FDA Orders Juul To Pull Products From US Market

FDA Rules To Ban Juul Products

On Thursday, the US Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to Juul Labs Inc. that mandates the company must stop selling and distributing “all of their products currently marketed in the US marketplace.” These products include the Juul e-cigarette device and 4 types of Juulpods, consisting of the Virginia tobacco-flavored pods with Nicotine concentrations of 3% and 5% and menthol-flavored pods with Nicotine concentrations of 3% and 5%. Furthermore, Juul, a powerhouse in the US e-cigarette market, must remove all products currently on the market, or they risk enforcement action.  

The FDA claims that the company failed to provide enough information proving the products were safe for people of any age, not just the youth. Juul’s “conflicting and insufficient data” prevented the FDA from assessing the potential health risks of its products. The FDA decision is a part of a campaign to review e-cigarettes to ensure they are “appropriate for the protection of public health.” This quote means that e-cigarette companies must prove through data that their products are more of an aid to adult traditional cigarette smokers than a risk to the youth and general public. 

Previous Investigations Into Juul’s Marketing Tactics

Juul has long been in the hot seat due to allegations that the company knowingly sought teenage users with intentional marketing. Four years ago, the FDA began investigating Juul’s marketing efforts. Previous marketing campaigns included video clips of young, “hip” individuals using the Juul e-cigarettes with “youth-friendly” flavored pods, including flavors like “crème brûlée” and “cool cucumber.” The company has since modified these particular flavor names to more specific titles and only uses real people, not actors, who have switched from cigarettes to Juul in its advertisements. 

James Monsees, one of Juul’s co-founders, previously stated that selling Juuls to young people was “antithetical to the company’s mission;” however, a former senior manager said that he and others in the company were “well aware” that the products could appeal to teenagers. In fact, the company went well beyond appealing to teenagers during its launch period, from June 2015 through early 2016. According to a 2020 lawsuit filed by the Massachusetts attorney general, Juul purchased ad space on numerous youth-focused websites, including Nickelodeon, the Cartoon Network, Seventeen magazine, and educational sites for middle and high school students.

Harms Of Nicotine On The Youth

E-cigarettes, also known as vapes, make Nicotine increasingly accessible and tempting to young people due to pervasive marketing and enticing flavors. According to the FDA, nearly 10.7 million young people ages 12-17 have used e-cigarettes or are open to trying them. Additionally, research by the Centers for Disease Control and Prevention (CDC) found that two-thirds of Juul users aged 12-24 did not know that the company’s products always contain Nicotine. While e-cigarette users may inhale fewer toxins than traditional cigarette smokers, that is not to say that vaping is without its harm. Nicotine inhalation remains a serious health concern for teenagers, whose brains and bodies are still developing. Additionally, some e-cigarette products contain more Nicotine compared to traditional cigarettes. According to Juul, a single Juul pod contains as much Nicotine as a pack of 20 regular cigarettes.

The risks of vaping for young people include Nicotine addiction, mood disorders, and permanent lowering of impulse control. Additionally, young people who use e-cigarettes may be more likely to try traditional cigarettes in the future, which is counter-intuitive to the mission of Juul and similar e-cigarette companies to reduce the number of adults using cigarettes.    

Are All E-Cigarettes Banned Now?

The FDA is not issuing a “blanket ban” on all e-cigarettes; however, the agency is reviewing applications for millions of products. The agency has only approved 23 applications for sale on the US market. For products to be approved, the benefits to public health must outweigh the potential harm, and the agency must consider if the product can help traditional cigarette smokers quit. 

What’s Next For Juul, Other E-Cig Companies, And Consumers?

On Friday, a federal appeals court granted Juul a reprieve to keep selling its products pending further court review of the FDA’s decision to ban Juul’s products. The e-cigarette company argued that the FDA’s decision was influenced by political forces that wanted to blame the company for the youth vaping crisis. However, the FDA did not explicitly state underage use in its decision to ban Juul from the US market. It will be up to the appeals court to decide whether Juul should be allowed to sell its products while the company pursues its appeal of the FDA’s decision.

Those who have been using Juul products to transition away from cigarettes and cigars may switch to other electronic Nicotine delivery system (ENDS) products that the FDA has approved based on their potential to benefit adult smokers. Potential replacements approved by the FDA include products by R.J. Reynolds Vapor Company, NJOY LLC, and Logic Technology Development LLC. It is unclear if the FDA’s ban of Juul products, if upheld, will set a precedent for other popular e-cigarette companies.