WASHINGTON aEUR – Tuesday’s administrative stay by the Food and Drug Administration was issued in response to an order Juul issued last month requiring it to withdraw its electronic cigarettes from market.
Twitter: The agency stated that the temporary suspension of the marketing denial order was for review purposes only and does not reverse it.
On June 23, the FDA issued an initial order prohibiting Juul sales. The ban was temporarily blocked by a federal appeals court a day later.
After years of delays, the FDA took the first FDA action. It was part of a broad effort to scientifically examine the multibillion-dollar vaping market.
Companies must prove that e-cigarettes are good for public health in order to remain on the market. This means that e-cigarettes must be proven to have a positive effect on public health.
Initial FDA statements stated that Juul’s application had left regulators with serious questions and didn’t provide enough information to assess any health risks. Juul claimed it had provided enough data and information to address all concerns.
Juul requested a stay while the court reviewed the case. This was granted by a three-judge panel of U.S Court of Appeals for District of Columbia Circuit.
The FDA stated Tuesday that it had determined that “there are scientific problems unique to the Juul application which warrant additional review.”
It said that the review and stay do not give Juul the authorization to ship, market, or sell Juul products.
