The Food and Drug Administration has decided to temporarily suspend Juul Labs’ vape products, citing “scientific concerns” that warrant a review of the agency’s ruling last month banning the company’s e-cigarettes. .
The agency’s decision to conduct an internal review effectively removes the dispute from the public eye in the appeals court, where Juul was initially granted a temporary reprieve, and returns to the agency’s private administrative process. But the FDA warned that the last step first announced in a tweet on Tuesday evening, should not be misconstrued as a decision revoking the original injunction.
The FDA’s decision marks a turn in Juul’s journey to seek official authorization under rules that required it and other companies to prove that their products provide more public health benefits than harm. It was blamed for the teenage vaping crisis more than four years ago, which sparked widespread anger from parents, schools, local policymakers and Congress.
On June 23, the FDA surprised many when it issued an order ordering Juul to stop selling its e-cigarette products in the United States. In a statement, the agency said Juul’s applications to remain on the market had “no evidence” to prove they would benefit public health and contained “insufficient and conflicting data” about “potentially harmful chemicals leaching” from are e-liquid pods.
The ban was celebrated by those who said the company should be held accountable for enticing teens to use the product with appealing mango and crème brûlée flavors and advertisements depicting young people. The FDA’s decision was panned by those who pointed to e-cigarettes as a quitting alternative for millions of adult smokers who switched to the devices, which are widely believed to be less toxic than traditional cigarettes.
Vaping companies are required to seek FDA approval to sell their products, and many are now going through that process. The FDA has said it had approved a handful of vaping devices and rejected more than a million applications.
For his part, Juul had already filed a petition in support of a longer-term appeal to the US Court of Appeals in Washington, DC, in which he called the agency’s ban “discriminatory” and accused it of “threatening” behavior.
In the letter filed last week, Juul claimed it had helped two million adult smokers quit traditional cigarettes. Juul also said it had been treated unfairly, noting that it had been singled out by members of Congress who urged the agency to reject the company.
Juul also said it had only been given one chance to address the FDA’s concerns before issuing the denial. By contrast, other companies were allowed to submit up to 14 amendments to their applications, Juul said in its court filing.
The FDA has not released the document outlining the reasons for denying Juul’s marketing application. Juul’s lawsuit said the agency alleged “more than two dozen places” that Juul had not provided enough data on four chemicals.
The company’s filing said the four chemicals were identified in an investigation into toxins that leach from the plastic pods into the e-liquid inside, which vaporizes when heated and is then inhaled by users. The agency objected that none of those chemicals had appeared in Juul trials that listed the composition of the aerosol plume of its devices, the company said in its court briefing.
Juul said it has provided thousands of pages of data that would have revealed those chemicals if they were detectable in the aerosol.
dr. Laura Crotty Alexander, an e-cigarette researcher and associate professor of medicine at the University of California, San Diego, has published studies critical of the effects of Juul devices on the brains of mice.
But after reviewing the company’s court documents, she said her argument was valid: It’s possible that chemicals that appear in one liquid turn into another compound after they’re heated and vaporized. dr. Crotty Alexander said this happened in her own investigations into chemicals in e-cigarettes.
“It’s not surprising that a chemical that was originally liquid is not an aerosol,” said Dr. Crotty Alexander. The names of the chemicals in question had been redacted, she noted, making it difficult to judge further.
Joe Murillo, Juul’s Chief Regulatory Officer, said the chemicals in the liquid “may not be transferred and detected in the aerosol due to several factors, including the volatility of the compounds or chemical structure.”
In his lawsuit, Juul emphasized that the FDA had all the information it needed to see that leached chemicals were undetectable in the aerosol.
Juul “provided that data – 6,000 pages of it,” the company said in its filing. “Had the FDA done a more thorough review (as it did for other applicants), it would have seen data showing that those chemicals are undetectable in the aerosol that Juul users inhale.”
Theodore Wagener, director of the Center for Tobacco Research at Ohio State University, said the agency’s initial ban was striking, as independent research teams, including his own, had found that Juul devices were far less toxic than traditional cigarettes.
“Juul aerosol has significantly lower and fewer toxins than cigarettes,” said Dr. Wagener, noting that Juul’s devices also contain lower levels of chemicals than other e-cigarettes. “That made this surprising to me.”
