FDA Says Juul Can’t Claim to Be Safer Than Cigarettes

By the ninth grade, Phillip Fuhrman was already addicted to Juul, as were many of his friends. Some of them had reservations about using the e-cigarettes. Nicotine is bad for you, right? But their concerns about vaping were quickly explained away by a speaker who visited their school in April 2018 to give a presentation about mental health and addiction. Fuhrman testified to Congress in July that the speaker said he was connected to Juul, and told the kids that e-cigarettes were “totally safe” and that the US Food and Drug Administration (FDA) would soon announce that Juul products were 99 percent safer than regular cigarettes.

On Monday, the FDA chastised Juul for these and other scientifically unsubstantiated claims that advertise e-cigarettes as “modified risk tobacco products,” suggesting they are safe, relatively risk-free ways to quit smoking. Marketers can’t make those claims unless the FDA has reviewed the products and agrees that the company has rigorous scientific data to back them up. In a separate letter, the FDA requested Juul turn over information about its youth marketing strategies and Juul’s use of nicotine salts.

“We are reviewing the letters and will fully cooperate,” a Juul spokesperson said via email.

Juul, which dominates the US e-cigarette market, has been exceptionally popular among teenagers and young adults. The Centers for Disease Control (CDC) estimates that one in five high schoolers use e-cigarettes. In addition to covertly promoting the products in schools and camps, the company also had an active social media presence and sought out influencers to promote its products, according to a memo from the House Subcommittee on Economic and Consumer Policy.

These marketing techniques were common and well documented, says Robert Jackler, a researcher at Stanford who studies e-cigarette marketing. “This has been going on for years,” says Jackler, who also testified at the two-day congressional hearing on e-cigarettes in July. He speculates the FDA is reacting to pressure from US Representative Raja Krishnamoorthi (D-Illinois), who chaired the hearing, and from Senator Dick Durbin (D-Illinois). Both Krishnamoorthi and Durbin have urged the FDA to take action in recent weeks to curb the youth vaping epidemic.

E-cigarette companies, including Juul, often feature advertisements that explicitly promise their products will help smokers quit—some ads show a hand crushing a pile of combustible cigarettes or describe the products as a “smart choice” for smokers who want to change. Other advertisements make those claims implicitly, encouraging smokers to “switch” to Juul, without naming or showing regular cigarettes as the alternative.

But there’s scant scientific evidence to back up claims that e-cigarettes are safe or that they are an effective tool for helping smokers quit. Some studies show e-cigarettes are linked to increased risk of stroke, chronic obstructive pulmonary disease, and wheezing. Others show that the high levels of nicotine in e-cigarettes can cause seizures and that some flavorings are toxic. Right now, the FDA and the CDC are racing to identify the causes of five deaths and some 450 mystery respiratory illnesses tied to vaping.

One study in The New England Journal of Medicine found that e-cigarettes were more effective than other nicotine-replacement therapies at helping users quit. But the study also combined e-cigarettes with counseling and behavioral support. Other studies have been less conclusive.

When Juul arrived on the market in 2015, it promised to disrupt the tobacco industry. But the company’s advertising follows in a long history of tobacco products that made dubious safety claims. In the 1950s, Camel cigarettes made their products appear healthier with advertisements claiming “more doctors smoke Camels than any other cigarette!” Later, companies advertised filters, low-tar cigarettes, and lite, mild, or ultra-lite products, all of which promised to reduce risk and none of which actually did. Jackler says that this history of false advertising makes the public health community particularly skeptical of any products that claim to reduce the risks of smoking.

“They’re not moving fast enough given the seriousness of the youth epidemic,” says Vince Willmore of the anti-vaping advocacy group Campaign for Tobacco Free Kids. Willmore wants the FDA to take much more aggressive action, including banning the sale of all flavored e-cigarette pods, a particular draw for teenagers. Juul no longer sells flavors like mango and cucumber, which were favorites among teenagers, in stores, but they are available on its website. Other companies still sell flavored pods in stores and online. Willmore says the letters and investigation are a step forward, but that the FDA is falling short of the “comprehensive approach we need to prevent kids from using e-cigarettes.”

The FDA gave Juul 15 days to respond to the warning and to create a plan to prevent further violations. For teenagers like Fuhrman, who are already struggling with full-blown nicotine addictions, advocates say this action comes too late.

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