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Retired nurse practitioner Heidi Sykora discusses her article, “The case for regulating, not banning, kratom.” She provides an evidence-based perspective on why kratom (Mitragyna speciosa) should not be treated as a dangerous opioid, clarifying the significant pharmacological difference between the natural kratom leaf and the potent, synthesized 7-OH. Heidi explains that while kratom dependence is possible, its addiction and withdrawal profile is much milder than classical opioids, and that severe psychiatric risks are rare and often linked to adulterated products. This discussion centers on the failure of prohibition and advocates for sensible regulation, like the Kratom Consumer Protection Act (KCPA), to ensure consumer safety, product purity, and accurate labeling. Learn the science-based facts about kratom regulation and why banning it might increase public health dangers.

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Transcript

Kevin Pho: Hi. Welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome Heidi Sykora. She is a nurse practitioner, and today’s KevinMD article is “The case for regulating, not banning, kratom.” Heidi, welcome to the show.

Heidi Sykora: Well, thank you so much for having me. I really appreciate it.

Kevin Pho: All right. Before talking about your article, just briefly share your story and journey.

Heidi Sykora: I am a retired nurse practitioner and health care executive. Most of my career was really focused on developing clinical guidelines and programs, as well as, of course, seeing patients. Typically, I would tend to see the most vulnerable patients, especially geriatric oncology patients. Actually, I got my master’s the year before you started your journey and your publication, so I have been following you for a long time. It is a real honor to be here.

Kevin Pho: All right. Thank you so much for sharing your perspective. Today we are going to talk about kratom, which we have talked about on KevinMD and on this podcast before. Tell us what your latest article is about. It is titled “The case for regulating, not banning, kratom.”

Heidi Sykora: I think it is really important that people understand, especially policymakers and also health care providers, the difference between kratom and a substance called 7-OH. These have been conflated in media reports and the literature, and they are very different. That was my main objective of the article: to make it very clear that kratom is a natural plant that has been used safely for centuries.

It is actually complex. It has over 40 different alkaloids in it. I believe they have identified even 50 now, and the primary alkaloid is called mitragynine. That makes up about 60 percent of the plant. It is a partial mu-opioid agonist, but it also acts on multiple other receptors. It has some dopaminergic, some adrenergic, and some serotonergic activity as well.

In low doses, it has a stimulating effect, kind of like coffee, but in higher doses, it can be effective for pain relief. The problem has been that recently a new substance called 7-OH has come onto the market. It is a semisynthetic substance where they actually use really strong chemicals to draw out this trace metabolite of mitragynine called 7-hydroxymitragynine.

In the natural form, that is not a problem at all because it is in such small amounts that as it metabolizes through the liver, mitragynine breaks down into 7-hydroxymitragynine. But it really is so small it doesn’t cause a problem. However, when you bypass that system and you make that 7-hydroxymitragynine into pill form or whatever form it might come in, then it really is a very strong opioid-like substance and it has more of a potential for harm. That is the big difference. That was my concern. I saw a lot of articles that were conflating the two. They are two totally different substances as far as what you get in retail sales.

Kevin Pho: Tell me, for patients when they see kratom advertised in their drug store or grocery store, tell us the type of formulations that are currently available. Typically, what do patients look to kratom to treat?

Heidi Sykora: A really large study was done by Johns Hopkins, and it showed that people are using it mostly for pain control. I can’t remember the exact percentage, but pain control and opioid withdrawal symptoms are common reasons. That is really important because the natural kratom plant does not lead to respiratory depression. So it is a much safer option for people than getting illicit opioids or any other illicit drug. They can use the actual kratom plant to help with their withdrawal symptoms. PTSD is another reason; a lot of the veterans have seen benefit for that using the kratom plant. Anxiety and depression are some of the other reasons.

Kevin Pho: In terms of the available formulations that patients can just buy from a drug or grocery store, what are they typically composed of?

Heidi Sykora: I think the closer you are to the natural plant, the longer the history we have of safe use and the more we know about it. So people can purchase natural kratom plant powder. The most important thing is to make sure that it is a manufacturer that is following what we call the Kratom Consumer Protection Act that has been passed in 18 states.

Hopefully, it will be passed in all 50 states very soon, but that requires, first of all, age greater than 21. It requires that the products are manufactured or packaged using good manufacturing practices and that they are lab tested. I think that is really important. Consumers should be able to go on the manufacturer’s website and see a certificate of analysis that shows that there are no adulterants, that the alkaloid levels are in line with the natural plant, and that there are no heavy metals, etc.

Labeling, of course, should be appropriate with the ingredients and the serving size. I think I might be missing something, but that is the general Kratom Consumer Protection Act or KCPA. That is, in my opinion, the safest way that consumers can get that. You can order it online. There are many smoke shops that also carry kratom products.

