FDA to Reexamine Juul Labs' Marketing Application, Delaying Ban on Its e-Cigarettes

FDA to Reexamine Juul Labs' Marketing Application, Delaying Ban on its E-Cigarettes
The U.S. Food and Drug Administration said it would reexamine Juul's marketing application and postpone its prohibition on the sale of e-cigarettes. PATRICK T. FALLON / Getty Images

Following the company's request for an expedited review of the regulator's verdict, a U.S. federal appeals court temporarily paused the FDA's ban on Juul.

The FDA said on Tuesday, July 5, that it uncovered scientific concerns with Juul's application that need more examination.

A Federal Appeals Court Halted FDA's Ban Few Weeks Ago, Giving Juul a Reprieve

The U.S. Food and Drug Administration said late on Tuesday, July 5, that it will conduct another examination of the business' marketing application, postponing its ban on selling Juul Labs' e-cigarettes.

Following an appeal by the business for an urgent review of the regulator's ruling, a U.S. federal appeals court suspended the FDA's ban a few weeks ago, giving Juul a brief respite.

The FDA's decision to prohibit sales of the once-hot vape firm's goods is described as "exceptional and illegal" by the company, which points to, among other things, the agency's approval of comparable e-cigarette products manufactured by different manufacturers.

According to the FDA, Juul's application raised severe concerns and lacked sufficient details to allow officials to assess any possible health hazards. Juul said it provided adequate data and information to resolve every problem mentioned.

Juul's request for a stay while the court considers the matter was granted by a three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit.

The FDA said on Tuesday (July 5) that it had found specific scientific problems with the Juul application that called for further investigation.

However, it said the review and the stay do not represent approval for the marketing, sale, or shipping of Juul products.

U.S FDA Released an E-Cigarette Prevention Campaign Last Month, Resulting in the Prohibition of Juul's E-Cigarettes

According to the U.S. Food and Drug Administration, on June 8, the 'Next Legends' Youth E-cigarette Prevention Campaign has officially begun as part of the agency's continuous efforts to safeguard children from the risks associated with tobacco use.

Through distinctive branding and specialized content developed to motivate a new generation to live Native strong and vape-free, the campaign will educate American Indian/Alaska Native (AI/AN) children aged 12 to 17 about the dangers of vaping.

More than half of the 400,000 Native American teenagers in the U.S. are in danger of using tobacco products, including e-cigarettes. According to studies, Native kids exhibit disproportionately high levels of e-cigarette experimentation and current usage compared to their non-Native classmates.

Following its announcement, FDA said on June 23 that it is banning the sale of Juul e-cigarettes in the U.S. market.

The FDA is reviewing the vaping sector more broadly as a result of years of pressure from public health organizations and lawmakers to regulate the market as severely as other tobacco products. This pressure increased as vaping grew more prevalent among high school students.

Since 2018, Juul has dominated the e-cigarette industry, according to Euromonitor International. The corporation owned 54.7% of the $9.38 billion U.S. e-vapor industry as of 2020.

According to statistics collected by the federal government in 2019, it was discovered that more than one in four high school pupils had used an electronic cigarette during the preceding 30 days. This figure was up from 11.7 percent only two years earlier. In 2020, lung ailments were linked to vaping, which heightened worries about e-cigarettes.

Because of increased regulatory monitoring and the wide spread of the coronavirus, consumption rates among high school students dropped to 11.3% in the previous academic year.

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