The FDA Should not Support a Kratom Prohibition Now

In normal times, there would be no doubt that a medication having opioid-like effects should be shown safe and effective before being extensively promoted and authorized by the Food and Drug Administration (FDA).

But these aren’t ordinary times, and kratom, a herbal supplement, isn’t a regular medication.

In reality, whether or not to prohibit kratom is a good litmus test for whether the Biden administration will truly utilize the harm reduction concept to drive drug policy—or merely parrot the current term to disguise continued involvement in the war on drugs.

Kratom is used by an estimated 10–16 million Americans as an alternative to opioids, most often to alleviate pain or as a street drug replacement.

The herb, properly known as Mitrogyna speciosa, has a long history of usage in Southeast Asian herbal medicine, most notably as an opium replacement.

It’s usually offered as a bitter powder that may be brewed into a tea or taken in capsule form.

Because kratom has never received enough worldwide attention to warrant an American or global ban, our weak regulation of plant-based “health supplements” permits it to be marketed lawfully in the United States.

During the overdose crisis, both pain patients and those with addiction have progressively lost access to prescription opioids, resulting in a dramatic increase in sales.

Kratom appears to be considerably safer than all illicit and most prescription opioids, according to the CDC, which found it to be involved in fewer than 1% of overdose deaths between 2016 and 2017.

Researchers believe that it is 1,000 times less likely to kill than normal prescription opioids, based on the vast number of people who take it regularly and the low number of fatalities.

Furthermore, virtually all overdose deaths linked to kratom were accompanied by harsher substances that kill more frequently, so it’s unclear if it had a large or even minor role.

For example, illegal fentanyl and its analogs, which are hundreds of times more powerful, were implicated in nearly two-thirds of the 152 deaths reviewed by the CDC.

Sole seven times was kratom the only chemical found, and even then, researchers can’t rule out the potential of other substances that went undiscovered.

Regardless of the precise facts regarding individual substances, prohibition has been America’s primary method for dealing with drug problems for more than a century.

Except for alcohol, caffeine, and cigarettes, almost every drug that has been publicly linked to recreational usage has been either outright prohibited or restricted to medicinal use.

Prohibition policies, such as the war on drugs, presume that limiting drug sales and possession would address the problem completely.

When policymakers are motivated by harm reduction, however, they must determine whether banning a specific drug or permitting ongoing sales would cause greater harm—in light of other substances that it may substitute and other variables such as the harms associated with arrest and jail.

For example, introducing kratom without restrictions in a nation where no one is abusing harsher opioids and no one is already taking it may be hazardous.

However, in a country where overdose fatalities are at an all-time high, primarily due to street fentanyl, eliminating a safer alternative would almost definitely increase mortality.

Unfortunately, kratom prohibition may be on the way: the FDA is currently seeking public input on whether the United States should support an international ban on the substance, which the United Nations is reviewing through the World Health Organization.

The DEA’s position is clear: it opposes the over-the-counter sale of kratom as a health supplement and wants it banned unless it can be shown medically beneficial.

Under its treaty commitments, the United States would be obligated to prohibit the substance domestically if there was a worldwide prohibition.

The FDA has already attempted to prohibit kratom in collaboration with the Drug Enforcement Administration.

The DEA stated in 2016 that kratom will be placed on Schedule I of the Controlled Substances Act, a category reserved for substances with the potential for abuse but no medicinal value. Marijuana, MDMA (ecstasy), and LSD are now classified in this category, along with substances like cocaine; the categorization makes medical study exceedingly difficult, creating a catch-22.

However, consumers appear to have effectively fought back for the first time since the Harrison Act of 1914, which officially entrenched drug prohibition.

When LSD and MDMA became popular in the 1960s and 1980s, the DEA had little trouble scaring the public and Congress into fearing them.

By 2016, however, both journalists and government leaders were considerably less convinced that restrictions were effective—and, not coincidentally, kratom sales had grown to a billion-dollar business. The idea was withdrawn.

The FDA, on the other hand, appears to still want it off the market.

“Kratom is misused for its potential to generate opioid-like effects…,” it said in a call for public feedback on whether the medication should be banned internationally. Kratom is an increasingly popular substance of abuse that is widely available in the United States’ recreational drug market.

There is evidence that kratom is misused alone and in combination with other psychoactive drugs… Kratom is often used to self-treat chronic pain and opioid withdrawal symptoms in the United States.”

The industry and advocates of kratom perceive this as the DEA’s attempt to circumvent its past inability to get direct support for a domestic prohibition.

Mac Haddow of the American Kratom Association (AKA) argued in comments to Marijuana Moment, a policy newsletter, that the FDA’s intent to support a global 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.”

In an ideal world, we’d have a responsive regulatory system that enabled the safest medicinal and recreational medicines to be approved—one that made choices based on proportional dangers rather than moral panics fueled by worries about race, class, and ethnicity rather than real drug effects.

However, it’s reasonable that the FDA would attempt to ban kratom within our existing system: the only option for a drug with dangers and the potential to create a high is prohibition or regulation as a medication, which cannot be done without first conducting clinical trials for safety and efficacy.

We must change this if we are to truly implement harm reduction policies.

Prohibiting a drug that does less damage than other freely available alternatives would exacerbate the problem.

President Biden’s approach must be more flexible; else, rather than decreasing harm, it would exacerbate it.