The Food and Drug Administration will allow Juul Labs’vaping products to be temporarily left on the market because of “scientific issues” that justify a review of last month’s authorities’ decision to ban Juul Labs e-cigarettes. I decided.
The Agency decision By conducting an internal review, Juul effectively removes the dispute from the public eye and returns it to the authorities’ private management process at the Court of Appeals, where Juul initially received a temporary grace.But the FDA first warned of its latest move Announced in a tweet It should not be mistaken for a decision to cancel the original order on Tuesday night.
The FDA’s decision is a twist on Juul’s journey to seek formal approval under rules that require the FDA and other companies to prove that their products bring more benefits to public health than harm. It was due to the e-cigarette crisis of teens over four years ago, which elicited widespread anger from parents, schools, local policy makers, and Congress.
On June 23, the FDA surprised many when it ordered Juul to stop selling e-cigarette products in the United States.and statementThe agency said that the application for Juul to stay on the market is “lacking evidence” to prove that it is useful for public health, and “leaching of potentially harmful chemicals” from e-liquid pods. Included “insufficient and inconsistent data”.
The ban should be held by people who said the company should be held to explain that it tempts teenagers to use the product in ads depicting attractive mango and creme brulee flavors and young people. It was celebrated. The FDA’s decision was disseminated by those who pointed out e-cigarettes as a smoking cessation alternative for millions of adult smokers who switched to devices that are widely accepted as less toxic than traditional cigarettes.
Vaping companies need to seek FDA approval to sell their products, many of which are currently in the process. The FDA says it approved A handful of vapings Rejected devices and over 1 million applications.
For that part, Juul has already Submitted a brief document to support a long-term appeal In the United States, the Washington, DC Court of Appeals called the authorities’ ban “discriminatory” and accused it of being a “threatening” act.
In a summary submitted last week, Juul claimed that 2 million adult smokers helped quit traditional tobacco. Mr Jul also said it was mistreated and that he was selected by a member of parliament who nudged a government agency to spur the company.
Juul also said he had only one opportunity to address the FDA’s concerns before issuing the denial. In contrast, other companies were allowed to submit up to 14 amendments to their application, Juul said in a court filing.
The FDA has not published a document outlining why Juul’s marketing application is rejected. According to Juul’s court filing, authorities claimed that “in more than 20 locations” Juul did not provide sufficient data on the four chemicals.
According to the company’s filing, the four chemicals were identified in a study examining toxins leaching from plastic pods into the electronic liquid inside. Toxins evaporate when heated and are inhaled by the user. Authorities took the fact that none of these chemicals appeared in Juul’s study listing the composition of the device’s aerosol plume, with the exception of the company, the company said in a court briefing.
Juul said he provided thousands of pages of data that would have disclosed these chemicals if they were detectable in aerosols.
Dr. Laura Crotti Alexander, Electronic Cigarette researcher An associate professor at the University of California, San Diego has published a critical study of Juul devices. Impact on Mouse brain.
However, after reviewing the company’s court documents, she said the claim made sense. Chemicals that appear in a liquid can turn into another compound after being heated and vaporized. Dr. Crotti Alexander said it happened in her own research on the chemicals contained in e-cigarettes.
“It’s not surprising that the chemicals that were originally liquids aren’t aerosols,” said Dr. Crotty Alexander. She said the name of the chemical in question has been edited, making further assessment difficult.
Joe Murillo, Juul’s Chief Regulator, states that chemicals in liquids “may not move or be detected in aerosols due to a variety of factors, including the volatility and chemical structure of compounds.”
In a court filing, Juul emphasized that the FDA has all the information needed to ensure that the leached chemicals are not detected in the aerosol.
Juul “provided that data — 6,000 pages of it,” the company said in a filing. “If the FDA had done a more thorough review (as with other applicants), we would have seen data showing that these chemicals are not observable in aerosols inhaled by Juul users. “
Theodore Wagener, director of the Ohio State University Tobacco Research Center, said authorities, including himself, have found that Juul devices are much less toxic than traditional tobacco. Said that the first ban was impressive.
“Sure, Juul aerosols are significantly lower levels and less toxic than cigarettes,” said Dr. Wagener, noting that Juul’s devices have lower levels of chemicals than other e-cigarettes. “That’s why it surprised me.”
