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.


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 authenticity and accuracy of the content of the article. The compilation of this article is only for industry exchange and research.


Due to limitations in the translation ability, the translated article may not fully express the same meaning as the original. Please refer to the original text for accuracy.


2FIRSTS maintains complete alignment with the Chinese government regarding any domestic, Hong Kong, Macau, Taiwan, or foreign-related statements and positions.


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


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Uruguay bans import, sale of e-cigarettes citing health risks.
Uruguay bans import, sale of e-cigarettes citing health risks.
Uruguay President Yamandú Orsi announced a full ban on e-cigarette imports, registration, and sales at a press conference.
Jun.05 by 2FIRSTS.ai
Brazilian Health Minister Reaffirms Opposition to E-Cigarette Legalization, Supports Total Sales Ban
Brazilian Health Minister Reaffirms Opposition to E-Cigarette Legalization, Supports Total Sales Ban
On World No Tobacco Day 2025, Brazil’s Health Minister Alexandre Padilha reiterated his support for a total e-cigarette ban, backing the national policy that prohibits their sale, import, and advertising under RDC 855/2024.
May.29 by 2FIRSTS.ai
2Firsts Observation | DEMANDVAPE and Other Leading U.S. E-Cigarette Distributors Launch Registration Systems, Open Only to Businesses
2Firsts Observation | DEMANDVAPE and Other Leading U.S. E-Cigarette Distributors Launch Registration Systems, Open Only to Businesses
U.S. e-cigarette distributor DEMANDVAPE has launched a registration system for corporate users only, with new warnings on nicotine health risks and battery safety.
May.22 by 2FIRSTS.ai
Product|BAT Japan Launches glo Hilo with 5-Second Heat-up Time in Japan
Product|BAT Japan Launches glo Hilo with 5-Second Heat-up Time in Japan
BAT Japan has launched its latest heated tobacco device, glo Hilo, in Miyagi Prefecture on June 9. The device features a 5-second preheat time and Bluetooth connectivity with the “myglo” app, allowing users to track puff count and customize session duration. It is priced at ¥3,980 (approximately $23.44).
Jun.09 by 2FIRSTS.ai
Philippines Considers Higher Taxes on E-Cigarettes to Curb Youth Usage
Philippines Considers Higher Taxes on E-Cigarettes to Curb Youth Usage
The Philippines may raise e-cigarette taxes to curb teenage use, which has hit 40%. The Senate is debating a tax reform, stressing the need for strict enforcement against illegal trade. A biennial tax adjustment plan is proposed to boost government revenue.
May.22 by 2FIRSTS.ai
Iowa's PMTA Registration Bill Suspended: Judge Rules It Violates Federal Preemption
Iowa's PMTA Registration Bill Suspended: Judge Rules It Violates Federal Preemption
A judge in Iowa has ruled to suspend the state's PMTA registration bill (HF 2677) targeting e-cigarette products. The court found that the bill violates the federal preemption clause in the U.S. Constitution, interfering with the exclusive regulatory authority of the FDA. The bill has been put on hold pending further judicial review.
May.06 by 2FIRSTS.ai