The Food and Drug Administration has ordered all Juul e-cigarette products off the market. Juul is the most popular e-cigarette in the U.S. and has a fair claim to being the most effective product to transition smokers away from cigarettes.
Whether e-cigarettes are safer than combustible cigarettes is not in doubt. The FDA acknowledged as much when it authorized the Vuse e-cigarette product in 2021 and claims it recognizes the role these safer nicotine alternatives can play in reducing smoking. But banning Juul shows just how threadbare the FDA’s commitment to tobacco harm reduction really is.
For products like Juul to be authorized by the FDA, they need to demonstrate they are a public health benefit to the population as a whole. In its denial of Juul’s application, the FDA says it “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
However, the agency adds: “To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods.”
The FDA’s Juul denial makes a mockery of the claim it’s evaluating science in the best interests of public health. E-cigarettes aren’t just safer than combustible cigarettes, they’re more effective in helping smokers quit than FDA-approved therapies like nicotine gum and patches. A study published in the New England Journal of Medicine found e-cigarettes to be twice as effective as traditional nicotine replacement therapies.
The decision also punctures a hole in the logic of the FDA’s recently announced policy to reduce nicotine levels in cigarettes to minimally or non-addictive levels. Critics of the policy have said that smokers will simply smoke more cigarettes during the day to make up for the decrease in nicotine content. The FDA argues, “if an acceptable legal alternative exists, there will be little or no incentive for consumers to attempt to subvert it.” But by banning the most popular e-cigarette among adults, the agency’s commitment to transitioning smokers to safer alternatives rings hollow.
Anti-vaping campaigners and politicians continue to blame the upsurge in youth vaping that occurred from 2017 to 2019 on Juul. But the FDA should not be swayed by this public criticism. This is especially important considering Juul complied with nearly every request made by critics including pulling its original marketing campaigns in 2016, voluntarily removing all of its non-tobacco and menthol flavors from the market in 2019, and supporting an increase in the tobacco age from 18 to 21.
While Juul is still popular with adult vapers, it is no longer the most popular product among youth who vape, a number that has collapsed in the past two years by almost 60%. According to the latest National Youth Tobacco Survey, 89% of youth don’t vape and 95% don’t vape frequently.
Furthermore, Juul’s application for approval by the FDA provided ample evidence of the benefits of switching from cigarettes to Juul. The application, filed in 2020, cost $100 million and was hundreds of thousands of pages long. Juul is appealing the ban and The Wall Street Journal reports:
In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale. Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.
“FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul said in court documents.
In the absence of successful litigation or the authorization of Juul’s next-generation products, there is little doubt some Juul users will return to smoking, and a portion of smokers who would have transitioned to Juul will continue to light up.
The FDA’s decision creates a policy environment where the most dangerous nicotine products are legal and available while selling one of the safest and most effective products for reducing smoking will be criminalized.
The great public health scholar Michael Russell said, “people smoke for nicotine but they die from the tar.”
The Biden administration would do well to remember those words if its goal is to save lives from smoking rather than make nicotine the target of a new war on drugs.
A version of this commentary first appeared in the New York Daily News.