects of vaping.
About 6.9 million adults used e-cigarettes in 2017, according to a US Centers for Disease Control and Prevention report released Thursday.

But the FDA says it didn't foresee the "epidemic" of youth e-cigarette use. More than 2 million middle and high school students were current users of e-cigarettes in 2017, the FDA said, and e-cigarettes were the most commonly used tobacco product by youth.

The FDA announced in September it would investigate major e-cigarette makers Juul, MarkTen, Vuse, Blu and Logic, including reviews of marketing and sales practices. It also said it cracked down on 1,300 retailers who illegally sold e-cigarettes to minors.

CNN reached out to Juul but did not immediately hear back.
The FDA recently launched a massive education campaign aimed at the nearly 10.7 million teens at risk for e-cigarette use, taking the message that vaping is dangerous into high school bathrooms and social media feeds.

"E-cigs have become an almost ubiquitous -- and dangerous -- trend among teens," Gottlieb said in September. "The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. It's simply not tolerable."

How Juul's plan to teach students about vaping went up in smoke

The leading maker of e-cigarettes, Juul Labs, attempted to roll out an anti-vaping curriculum in schools earlier this year, offering school districts thousands of dollars and new technologies to implement it, according to documents and emails obtained by CNN.

The company abandoned these efforts in May, not long after its initial outreach, in response to a backlash from health and education advocates.
"Under no circumstance should anybody from the tobacco, nicotine, vaping industries be involved in or implementing tobacco prevention programs," said Bonnie Halpern-Felsher, professor of pediatrics in Stanford University's Division of Adolescent Medicine. She published an article last month slamming the curriculum in the Journal of Adolescent Health.

Halpern-Felsher, who is also the founder and executive director of the Stanford Tobacco Prevention Toolkit, had been developing her own curriculum on vaping when she was approached by California education advocates who had gotten wind of Juul's curriculum in late 2017.
She recalled their message: "You guys need to do something yesterday."

What's in it?
Halpern-Felsher said the Juul curriculum was "completely missing the most important pieces" of a bona fide prevention effort.
For example, it didn't discuss the role of industry and marketing in promoting nicotine use. And it touted mindfulness as a prevention tool, despite what she described as a lack of evidence that it works in this context. Some of the curriculum's exercises included guided meditation and swinging a pendulum over a piece of paper to discuss the "power of the mind," she writes in the article.

In a version of the curriculum provided by Halpern-Felsher, teachers are referred to a primer video, which links to an Australian vaping company and says that people vape to "reduce harm" and "save money" over cigarettes. (The Stanford toolkit describes the former as a "misperception.")
At the end of the video: a popup box that says, "New to vaping? We'll help you take those first steps."
The materials rarely mention Juul by name, Halpern-Felsher said.
What they did mention, however, was her own work -- the Stanford toolkit -- which was referenced as a resource in Juul materials reviewed by CNN.
She became aware of this when a colleague falsely accused her of working with or receiving money from the company.
"That's when I said, 'wait, something's going on here,' " Halpern-Felsher said.

On the alert
Also named in Juul documents was the Spokane Regional Health District, which has its own tobacco and vaping prevention programs.
"The Spokane Regional Health District is listed as one of the resources on which they based their prevention initiative, which was of great concern to Spokane," Frances Limtiaco, program manager for the Washington State Department of Health's Tobacco and Vapor Product Prevention and Control Program, wrote in an emailed statement.
"However, we were never able to determine how this came to be," she added.

This prompted Limtiaco and her colleagues to send out an alert in March to Washington schools warning them that "Juul Labs are piloting their prevention program ... to middle and high schools."
"The tobacco industry has a long history of sponsoring youth prevention programming that ultimately undermines evidence-based tobacco control efforts, and JUUL is no different," the alert said.
No schools or school districts responded to the alert saying they had received offers from the company, Limtiaco noted.
A similar alert was sent by email in February by school health officials with the California Department of Education.
"People have said to me in the schools ... 'I'm concerned because I'm hearing about Juul trying to come to our schools and offering this money,' " Halpern-Felsher said.
"There was a lot of confusion."

Devices for vices
The Stanford and Spokane resources appeared in a December company memo outlining Juul's plans, which included "designing alternatives to traditional prevention programs" by culling from "best practice resources."
A Juul Labs spokeswoman, Victoria Davis, confirmed that the memo was a company document.
Also noted in the December memo is the progress the initiative had made: It had contacted 15 school districts in California, committed two schools to the program and engaged "long-time educational leaders Wendell Greer and Bruce Harter to lead the prevention effort in schools and school districts."
Harter and Greer did not immediately respond to requests for comment. They served together as administrators of California's West Contra Costa Unified School District; Harter was its superintendent.

Emails show that Harter attended a meeting in February to promote the Juul program at California's Tobacco Education and Research Oversight Committee. Meeting minutes show that Harter was there in person and Greer via teleconference.

