A federal judge on Wednesday ordered the Food and Drug Administration (FDA) to speed up its reviews of thousands of electronic cigarettes currently on the market, siding with public health groups that sued the agency.

The lawsuit was filed in federal court in Maryland last year by the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and other public health groups. They argued that the FDA’s delay in regulating e-cigarette products led a spike in underage vaping.

According to the judge, the FDA’s decision to delay reviewing electronic cigarette products for several years amounted to a serious dereliction of duty.

The decision amounted to “an abdication of its statutory responsibilities,” Judge Paul Grimm ruled. While it tried to figure out how to implement the law, FDA, he said, essentially afforded “the manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”

Grimm ruled that FDA has two weeks to submit a specific plan of action on moving forward with the reviews. Grimm noted that the agency will still have to go through the standard rulemaking procedures, but added that “manufacturers long have been on notice” that they will have to submit their products for FDA reviews.

[I]f they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making,” Grimm wrote.

An FDA spokesman said the agency is reviewing the decision.


Read full article here.

Nathaniel Weixel – The Hill – May 15, 2019.

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