Federal Appeals Court Delays FDA’s Ban on Juul E-Cigarettes

A few days ago, federal regulators ordered all of the popular Juul e-cigarette products off the market, a move made by the Food and Drug Administration (FDA) based on what it said was “inconsistent and conflicting data” on safety.

The Food and Drug Administration said it was denying Juul’s applications to continue selling the company’s e-cigarette device and prefilled cartridges in menthol and tobacco flavors. The big surprise was the reason: Rather than focusing on youth use, the agency said the company failed to provide sufficient information proving the products were safe — for people of any age.The agency said some of the company’s study findings raised concerns about possible damage to DNA and “potentially harmful chemicals leaching” from the prefilled cartridges that contain liquid nicotine, flavorings and other chemicals.“It’s about anybody who would use the product and potential safety issues that the company failed to adequately address,” said Mitch Zeller, former director of the FDA’s Center for Tobacco Products.

Now, a federal appeals court has blocked the FDA’s ban.

Juul can continue to sell its electronic cigarettes, at least for now, after a federal appeals court on Friday temporarily blocked a government ban.Juul filed an emergency motion earlier Friday, seeking the temporary hold while it appeals the sales ban.The e-cigarette maker had asked the court to pause what it called an “extraordinary and unlawful action” by the Food and Drug Administration that would have required it to immediately halt its business.The FDA said Thursday that Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges.The action was part of a sweeping effort by the agency to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

It appears that the FDA is OK with other e-cigrarette firms.

Juul had sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market by submitting research that compared Juul products to combustible cigarettes and other brands of e-cigarettes. The FDA has authorized tobacco-flavored e-cigarettes from Juul’s biggest rivals, Reynolds American Inc. and NJOY Holdings Inc.

Meanwhile, nobody in the Biden administration is rushing to shut down the influx of deadly fentanyl. In California, a suspected drug dealer was charged Friday with several felonies for possessing enough of this drug to kill 12 million people.

Alfonso Gomez-Santana, 60, of Fullerton has been charged with one felony count of sale or transport of a controlled substance and two felony counts of possession of sale with intent to sell. He faces a maximum sentence of 6 years and 8 months in the Orange County Jail if convicted on all counts.California Highway Patrol officers discovered four kilos of the deadly drug inside the man’s vehicle during a traffic stop in Fullerton and a search of the man’s Fullerton home revealed 20 more kilos of fentanyl, $250,000 in fentanyl pills, and 122 grams of methamphetamine. A lethal dose of fentanyl is as little as 2 milligrams.Gomez-Santana was arrested on Wednesday after CHP officers pulled him over near South Lemon Street and Orangethorpe Avenue in the city of Fullerton and discovered four kilos of fentanyl in his vehicle and additional fentanyl and methamphetamine inside his Fullerton home.

Tags: Biden Administration, FDA

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