PHARMACIST STEVE

Criticism Has Delayed a Kratom Ban but Probably Won’t Prevent It

The DEA’s backtracking underlines the arbitrariness of the government’s pharmacological taboos.

The Drug Enforcement Administration’s decision to withdraw its ban on kratom, a pain-relieving leaf from Southeast Asia, underlines the arbitrariness of the federal government’s pharmacological taboos, which are based on undefined terms subjectively interpreted by bureaucrats with broad discretion to decide which substances Americans may ingest. The DEA’s backtracking was prompted by complaints from kratom consumers, the companies that serve them, researchers who study the drug, and members of Congress. But despite the agency’s newfound interest in public input on the question of kratom’s legal status, it seems likely that we will end up with the same prohibitory result after a somewhat more elaborate process of post hoc rationalization.

When the DEA announced at the end of August that it was temporarily placing kratom’s main active ingredients in Schedule I, the most restrictive category under the Controlled Substances Act (CSA), it declared that a ban was “necessary to avoid an imminent hazard to the public safety.” When the ban did not take effect on September 30 as expected, DEA spokesman Russell Baer assured Washington Post drug policy blogger Christopher Ingraham that “it’s not a matter of if—it’s simply a matter of when, in terms of DEA publishing the final order to temporarily schedule kratom.” Since Acting DEA Administrator Chuck Rosenberg “has determined that kratom represents an imminent hazard to public safety,” Baer said, “I have a sense that publishing our final order will be sooner as opposed to later.”

Rosenberg’s determination was based on an unpersuasive, weakly supported analysis that dismissed kratom’s benefits and exaggerated its hazards. Critics pointed out that the DEA’s emergency scheduling authority, which Congress approved in 1984 at the agency’s behest, was aimed at dangerous new synthetic drugs that might cause many injuries and deaths during the time required by the standard scheduling process. Here is how then-DEA Administrator Francis Mullen explained his understanding of “imminent hazard to the public safety” in a letter to legislators:

The “imminent hazard” implies a need for immediate response to a drug trafficking and abuse situation that has occurred with such rapidity and with insufficient warning that normal control mechanisms would result in a large number of deaths and injuries or the continuance of an uncontrolled trafficking situation….The burden would be on the Government to prove that such an urgency exists and that the public safety would be jeopardized during the period that a drug would remain uncontrolled during routine scheduling action.

As examples of substances that would be covered by the new provision, Mullen cited “newly synthesized drugs or uncontrolled analogs of existing drugs such as PCP and fentanyl,” which “can cause widespread deaths and injuries in a very short period of time following their synthesis.” Kratom, a “minimally toxic” natural substance that humans have used for centuries with little evidence of serious harm except in exreme cases, hardly fits that description. “The use of this emergency authority for a natural substance is unprecedented,” noted Sen. Orrin Hatch (R-Utah) in a September 29 letter to Rosenberg.

Whatever legislators may have had in mind when they created this prohibition shortcut, they did not define “imminent hazard to the public safety.” The CSA says only that the attorney general (who has delegated his scheduling authority to the DEA) should consider a substance’s “history and current pattern of abuse,” “the scope, duration, and significance of abuse,” and “what, if any, risk there is to the public health.” That formulation leaves bureaucrats like Rosenberg free to describe any uncontrolled psychoactive substance, no matter how favorable its risk-to-benefit ratio, as “an imminent hazard to the public safety.”

The unscientific nature of that determination is clear from the fact that the DEA has reconsidered it in response to political pressure, as opposed to new evidence. Suddenly Rosenberg’s contrived kratom crisis no longer exists, giving the DEA time to solicit comments it supposedly had no time to consider before announcing its ban. According to a Federal Register notice published today, the DEA will be accepting public comments on the subject through December 1. The agency also has asked the Food and Drug Administration (FDA) to “expedite its scientific and medical evaluation and scheduling recommendation for these substances.”

Guidance from the FDA is part of the standard scheduling process but is not required for a temporary ban, which lasts at least two years and can be extended to three. During that time the DEA is supposed to decide whether the ban should be made permanent. In theory, the criteria for permanent scheduling are more demanding, but they are still elastic enough that the DEA can put pretty much any psychoactive substance it does not like in Schedule I, unless that substance has been approved by the FDA as a medicine or is excluded by statute from the CSA’s schedules (as alcohol and tobacco are).

The process described in the DEA’s notice sounds like an amalgamation of temporary and permanent scheduling. “Once DEA has received and considered all of this information [i.e., public comments and the FDA’s advice],” the agency says, it “will decide whether to proceed with permanent scheduling of mitragynine and 7-hydroxymitragynine [kratom’s main active ingredients], or both permanent and temporary scheduling of these substances.” Note that not scheduling kratom does not seem to be an option as far as the DEA is concerned, although the FDA theoretically could say there’s not enough evidence to justify treating it as a controlled substance.

The fact that the DEA still seems determined to schedule kratom should give pause to anyone celebrating the withdrawal of the original ban notice. According to the DEA’s position on marijuana, which remains in Schedule I despite multiple petitions urging its reclassification, a controlled substance belongs in that category unless it has a “currently accepted medical use,” which can be proved only with the sort of large, expensive clinical trials that the FDA requires before approving a new pharmaceutical. The DEA already has said there are no such studies of kratom, which means kratom has “no currently accepted medical use”—notwithstanding DEA spokesman Melvin Patterson’s seemingly contradictory statement that kratom is “at a point where it needs to be recognized as medicine.”

Assuming the DEA has ruled out leaving mitragynine and 7-hydroxymitragynine uncontrolled, which seems to be the case, the only way it can avoid banning them is by reconsidering its longstanding, court-approved interpretation of “currently accepted medical use,” which is a criterion for every schedule except Schedule I (and another crucial CSA phrase that Congress left undefined). It seems quite unlikely that the DEA will take that step, which would cast new doubt on its classification of marijuana and various other Schedule I drugs. Hence it looks like the uproar over prohibition of kratom will delay but not prevent that outcome.

Filed under: General Problems