Juul Labs Sues FDA for Withholding Ban Documents

According to a report by Reuters, Juul Labs is suing the FDA in order to force the agency to disclose the documents behind its order banning the company's products.

On June 23, the FDA ordered Juul Labs to pull its electronic cigarettes from U.S. stores, stating that the evidence provided by the e-cigarette manufacturer was insufficient to demonstrate that they are "appropriate for protecting public health.

The federal appeals court subsequently granted Juul Labs an emergency stay to allow judges time to assess the company's appeal. The e-cigarette company requested that the FDA maintain its order during the appeal period.

E-cigarette maker Juul has filed a lawsuit against the US Food and Drug Administration (FDA) for allegedly withholding important scientific materials relating to the ban on flavored e-cigarette products. The lawsuit, filed on September 21 in a federal court in Washington, accuses the FDA of using exemption privileges to unfairly withhold the materials, which are crucial to understanding the basis for the ban imposed on June 23.

Juul stated that these materials will demonstrate whether the FDA has appropriately balanced the public health benefits and risks of its product, including claims of aiding smokers in quitting and the scientific rationale of the agency's reasoning, as legally required.

Juul stated that the public should have a comprehensive understanding of the scientific facts behind one of the most controversial and closely watched decisions by the FDA in recent years.

Juul has accused the FDA of violating the Federal Freedom of Information Act by withholding most of the "scientific and regulatory discipline review" behind the sales ban.

Statement:

This article is compiled from third-party information and is intended for industry exchange and learning purposes only.

This article does not represent the views of 2FIRSTS and 2FIRSTS cannot confirm the truthfulness or accuracy of its content. The translation of this article is for industry exchange and research purposes only.

Due to limitations in translation abilities, the translated article may not exactly reflect the original wording. Please refer to the original article for accuracy.

Regarding any domestic, Hong Kong, Macao, Taiwan, or foreign-related statements and positions, 2FIRSTS maintains complete consistency with the Chinese government.

The copyright for compiled information belongs to the original media and author. If there is any infringement, please contact us for deletion.