UNITED STATES
Additional review on Juul e-cigarettes

The US Food and Drug Administration (FDA) has said it will do an additional review of Juul’s marketing application after issuing a ban on the products, reports Reuters.

The FDA has put its ban on the sale of Juul Lab Inc’s e-cigarettes on hold as it prepares to conduct an additional review of the company’s marketing application. A US federal appeals court had stayed the FDA’s ban after Juul appealed the decision asking for an emergency review of the regulator’s order, reports Reuters. The FDA had claimed that Juul had not shown sufficient evidence to prove that its products were appropriate for public health and had therefor issued the ban. Juul on the other hand hit back at the FDA saying the decision was "extraordinary and unlawful" and citing the agency’s authorisation of e-cigarette products from other manufacturers, reports Reuters.
Jefferies analysts have suggested that the FDA’s announcement regarding an additional review of Juul products is a concession that data had indeed been overlooked and possibly a wrong decision made. The analysts wrote in a note that Juul products would likely spend very little time, if any at all, off the market.
"We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for JUUL products," said Joe Murillo, Juul's chief regulatory officer said in a statement.

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