FDA Suspends Ban on Juul While Vaping Company Appeals

The Food and Drug Administration announced that its ban on Juul Labs Inc. products would be lifted while the e-cigarette maker appealed the agency's decision.

Source: WSJ | Published on July 6, 2022

A woman is holding a Juul e-cigarette, in Montreal.

The FDA ordered Juul to remove its e-cigarettes from the US market in June, citing a lack of sufficient evidence that they were safe. A federal appeals court then granted Juul a temporary stay of the order, and Juul was requesting a longer stay in order to continue selling its e-cigarettes during the appeal process. Juul had separately requested that the FDA stay its own order pending the appeal.

The FDA announced on Twitter late Tuesday that it had stayed its marketing denial order. The agency stated, "The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review." According to the agency, the administrative stay suspends the order temporarily during the additional review but does not revoke it.

According to Juul's court filings, the FDA initially denied Juul's request for a stay, prompting Juul to seek a stay of the ban in court.

In court filings, Juul claimed that the FDA mishandled its application. Juul claimed in court that the FDA ignored more than 6,000 pages of data on the aerosols that users inhale that the company had submitted to the agency. In court filings, Juul also claimed that the FDA's decision was influenced by political pressure. The FDA had until July 7 to respond to Juul's federal court motion.

To remain on the market in 2020, all e-cigarette manufacturers in the United States were required to submit their products for FDA review. Only vaping products deemed "appropriate for the protection of public health" may be authorized by the FDA; in other words, a product's potential health benefit as a safer alternative for adult cigarette smokers must outweigh any potential risks.

When it took Juul off the market, the FDA stated that it was unaware of any risks associated with using Juul's devices. The FDA expressed concern about some of the research Juul submitted to the agency due to insufficient and conflicting data, including information on potentially harmful chemicals leaching from the company's refill pods into the liquid they contain. According to the FDA, Juul also failed to provide sufficient information on the potential risk that chemicals in its aerosols or liquids could damage users' DNA or chromosomes.

The FDA has cleared the way for Juul's main competitors, Reynolds American Inc. and NJOY Holdings Inc., to continue selling tobacco-flavored e-cigarettes. Observers in the industry expected Juul to receive similar approval.

Are you retail Agent Looking for a Quote?