The Department of Justice informed the Food and Drug Administration it has no jurisdiction over the lethal drugs that are used in executions.
“Your office has asked us whether FDA has authority to regulate articles used in historically accepted methods of execution. Some of those articles — like electric chairs and gas chambers — exist for the sole purpose of effectuating capital punishment. Others — like substances used in lethal-injection protocols and firearms used by firing squads — have other intended uses,” the DOJ wrote in an opinion released earlier this month. “FDA has not historically exercised jurisdiction over articles intended to carry out a lawful sentence of capital punishment.”
“Congress has repeatedly authorized the death penalty on the assumption that there are lawful means to carry it out, but the regulation of such articles under the FDCA would effectively require their prohibition because they could hardly be found ‘safe and effective’ for such an intended use,” the opinion said, referring to the federal Food, Drug, and Cosmetic Act, which gives the FDA its regulatory authority.
The DOJ concluded “that articles intended for use in capital punishment by a State or the federal government cannot be regulated as ‘drugs’ or ‘devices’ under the FDCA. FDA accordingly lacks jurisdiction to regulate such articles for that intended use.”
The Washington Post reports the opinion comes as Texas and the FDA have been in a legal battle since 2015 over some drugs used in executions. The FDA blocked Texas from importing an anesthetic from an overseas distributor because the drug, sodium thiopental, was not approved for use in the United States and was improperly labeled.
Texas said the FDA was interfering with the state’s law enforcement responsibilities. Other states have tried skirting the ban by going through suppliers in East Asia, despite warnings from the FDA.
