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.

EVO NXT: two days, four zones, countless opportunities
EVO NXT: two days, four zones, countless opportunities
Mar.30
 NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
According to The New York Times, Reynolds American donated $5 million to a Trump-backed super PAC shortly before the FDA introduced a new policy that could benefit major tobacco companies seeking to sell flavored vaping products.
News
May.21
Ukrainian Lawmaker Proposes Ban on Vapes, Heated Tobacco Devices and Hookahs for Under-17s
Ukrainian Lawmaker Proposes Ban on Vapes, Heated Tobacco Devices and Hookahs for Under-17s
Ukraine’s Verkhovna Rada has registered a bill that would ban the use of tobacco products, vapes, hookahs, herbal smoking mixtures and heated tobacco devices by people under 17. The bill was introduced by People’s Deputy Georgiy Mazurashu and has already been sent to the relevant parliamentary committee. The author said one reason for the initiative is the prevalence of vaping among adolescents.
Apr.28 by 2FIRSTS.ai
Spanish Congress Health Committee Approves Motion to Restrict Vape and Nicotine Pouch Sales to Authorized Channels
Spanish Congress Health Committee Approves Motion to Restrict Vape and Nicotine Pouch Sales to Authorized Channels
Spain’s Congress Health Committee has approved a non-binding motion calling for the sale of vapes, nicotine pouches, and related products to be limited to regulated authorized channels, excluding internet sales and non-specialized stores. The motion was introduced by the Socialist Parliamentary Group and approved after a negotiated text with the Popular Party.
Apr.15 by 2FIRSTS.ai
KT&G Overseas Tobacco Revenue Jumps 24.6%, Attracting Global Capital
KT&G Overseas Tobacco Revenue Jumps 24.6%, Attracting Global Capital
South Korean tobacco company KT&G is drawing growing global investor attention after reporting record overseas tobacco sales, with international institutions including Capital Group and BlackRock increasing their stakes.
Business
May.19
FDA Wins Default Entry in Case Against E-Cigarette Distributor, to Seek Permanent Injunction
FDA Wins Default Entry in Case Against E-Cigarette Distributor, to Seek Permanent Injunction
The U.S. Food and Drug Administration (FDA) has made procedural progress in its lawsuit against North Carolina-based e-cigarette distributor Dream Distro LLC and its owner. A federal district judge granted the government’s request for entry of default after the defendants failed to respond to the complaint within 21 days of service. The government will next seek a default judgment, including a permanent injunction.
Apr.09 by 2FIRSTS.ai