The FDA banned Stanford-born company Juul from selling its products. Researchers disagree on if that was the right call.

Oct. 4, 2022, 12:42 p.m.

Following the Food and Drug Administration’s (FDA) initial ban on Juul sales in the U.S., researchers specializing in the effects of e-cigarette usage expressed mixed opinions on Juul’s role in the teenage vaping crisis and its future in the U.S. market.

The FDA temporarily banned Juul products on June 23 in response to Juul’s alleged role in fueling the teen vaping crisis through youth advertising campaigns promoting their smooth salt-based nicotine formulas. However, less than two weeks later, the FDA announced it would temporarily freeze the ban as they further reviewed the case.

Adam Bowen M.S. ’05 and James Monsees MFS ’06 have said they initially founded Juul Labs to produce a healthier and less-stigmatized way to deliver nicotine. However, the company has faced numerous controversies regarding the safety and effects of its products.

“We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health,” wrote Juul Lab’s Chief Regulatory Officer Joe Murillo in a public statement on the FDA’s decision to freeze the ban. The Daily was not able to reach Bowen and Monsees for comment.

For Juul products to remain on convenience store shelves across the nation, the company must prove that it has created a net positive for the country’s public health by getting adult smokers off cigarettes while preventing teenagers from latching onto their products.

Bonnie Halpern-Felsher, a developmental psychologist and the director of the Stanford Reach Lab, said that the cons associated with selling e-cigarettes like Juul in the U.S. market far outweigh its pros. As teenage nicotine addictions spike, Halpern-Felsher claims that vaping may be an easier gateway to nicotine addictions.

“Teens did not want to use cigarettes,” Halpern-Felsher said. “They thought they were gross. They thought they were for old people. Then, suddenly a new, cool, blingy, high-tech and good-flavored salt-based nicotine [Juul] came on the market and attracted young people.”

Other researchers also argue that vaping may act as a gateway into cigarette usage for teens. Harvard University School of Public Health professor Howard Koh wrote in a statement to The Daily that “such non-combustible products (like Juul) are highly addictive, associated with progression to cigarette use for at least some youth.” A study conducted by the Children’s Health Study found that young people who use e-cigarettes are 6.5 times more likely to transition into combustible usage than those who do not. 

Juul pulled their fruit-flavored vape pods off the market on Jan. 2, 2020, following the FDA’s finalization of a policy regulating unauthorized flavored e-cigarette products. This left only menthol and mint-flavored pods on the market. Halpern-Felsher thinks this may have helped reduce the appeal of e-cigarettes for teenagers, but she believes it is not enough as teenagers still enjoy using menthol and mint flavors.

The temporary ban on all Juul products as well as the subsequent freeze followed Juul’s decision to take fruit-flavored pods off the market. Since the freeze, Halpern-Felsher said she does not understand what the future looks like for Juul and its U.S. customers, particularly teenagers. “It just worries me,” Halpern-Felsher said. “These products are hurting our kids, and that’s what I care about.”

Still, Halpern-Felsher thinks there could be a place for e-cigarettes such as Juul on the market as long as they are not in the hands of teenagers. This could be done by prescribing e-cigarettes to adult smokers trying to quit while reducing the amount of nicotine in the vape as time goes on.

On the other hand, Michael Siegel, a professor in the Department of Public Health and Community Medicine at Tufts University, says that Juul products are not a gateway to teen smoking. Siegel believes that the FDA should approve most, if not all, Juul products seeking authorization but restrict their sale to vape shops.

“There is no question that Juul products (and e-cigarettes generally) have enormous health benefits for smokers, helping them to quit and literally saving their lives,” Siegel wrote in a statement to The Daily. “I can’t overemphasize the enormity of these public health benefits.”

Addressing the claim that Juul is influencing teens who would not have otherwise been inclined to smoke, Siegel said that the types of kids using Juul products are of the “experimenter” type who would have probably experimented with cigarettes anyways. 

Additionally, he said that “approximately 80% [of teenage vapers] are also using other forms of nicotine, such as actual tobacco products, or they are using THC products.” Siegel believes there is no compelling evidence that e-cigarettes are a common gateway for smokers and that there is, in fact, strong contradictory evidence. For example, a study led by researchers at the University of North Dakota found that most vape users would have smoked cigarettes anyways due to several cultural and institutional forces. The study suggested that while vaping may increase the chances of trying a cigarette, it doesn’t appear to increase the likelihood of that person becoming a regular smoker. 

The FDA made its initial decision to ban Juul due to an insufficient demonstration that their devices were not toxic. Siegel said that “this is garbage” and the fact that Malboro, Camel and Newports can be marketed without restriction is the “most insane public health policy imaginable.” 

“It is impossible to understand how the FDA can allow any and all tobacco cigarettes to remain on the market and then argue that some e-cigarettes are too dangerous,” Siegel wrote. “That is one of the most ridiculous arguments imaginable.”

The regulation of e-cigarette devices is a controversial topic, and it is difficult to determine whether products like Juul are overall helping or hurting American consumers. Although Koh believes e-cigarettes could promote harm reduction for adult smokers unable or unwilling to quit, he said that “we will need much more strong regulatory planning and actions, backed by careful alignment and close collaboration of all stakeholders, to make all these plans a reality and save lives.”

Nataly Delcid is a high schooler writing as part of The Daily’s Summer Journalism Workshop.Kenneth Lee is a high schooler writing as part of The Daily’s Summer Journalism Workshop. Contact them at workshop 'at'

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