Science

The FDA Shouldn’t Support a Ban on Kratom


In ordinary times, there would be no question about whether a drug with opioidlike effects should be proven safe and effective and approved by the Food and Drug Administration (FDA) before it is widely marketed. But these aren’t ordinary times and the herbal supplement kratom is not a typical drug.

In fact, the issue of whether or not to ban kratom is an excellent litmus test of whether the Biden administration will actually use the philosophy of harm reduction to guide drug policy—or just spout the trendy catchphrase as window dressing to hide ongoing engagement in the war on drugs.

An estimated 10–16 million Americans currently use kratom as an alternative to opioids, most commonly to treat pain or as a substitute for street drugs. The herb, formally known as Mitrogyna speciosa, has a centuries-long history of use in herbal medicine in Southeast Asia—notably as a substitute for opium. It is typically sold as a bitter-tasting powder, which can be made into a tea or swallowed in capsules.

Since kratom never drew enough international attention to spur an American or global prohibition, our lax regulation of “health supplements” made from plants allows it to be sold legally here. Sales have risen sharply in recent years, as both pain patients and people with addiction have increasingly lost access to medical opioids during the overdose crisis.

Kratom does appear to be far safer than all illegal and most prescription opioids: a CDC study of some 27,000 overdoses that occurred between 2016 and 2017 found that it was implicated in less than 1 percent of deaths. Given the large number of people who regularly use it and the low number of fatalities, researchers estimate that it is more than 1,000 times less likely to kill than typical prescription opioids.

Moreover, in nearly all overdose deaths associated with kratom, it was accompanied by stronger drugs that kill more often, so it is not clear that it actually played a major role or even any at all. For example, around two thirds of the 152 deaths the CDC studied also involved illicit fentanyl and its analogues, which are thousands of times more potent. In only seven cases was kratom the only substance identified—and even here, researchers cannot rule out the possibility of undetected drugs.

Regardless of the specific facts about particular drugs, however, for more than 100 years, the main strategy America has used to deal with drug problems is prohibition. With the exception of alcohol, caffeine and tobacco, nearly every substance that has publicly been associated with recreational use has either been banned entirely or strictly confined to medical use. Prohibition policy—such as the war on drugs—assumes that restricting drug sales and possession will solve the problem, period.

In contrast, when policy makers are guided by harm reduction, they have to assess whether banning a specific drug or allowing continued sales will do more damage—in the current context of other drugs for which it may substitute and other factors like harms associated with arrest and incarceration.

For example, in a country where no one was misusing stronger opioids and no one was already using kratom, introducing it without controls could well be harmful. However, in the context of an America with the highest number of overdose deaths ever—driven largely by street fentanyl—removing a safer substitute almost certainly will increase mortality.

Unfortunately, kratom prohibition may be coming: the FDA is now asking for public comment about whether the U.S. should support an international ban on the drug, which the United Nations, through the World Health Organization, is considering.

The agency’s own position is clear: it opposes over-the-counter sales of kratom as a health supplement and wants its sales to be illegal unless it is proven medically effective. An international ban would automatically require the U.S. to prohibit the drug domestically, under its treaty obligations.

In concert with the Drug Enforcement Administration, the FDA previously has sought to ban kratom. In 2016, the DEA announced that it planned to place kratom into Schedule I of the Controlled Substances Act—the category intended for drugs that have potential for misuse and have no medical use. Along with drugs like cocaine, this is where marijuana, MDMA (ecstasy) and LSD currently languish; the classification itself makes research to determine medical usefulness extremely difficult, creating somewhat of a catch-22.

But for what is apparently the first time since the Harrison Act of 1914 legally enshrined drug prohibition, consumers successfully fought back. The DEA had no problem getting the media and Congress terrified of LSD and MDMA when those drugs became popular in the 1960s and 1980s respectively. By 2016, though, both journalists and elected officials were far more skeptical of the usefulness of prohibitions—and, probably not incidentally, kratom sales had by then become a billion-dollar industry. The proposal was dropped.

The FDA, however, still seems to want it off the market. In its call for public input about whether the drug should be globally banned, it described the herb this way:

“Kratom is abused for its ability to produce opioid-like effects…Kratom is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Evidence suggests that kratom is abused individually and with other psychoactive substances… In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms.”

Kratom supporters and the industry see this as the agency’s attempt to bypass its previous failure to win direct support for a domestic ban. In comments made to Marijuana Moment, a policy newsletter, Mac Haddow of the American Kratom Association (AKA) argued that the agency’s intent to support a worldwide prohibition was an “abuse” of its authority, adding, “More overdose deaths will occur if kratom is banned, and that is exactly what the FDA is trying to do.”

Ideally, we would have a responsive regulatory system that allowed for the approval of the safest medical and recreational drugs—one that based its decisions on relative harms, rather than on moral panics that are more associated with fears about race, class and ethnicity than actual drug effects.

But in our current system, it’s certainly understandable that the FDA would seek to ban kratom: the only alternative for a substance that has risks and can cause a high is prohibition or regulation as a medicine, which cannot be done without clinical trials for safety and efficacy first.

If we are genuinely to enact harm reduction policy, we have to change this. Banning a substance that does less harm than other widely available substitutes will make things worse. President Biden’s policy needs to be more flexible; otherwise, it will increase harm rather than reducing it.

This is an opinion and analysis article; the views expressed by the author or authors are not necessarily those of Scientific American.


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