The Food and Drug Administration on Tuesday issued an administrative stay of an order last month for Juul to recall its e-cigarettes from the market.
The agency said on Twitter that the moratorium is temporarily suspending the marketing denial order while it is under further review, but not rescinding it.
Food and Drug AdministrationJuul sales on June 23. A day later, the federal appeals court temporarily blocked the government ban.
The FDA’s initial action was part of a sweeping effort by the agency to conduct a scientific examination of the multibillion-dollar e-cigarette industry after years of regulatory delays.
To survive in the market, companies must show that e-cigarettes benefit public health. In practice, this means demonstrating that adult smokers who use them are more likely to quit or reduce smoking, while adolescents are less likely to get involved.
The FDA originally said Juul’s request left regulators with important questions and did not include enough information to assess any potential health risks. Juul said it had provided sufficient information and data to address all of the issues raised.
Three-judge panel of the United States Court of Appeals for the District of Columbia CircuitFor custody during court review of the case.
On Tuesday, the US Food and Drug Administration (FDA) said it had identified “there are unique scientific issues for the Juul application that require additional review.”
However, it said the discontinuation and review “do not constitute an authorization to market, sell or ship Juul Products.”