Last Friday, a US federal judge ordered the Food and Drug Administration (FDA) to impose a deadline of 10 months for filing e-cigarette applications and one year for approvals. This decision is a continuation of the "shorter" deadline proposed by the FDA last month.
Last month, the FDA proposed a shorter deadline after the Maryland Federal Court ruled in a lawsuit by anti-smoking groups that the agency had exceeded its authority by allowing the e-cigarette to stay on the market until 2022, before companies are forced to apply for authorization.
« I will impose a ten-month deadline for submissions and a one-year delay for approval, as suggested by the FDA", Wrote the American judge Paul Grimm in a court order Friday.
Last month, the agency had offered e-cigarette manufacturers to have until August 2021 to submit a formal request for sale of their products. But the public health and tobacco control groups behind the lawsuit are demanding that e-cigarette manufacturers make their requests 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.