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FDA Playing Catch-Up as JUUL and Imitators Give Nicotine Jolt to E-Cig Business

An ad promoting the JUUL device. Note the warning in tiny type at the bottom: 

”This product contains nicotine. Nicotine is an addictive chemical.” An ad promoting the JUUL device. Note the warning in tiny type at the bottom: ”This product contains nicotine. Nicotine is an addictive chemical.”
Teenagers from local high schools flock to Brooklyn Vape in downtown Brooklyn. The store is small – a single room with vape paraphernalia stacked to the ceiling in glass cabinets. Many of the teens walk awkwardly through the shop and ask the clerk, a man who goes by Ali and wouldn’t give his last name, if they can buy an e-cigarette. Ali says most of them ask for a JUUL, a vaporizer fashioned into a sleek, rectangular prism that can vanish into a closed fist, but occasionally they’re looking for something a little different.

“Sometimes they ask for the Phix,” Ali said. “About once a week they ask for the Suorin Drop or Suorin Air.” Then, Ali says, when it comes time to buy, they say they left their IDs at home.

The federal government classifies e-cigarettes as tobacco products and, as such, youths under 18 (or under 21 in New York City) are barred from buying them. Of course, rules never stop all teenagers, and a teen vaping trend has gained serious steam over the last year. Most of the attention revolves around the JUUL device, whose starter kit normally sells for about $50, but new offerings with similar features have rapidly entered the market.

“We’ve already begun to see a whole new generation of e-cigarettes, all of which are designed to deliver far higher levels of nicotine in far more sleek containers than have existed in the past,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. “Whether intentionally or by mistake,” he later added, “the original creators of JUUL produced the perfect next-fad product for our nation’s kids.”

For public health authorities, the popularity of JUUL and its rivals highlights the conundrum of e-cigarettes. They provide a safer way for smokers to get their nicotine fix by delivering far less of the toxic and cancer-causing baggage of conventional cigarettes. But will e-cigarettes ultimately lead to less tobacco smoking or more? Critics fear, and some studies suggest, that many kids who would never experiment with regular cigarettes will try e-cigarettes, become addicted, and graduate to tobacco as a more satisfying way to get nicotine. “If you could get every smoker to switch to vaping, that would be a huge public health victory,” said Meghan Morean, a psychologist at Oberlin College who studies substance abuse among teens. “But sometimes great ideas have really negative unintended consequences.”

The concerns are being heightened by the massive numbers of adolescents taking up vaping – at a point in their lives when heavy nicotine consumption can affect brain development. The University of Michigan’s most recent national survey of drug use by adolescents found that, in 2017, 19 percent of high school seniors reported nicotine vaping in the previous 12 months. The Centers for Disease Control and Prevention today released data showing that 11.7 percent of high school students last year reporting using e-cigarettes in the previous 30 days, up from 1.5 percent in 2011.

A lack of regulation has eased the way for the boom in e-cigarette sales. Last summer, the U.S. Food and Drug Administration came under fierce attack from public health advocates for granting e-cigarette makers a long delay in seeking approval for new products. Under the moratorium announced by the agency, the companies will have until 2022 to submit information on their manufacturing and marketing practices. But now, amid growing alarm about teens taking up the vaping habit, the FDA has started to take some action.

In April, the FDA announced an undercover operation cracking down on retailers that sell JUUL products to minors. The agency also demanded that JUUL Labs, the San Francisco-based company that markets the JUUL device, turn over documents related to its marketing practices and research, including information on the health effects of its products.

E-cigarette products on display at a Brooklyn, N.Y. shop. (Photo by Angus Chen)

“We don’t yet fully understand why these products are so popular among youth. But it’s imperative that we figure it out, and fast. These documents may help us get there,” FDA Commissioner Scott Gottlieb said in a written statement. In May, the FDA demanded similar records from other e-cigarette manufacturers, including J Well, YGT Investment, 7 Daze, Liquid Filling Solutions and SVR.

JUUL officials declined to answer a question from FairWarning about whether they felt any qualms about their device’s powerful appeal to youth. But they pointed to a company statement that their “mission is to eliminate cigarettes and help the more than one billion smokers worldwide switch to a better alternative… At the same time, we are committed to deterring young people, as well as adults who do not currently smoke, from using our products. We cannot be more emphatic on this point: No young person or non-nicotine user should ever try JUUL.”

JUUL Labs has set up a $30 million fund to investigate and prevent underage nicotine use, and reached out to Iowa Attorney General Tom Miller to set up an advisory group that would influence JUUL’s future policies and designs. That group would have no real power over JUUL, though, and what the company does won’t affect the policies of the vape industry as a whole.

