In late June, I reported that a federal court halted the implementation of a ban by the Food and Drug Administration (FDA) on the selling of Juul e-cigarettes.
Now the agency has temporarily suspended the ban, as it completes to review of the application.
The US Food and Drug Administration announced Tuesday that it temporarily stayed the marketing denial order it placed on Juul Labs for the company’s products in the US.
This means that Juul products will continue to stay on the market while the FDA considers “scientific issues unique to the JUUL application that warrant additional review.” The agency noted that it isn’t rescinding its order and that all vaping or nicotine-delivery products are still required to have FDA authorization to stay on the US market..
The company had requested that the FDA rescind the order.
Juul had separately asked the FDA to stay its own order pending an appeal.
Juul alleges that the FDA mishandled its application by overlooking more than 6,000 pages of data submitted to the agency. In court documents, the San Francisco-based company also accused the FDA of being influenced by political pressure rather than science when it implemented the ban.
The agency asserted it is merely following the science related to the health benefit vs risks associated with the Juul products.
In a statement, the agency said that Juul’s applications to remain on the market “lacked evidence” to prove they would benefit public health and included “insufficient and conflicting data” about “potentially harmful chemicals leaching” from its e-liquid pods.
…The initial ban was celebrated by those who said the company should be held to account for luring teenagers to use its product with appealing mango and crème brûlée flavors and ads depicting young people. The F.D.A.’s decision was panned by those who pointed to e-cigarettes as a cessation alternative for millions of adult smokers who switched to the devices, which are widely credited with being less toxic than traditional cigarettes.
Vaping companies have been required to seek the F.D.A.’s authorization to sell their products, and many are going through that process now. The F.D.A. has said that it had approved a handful of vaping devices and denied more than a million applications.
Meanwhile, illegal opioids continue to be a bane for our nation, as evidenced by the recent seizure of over 200,000 fentanyl pills in Colorado.
State and federal authorities confiscated 200,000 fentanyl pills, 9.4 pounds of heroin, a kilogram of cocaine and multiple firearms in an operation they say culminated in one of the largest seizures of fentanyl pills in Colorado history.
The Drug Enforcement Agency and the 18th Judicial District Attorney’s Office announced the bust Wednesday in Centennial, saying eight people have been indicted on allegations they were smugglers and distributors in a drug trafficking organization that focused on methamphetamine, heroin and fentanyl, the deadly synthetic opioid.
…“In my opinion, bulk fentanyl quantities like this hold the caliber of weapons of mass destruction-type concern when we take into consideration the worst possible outcomes of this poison being pushed out in mass to our communities,” said Brian Besser, the special agent in charge of the DEA’s Denver Field Division. “The availability and accessibility of fake pills (laced with fentanyl) right now is absolutely staggering. They are available everywhere and can be obtained with little effort.”
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