Kratom And The FDA

Kratom and the FDA have a been at odds since the plant’s popularity exploded over the past decade. Plants are vital to life on Earth. They produce oxygen, food, shelter, and medicine. But just because plants are natural doesn’t mean they can’t be dangerous. Take hemlock and nightshade, for example, both deadly poisons. But is kratom dangerous?

Whose job is it to protect us from plants? Who decides which plants we can use and which ones we can’t? How do those with the power determine which plants are just too dangerous?

In this article, we’ll look at the relationship between kratom and the FDA. We’ll look at the FDA’s role in regulating natural products like kratom. We’ll review why advocates want to keep kratom legal and why the FDA wants it off the market. Finally, we’ll look at the evidence to see what history and science have to say.

The Role of the FDA

It can be hard to understand who regulates what when it comes to what we put in our bodies: there’s the FDA, the CDC, the DEA, the ATF, and the USDA, among others. They all keep an eye on what gets onto the market, for better or worse.

The U.S. Food and Drug Administration (FDA) has a say in vaccines, blood, x-ray equipment, cosmetics, veterinary products, tobacco products, and much more. It also regulates dietary supplements, which is where kratom comes in.

Although the FDA regulates dietary supplements, they don’t approve them. That means any statement claiming a new diet pill or herbal remedy is “FDA approved” is misleading.

Products like these can be made available to consumers without FDA approval. The Agency only steps in when there’s a problem. That’s good if you’re trying to get your product on the market. It’s not great if something harmful makes it into stores.

Pro Kratom Advocacy

Pure kratom is nothing more than the dried leaf of the Mitragyna speciosa plant. Varieties like Red Bali, White Thai, and Green Maeng Da come from the age of the leaves and where they’re grown. Kratom is typically sold in powder form, either loose or in capsules.

People who use kratom say it has benefits like improving alertness or encouraging relaxation. A very outspoken group of people swear by kratom to aid in recovery from opioid use disorder (OUD).

The biggest national advocate for kratom is the American Kratom Association. The non-profit seeks to educate the public and fight anti-kratom legislation.

The AKA’s goal is to keep kratom legal but regulated. Under regulation, the FDA would presumably weed out unscrupulous vendors. By establishing laws that guide the production and distribution of kratom, the AKA hopes kratom would be safer for everyone.

Restriction of Kratom

In 2016, another federal agency, the DEA, sought to classify kratom as a Schedule I narcotic. That would have put kratom in the same category as heroin, marijuana, and LSD. The DEA’s definition of a Schedule I drug is one that has “no currently accepted medical use and a high potential for abuse.”

The DEA has since withdrawn its proposal to put kratom in this category, mainly due to public outcry. But the Federal government isn’t done with kratom. In April 2021, the FDA issued its updated RED LIST of kratom importers, directing FDA agents to detain any incoming shipments from that list.

The FDA’s Argument

Why has the FDA targeted kratom? There are many theories as to the true reasons for the FDA’s interest in kratom. However, the Agency’s official statements indicate that kratom is dangerous for three main reasons.

The FDA expressed concern using kratom as self-treatment for opioid abuse disorder “may keep some patients from seeking appropriate, FDA-approved therapies. Reliance on products with unsubstantiated claims may delay those who suffer from OUD from entering recovery and may put them at greater risk of overdose and death.”

The Administration has also stated its worry that kratom could become the next opioid epidemic, stating “the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”

Lastly, the FDA doesn’t think that kratom is safe. It cites 36 cases of death reported as “associated with the use of kratom-containing products.” It also lists potential health dangers, including seizures, liver damage, and withdrawal symptoms.

The Evidence

There’s an ongoing battle over whether kratom should remain legal in the United States. Alabama, Arkansas, Indiana, Rhode Island, Vermont, and Wisconsin have already outlawed kratom. How worried should we be about this botanical substance?

Deaths associated with kratom overdose have indeed happened. However, in every case, there were other substances or medical conditions involved that prevented clear evidence of causation. See the CDC’s study.

The CDC reported in 2019 that less than one percent of overdose deaths reported to SUDORS in 2016-2017 were kratom-related. (SUDORS is the State Unintentional Drug Overdose Reporting System, which relies on reports from 66 states and municipalities.)

Should we be concerned that kratom will become a drug of choice, adding to the problems of epidemic opioid use? A study by researchers at the University of Louisiana anonymously surveyed 500 people in a substance use disorder residential treatment program.

The study found that “[…] kratom was not preferred and was indicated as having less appeal than NPO [non-prescription opioids], heroin, amphetamines, Suboxone.”

Most users of kratom aren’t taking it to relieve OUD withdrawal symptoms or to get high. A 2016 survey of over 6,000 kratom users reported that the vast majority use it as a pain management tool. Only 9% said they use it to relieve OUD withdrawal.

Lastly

There’s one thing nearly everyone agrees on: we need more research on kratom. There have been studies on the effect of kratom on mice, but no clinical human trials. Making kratom illegal would dramatically inhibit any future research.

According to an article in the International Journal of Drug Policy, “Notably, officials in Thailand have thrice considered ending their kratom ban since 2000, citing no known cases of overdose, death, or violence following at least 100 years of traditional use.” As of June 2020, the ban was officially lifted.

Plenty of anecdotal evidence exists to support the use of kratom, including its centuries-long use in its native habitat of Southeast Asia. While anecdotal evidence isn’t science, it’s certainly a valid indication of where we should begin.