On June 23, 2022, the U.S. Food and Drug Administration (FDA) ordered the removal of Juul’s vaping devices and pods from the market citing “inconsistent and conflicting data” regarding the safety of Juul products. The FDA’s marketing denial orders would prevent Juul from continuing to sell and distribute its products and mandate removal of products that are currently on the market. Just one day after the release of the FDA order, Juul filed an emergency motion for a temporary stay while it appeals the decision. The U.S. Court of Appeals for the District of Columbia Circuit granted the temporary stay until at least July 12, 2022.
FDA Finds Insufficient Evidence of Toxicological Effects
The FDA had determined that Juul’s application did not contain adequate evidence about the toxicological effects of its products. Without providing enough information regarding the composition of Juul devices and pods, the company was unable to demonstrate that it could meet public health standards. The FDA noted that Juul had the opportunity to indicate it met those standards, but it failed to provide such evidence. The FDA has reinforced its commitment to granting marketing authorization only to products that meet its rigorous public health criteria.
The Effects of the FDA’s Order
The FDA order specifically banned Juul devices, and tobacco and menthol-flavored pods from sale and distribution in the U.S. Previously, in 2019, Juul stopped selling its flavored vaping pods due to allegations that the company willfully targeted adolescents and teens with its flavored products. After 2019, only the tobacco and menthol flavored products had remained on the market. The FDA has also stated that it intends to review products manufactured by other cigar and e-cigarette companies.
Juul is Granted a Temporary Stay
Juul filed an emergency motion while it appeals the FDA ban. Juul argued that the FDA order is an “extraordinary and unlawful action.” While the FDA order bans Juul products due to inadequate data, the FDA emphasized that it has no clinical information that indicates that Juul devices pose an immediate hazard to consumers. The FDA will decide by September 9 whether Juul will be authorized to keep marketing its products in the United States.
While e-cigarettes were originally marketed as a method to assist smokers in quitting their smoking habit, there are conflicting reports as to whether vaping actually helps smokers quit smoking. Moreover, Juul has been accused of recklessly marketing its products to teens and failing to warn consumers about the hazards of vaping. Use of Juul products has been linked to a number of serious health conditions. While the long-term effects of vaping are not totally understood at this time, there are a number of studies that have shown that electronic cigarettes present their own specific risks.