Dietary Supplement? Or Drug? The Kratom Regulation Debate

    Is kratom a plant (Mitragyna speciosa)originating in Southeast Asia and long used in traditional medicines for the mild opioid-like and stimulant properties of its leavesthat can relieve pain and opioid withdrawal symptoms, induce relaxation, and provide what some people would call “reinforcing characteristics” of riskier substances to which people are addicted?

    Or is it a drug product, currently sold in head shops and other venues without regulation in the US and subject to potential contaminationone that in some eyes could be foisted upon an unsuspecting public, some of whom could possibly become ill, addicted or even die from consuming it?

    The people who want to make kratom more accessible want it to be regulatedbut not like a drug or a medication.

    More and more, it’s looking like the best of both worlds—a plant that can be a beneficial regulated product, if used correctly—although, as is often true of currently unregulated substances, more research is needed.

    The people who want to make kratom more accessible want it to be regulatedbut not like a drug or a medication. The American Kratom Association (AKA), with the support of thousands of letter-writers, is pushing for it to be regulated instead like a vitamin or food supplement. This means it would not be prescribed, nor sold over-the-counter.

    But that scenario would require approval by the Food and Drug Administration (FDA), which under the leadership of Commissioner Scott Gottlieb seemed bent on characterizing kratom as dangerous enough to be made illegal, period.

    But with the March 5 announcement of Gottlieb’s resignation, things are looking up for kratom and the many Americans who use it, according to C.M. (“Mac”) Haddow, senior fellow on public policy for the AKA.

    “We are very glad that commissioner Gottlieb will be replaced by someone who will have a more reasonable view,” said Haddowalthough not all of the reported contenders to replace Gottlieb have stellar drug policy records. Haddow doesn’t blame Gottlieb, however, for the FDA’s anti-kratom bias, which he says was there for years.

    “But right to try ought to apply here,” said Haddow. “By God, we should do it.”

     

     

    The Dietary Supplement Pathway

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 explicitly does not apply to tobacco, but does apply to anything intended to supplement the diet that contains a vitamin, a mineral, an herb, an amino acid, or other “concentrate, metabolite, constituent, extract” intended for human consumption.

    It must be labeled as a dietary supplement, and not as a part of a conventional meal or food item. DSHEA cannot be applied to a new drug, antibiotic or biologic.

    This is the pathway that Kratom advocates hope to take to legitimacyfar from Schedule I of the Controlled Substances Act, where marijuana, for example, still resides. Placing kratom on Schedule Ibanning itwould not only deny millions of the potential benefits of the plant, advocates say, but also have adverse health and legal consequences for the many Americans who already use kratom for reasons as diverse as pain management and pleasure.

    As the first campaign manager for Sen. Orrin Hatch (R-Utah, now retired), who sponsored DSHEA, Mac Haddow gained a lot of experience in this area. The FDA commissioner at the time, David Kessler, hated DSHEA, according to Haddow, and said the law was so bad that he told the agency not to enforce it.

    Before the 1994 law, vitamins and dietary supplements were not regulated. But unscrupulous vendors, trying to increase their market share, were selling supplements that were killing people, said Haddow.

    “So, is kratom natural? Yes. Is it a vitamin? No. Should it be studied? Yes.”

    In fact, kratom has also been found to cause some deaths, though a very small number in the context of overall use: 11 deaths (of which only two resulted from kratom use only, the others from combinations with other substances) and other harms were noted by a recent study of kratom exposures reported to US poison control centers from 2011 to 2017.

    “These reports were not simple call-ins,” H. Westley Clark, MD, JD, dean’s executive professor at Santa Clara University and former director of the Center for Substance Abuse Treatment at the Substance Abuse and Mental Health Services Administration, told Filter. “These people needed either EMS or hospital interventions, with symptoms ranging from agitation and irritability to seizures, tachycardia, nausea, vomiting and hypertension.”

    There were 1,807 reported exposures during this period, with multi-substance exposures associated with higher risks of health care facility admissions and serious outcomes.

    Clark is skeptical of moves to get kratom approved through DSHEA. “So, is kratom natural? Yes. Is it a vitamin? No. Should it be studied? Yes.”

    But that still doesn’t imply that kratom should be banned.

