The business case for kratom: Why this controversial herbal remedy presents opportunities worth the risk, says expert

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When people find out I manufacture kratom products for clients, they often ask whether kratom is legal. My answer? “It depends.”

Made from the leaves of Mitragyna speciosa, a tree native to Southeast Asia, kratom has been consumed for centuries for focus, mood elevation, and pain relief. Even today, some people in these regions report daily use of kratom but its consumption is controversial in the United States. The Food and Drug Administration takes a dim view of kratom, warns consumers not to use it, and has thus far seized and destroyed millions of dollars’ worth of kratom products. Six states have banned kratom entirely—but despite many sternly worded statements from regulatory agencies, it remains legal at the federal level.

I’ve tracked public opinion, state laws, and FDA policy on kratom manufacturing for years. While being a kratom producer certainly has its challenges, shifting public opinion on the plant as well as new scientific consensus on its benefits have expanded business opportunities for legitimate companies to explore.

Kratom Makers and FDA Opposition

Anyone considering getting into kratom production does need to be aware of the FDA’s hostility to kratom. After a decade of working in the cannabis industry, I’m well accustomed to regulatory animosity—but it’s a factor that may dissuade some from getting in the game.

The agency, which rejects the majority of New Dietary Ingredient (NDI) notifications, has rejected notifications for kratom six times thus far. Kratom producers are often treated like criminals. The agency’s animus contributes to kratom’s PR problems. Import alerts and ominous reports insisting that those who take kratom risk “addiction, abuse, and dependence” often seem designed to scare the public into thinking it’s a deeply dangerous substance. (It’s not, but we’ll get to that in a moment.)

The lack of standards around how the plant matter is sourced, processed, or labeled is a real problem—but just like CBD, this dearth of oversight is actually also a bureaucratically created roadblock. In virtually every story about the dangers of kratom, a disturbing headline usually leads to an article about the danger of consuming an unregulated product, not harm caused by the actual plant. Our agencies and our media usually fail to make that distinction.

I and other ethical manufacturers continue to call for universal standards and testing for kratom, but without FDA willingness to oversee and regulate kratom, product inconsistency and lack of regulation will continue to provide ammunition for kratom critics.

The New Scientific Consensus on Kratom

Setting regulatory issues aside: Is Mitragyna speciosa itself harmful to humans?

Well, while hard data on the number of kratom consumers is tough to come by, studies indicate millions of Americans currently use kratom regularly to manage chronic pain and addiction issues.

• A 2019 study in the American Journal of Preventive Medicine estimated that 10 to 16 million Americans currently use kratom as an opioid alternative.
• A 2016 Pain News Network survey of 6,400 kratom consumers found that over half the respondents used kratom for pain relief, while others used it to manage anxiety, addiction, and depression.
• A full 90% of the survey’s respondents said kratom was “very effective” in treating their medical condition.

Numerous researchers have concluded that kratom’s dangers have been overblown. In fact, contrary to the FDA’s stance, leading scientists, healthcare professionals, and addiction experts argue that kratom should actually be studied as a viable alternative to opioids. A small sampling of the consensus:

• A 2017 study on the abuse potential of kratom published in Psychopharmacology found that the plant poses “no documented threat to public health.”
• A 2021 article published in Frontiers in Pharmacology concluded that “kratom may have potential as a harm-reduction agent in the treatment of opioid use disorder, similar to cannabis.”
• In 2021, the World Health Organization’s Expert Committee on Drug Dependence investigated kratom and found insufficient evidence that kratom has adverse effects on people who consume it.
• In a 2021 Scientific American op-ed titled “The FDA Shouldn’t Support a Ban on Kratom,” Maia Szalavitz cites data showing that “kratom does appear to be far safer than all illegal and most prescription opioids.”
• In a 2021 STAT article, law professor Mason Marks expressed incredulity at the agency’s continued kratom vendetta: “Why does the FDA vilify kratom?....It is likely no more dangerous than many household products or over-the-counter medicines.”
  

The arguments that kratom is a threat to public safety simply don’t hold up to scientific scrutiny.

Kratom Is in Demand—and Growing More Acceptable

Because kratom offers accessible pain management and harm reduction, it’s only grown more popular as consumers shy away from opioids. Consumer trends and public acceptance are also moving in kratom’s direction: As with cannabis and psychedelics, formerly illicit industries have become increasingly accepted, especially as new research indicates these substances can actually support health and well-being.

Intra-industry attitudes are shifting, too. Two years ago there were zero domestic merchant processors who were willing to take on the risk of kratom. Today, qualified payment processors are beating down my door to handle my accounts.

Another positive: Relative to cannabis, CBD, and other plant remedies and supplements, there aren’t many kratom brands. Good products will garner attention—and consumer demand is already there. In American smoke shops, kratom sales outperform sales of CBD and delta-8 and are second only to tobacco. Kratom is so sought after that O.P.M.S., the biggest kratom brand in the world, sells only a limited amount to distributors, who are required to purchase other O.P.M.S. SKUs alongside their kratom orders.

There is real money to be made in this space. There are barriers to entry—but fortune does favor the bold.

Kratom’s Risks Are Worth It—But Profit Margins Alone Won’t Fuel Success

To launch a successful kratom line, you need risk tolerance, internet savvy, mass marketing, and SEO fluency. But in my experience, building a successful brand requires a purpose-driven mission. If kratom simply looks like a good bet on paper for the latest lucrative supplement trend, and you’re not interested in understanding how it works or in connecting with the community that’s sprung up around it? Your odds of success are low.

David Reynolds Derian is the best example of a purpose-driven kratom producer. As CEO of BotanaWay, he’s been in the kratom industry since 2010 and is known as the godfather of American kratom. He’s knowledgeable about the plant, deeply involved with patient advocacy, and believes wholeheartedly in kratom’s ability to improve quality of life for consumers. While Derian cautions that the kratom space is “very fast-moving and hard to break into,” he also pointed out that kratom advocacy groups have been extremely effective in their defense of it: “I never would have foreseen how big kratom advocacy organizations would get and how successful they have been. Kratom consumers have been given hope, and when that is threatened to be taken away they become very vocal and stand up for it.”

This unfairly maligned plant remedy means a great deal to many people. If you’re ready to embrace some risk tolerance, inspired to help others, believe in your brand, and are ready to do the work it takes to create an outstanding product? The odds of success with kratom are in your favor.

About the Author

Robert Johnson is CEO of Custom Capsule Consultants, a leading California white-label supplement manufacturer, as well as the creator of the CBD Is Better and Mycroboost product lines. He has worked as a consultant, product developer, and consumer trend expert in the hemp, cannabis, and supplement spaces since 2008.