Juul Labs Appeals FDA Marketing Rejection Order

The FDA stated in a press release regarding its refusal of a marketing application that Juul Labs' tobacco products lacked sufficient evidence regarding their toxicological characteristics before being introduced to the market. Additionally, due to insufficient and conflicting data, some research results have raised concerns.

Juul Labs believes that every flaw in the marketing restrictions is based on an incorrect and incomplete evaluation of the data. If the data is properly evaluated in the pre-market applications, FDA can accurately assess the toxicological characteristics of Juul products relative to other tobacco products, including combustible cigarettes. The appeal also states that all perceived limitations can be resolved through clarification by FDA in the usual iterative process followed for previous applications.

Juul Labs has filed an appeal at an approximate value of 10.75, requesting the overturning of the marketing refusal order and reinstatement of its pre-market tobacco product application for substantive review by the FDA. This would allow for a comprehensive and fair assessment of Juul's system to determine whether it is suitable for protecting public health. In a press release, Juul stated that they believe their marketing authorization should be granted once all scientific evidence presented in the application is reviewed comprehensively by the FDA - in accordance with legal requirements and without political interference.

Background: In July 2020, Juul Labs submitted a premarket tobacco product application to the FDA for its currently marketed products and new devices with age verification technology. The application includes over 125,000 pages of data, information, and analysis from more than 110 scientific studies covering non-clinical (over 75 studies), clinical (14 studies), and behavioral (21 studies) research plans to support Juul's product marketing. The company also evaluated the correlation between its products and combustible cigarettes, FDA-authorized heated tobacco products (IQOS), and other vapor products on the market.

Despite the scientific evidence, on June 23, 2022, the FDA issued a marketing denial order for Juul Labs' tobacco products prior to their release. On July 5, the FDA maintained the marketing denial order and announced it will review the decision after determining "unique scientific questions requiring further review" exist with the application.

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