Juul Labs requested that a federal court temporarily block an order of the Food and Drug Administration to cease selling electronic cigarettes in the United States. This was granted by Juul Labs.
The e-cigarette manufacturer had requested the U.S. Court of Appeals in Washington, D.C. Circuit to stop what it called an "extraordinary, unlawful action" taken by FDA to force it to close down its business. As it prepares for appeal against the FDA's decision, the company, which is partially owned by Altria tobacco giant, has filed an emergency motion at the appeals court.
Thursday's FDA order directed Juul to stop selling its vaping devices and tobacco- and menthol-flavored cartridges. This was part of an extensive effort by the FDA to provide scientific oversight to the multibillion dollar vaping industry, which has been plagued with regulatory delays for years.
Companies must prove that e-cigarettes are good for public health in order to remain on the market. This means that e-cigarettes must be proven to have a positive effect on public health.
FDA stated that Juul's application raised significant questions from regulators and didn't provide enough information to assess potential health risks. Juul claimed it provided enough data and information to address all concerns. According to Juul, the FDA rejected its request to suspend its order to prevent a major disruption in its business.
E-cigarettes were created to be an alternative for those who smoke and help them quit. The products have also led to a rise in youth vaping.
According to the Associated Press, studies have not found conclusive evidence that vaping can help smokers quit smoking. The FDA tried to regulate vaping products but was repeatedly thwarted by lobbying from the industry.
In 2018, Juul's fruity-flavored, high-nicotine cartridges became a national craze among high school and middle-school students. The FDA restricted small vaping devices' flavors to only tobacco and menthol in 2020. Separately, Congress increased the purchase age of all vaping and tobacco products to 21
Juul is still a top seller but its share in the U.S. ecigarette market has fallen to half. Recent federal surveys showed that teens are using less Juul products and their vaping rates have dropped.
These devices heat nicotine solutions into vapor which can be inhaled. This eliminates many of the harmful chemicals that are produced by smoking tobacco.
In Friday's court filing, the company stated that it submitted a 125,000-page FDA application nearly two years ago. According to the company, the application contained several studies that evaluated the health risks for Juul users.
Juul stated that FDA cannot claim that it was in the public's "critical and urgent interest" to remove its products immediately after the agency reviewed them.
The FDA had denied the company's application, but approved applications from competitors that have similar products. R.J. Reynolds, Logic, and other companies have been approved by the FDA, but many others were rejected.
After Juul's popularity among high school and middle school students, the FDA pressured Juul into stopping all advertising and removing its dessert and fruit flavors. In the following year, FDA restricted small vaping devices' flavors to tobacco and menthol.