JUUL fired up the e-cigarette business. The original e-cigarettes came in two basic styles. One was a long, slim cylinder with a LED light that lit up on draws – making it look like a tobacco cigarette – and the other was a large, handheld battery with an atomizer screwed on top that hissed and turned users into fog machines.

Adam Bowen and James Monsees, JUUL’s designers and the founders of the business that became JUUL Labs, intended their e-cigarette to be different. They wanted it to be the cigarette-killer, JUUL spokeswoman Victoria Davis said via e-mail. For that, it had to be sexier than cigarettes. The design featured a gem-shaped cartridge window separating the JUUL’s gunmetal gray battery from a black mouthpiece. There are no buttons – sucking on the mouthpiece activates the device. And JUUL comes with disposable pods, which each last about 200 puffs and are filled with 50 milligrams of nicotine – about the same as a pack of cigarettes. The whole thing is shorter than the palm of your hand and resembles a long, slim USB memory drive.

It was important that the JUUL didn’t look like older e-cigarettes or tobacco cigarettes. “We know adult smokers who want to switch [to e-cigarettes] do not want to be reminded of combustible cigarettes,” Davis said. Likewise, teenagers often are turned off by traditional cigarettes. “They don’t want to be considered smokers,” said Oberlin College’s Morean.

The new approach clicked. Upon its introduction three years ago, JUUL was greeted with a review in Wired magazine headlined, “This Might Just Be the First Great E-Cig.” Meanwhile, with JUUL the dominant company, the e-cigarette industry’s revenues have boomed. According to a recent Wells Fargo analysis, overall sales for the vape industry in the U.S. this year will grow about 25 percent to reach $5.5 billion.

A JUUL nicotine delivery device (JUUL Labs photo)

Milan, a Brooklyn high school student whose last name is being withheld to protect her privacy, offers an explanation for JUUL’s popularity. “It’s about style,” she said. “Because the design is so cool, it lures people in.” Plus, Milan added, “Because it’s small, you can get away with” using it in school.

Other manufacturers have followed JUUL’s lead in coming out with their own thin, sleek devices with interchangeable, prefilled pods. Ramakanth Kavuluru, a data scientist at the University of Kentucky who has tracked e-cigarette use on social media, likens the trend to what happened in the smartphone business. JUUL, he says, was the iPhone of e-cigarettes. The others are like Androids – emulating the industry leader but offering a wider range of flavors and nicotine concentrations.

A new vape, the Suorin Drop, seems to be emerging as a top rival to JUUL among youths. Video reviews have come out on YouTube with titles like “Suorin Drop (THE JUUL KILLER)” and “Suorin Drop, Better than the JUUL?” In one video, a young man holds up a JUUL and says, “I’ve had this JUUL for many months but it hasn’t been getting me that buzz lately, you know?” Then he holds up a Suorin Drop. It’s a flat device that, like the JUUL, can fit in the palm of a hand, but is shorter, wider and molded into the shape of a teardrop.

Perhaps the biggest selling point is the fact that Suorin pods are refillable. Vapers can buy liquids that have even higher concentrations of nicotine, and more flavors, than the JUUL. It’s cheaper, too. A four-pack of JUUL pods costs about $17, while a bottle of vape juice that would refill a Suorin several times can go for $15 or less.

Because the Suorin is shorter than the JUUL, surreptitious vaping is easier. Matt, a 15-year-old Suorin user from San Jose, California, says teachers at his school are catching onto the JUUL and other vapes that look like it. But, he said, “They don’t know what the Suorin looks like,” making it easier to sneak at schools.

The Suorin Drop so far doesn’t seem to have caught the FDA’s attention, either. The company that makes it, Shenzhen Bluemark Technology Co, wasn’t among the e-cigarette firms ordered this spring to provide information to the agency about its youth business.

In response to a question from FairWarning about whether the company was concerned about selling a product widely used by underage consumers and exposing them to the risk of nicotine addiction, Shenzhen Bluemark replied, “Our product is intended for use by adult smokers of legal age who want to get rid of cigarette[s].” The company said it has taken measures to ensure its product isn’t sold to minors.

Meanwhile, adolescents who are heavy users of e-cigarettes risk becoming addicted to the nicotine. “I don’t feel like I need it like some of my friends who are at the point like, ‘Oh my God, I’m so addicted. I need it,’’’ Matt said.

“I’m just like whatever,” he said. “ I just use it a couple times.” A couple times a day? After a moment, Matt replied, “A couple times every hour maybe. But my friends use it every five minutes.”

This story was produced by FairWarning, a nonprofit news organization based in Pasadena, California, that focuses on public health, consumer and environmental issues.
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