Now, the farther away you get from the natural plant, the less we know. Of course, more safety concerns come into play. From the natural plant, there are full-spectrum extracts. Basically, they use food-grade solvents and they just extract the fiber out. It is a very fibrous plant, so most of the powder itself is actually fiber. Those full-spectrum extracts reflect the natural balance of that plant, so the safety profile on those is very good.

There are concentrated extracts. For those, you are extracting more of the mitragynine and increasing that level. So that is going to be stronger and have more of a safety concern, especially for those who have problems with addiction because that can lead to more problems for people who have those kinds of concerns.

Then, of course, we go all the way to the semisynthetic and synthetic substances, which, in my opinion, are drugs. Those I think should go through the new drug application.

Kevin Pho: And are those clearly labeled? So if a patient goes to a smoke shop or a drug store and looks for kratom, is it clearly labeled which is more directly a derivative from the natural plant versus something that is more mitragynine, or even synthetic? Is that obvious to consumers?

Heidi Sykora: Not necessarily. It definitely takes some education, and this is why reasonable regulation is so important. This should have been done years ago. Unfortunately, the FDA in 2016 attempted to ban kratom, but natural kratom leaf and mitragynine specifically do not meet the criteria for scheduling per the eight-factor analysis. So that is why kratom was not scheduled. However, they did not accept it as a new dietary ingredient either. So it lies in this kind of no man’s land basically.

Regulation is really what is needed to make sure that consumers really know what they are getting. The American Kratom Association developed the Kratom Consumer Protection Act and the Good Manufacturing Practices Program. So they have vendors on their website that have met those criteria. It is not perfect, but at least it is a start. Those states that have the Kratom Consumer Protection Act limit the level of 7-OH in any kratom product. For the states that have the KCPA, those products really should be in line with safety and much safer for consumers.

Enforcement is a whole different issue, though. Some of the KCPA states have 7-OH products on the shelf. Their Kratom Consumer Protection Act should avoid that or at least give them the authority to enforce that and take those products off the shelves.

Kevin Pho: So there have been cases that we have heard in mainstream media about people using kratom that is linked to liver injury. The FDA has issued warnings about kratom and some serious risks about it. So what form of kratom are these referring to? Or are they just throwing everything under the bus of a single label when in reality it is more nuanced than that?

Heidi Sykora: Reality is definitely more nuanced. There has been a lot of bias against natural products, of course. Part of that is the unknown. But for kratom, there are just plenty of clinical studies on it. There are case reports that seem to be magnified. Typically, what you are hearing involves one or two case reports that have a lot of confounding variables and do not even collect the product. Just because someone says “I took kratom” doesn’t necessarily mean that they took natural whole-leaf kratom. It could be anything that they are calling kratom. I think that is an important distinction.

For example, regarding the kratom-reported deaths, almost all of those have been due to polydrug use or some other underlying factor. But if kratom is an ingested substance, it seems like the media focuses on the kratom instead of the cocaine, the methamphetamine, or whatever else was in their system. Of course, toxicology reports are another conundrum because sometimes if kratom is found, or somebody is known to have taken kratom, they only test for mitragynine. They don’t test for any other substances. We found those cases as well. It really does take the details to understand what the real truth is. It has been real eye-opening for me to see the disingenuous article titles and sometimes the articles themselves that just really don’t meet the standard that I would expect.

Kevin Pho: So what would you like to see? Because I know that there are some states that ban kratom entirely. When you say that you want kratom to be regulated specifically, in your ideal world, what would that look like?

Heidi Sykora: I think federal regulation would be ideal. A federal Kratom Consumer Protection Act would really protect access for all the millions of people who benefit from kratom. It would also put some safety net around it to make sure that youth are not getting it (that means 21 and up), that any alkaloid level is not able to be altered, increased, or concentrated, etc.

I’d like to see it be sold in more nutrition stores with people who can do some education rather than the current smoke shop format that we have. I think that that would be the most ideal thing.

Kevin Pho: And the Kratom Consumer Protection Act, tell us exactly what’s included in that.

Heidi Sykora: The Kratom Consumer Protection Act is common-sense regulation that limits the level of 7-OH in any product to less than 2 percent of the total alkaloid level or one milligram per serving. It requires product preparation with good manufacturing practices, lab testing of all products to ensure purity, restricting sales to those over 21 and older, and proper labeling.

Kevin Pho: We are talking to Heidi Sykora. She is a nurse practitioner. Today’s KevinMD article is “The case for regulating, not banning, kratom.” Heidi, let’s have some take-home messages that you want to leave with the KevinMD audience.

Heidi Sykora: 7-OH is not kratom. 7-OH is a semisynthetic drug. The natural kratom plant has been used safely for centuries. Let’s not throw out the baby with the bathwater. The FDA has recommended a ban on 7-OH, and they made it very clear that they are not targeting the natural kratom plant.

Kevin Pho: Heidi, thank you so much for sharing your perspective and insight. Thanks again for coming on the show.

Heidi Sykora: Thanks.