The Food and Drug Administration has decided to temporarily allow Jules Labs’ vaping products to remain on the market, citing “scientific issues” that could lead to a review of the agency’s ruling last month to ban the company’s e-cigarettes.
The agency’s decision to conduct an internal review effectively took the dispute out of public view in the Court of Appeal, where Jules was initially granted a temporary release and returned it to the agency’s personal administrative process. But the FDA has warned that its latest move, first Announced in a tweet On Tuesday night, the decision to withdraw the original order should not be misunderstood.
The FDA’s decision is a turning point in Jul’s journey to seek government approval under the rules, which must prove that it and other companies do more good for public health than harm their products. It was blamed for the juvenile steam crisis more than four years ago, sparking widespread outrage from parents, schools and local policymakers, as well as Congress.
On June 23, the FDA surprised many when it issued an order to Jules to stop selling its e-cigarette products in the United States. In a statement, the company said Jul’s applications were “lacking evidence” to stay on the market to prove that they would benefit public health and included “insufficient and conflicting data” about “potentially harmful chemical leaks” from its e-liquid pods.
The ban was celebrated by those who said the company should be held responsible for tempting teenagers to use the product with its attractive mango and cream brulei flavors and youth-advertised ads. They panned on the FDA’s decision to point to e-cigarettes that switched to devices as a stop option for millions of adult smokers, which is widely credited with being less toxic than conventional cigarettes.
Vaping companies have had to seek FDA approval to sell their products, and many are now going through that process. The FDA says it has approved several vaping devices and denied more than a million applications.
For its part, Jules has already made a brief appeal in support of a long-term appeal to the U.S. Court of Appeals in Washington, D.C., calling the agency’s ban “discriminatory” and accusing it of “threatening” behavior.
In a briefing filed last week, Jules argued that it has helped two million adult smokers quit traditional cigarettes. Jules added that it was treated unfairly, noting that it was isolated by members of Congress who pushed the agency to boycott the agency.
Jules added that it had only one chance to address the FDA’s concerns before issuing the denial. In contrast, other agencies were allowed to submit 14 amendments to their applications, Jules said in his court filing.
The FDA has not released documents outlining the reasons for rejecting Jul’s marketing application. Filing in Jul’s court said the agency claimed “in more than two dozen places” that Jul had not provided adequate information on the four chemicals.
The company’s filing states that four chemicals were identified in a study that tested toxic substances in e-liquids from its plastic pods, which evaporate when heated and are inhaled by users. The agency said in its court briefing that none of these chemicals were present in the joule study listed in the makeup of the aerosol plum of its device.
Jules said it provided thousands of pages of data so that if those chemicals could be detected in aerosols, they would be released.
Dr. Laura Crotte Alexander, an e-cigarette researcher and associate professor of medicine at the University of California, San Diego, has published a critical study of the effects of the jull device on the rat brain.
But after reviewing the company’s court papers, he said his argument was understandable: it is possible that the chemicals displayed in the liquid turned into a different compound after being heated and evaporated. Dr. Croti Alexander says that happened in his own research on the chemistry of e-cigarettes.
“It is not surprising that a chemical that was originally liquid is not an aerosol,” says Dr. Crotte Alexander. The name of the chemical in question was corrected, he noted, making it difficult to further evaluate.
Joel Murillo, Jul’s chief regulator, said the chemicals in the liquid “cannot be transferred and detected in the aerosol due to a variety of factors, including compound instability or chemical composition.”
In his court filing, Jules insisted that the FDA had all the information needed to see if any leached chemicals could be detected in his aerosol.
Jules “provided that information – 6,000 pages of it,” the company said in its filing. “If the FDA had done a more thorough review (as it did for other applicants), it would have seen data that those chemicals are not observable in aerosols that Joule users breathe.”
Theodore Wagner, director of The Ohio State University’s Center for Tobacco Research, said the agency’s initial ban was interesting because independent research teams, including his own, have found that joule devices are much less toxic than conventional cigarettes.
“Joule aerosols definitely have significantly lower levels and less toxic substances than cigarettes,” said Dr. Wagner, adding that Joule’s devices contain lower levels of chemicals than other e-cigarettes. “That’s what surprised me.”