FDA’s efforts to ban kratom will lead to more overdoses, deaths

Robert Johnson | Nov 03, 2021

For kratom advocates, public health experts and addiction specialists, watching FDA’s continuing anti-kratom efforts feels like watching a fire truck race by raging high-rise fires to fine someone for watering their lawn.

2020 was the deadliest year in American history for lethal drug overdoses, with a record high 93,331 deaths. Leading physicians and substance abuse experts directly link this tragedy, in part, to FDA’s failure to properly understand, screen and regulate highly addictive opioid medications. Yet in response to this grim landmark, FDA is apparently pursuing a global ban on kratom, a botanical supplement that’s been used as a pain remedy for centuries.

Make it make sense.

As a supplement manufacturer who’s made products for kratom brands, I know we need regulatory bodies to protect the public. No one wants to return to the days where blindness-inducing lash enhancers or mercury-loaded skin creams filled American drugstore shelves. But FDA’s current approach to kratom does not protect us. On the contrary, experts are warning FDA’s efforts to ban kratom could potentially increase opioid addictions, overdoses and deaths because millions of Americans currently lean on kratom to manage such conditions as chronic pain and addiction.

An estimated 10 to 16 million Americans currently use kratom for various health reasons. In a 2016 Pain News Network survey of more than 6,400 kratom consumers, more than half said they used kratom for pain relief, while others used it to manage anxiety, opioid withdrawal, depression and alcoholism. A full 90 percent said kratom was “very effective” in treating their medical condition or pain.

In 2016, former New York State Senator David Carlucci was so concerned about the supposed dangers of kratom that he actually introduced legislation to ban its sale in his state. But he changed his mind after he was flooded with comments from thousands of people about how kratom had changed and even saved their lives. “I came to see kratom as a form of harm reduction,” Carlucci reflected via email to me, “essential to regulate so that it can be bought and consumed safely.”

As assistant law professor Mason Marks noted in STAT, kratom actually “fills an important niche in the public health ecosystem….If the FDA secures a global kratom ban, countless people could die by suicide and unintentional overdose.” Why, in the midst of a devastating overdose crisis (which itself is partly rooted in an epidemic of pain) would FDA devote valuable resources to curtailing access to a plant used for pain management for hundreds of years? How is that protecting public health?

Of course, I’m far from the first person to ask this question. In a recent Scientific American op-ed titled “The FDA Shouldn’t Support a Ban on Kratom,” journalist Maia Szalavitz acknowledges kratom “can be abused,” yet “given the explosion in opioid deaths, eliminating this safer substitute will almost certainly lead to more deaths.” Professor Marks is frank in the STAT article: “Why does the FDA vilify kratom?….A [kratom] ban will only encourage people to consume more harmful illicit substances like heroin or fentanyl, and many will die by suicide or from unintentional overdose.”

Lawmakers, scientists and members of the public have pushed back as well. When DEA announced plans in 2016 to designate kratom a Schedule I controlled substance (complete with a lurid description of the botanical as a “SE Asian drug…[and] imminent hazard to public safety”), more than 120,000 Americans signed a petition opposing the ban, and 51 members of Congress urged DEA to heed the will of “citizens and the scientific community.” Researchers who analyzed the abuse potential of kratom concluded, “There has been no documented threat to public health that would appear to warrant emergency scheduling of the products, and placement in Schedule I of the CSA carries risks of creating serious public health problems.”

The fight should have ended there, with FDA admitting its arguments were flimsy and held no water. However, despite the widespread consensus from scientists, medical professionals and addiction experts that kratom should actually be studied as a viable alternative for opioid pain management and addiction recovery, the World Health Organization (WHO) is now considering a global ban on kratom.

FDA disclosed in a Federal Register notice over the summer that kratom was proposed for a pre-review—or preliminary analysis—by WHO’s Expert Committee on Drug Dependence (ECDD) to determine whether current information justifies a critical review. The 44th ECDD convened in an Oct. 11-15 meeting to assess kratom and other substances subject to pre-review or critical review. In a critical review, the ECDD determines whether information presented “may justify the scheduling or a change in the scheduling of the substance in the 1961 or 1971 Conventions.”

A critical review could lead to a worldwide ban of kratom, but who’s really behind the effort to crack down on consumers’ access to the botanical? FDA spurred WHO to review kratom, according to Mac Haddow, senior fellow on public policy at the American Kratom Association. “I believe it is obvious that FDA is the instigator of this effort,” Haddow told me via email.

FDA continues to insist kratom causes addiction and death, but a review of its data doesn’t hold up to scrutiny. In 2019, CDC analyzed 27,338 overdose deaths that occurred over an 18-month period. Kratom was detected in 152 (0.56%) of these deaths, but only seven tested positive for kratom alone—and even in those cases, kratom could not be proven to be the cause of death.

Even a cursory investigation of the agency’s documentation shows the vast majority of these fatalities linked to kratom occur in people whose actual cause of death was overdosing on combinations of lethal substances like fentanyl, heroin, cocaine, benzodiazepines and alcohol. They simply happened to have kratom in their system as well—yet the FDA has the temerity to label these events “Kratom deaths.”

FDA’s lack of substantiated arguments for its hardline approach to kratom would be embarrassing if it weren’t so hazardous to public safety. I understand FDA is not here to make friends: the agency is a referee, and it’s easy and enjoyable to boo the refs and their calls. I’m simply calling on FDA to fulfill its promises, follow the science and do its job by focusing its resources on protecting us from lethal substances that poison communities and destroy lives. Kratom isn’t one of them.

Robert Johnson is the CEO of Custom Capsule Consultants, a California-based supplement manufacturer that offers full production services, end-to-end product development, custom formulations, and white-label and private-label products. He is the creator of the CBD Is Better line of vegan softgels, and co-founded TetraLabs, where he helped launch the first-ever CBD softgel supplement. Johnson has worked as a consultant, product developer and consumer trend expert in the supplement space since 2008.

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