FDA Delays Decision on the Sale of Juul, Other Popular Vaping Products

Texas physicians should be disappointed that the Food and Drug Administration (FDA) recently postponed a long-awaited decision on whether products by Juul – which make up 40% of the e-cigarette market – should remain in the hands of consumers, says Pasadena pediatrician Lindy McGee, MD. 

“I’m still hopeful that they’ll make the right decision for teens and ban flavors for e-cigarette products, just as they did for traditional tobacco products back in 2009,” said Dr. McGee. She has testified on behalf of the Texas Medical Association on tobacco legislation and works on that topic with the Texas Pediatric Society and the American Academy of Pediatrics. 

On Sept. 9, FDA issued “marketing denial orders” for more than 946,000 flavored electronic nicotine delivery systems, which made up 93% of all applications. However, FDA’s decision excluded Juul as well as the other top-selling companies, including Vuse and NJOY. 

FDA says it based its decision largely on whether these products protect public health. 

Applications for the products that were denied “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products,” the agency said. “This determination includes consideration of how the products may impact youth use of tobacco products and the potential for the products to completely move adult smokers away from use of combustible cigarettes.” 

Medical and public health organizations criticized the delay in ruling on Juul and the other best-selling products because they dominate the vaping market. 

“The U.S. Food and Drug Administration … was required to take action on e-cigarettes, but the agency failed to meaningfully do so,” Lee Savio Beers, MD, president of the American Academy of Pediatrics said in a statement. “Children and teens will suffer the consequence of FDA’s inaction.” 

The 2020 National Youth Tobacco Survey shows that 1.8 million fewer U.S. youth used e-cigarettes compared with 2019. However, youth e-cigarette use has increased dramatically since 2011, and 3.6 million youth still currently use e-cigarettes, the survey says. 

Like many pediatricians, Dr. McGee has seen evidence that vaping can damage young lungs. 

“For example, I’ve seen a patient who had some long-term complications that we think stem from vaping where he had to see a pulmonologist and get on some longer-term medications to control it,” she said. 

Vaping is so new that its impact on health is unknown, but there’s no doubt that breathing in a mixture of chemicals is unhealthy and that some chemicals used in e-cigarettes are known carcinogens, Dr. McGee says. 

“Our bodies weren’t mean to metabolize chemicals through our lungs – our bodies were meant to metabolize air through our lungs,” she said. “So any toxins going into our lungs is not going to be helpful.” 

FDA gave no timetable for its decision on products from Juul or the other companies, saying it is “committed to completing the review of the remaining products as quickly as possible.” 

 Earlier this year, Texas public health won a long-awaited victory by putting vaping products on the same regulatory footing as products made with tobacco. Senate Bill 248 by Sen. Nathan Johnson (D-Dallas), which TMA supported, required those who sell vaping products to obtain a permit from the state comptroller, just as those who sell tobacco products do. The comptroller’s office can impose fines on those who violate the law. 


Last Updated On

September 29, 2021

Originally Published On

September 28, 2021

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