Justice Dept. says FDA lacks jurisdiction to regulate drugs in executions

The Justice Department said in a legal opinion Tuesday that the Food and Drug Administration (FDA) does not have jurisdiction over drugs used in lethal injections.

The DOJ’s Office of Legal Counsel said that “articles intended for use in capital punishment by a state or the federal government cannot be regulated as ‘drugs’ or ‘devices.’” Therefore, it stated, the FDA “lacks jurisdiction.”

The opinion was signed by Assistant Attorney General Steve Engel, an appointee of President TrumpDonald John TrumpLawsuit alleges Trump campaign paid women less than men Graham encourages Donald Trump Jr. to plead the 5th Crunch time for Senate disaster aid talks MORE.


The opinion is the result of a years-long dispute between Texas and the FDA that began in 2015 when the agency blocked the Lone Star State from importing shipments of an anesthetic from an overseas distributor. The FDA said the importation was illegal because the drug was not approved in the U.S. and was mislabeled.

Texas officially filed suit in 2017, shortly before Trump took office, saying the FDA was meddling in its law enforcement obligations.

The Justice Department’s legal opinion sides with Texas in the suit, though it is unclear if it will have immediate impact. The FDA has been operating under a 2012 court injunction prohibiting the drug, sodium thiopental, from being imported.

The Justice Department has not indicated if it will fight to have the injunction removed, an effort that could result in a lengthy court battle.

President Trump and both of his Senate-confirmed attorneys general, Jeff SessionsJefferson (Jeff) Beauregard SessionsRosenstein: Comey has become ‘a partisan pundit’ Rubio asks Barr to investigate Kerry over Iran meetings Rosenstein quotes Mueller in commencement address MORE and William BarrWilliam Pelham BarrBarr names Connecticut prosecutor to investigate Russia probe’s origins: report Rubio asks Barr to investigate Kerry over Iran meetings Rosenstein quotes Mueller in commencement address MORE, have voiced support for capital punishment.

States have had difficulties in obtaining drugs for lethal injections in recent years after drug companies objected to having their products used in executions, causing a shortage in available materials, according to The Washington Post. Some pharmaceutical companies have gone to court to prevent their products from being used in lethal objections.

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