Electronic cigarette maker Juul Labs went bankrupt on Friday after filing a petition with the Federal Court of Appeals to temporarily suspend the US Food and Drug Administration's ban on the sale of. It is reported that they are considering. That product.
Juul is working with legal counsel to assess whether a bankruptcy should be filed if the court does not grant a request for relief against the FDA's ban,Wall Street. The journal reported. Cite sources familiar with the matter. Such an application would be a surprising dip for companies that once withdrew a $ 38 billion valuation before a series of regulatory crackdowns.
Juul officials have requested the Federal Court of Appeals in Washington, DC to issue an emergency stay in an FDA order until a review of the decision can be requested. The company claimed that if the stay was not allowed, it would suffer irreparable damage and said similar e-cigarette products were still on the market.
"The FDA's decision is arbitrary and capricious and lacks substantive evidence," Juul said in a filing, according to the journal. The
post asks Juul and the FDA for comment.
Juul was considering bankruptcy the day after the federal government refused to bid to continue selling certain e-cigarettes and pods. The FDA's decision follows years of promotion among lawmakers and other public figures seeking to crack down on the harmful effects of youth e-cigarette tendencies.
Juul's filings are "huge political" by the FDA. While some of our competitors now have a larger market share and much higher underage usage, it has become politically convenient to blame [Juul] for youth e-cigarettes. Later Congressional Pressure.
The FDA applies its ban to "all products currently on the market" in the United States, including Juul devices and pods with 5% and 3% nicotine concentrations. Said.
The FDA argued that Juul had the opportunity to provide evidence to support the application to continue selling the product, but did not meet the requirements.
"Like all manufacturers, Juul had the opportunity to provide evidence that marketing of its products meets these criteria," said the FDA's Tobacco Product Center. Director Michele Mital said.
"But the company didn't provide that proof and instead left an important question. Without the data needed to determine the associated health risks, the FDA refused to market these. We are issuing orders, "Mital added.
Immediately after the ban, Juul's Chief Regulatory Officer Joe Murillo said: The company did not agree with the decision and was planning to appeal.
"We intend to seek a stay and are exploring all options under FDA regulation and law, including appeals to decisions and involvement with regulatory agencies. We are nationwide. Continue to do everything in its power to continue to serve millions of American adult smokers who have successfully transitioned from the flammable cigarettes that remain available on the market shelves. We are working on it, "said Murillo.
Juul currently occupies about 50% of the e-cigarette market. Some consumers reportedly stocked up on productsthat were still on the market after the ban was announced.
Juul faced regulatory crackdowns after allegations that its products were targeted at underage users. This is a claim that the company denied.
To deal with federal surveillance, Juul had already withdrawn flavored e-cigarettes from the market. However, Juul faces numerous proceedings over allegations of selling its products to teens.
E-cigarettes and other vapor-breathing products have been claimed as healthier alternatives to traditional tobacco products, but due to lung disease associated with this trend, what nationwide Hundreds of people have died or been hospitalized.
