FDA Spares JUUL From Market Dismissal

Since the end of August, the U.S. Food and Drug Administration has been taking direct action against e-cigarette companies. The agency has forced electronic nicotine delivery systems out of the U.S. market by the thousands. One company has weathered the storm so far: JUUL Labs, which the FDA has neglected to pursue despite the company’s central role in litigation against e-cigarette manufacturers.

According to Law360, on September 9th the FDA announced that although it has passed judgment on over 950,000 e-cigarette products and accessories, it would be delaying its judgment on JUUL Labs products.

The FDA has reviewed over 6.5 million applications that were filed to meet a court-ordered deadline of September 9, 2020. In the year since, the FDA has rejected almost a million applications on the grounds that the premarket approval applications failed to provide sufficient evidence that the products’ potential benefit to adult smokers outweighed the risk of enticement to underage users.

As such, the FDA has gone after sweet, fruity, or mint-flavored e-cigarette products arguing that flavors like “Dr. Cola” or “cinnamon toast cereal” are designed to appeal to underage users. The FDA stated that according to the agency’s research, 80% of e-cigarette users between the ages of 12 and 17 use such enticingly flavored nicotine products.

JUUL Labs is not seeking market approval for any fruit-flavored products, having pulled them from shelves in November 2018. Instead, the e-cigarette manufacturer backed by tobacco giant Altria is seeking approval for its Virginia tobacco and menthol-flavored products. The FDA has stated that applications from companies with larger market share were receiving priority for agency review.

In a statement to Law360, JUUL Labs expressed support for the FDA’s actions, stating: “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate.”

The FDA stated that its judgment on JUUL is in the final stages of review. A spokesman told Law360, “The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress.”

The FDA is now turning its attention from applicants to those who either had their applications rejected or who never applied for regulatory approval. The FDA has called those entities “our highest enforcement priorities.”

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