U.S. federal judge orders FDA to implement 10-month deadline for e-cig applications
14 July, 2019, 3:16 pm
(Reuters) – A U.S. federal judge on Friday ordered the Food and Drug Administration to impose a 10-month deadline for the submission of e-cigarette applications, turning the screws on companies like Juul Labs Inc whose products have come under intense scrutiny for their popularity among teenagers.
The FDA last month proposed the shorter timeline after the U.S. District Court for Maryland ruled in a lawsuit filed by anti-tobacco groups that the agency had exceeded its authority in allowing e-cigarettes to remain on the market until 2022 before companies applied for regulatory approval.
“I will impose a ten-month deadline for submissions and a one-year deadline for approval, as the FDA suggested,” U.S. Judge Paul Grimm wrote in a court order on Friday.
Before last month, the agency had proposed makers of e-cigarettes have until August 2021 to submit a formal application to keep selling their products.
But the public health and anti-tobacco groups that originated the suit countered that e-cigarette and cigar makers submit applications within 120 days.
“Today’s ruling is an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth,” acting FDA Commissioner Ned Sharpless said.
Juul said in a statement that it was closely assessing the court’s ruling, while adding that it was fully committed to the FDA’s application process.