"We conclude that articles intended for use in capital punishment by the federal government cannot be regulated as 'drugs' or 'devices' under the Federal Drug and Cosmetic Act," Steven A. Engel, the head of the department's Office of Legal Counsel, 26-page legal opinion signed May 3. "FDA has lacks jurisdiction to regulate such articles."
The decision comes as lethal injection drugs are in short supply. And it follows the FDA's 2015 seizure of 1,000 vials of Sodium Thiopental
The FDA in January 2017, requesting that the agency release the drug from federal custody.
Sodium thiopental has been used in lethal injections since the 1970s, the DOJ said. It is typically used as part of a three-drug cocktail that puts a prisoner to sleep, then brings to paralysis and finally, stops the heart.
In 2009, the American manufacturer of the drug stopped producing it. And in 2012, the U.S. Pat. District Court of the District of Columbia issued an injunction that required the FDA to block the import of the drug "on the grounds that it was unapproved and misbranded." Texas: FDA should release impounded execution drug ” data-src-mini=”//cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-small-169.jpg” data-src-xsmall=”//cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-medium-plus-169.jpg” data-src-small=”http://cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-large-169.jpg” data-src-medium=”//cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-exlarge-169.jpg” data-src-large=”//cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-super-169.jpg” data-src-full16x9=”//cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-full-169.jpg” data-src-mini1x1=”//cdn.cnn.com/cnnnext/dam/assets/130515154110-lethal-injection-table-small-11.jpg” data-demand-load=”not-loaded” data-eq-pts=”mini: 0, xsmall: 221, small: 308, medium: 461, large: 781″ src=”data:image/gif;base64,R0lGODlhEAAJAJEAAAAAAP///////wAAACH5BAEAAAIALAAAAAAQAAkAAAIKlI+py+0Po5yUFQA7″/>
In contrast to the injunction, Tuesday's opinion said "FDA lacks jurisdiction to regulate articles intended for use The FDA, the Justice Department said, cannot regulate an article that is intended for capital punishment in the US.
"FDA did not expressly assert the authority to regulate articles intended for use in executions at any time before 2017, and we believe that such an assertion cannot be reconciled with the [Federal Food, Drug, and Cosmetic Act] and other federal law," the opinion says.