"We specify that articles intended for use of state penalties through a state or federal government can not be regulated as & # 39; medicines & # 39; or & # 39; devices & # 39; "under the Federal Food, Drug and Cosmetic Act," Steven A. Engel, the head of the Department's Office of Legal Counsel, wrote on a 26-page legal opinion signed on May 3. "The FDA is there is no sufficient jurisdiction to protect such articles for intended use. "
The decision came as deadly drug injection was in short supply. And it follows the 2015 seizure of the FDA's 1,000 vials of sodium thiopental – a drug used in lethal methods of heating – from the Texas Department of Criminal Justice.
The state has roamed the FDA in January 2017, the agency will provide the drug from federal conservation.
Sodium thiopental is used in deadly injections since the 1970s, the DOJ said. It is often used as part of a three-ban cocktail that first puts a prisoner to sleep, then causes paralysis and finally, stops the heart.
In 2009, the only American drug manufacturer stopped doing so. And in 2012, the U.S. District Court for the District of Columbia has issued an injunction requiring the FDA to block the import of drugs "for reasons that it has been disapproved and misbranded."
In contrast to the policy, Tuesday's statement says "FDA is lacking jurisdiction to control articles for use that are not traditionally controlled by the FDA, when articles can not be safe and effective for such use. "
The FDA, the Justice Department said, could not control a articles intended for US death penalty.
"The FDA does not explicitly assert the authority to regulate articles applied to the use of executions any time before 2017, and we believe that such assertion can not be reconciled with [Federal Food, Drug, and Cosmetic Act] and other federal law, "according to opinion.