Last Friday, a US federal judge ordered the Food and Drug Administration (FDA) to impose a 10-month deadline for filing e-cigarette applications and one year for approvals. The move is a follow-up to the “shorter” deadline proposed by the FDA last month.
Last month, the FDA proposed a shorter time frame after the Maryland federal court ruled in a lawsuit brought by anti-smoking groups that the agency had overstepped its authority by allowing e-cigarettes to remain in the market until 2022, before companies are required to apply for authorization.
« I will impose a ten month deadline for submissions and a one year deadline for approval as suggested by the FDA“, Wrote the American judge Paul Grimm in a court order Friday.
Last month, the agency offered e-cigarette manufacturers to have until August 2021 to submit an official request to sell their products. But the public health and tobacco groups behind the lawsuit are asking e-cigarette makers to make their claims within 120 days.
«Today's decision is an important step forward for public health and confirms the FDA's commitment to accelerate the review of these products, especially those of greatest interest to young peopleSaid the acting commissioner of the FDA, Ned Sharpless.