Juul Labs continues legal battle against FDA

Sep.22.2022
Juul Labs continues legal battle against FDA
E-cigarette maker Juul sues FDA over refusal to release scientific materials, claiming violation of federal laws.

The battle between Juul Labs and the US Food and Drug Administration (FDA) continues to escalate. The vapor manufacturer has now filed a lawsuit against the FDA in response to a marketing denial order (MDO) sent to them by the agency.


Photo credit: Insurance Journal


According to a report from Reuters, Juul Labs has filed a lawsuit against the FDA in a federal court in Washington, D.C. for improperly withholding scientific materials that were released on June 23rd. Juul Labs claims that the FDA invoked privilege under a widely abused deliberative process, which led to the unjust detainment of crucial core scientific materials.


The company maintains that these materials will demonstrate whether or not the FDA has appropriately balanced the public health benefits and risks of its products, including claims that Juul e-cigarettes help smokers quit combustible cigarettes, and whether or not the agency's reasoning is scientifically sound.


Juul Labs stated that the public should have a comprehensive understanding of the facts behind one of the most controversial and heavily scrutinized decisions made by the institution in recent years.


An FDA spokesperson declined to comment, stating that the agency does not discuss pending litigation.


Juul Labs has accused the FDA of violating federal freedom of information laws by failing to conduct thorough scientific scrutiny in their decision to refuse to sell their products.


The company stated that it filed an administrative appeal with the institution regarding its MDO, but the FDA missed the September 13 deadline for resolution.


On June 24th, the Federal Appeals Court temporarily suspended Juul's Marketing Denial Order.


Earlier this month, Juul Labs reached a settlement in a lawsuit accusing them of targeting minors with their marketing with 33 states and Puerto Rico.


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