Juul defends product benefits in FDA court battle

Jun.29.2022
Juul defends product benefits in FDA court battle
Juul argues that FDA ignored data showing benefits to public health, and bans have "serious flaws.

Electronic cigarette giant Juul has defended itself in court filings submitted on Tuesday, stating that the US Food and Drug Administration (FDA) ignored extensive data included in its application that showed the product is beneficial for public health. Juul also claimed that the ban on its product has "serious flaws.

 

In court documents, Juul stated that it included over 110 scientific studies and more than 125,000 pages of data and analysis, which showed that its products provide "significant public health benefits.

 

The company claims that its electronic cigarette helps people transition from traditional cigarettes to e-cigarettes, reducing their exposure to "deadly toxins." It also claims that e-cigarettes are "less attractive to non-smokers.

 

Last week, the FDA announced a ban on Juul's marketing and sale of their products. According to the agency's decision, products already on the market must be removed. According to the US Food and Drug Administration, Juul failed to prove that keeping its products on the market "serves the public interest in protecting public health.

 

One day after the FDA announced a ban, a federal appeals court has temporarily blocked the decision, pending further arguments.

 

In their statement, Juul argued that the FDA's refusal of their application and demand for all Juul products to be removed from shelves was based on arbitrary reasons instead of acknowledging significant public health successes. They claimed that the FDA's decision failed to address scientific facts.

 

Juul has refuted the FDA's claim that it did not provide data on the impact of four chemicals in its aerosol. Juul has stated that it has actually provided over 6,000 pages of valuable data.

 

Juul appears to suggest that the FDA has succumbed to political pressure from lawmakers, claiming that Congress has unprecedentedly intervened in the approval process.

 

Juul has expressed concern that if the ban is enforced, the company will suffer "significant and irreversible harm," and is advocating for its products to continue being available in the interest of public health.

 

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