FDA Agrees to Delay JUUL Market Removal to Give Manufacturer Time to Appeal

The FDA indicates it will give the manufacturer time to appeal its decision and address some scientific issues before enforcing a JUUL market removal order.

The U.S. Food and Drug Administration (FDA) has agreed to stay enforcement of a JUUL market removal order issued last month, to allow the manufacturers of the controversial e-cigarettes time to appeal the decision.

JUUL vape pens were introduced in 2015, and were designed to look like USB drives, allowing teens to hide their vaping habit from parents and school officials. After the manufacturer aggressively marketed a variety of fruity and sweet JUUL flavors through social media influencers, the e-cigarette quickly became the most widely used among teens through the U.S., and have been blamed for creating a new generation of Americans addicted to nicotine.

As part of an on-going effort to combat the teen vaping epidemic, federal regulators issued a market denial order (MDO) on June 23, which required a JUUL recall from stores nationwide, after the manufacturer failed to establish that the products provided enough benefit for adult smokers to overcome the risk of teens vaping with JUUL.

Almost immediately after that order, JUUL Labs, Inc. got a federal appeals court to agree to temporarily block the FDA order, asking for more time to file an appeal, and claiming it was being treated unfairly by the agency.

Now, the FDA is saying the court order is not necessary. On July 5, the agency announced it was placing its own administrative stay on the Juul market removal order.

“The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review,” the agency said in an update on the order. “This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it.”

The update notes that the stay should not be interpreted as authorization to market, sell or ship JUUL products.

The FDA has not explained why it rejected JUUL’s application for approval, beyond saying that the company’s marketing plans failed to show how the company would protect public health from the dangers of its nicotine-based products, which have already gained a reputation as an enticement for teens and underage tobacco users.

Why JUUL Was Removed From Market

The decision to remove JUUL from the market came after the FDA ordered all manufacturers to submit premarket tobacco product applications (PMTAs) for any nicotine based e-cigarette and vaping products in September 2021.

While a number of other vaping products have been authorized by the agency in recent months, such as Vuse, the Food and Drug Administration determined that JUUL failed to provide sufficient evidence to determine relevant health risks and that continuing to sell JUUL would be appropriate for the protection of public health.

The agency has been using its oversight authority under 910 of the Federal Food, Drug, and Cosmetic Act to claim regulatory responsibility of all Electronic Nicotine Delivery Systems (ENDS), which includes e-cigarettes, vaping products, and all liquids used with the devices.

Under new rules, manufacturers are required to provide evidence that their vaping products benefit adult smokers enough to overcome the public health threat they represent to youth, as well as how they intended to prevent the lithium ion batteries from exploding.

JUUL has faced sharp criticism in recent years for specifically designing their product to appeal to children, while failing to warn about nicotine concentrations and potentially harmful chemicals in the vape pens. As a result, the company currently faces hundreds of JUUL lawsuits brought by families of teens and young adults now left with a life-time nicotine addiction.

The first JUUL addiction lawsuits are scheduled to go before juries in September 2022, which could expose the company to substantial damage awards for creating a new generation of Americans addicted to nicotine.