Death Penalty

The Justice Department Rules That the FDA Cannot Regulate Lethal Injection Drugs

The opinion stems from an injunction currently preventing Texas from importing sodium thiopental.


The Department of Justice (DOJ) recently decided that the Food and Drug Administration (FDA) has no authority to regulate "articles intended for use in capital punishment," including the drugs used in lethal injections.

The opinion was published earlier in May and signed by Trump-appointed Assistant Attorney General Steven Engel:

Electric chairs and gas chambers are "articles" that were created for the sole purpose of capital punishment. Because of this, it is clear that the FDA does not have authority over them. Other articles, such as the drugs used in lethal injections or the guns used in firing squads, were created for functions beyond execution. While the FDA has technically never claimed jurisdiction over the former, its authority over the drugs used for lethal injections is questionable.

For example, the FDA has jurisdiction over hot tubs, saunas, and treadmills, ONLY when they are "intended for medical purposes." The FDA has no authority when they are used for recreational purposes as that is beyond its jurisdiction.

In a similar way, the FDA regulates drugs based on whether or not they "are safe and effective for their intended uses." An article approved for one use is currently not allowed to be imported for a separate use. Sodium thiopental, one of the three drugs used in the standard lethal injection cocktail since the 1970s, is one of the articles in question. Sodium thiopental is an anaesthetic used in surgical procedures. Corrections facilities multiply the normal 300-milligram dosage anywhere from six to 17 times for the purpose of execution.

The DOJ acknowledges that the FDA has jurisdiction over drugs used in animal euthanasia because it is a standard practice accepted in veterinary care. Capital punishment, on the other hand, is not accepted as medical care.

The DOJ also observes that lethal injection drugs would be unable to meet FDA compliance since the agency requires labels to include warnings about "unsafe dosages." It is understood that warning against fatal use would be irrelevant for any drug used for the purpose of death.

Because of these observations, the DOJ concludes that the FDA cannot regulate any article of capital punishment because the intended use, capital punishment, is not medical and therefore falls beyond the FDA's scope. The FDA is only free to regulate the same drugs when used in medical care.

The opinion stems from a years-long fight between the FDA and the state of Texas over an injunction blocking the importation of sodium thiopental. The injunction remains in place for now.

Though states are eager to possess sodium thiopental for executions, U.S. manufacturer Hospira ceased production of the drug altogether in 2011. After the company moved production to Italy, the Italian government demanded that the company ensure that the drugs would not be used to administer the death penalty. Hospira determined that while they did not condone the use of their drug for capital punishment, they did not have the ability to ensure that it would remain out of the hands of U.S. corrections facilities. In a statement following the decision to shut down entirely, the company said it regretted that hospitals "who use the drug for its well-established medical benefits" will no longer have access to the product.

A sodium thiopental shortage caused states to look for other manufacturers and drugs. Oklahoma, for example, began to use pentobarbital, a drug intended to euthanize animals. Opponents renewed their criticism of the drug following two botched executions in Oklahoma in 2014. When the Danish manufacturer announced that it would no longer supply the drug for lethal injections, states turned to synthetic versions.

The FDA has largely lost its claim as any sort of moral gatekeeper. Stories like the one portrayed in the 2013 movie Dallas Buyers Club show how the FDA's heavy-handed regulations punish those seeking life-saving medicine. Rather, the DOJ opinion, as well as Texas' and other states' aggressive fight to access drugs for lethal injection show just how far the government is willing to go to kill.

Public opinion currently supports the death penalty. Pew Research Center found that the decades-long decline in support for the death penalty was thwarted by a rise in 2018. Pew also found in 2015 that the majority of people recognize that there is a risk of putting an innocent person to death and that the death penalty is unlikely to deter serious crime.