JUUL Asks Court to Block FDA Ban On E-Cigarettes

Juul Labs Inc. was given a temporary reprieve from the Food and Drug Administration’s directive to remove its e-cigarettes from the American market by a federal appeals court on Friday.

Juul’s appeal to postpone the FDA prohibition was approved on Friday afternoon by a panel of justices from the U.S. Court of Appeals for the D.C. Circuit, according to court records. The judges said that the interim stay does not address the merits of the case and merely provides the court time to hear arguments.

According to people familiar with the situation, Juul has been working with its legal counsel on options including a potential bankruptcy filing if the business is unable to obtain relief from the government’s prohibition in addition to challenging the FDA’s order. According to the persons, Kirkland & Ellis, the company’s legal counsel, is offering advice on the backup plans.

Read More

On Thursday, the FDA started to execute its directive by notifying stores. While this was happening, several customers rushed to stock up on Juul products before they might be removed from the market.

According to its court filing, which was partially redacted, Juul petitioned the court for relief on Friday morning, arguing that the FDA’s order was exceptional and illegal and that it would suffer serious, irreparable harm without a stay.

Juul stated in its complaint that the FDA’s decision “is arbitrary and capricious and lacks meaningful evidence.” According to the company’s application, the FDA had approved identical e-cigarettes made by its rivals.

According to an FDA representative, the FDA doesn’t comment on ongoing or pending lawsuits.

On Thursday night, Hillsborough, New Jersey resident Randi Smith, 35, discovered herself among a group of Juul users looking for leftover items in local convenience stores.

They weren’t there, Ms. Smith remarked, “grabbing chocolates and coffee.” Everyone was sort of circling the front cashier area, looking up and down to see if someone was behind the counter.

Despite Juul no longer being sold at the QuickChek near her home, she was still able to get eight pods from a 7-Eleven. If the prohibition remains in place, Ms. Smith, who claimed to have started using Juul products three years ago to quit smoking cigarettes, said she would probably move to a different e-cigarette brand.

The FDA stated on Thursday that although it was not aware of any risks related to using Juul devices, the manufacturer had not provided enough proof of their safety. According to the FDA, shops should stop carrying Juul’s products, and customers should look for alternatives. The FDA advised Juul users to switch to authorized vaping products. Juul stated that it disagreed with the FDA’s conclusions and that it had given the regulator plenty of data.

In its court document from Friday, Juul claimed that the FDA’s decision came as a result of “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage use rates.”

According to Juul, the FDA’s directive to take all Juul products out of U.S. retailers right once is a change from the agency’s custom, which calls for a transitional period. The manufacturer of electronic cigarettes also questioned how the FDA handled the announcement, noting that The Wall Street Journal had reported on the ban a day earlier.

Juul stated in the court document that “regulation through leaks and public announcements is no way to manage agency action, much less to order a company to suspend basically all business operations.”

The effectiveness of Juul’s e-cigarettes was exclusively determined by the quality of the company’s application, according to Mitch Zeller, who resigned from his position as director of the FDA’s Center for Tobacco Products in April. He claimed that neither Juul’s prior deeds nor political pressure to outlaw Juul had an impact on the decision. He explained, “This was a scientific review carried out by subject-matter specialists. That is how the system is designed to operate.

Juul’s court filing is the most recent development in a four-year dialogue between the FDA and the startup, and it could determine the company’s financial future. Juul is currently the No. 2 manufacturer of e-cigarettes in the U.S., with more than $1 billion in sales in 2017.

Juul’s delicious tastes, trendy advertising, and USB-like vaporizer have been linked by regulators and lawmakers to an increase in teenage vaping in the United States in 2018 and 2019. Juul claims that the company has never targeted teenagers. In an effort to mend its reputation with regulators, lawmakers, and the general public, it stopped selling sweet and fruity tastes in 2019 and stopped the majority of its U.S. advertising.

In its court brief, Juul said that it had suggested precautions in its FDA application for preventing underage use that prioritized lowering appeal, restricting access, and discouraging third parties from selling its products to minors.

Due to government regulations raising the tobacco purchase age to 21 in the last few years, underage vaping has drastically decreased. Young people’s acceptance of Juul has also declined. According to federal research published in September, 6 percent of high school vapers reported using Juul, as opposed to the competitor Puff Bar, which was cited by 26% of respondents.

Juul had submitted studies that compared its products to conventional cigarettes and other brands of e-cigarettes in order to obtain permission for its tobacco- and menthol-flavored goods to remain on the American market. The FDA has approved tobacco-flavored e-cigarettes made by Reynolds American Inc. and NJOY Holdings Inc., two of Juul’s main competitors.

Juul’s chief regulatory officer, Joe Murillo, stated on Thursday that the business believed it had submitted enough information to fulfill the threshold for the protection of the public’s health and respond to the FDA’s inquiries. In particular, the FDA raised questions about the safety of chemicals in the company’s refill pods, nicotine liquids, and aerosols, claiming the research was contradictory and insufficient.

This is all about the ban on e-cigarettes, for more informative content visit techballad.com