Tobacco

FDA Rescinds Ban on Juul Product Applications

Action places the e-cigarette products back into scientific review
Juul
Photograph: Shutterstock

The Food and Drug Administration (FDA) has rescinded the marketing denial orders (MDOs) for Juul Labs Inc. regarding all of the company’s products marketed in the United States.

This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant,” the agency said.

Washington, D.C.-based Juul Labs issued the following statement regarding the FDA’s announcement:

Today, the FDA rescinded its June 2022 marketing denial orders (MDOs) for the Juul System and placed our applications back into scientific review.We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products. We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.These products (the Juul device and Virginia tobacco and menthol Juulpods in 5% and 3% nicotine concentration) will remain on the market during this review.”

The FDA said that rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied, but rather “rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.”

On June 23, 2022, the FDA issued MDOs to the Juul for its products marketed in the United States.

After the FDA reviewed the company’s premarket tobacco product applications (PMTAs), it determined they lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing them would be appropriate for the protection of the public health. Some of Juul’s study findings raised concerns due to insufficient and conflicting data, including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods, the FDA said.

Then on July 5, 2022, the FDA administratively stayed the MDO. “The agency has determined that there are scientific issues unique to the Juul application that warrant additional review,” the agency tweeted in 2022.

“Since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the agency said. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

As of June 6, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarette products that may be lawfully marketed and sold in the United States. Information on tobacco products that may be legally marketed in the United States is available in the agency’s new Searchable Tobacco Products Database.

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