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EPA Case Could Imperil FDA Warning Letters

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By Alexander Gaffney

A unanimous decision last week by the Supreme Court of the United States (SCOTUS) against the US Environmental Protection Agency (EPA) could place warnings letters sent by the US Food and Drug Administration (FDA) into a quagmire of litigation, report various sources.

In Sackett v. EPA, SCOTUS ruled the Administrative Procedure Act—the act governing how FDA and other federal agencies create regulations and make decisions—did not preclude the litigants from immediately challenging EPA compliance orders.

While the ruling rejected Sackett’s arguments that the orders—similar to FDA warning letters—violated Sackett’s due process rights under the constitution, the ruling could mire future warning letters in a sea of litigation, writes Nina Mendelson of the Center for Progressive Reform.

“EPA may use compliance orders less often and when it does use them, it may take much longer for the orders to go into effect,” concludes Mendelson.


Read more:

Center for Progressive Reform - SCOTUS Decision in Sackett v. EPA Weakens Government's Ability to Respond to Urgent Threats to Water Quality

The Pink Sheet Daily - FDA Warning Letters Could Face Litigation In Wake Of Supreme Court’s EPA Ruling

Center for Progressive Reform - After Sackett: What Next for Administrative Compliance Orders?

Penn Program on Regulation – Opinion: Rule of Law Prevails in Sackett v. EPA




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