The Way the FDA and DEA Ban Drugs Is Unaccountable and Arbitrary

A new report from the Government Accountability Office reveals that federal drug regulators do not have any clear policies or procedures for making scheduling decisions.

Since the beginning of the war on drugs over 55 years ago, the federal government has been classifying and regulating drugs through a "scheduling" system. A new report from the Government Accountability Office (GAO) reveals just how arbitrary scheduling decisions made by the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) can be.

In the United States, the primary law regulating drugs is the Controlled Substances Act (CSA) of 1970. The CSA establishes five "schedules" of drugs, tiered by their "potential for abuse," their medical use potential, and their likelihood of developing "psychological or physical dependence" in users. Of the five options, Schedule I is reserved for substances that have high potential for abuse and dependence and have no medical use. Schedule I is a grab bag of drugs, ranging from highly dangerous substances (like heroin), to taboo psychedelics (like psilocybin, LSD, and DMT), to marijuana (despite broad use and acceptance).

The DEA is the agency that enforces the implementation of the Controlled Substances Act and is responsible for scheduling and rescheduling drugs. The GAO report peels back the obfuscated layers of federal bureaucracy behind the scheduling process, revealing that major scheduling decisions made by the DEA follow a mostly made-up procedure: "DEA does not have any policies or procedures regarding how its staff are to conduct evaluations or schedule substances." 

Ouch. There aren't any policies?

The GAO says that when it asked DEA and FDA officials about their standard operating procedure for scheduling, they usually pointed to the CSA of 1970 or the longstanding memorandum of understanding (MOU) between the two organizations. But the GAO's meddlesome investigations found that neither document provides the guidelines that officials claim to be following. 

The report reads, "Based on our review of the MOU, it does not include policies and procedures specifically outlining DEA's responsibilities and procedures related to drug scheduling under the [CSA]." Officials then tried pointing to the CSA itself, claiming it included "clear and strict legal procedures" about scheduling. 

But the GAO disagrees: "Based on our review of the [CSA], it does not provide this level of specificity (e.g., roles, responsibilities, and procedures) regarding how DEA is to carry out these responsibilities." For an organization whose sole responsibility is to "enforce controlled substances laws," you'd think officials actually know the content of the most critical of those laws.

The problem is not just localized to the DEA. Given the FDA's role in reaching scheduling decisions, the GAO also examined that agency's procedures and found a similarly troubling lack of written standards. The report found that "FDA does not have policies or procedures that…clearly define the criteria and process for determining a substance's 'potential for abuse,' including its abuse potential relative to other substances." 

Without comparing abuse potential relative to other substances, drug regulators can bend the concept of abuse potential without accountability. When the DEA rejected a petition to reschedule marijuana in 2016, it cited marijuana's widespread use as evidence of its potential for abuse, without providing quantitative measures of addictiveness relative to other substances. A 2011 study found that 8.9 percent of marijuana users developed a dependence disorder—a low figure when compared to 67.5 percent of nicotine users, 22.7 percent of alcohol users, or 20.9 percent of cocaine users. Cocaine is a Schedule II drug, while nicotine and alcohol are federally legal (with some regulations).

DEA officials told the GAO that they made all scheduling decisions with heavy consultation from medical experts, all of whom hold advanced degrees. It seems unlikely that the DEA and FDA—agencies with thousands of staff members and billions in annual budgets—are just winging every assessment, but who is to say whether the "professional judgment" of drug regulators is right or wrong, if there is no procedure to check it against?

Accurate scheduling is very important, as lower schedules apply stricter regulatory barriers for research. Many drugs currently banned under the CSA have shown potential for use in experimental psychology but have to go through lengthy approval processes before they can be used in tests. Reason's Jacob Sullum has written how the federal ban on MDMA has prevented labs from finalizing experimental PTSD treatment. 

Thankfully, the past 10 years have seen slow but positive movement toward the federal rescheduling and legalization of some drugs, especially marijuana. In 2022, the Biden administration launched an inquiry seeking to reschedule marijuana, a policy which has been continued by the Trump administration. In April, acting Attorney General Todd Blanche signed an order that formally moved state-approved medical marijuana products from Schedule I to Schedule III. This is not legalization; marijuana is still federally banned. But it is a step in the right direction.

The federal government's blanket hostility to drug use has failed. For decades, federal drug policies have driven a nationwide system of prohibition that has led to over-policing and mass incarceration, without reducing overdose deaths. If the federal government is going to decide what people can and can't put in their bodies, it must do so with clarity and accountability.