     

    The Kratom Ban Pathway

    Haddow joined the AKA in August of 2016, when the federal government announced that it was considering scheduling kratom on the Controlled Substances Act under the emergency scheduling authority of the Drug Enforcement Administration. Less than two months later, thanks significantly to the AKA’s efforts, that proposal was withdrawn.

    Back in the early 1990s, when Haddow had worked in the dietary supplements field, advocacy was limited to what could be done on the ground. In cases where supplements were banned “people were so upset at not having their vitamins,” said Haddow.

    The threat of scheduling kratom as a controlled drug still lingers.

    Fast forward to 2016, and kratom advocates were able to harness the internet to push for the withdrawal of the proposed ban. Thousands of people were mobilized to write in, saying that they had used kratom to successfully step down from opioids, or to avoid using opioids altogether in pain cases.

    That’s when the DEA invited the FDA to do an “eight-factor analysis” to determine whether kratom should be placed onto Schedule I of the Controlled Substances Act.

    The AKA contracted Jack Henningfield, PhD, of Pinney Associates, to conduct a separate analysis of this issue. He had been working on kratom in his consulting life, and he concluded in the resulting review that kratom shouldn’t be scheduled, because this would create public health problems that did not exist as long as kratom was legal.

    As Haddow put it, kratom use existed, and mainly by people who were using it as an alternative to opioids or NSAIDs for pain management. “More people would die if they couldn’t get it,” said Haddow. They would be forced onto the black market, where illicit fentanyl was already killing people.

    However, the threat of scheduling kratom as a controlled drug still lingers.

     

     

    A Case of Kratom’s Use for Depression

    Murray Holcomb, MD, is a general surgeon based in Austin, Texas. He has been helping his son, now 30, who has suffered from depression and anxiety since college. After years of treatment that failed, Holcomb and his wife finally found kratom for their son.

    “My son had ECT, went to Mass General and the Mayo Clinic,” Holcomb told Filter. “He was prescribed increasingly high doses of Xanax, and was never an opioid addict.” But he continued to have severe depression and anxiety.

    He did have a job working as a contractor for Apple, however, and was on the verge of being recommended for a full-time job there. That all changed when he forgot to scan two items at Walmart and was arrested for shoplifting.

    After a night in jail, Apple withdrew the possibility of an offer for advancement and forced him to resign as a contractor. Then a friend of his died from an opioid overdose, and it was too much. He started drinking a lot.

    His parents put him in a long-term intensive residential treatment program, and he followed it. “He did the program—12 Steps, not drinking, on Prozac and Buspar—but still, six months into the program, he had anhedonia and was disphoric,” said Holcomb. “He wasn’t getting any better.”

    “His depression lifted immediately, he regained his footing, and he’s been fine for three years.”

    Then, three years ago, he started kratom, and within five days, the anhedonia and dysphoria  went away. “His depression lifted immediately, he regained his footing, and he’s been fine for three years.” Holcomb said.

    Holcomb thinks there are three classes of patients for whom kratom is suited: those with previous opioid addiction; those with chronic pain; and those (like his son) with treatment-refractory depression.

    These don’t sound like conditions for which a vitamin or nutritional supplement would be appropriate, do they? “The manufacturer should not be making those claims,” conceded Holcomb. “But people can make their own decisions.”

    Understandably, after all the years worrying about and caring for his son, Holcomb was very concerned when it seemed in 2016 that kratom might be banned. “When they thought this might happen, the psychiatrist put him on Suboxone,” said Holcomb.

    Suboxone is a medication demonstrated to reduce mortality for people with opioid use disorders. But the effects of losing kratom for Holcomb’s son, who had never had opioid use disorder, were terrible—the anhedonia returned with a vengeance.

    Holcomb’s son has since returned to using kratom, and once again saw a dramatic improvement in his condition. The cost of his kratom is about $100 a month, said Holcomb. His recommendation—advice his son follows—is that anyone who takes it should not take alcohol, benzodiazepines or other opioids.

    Although Holcomb’s son was never suicidal in terms of making attempts, his depression was so bad that he was not functional. “It’s unbelievably distressing to think kratom could not be available.”

    But is there proof that kratom relieves depression? As ever, more research is needed. But you could ask the same thing about some of the labeled medications, which have the same effect as placebo, notes Holcomb. He doesn’t dismiss the placebo effect. “Perception is important,” he said. “If you’re happy, you’re happy.”

