FDA temporarily suspends ban on Juul e-cigarettes

The Food and Drug Administration on Tuesday announced an administrative stay on the order it issued last month suspending sales of Juul e-cigarettes.

The marketing denial order is temporarily suspended, but it doesn't rescind, according to the tobacco division of the agency.

All electronic nicotine delivery systems or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed, according to FDA Tobacco. The stay and the agency's review do not constitute authorization to market, sell or ship JUUL products. The FDA had issued an order on June 23 banning the sale of Juul e-cigarettes. The agency said at the time that Juul had failed to provide enough evidence to prove that the products on the market would be appropriate for the protection of the public health. Today s action is further progress on the commitment of the FDA to make sure all e-cigarette and electronic nicotine delivery system products sold to consumers meet public health standards, FDA Commissioner Robert Califf said at the time. The agency has dedicated resources to reviewing products from companies that account for most of the U.S. market. These products are a significant part of the available products and they have played a disproportionate role in the rise in youth vaping. A federal appeals court blocked the agency's ban on Juul a day after it was issued. The decision on the case was not reflected by the court, which granted Juul's request for a stay.

The FDA said in its Tuesday announcement that there are scientific issues unique to the JUUL application that warrant additional review. In order to keep the e-cigarettes on the market, Juul must prove that adult smokers who use the product are likely to quit or reduce their smoking. The company must show that teenagers are not likely to become addicted to e-cigarettes.