A letter sent to the FDA by six tobacco control organizations demands the agency “take immediate action to protect the nation’s young people, and the public health, from the dramatic rise in teen usage of Juul electronic cigarettes.” The letter reiterates the groups’ demand in their lawsuit against the FDA that the agency reverse its decision to postpone premarket approval for existing vapor products until 2022.
The letter asks the FDA to shut down JUUL’s online sales, despite having no evidence that the company has sold products to minors through its website. In fact, JUUL Labs restricts sales to those ages 21 and above, even in states that allow sales to 18-year-olds.
The letter also claims that JUUL has released e-liquid flavors since the August 8, 2016, naming Mango and Cool Cucumber specifically. No vaping product can be legally marketed after that date without a marketing order from the FDA, which requires submission and acceptance of a premarket tobacco application (PMTA).
The six groups that authored the letter are the Campaign for Tobacco-Free Kids (CTFK), Truth Initiative, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association and American Lung Association.
“Juul is putting kids at risk of nicotine addiction and threatens to undermine decades of progress in reducing youth tobacco use,” says the letter. But youth smoking is at its lowest recorded level, with just 4.2 percent of high school seniors smoking daily in 2017, according to the National Institute on Drug Abuse. That’s more than an 80 percent decline from 1997, when 24.6 percent of 12th graders smoked daily.
The letter emphasizes results of a study conducted by the Truth Initiative, published today in the journal Tobacco Control, which the groups claim shows alarming trends in JUUL use and awareness by young people. However, the study showed that just 25 percent of 1,012 surveyed 15 to 24-year-olds even recognized a JUUL, and just 10 percent had used one (including just one puff ever). Among 15 to 17-year-olds, 21 percent recognized the device.
The study also showed that of the 25 percent that recognized the device, only 25 percent of those (63 people) said that people their age use the word “juuling” to describe the use of a JUUL. That’s just 6.3 percent of the total sample group — which seems very low for a product they claim is experiencing “skyrocketing popularity” among teens.
So far, the campaign against JUUL has generated hundreds of newspaper articles and TV news spots — along with the study, press releases and letters seen today — but no evidence of a real increase in teen vaping or smoking as a result of JUUL’s commercial success.
The groups are preemptively making excuses before the release of major national surveys in June — which may show no significant increase in teen vaping — by claiming that the JUUL name is so tied to its use that many teens don’t recognize “juuling” as being vaping at all. Thus, the logic goes, perhaps teens won’t consider juuling to be vaping when they answer survey questions about vaping or e-cigarette use.
“These groups have implicitly and explicitly claimed that JUUL’s growth and increase in market share is due to the extreme popularity of the product with teenagers,” Amelia Howard told Vaping360. The University of Waterloo (Ontario) sociologist is currently studying the JUUL phenomenon.
“They support this with a concocted narrative in which JUUL is special relative to other vaping products,” says Howard. “They say it attracts new and very young consumers, who would never ever vape or smoke, but are helplessly drawn to the JUUL, and are so infatuated by the brand that they’ve made it into a verb: juuling — which also prevents them from understanding that they are vaping.”
In a separate but coordinated action, Illinois Sen. Dick Durbin and 10 Democratic colleagues sent similar letters to the FDA, and also to JUUL Labs. The letters were announced in a CTFK press release, which summarized the demands being made of the FDA and JUUL Labs.
“Your company’s popular vaping device and its accompanying flavored nicotine cartridges are undermining our nation’s efforts to reduce tobacco use among youth and putting an entire new generation of children at risk of nicotine addiction and other health consequences,” said the letter from the Senators to JUUL Labs’ CEO Kevin Burns.
The tobacco control groups urged the FDA to take the following actions:
- Immediately ordering the removal of any Juul flavors, including the popular “mango” and “cool cucumber” flavors, which were introduced after August 8, 2016 without first seeking required FDA review and authorization. Such review is required for new or changed products under the FDA’s 2016 rule extending the agency’s authority to e-cigarettes. According to Juul’s own social media posts, the “mango” and “cool cucumber” flavors were not introduced until 2017
- Ordering the removal of Juul-like e-cigarette products that have recently been introduced by other manufacturers without required FDA review
- Suspending internet sales of Juul until stronger rules are established to prevent sales to kids and step up enforcement to prevent underage sales by brick-and-mortar retailers
- Reversing the FDA’s 2017 decision that allows e-cigarettes that were on the market as of August 8, 2016, to stay on the market until at least 2022 without undergoing review by the FDA. Health groups last month filed suit challenging the FDA’s delay, arguing it is unlawful and harms public health by leaving on the market products that appeal to kids
“If Juul fails to take the steps necessary to curtail youth use before the start of the next school year in fall 2018, the FDA should take strong, additional enforcement action up to and including suspension of Juul sales until it does so,” the letter says.
But one longtime tobacco control leader isn’t marching in lockstep with the crusaders. Iowa Attorney General Tom Miller, a Democrat who who sits on the Truth Initiative board of directors, issued a statement questioning many of the Truth study’s claims, and urging everyone concerned to slow down and look more closely at what is happening.
“We have enough information to be concerned, but not to make policy decisions,” wrote Miller. “Anecdotal information/stories are never enough to make good policy.”
“The company has achieved remarkable growth among e-cigarette users.” he said. “The current estimate for adult smoking prevalence for 2017 is 14.1 percent. This is the lowest ever recorded and is dropping at an accelerated rate. The most plausible explanation for at least part of this dramatic decline is smokers switching from cigarettes to e-cigarettes, including JUUL.”
JUUL chief executive Kevin Burns seemed conciliatory in his response to the attack. “I share the concerns expressed in this letter about youth access and believe no young person should ever try JUUL,” Burns said in a statement. “I look forward to discussing and working with members of Congress, the FDA and others about how we can make progress on preventing youth from ever using JUUL or other nicotine products.”
Burns, who until recently ran Chobani Yogurt, may not be fully aware of the situation he’s in. His company is threatening two large industries — the cigarette industry, and the tobacco control industry — with possible extinction. And the FDA Center for Tobacco Products is fully funded by tobacco company user fees.
“This needs to be understood in light of the politics of disruptive innovation,” says Amelia Howard. “Vaping solves the problem of smoking, and stands to make cigarettes — and the treatment of tobacco addiction — obsolete. JUUL, as an attractive mass market product, is particularly threatening to existing interests, and a perfect target.”
Burns and JUUL have no friends to throw them a lifeline. The more successful JUUL is at reducing the number of cigarettes sold, the more opposition they’ll face. “Working with” their opponents will be a fruitless task. JUUL needs to steel itself for a fight. And it needs to stop apologizing for doing nothing wrong.