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"We conclude that articles intended to be used as capital punishment by a state or by the federal government can not be regulated as" drugs "or" devices "under the (Federal Act on Foodstuffs, Medicines and cosmetics), "Steven A. Engel, head of the ministry's legal counsel office wrote in a 26-page legal opinion signed on May 3. "The FDA therefore has no jurisdiction to regulate such items for this intended use."
The decision comes as lethal injection drugs are in short supply. And that follows the FDA's 2015 intake of 1,000 vials of Thiopental sodium – a drug used in lethal injection procedures – of the Texas Department of Criminal Justice.
The state sued the FDA in January 2017, asking the agency to release the drug from federal detention.
Thiopental sodium has been used in lethal injections since the 1970s, the MJ said. It is usually used as part of a cocktail of three drugs that puts a prisoner to sleep, then causes paralysis and stops the heart.
In 2009, the only US manufacturer of the drug stopped producing it. And in 2012, the US District Court of Columbia issued an order directing the FDA to block the importation of this drug "on the grounds that it was neither approved nor wrongly".
Contrary to the injunction, Tuesday's opinion stated that "the FDA does not have jurisdiction to regulate items intended for unregulated use by the FDA, while these items can not be safe and effective for this intended use. "
The Department of Justice said the FDA could not regulate an item destined for the death penalty in the United States.
"The FDA has not expressly asserted the power to regulate items intended for use in performances before 2017, and we believe that such an assertion can not be reconciled with the [Federal Food, Drug, and Cosmetic Act] and other federal laws, "says the opinion.
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