Federal Judge Instructs FDA To Impose 10-Month Deadline On E-Cigarette Applications

The Food and Drug Administration was ordered by a United States Federal Judge on Friday to set the deadline at ten months for companies to submit e-cig applications. The ruling will have a negative effect on companies like Juul Labs Inc. who has faced scrutiny due to the popularity of their products among teenagers.

The shorter timeline was suggested by the FDA last month after a Maryland ruling on a lawsuit filed by anti-tobacco groups. The District Court ruled the FDA exceeded its authority when it decided to allow companies to continue selling e-cigarettes without regulatory approval until 2022.

United States District Judge Paul Grimm wrote in his judgment that he will establish a ten-month deadline for applications to be submitted and a year deadline for applications to be approved. Judge Grimm mentioned the availability of these products to the youth and a clear health emergency as two reasons for his decision.

Products from e-cigarette companies will remain on the market until a decision is made regarding their applications.

According to CNBC, the FDA was first given the responsibility to oversee e-cigarettes by the Obama Administration in 2016. The agency previously decided e-cigarette companies would not have to submit formal applications until August 2021.

Groups that oppose the sale of tobacco products countered that companies should be required to submit the applications within 120 days.

Ned Sharpless, the commissioner of the FDA, said the ruling by Judge Grimm is the first of a series of important steps that will lead to the review of tobacco product that has gained popularity with minors.

A spokesman for Juul says it will honor the application process but is monitoring closely Judge Grimm’s decision. Juul also wants the public to know it is preparing research to determine just how their products are used by consumers. This is an apparent response to the general belief that e-cigarette products play a large role in the popularity of vaping amongst young people.

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