The following day, health and education experts privately expressed concern about Juul's plans. One doctor described as "problematic" the company's plans to set up focus groups of student vapers:
"It's analogous to Philip Morris' research on kids they did under the guise of youth smoking prevention," wrote Dr. Pamela Ling, a professor of medicine at the University of California, San Francisco who works with the school's Center for Tobacco Control Research and Education.
"Why would you give this company access to kids like this?" she wrote in the February email.
Similarly, Halpern-Felsher expressed concerns to CNN that the curriculum itself could yield important insights about e-cig marketing to the industry.

For example, one student questionnaire asks, "What's appealing about using e-cigarette or JUULs? Why do students use them?" Schools were to be instructed to submit these forms to "JUUL consultants," documents show.
"We in the public health world ... got very nervous that that's how they're gathering data," Halpern-Felsher said.

The company's strategy also included developing technology that might disable the vapes, including "wireless nodes that alert school staff to use in schools," and an age-verification process that would require an adult's smartphone, according to the December memo.
In a February email that Halpern-Felsher shared with CNN, Harter said that Juul would be piloting these devices by the end of March. He promised that it would not only disable a vape, but it would also tip off school administrators as to where and when vapes were being used.
In August, Bloomberg also reported the rollout of Bluetooth-enabled Juuls that might verify vapers' ages and shut down in schools due to "geofences" surrounding the premises.
In an e-mailed statement, Davis told CNN, "We actively evaluate new technologies and features to help keep JUUL out of the hands of young people."

'Short-lived'
At the time of the December memo, the pilot program aimed to launch in February. But it was ultimately abandoned by mid-May, according to Davis.
Halpern-Felsher said she learned of at least one school that used materials from Juul after a student's mother contacted her.

"The discontinued curriculum guide was a short-lived initiative designed to provide educators with current information on vaping products in general to supplement existing tobacco prevention education," Davis said.

"We stopped distribution in response to feedback from those who thought our efforts were being misunderstood," she added.

According to emails obtained by CNN and dated in February, stipends in the amount of $10,000 had been offered to a number of school districts. In at least one case, a district said it had declined an offer of $20,000 plus "nodes" that could "jam the JUUL devices and render them useless."

Another school is quoted in these emails, shared by Halpern-Felsher, as saying that it had been offered gadgets that could locate Juuls being used on school premises and that Juul anticipated that the technology would be ready for use during the following school year.
Davis said stipends were offered in varying amounts "depending on their needs and complexity of programs." She said that receiving those funds was not contingent upon implementing the curriculum.

CNN also reviewed a template of Juul's memorandum of agreement, which promised 75% of the funding up front, with the remaining 25% contingent upon receiving a final report from the principal, which would contain details like how many students attended and when. Schools would also agree to allow Juul "consultants" to sit in on sessions, though not to participate.
Davis said fewer than 10 schools received stipends, which "were intended to cover the costs associated with operational expenses, resources, or training/material for teachers with the programs the school or district chose to employ." She did not comment on which schools received stipends.

'Step up'
In the months since Juul's program came to a halt, federal authorities have toughened efforts to crack down on underage vaping.
The US Food and Drug Administration will announce a "new action plan" this month to "firmly confront and reverse the youth addiction trends that are at epidemic levels," Commissioner Dr. Scott Gottlieb said in a statement Wednesday.
In another statement Friday, Gottlieb announced a public hearing next month that will "focus on the potential role of drug therapies to support cessation among youth, and the issues impacting the development of such therapies for children."

The agency recently expanded its investigation into e-cigarette companies, sending letters to 21 companies last month -- including Juul -- in an effort to uncover whether they are marketing products illegally and outside the agency's compliance policy.
That move came less than two weeks after the agency conducted a surprise inspection of Juul's corporate headquarters in San Francisco, seizing thousands of documents, many of which relate to its sales and marketing practices.

On Wednesday, Gottlieb said e-cig companies have acknowledged in meetings that flavored products play a role the products' appeal to kids. Beyond the FDA's own regulations, he has invited these companies to take voluntary steps to address what he described as a mutual goal to keep e-cigs out of kids' hands.

"For the e-cigarette industry, my message was simple: Step up," Gottlieb said.
Altria Group, one of the companies Gottlieb met with, announced last week that it was pulling a number of flavored vaping products from shelves until it receives FDA authorization or "when the youth issue is addressed," according to a statement by company Chairman and CEO Howard Willard.

The rapid spread of e-cigarettes, which work by heating a liquid until it vaporizes, was flagged in a 2016 report by the US surgeon general that cited a 900% increase in e-cigarette use by high school students from 2011 to 2015. E-cigarette use declined for the first time in 2016 but held steady the following year.
Halpern-Felsher said consumers and health experts have been locked in a contentious debate; while some see it as a smoking cessation tool for adults, others say "there's no good evidence there, period," she added.
"There's never been ... something so divisive in the public health world as vapes," she said.

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