    The dose that Holcomb’s son takes is “medium”: 5 grams twice a day of ground-up leaves. And he experiences no side effects, Holcomb said. He has since told his story on Capitol Hill as part of advocacy efforts for kratom access.

     

    Distribution, Recreation and Excessive Health Claims

    Kratom, the plant, grows in Indonesia and Thailand. It is imported to the United States either as a raw leaf or, more commonly, as a powder. Because of concerns about salmonella and other “cleanliness” issues related to both harvesting and shipping, brewing tea from the raw leaf is not preferable; the powder form, sold in bottles of capsules, is more common. But, even in these forms, the big concern is that because the market is unregulated, the kratom powder could have had things added to it.

    The first import ban resulted from a cluster of nine deaths in Sweden 10 years ago. But what should have been made publicand wasn’t at the timewas an investigation showing that in all nine cases, the product had been mixed with Tramadol, a synthetic opioid.

    “People tried to spike the effect of kratom with Tramadol,” said Haddow. This suggests that the market for kratom does include people who want the fuller effect of opioids, not an opioid alternative.

    The AKA is promoting any regulation that would ban spiking, require clear labeling, and make the product a dietary supplement.

    However, Haddow doesn’t think kratom would ever truly be a recreational drug. “It tastes so terrible that you gag on it,” he said. “And it does cause gastrointestinal distress” if too much is consumed. “People could be hurt,” he said. Of course, the same is true for other dietary supplements and even vitamins.

    Despite these concerns, the distribution network for kratom is expanding, said Haddow.

    He is a bit concerned about this. “We’re trying to protect the consumer, and they’re trying to expand the marketplace,” he said. “There are no controlled studies, We want to look at drug interactions.”

    The AKA is promoting any regulation that would ban spiking, require clear labeling, and make the product a dietary supplementnot an over-the counter or prescription drug. “It’s not a drug at all, we think it should be a dietary ingredient,” said Haddow. In this way, his organization is taking a very different path from marijuana proponents.

    The cause isn’t helped by excessive claims around kratom’s benefits. Haddow recalls coming across a kratom booth at a conference two years ago, where there was a sign saying kratom would cure cancer.

    “I asked, ‘How can you make that claim? That’s an impermissible health claim.’” He was told that the company’s lawyer approved it. The lawyer in question turned out to be a real estate attorney.

    One area of FDA crackdowns of which the AKA does approve is the making of such unsubstantiated claims.

     

    A “Mild Mood Boost” in Limbo

    So what does the AKA say kratom does? “The same thing as a dietary supplement,” said Haddow. “It gives you mild pain relief and a mild mood boost.”

    Some people would say that this is why people drink alcohol, or use other drugs. It is possible to push the herb definition, but there is no doubt that some people do take kratom for recreational purposes as well as therapeutic ones.  

    Almost everyone agrees that a total lack of regulation is not good.

    Occasional news reports, such as this one from 2017, of kratom being stolen from head shops underline this. Head shops, of course, are not normally associated with vitamins, nutritional supplements or health foods. “It appears from the head-shop robbery that as a vitamin or nutritional supplement label, [kratom] would require a wink and a nod,” said Clark, adding that people should be made aware that kratom, no matter why it is being used, has potential risks.

    However, Clark believes that regulating kratom as a dietary supplement would have one advantage. “The one good thing that could come from the vitamin or nutritional supplement label would be the good manufacturing processes,” he said. With the current, unregulated form of kratom sales, he asked, “who decides how much you should take and how often? Consumers should be informed about dosage, risk and adverse consequences of a psychoactive substance.”

    Kratom right now appears to be in limbo. Almost everyone agrees that a total lack of regulation is not good. Advocates, scientists and policy experts point out the harms to users that would be caused by regulating it as a drug. But as long as the DEA, the FDA and others view kratom as an opioid, it remains to be seen how realistic the dietary supplement path really is.


    Photo via Wikimedia Commons

    Correction, March 14th: This article was updated to clarify that Jack Henningfield was contracted by the AKA.

    • Alison Knopf

      Alison has written about substance use for more than 30 years. She has also written for many years about medical coding. A freelance writer, she is also the editor of Alcoholism & Drug Abuse Weekly, and managing editor of Child & Adolescent Psychopharmacology Update and Child & Adolescent Behavior Letter—all published by WILEY. She also writes for Addiction Treatment Forum.

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