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Senate Health Committee California State Senate
Follow its sittingsSpeaker 2
They're not. But the key point is that a low seven zero h leaf product and a high seven o h tablet are not the same exposure, not the same risk, and should not be treated as the same category. When a product is intentionally enriched with synthetic seven zero eight, the most relevant comparison is no longer Kratom as a botanical. It is actually no pure active substance that is sold in consumer packaging. So the main message for me would be that first, kratom is just not one substance.
Right? It's a mixture of various alkaloids. Second, one kratom related compound, specifically seven Oh, behaves much more like a traditional opioids than most people understand and realize. And and third, that the largest concern right now is the spread and controlled spread of products that can that concentrates this compound seven Oh and sell it in an easy to use forms. Thank you for your time, and I will be very happy to answer any questions.
Speaker 1
Thank you so much, doctor Kotterbash. I do have a few questions, and I also wanna point out that you are joining us from the University of Arkansas Medical Sciences Department. But how similar is metagenine and seven Oh to the classical opioid receptors activity, as far as their dependence potential and also the risk for respiratory depression?
Speaker 2
Yeah. So once again, metronome is it does not really have a very strong opioid receptor effects. Right? It's not really strong opioid receptor agonist. Right?
It's kind of more opioid like. Right? Although there are some cases being described in in in literature, you know, when consumed in a high concentrations, for example, those herbal products can also lead to opioid like effects. Seven zero eight, on the other hand, this is the product that the chemical alkaloid that has a very high potential. It's actually a very potent mu opioid agonist receptor.
In experimental studies, in in vitro, in in animals, actually, it's been shown to be even stronger than morphine. The animal studies clearly show that animals demonstrate the abstinence withdrawal, respiratory depression at the higher doses. Effects can be reversed by naloxone, which is a classical case of opioids. Right? There is also accumulating evidence in scientific literature published in the case reports when people occasionally or intentionally consume seven concentrated seven way products, and they displayed classical opioid like in intoxication from development of tolerance, abstinence, and withdrawal to several critical cases when buprenorphine even naloxone need to be used to revive people.
And, also, we know several lethal cases being published, including a few that happened in in in in California. Does
Speaker 1
naloxone work as well with reversing the effects of seven zero eight as it does with other opioids?
Speaker 2
Yes. According once again, according to the animal studies and also according to a few clinical cases when with an Oh overdose, there are actually several studies showing that one dose was not even enough in some cases, and a few doses needed to be administered in order to revise the patient.
Speaker 1
And to your knowledge, can chemical testing currently accurately identify kratom products that have been supplemented with seven zero eight?
Speaker 2
I would say that most of the forensic laboratories have that capacity to do that. The problem is that seven zero eight was never considered something that forensic laboratories would look into. So metronome was the principal component for for for for forensic laboratories to look into. So, technical, once again, labs can do that because it's the same equipment needed, but a certain standards need to be developed for seven zero eight in order to be able to quantify it in a in a in a laboratory settings. And, of course, if we're talking about the emergency department's clinical, there is no way at this moment to tell unless the patient admits that they actually all used a seven h product.
Speaker 1
So you were saying yes in labs. If a patient up in the emergency room, those labs don't have the capacity to differentiate between the two?
Speaker 2
No. Those labs currently not. And in terms of forensic psychology labs, they equipped with they have enough equipment. But there is most of them do not have validated assays to quantify seven zero eight. So what you need to do is actually develop obtain or develop the standards, validate the methods, and then laboratories can do that.
But it's not a routine panel across the country in the forensic psychology labs.
Speaker 1
So how burdensome or how far away do you think that we are from being able to test it just like a routine toxicology within a routine toxicology screen that we do when someone comes in and we think that they're intoxicated with something in the emergency room?
Speaker 2
Well, emergency rooms is always very difficult to do that because you don't have much time, right? As a clinician, your thought is to save the patient or who is unresponsive, you know, respiratory depression and so on. And if and, usually, naloxone, in this case, this can reverse the effects. In terms of confirming that this is a seven zero eight intoxication. Right?
So you need the biological specimen from a patient, and it obviously will take some time to to to run the analysis. So as a MD, as a clinician, you don't you guys don't have the luxury of time. But in order to confirm this, the samples can be sent to forensic psychology labs. That's the method there are there are a few methodologies that have been published recently. In the last few months, there are several papers published in various methodology to detect seven or eight, both in biological samples as well as then retail samples, you know, for those pills and shots and and tablets and gummies and you name it.
So, technically, it's it's probably just a matter of several months. However, I I think it's it's it's more of a regulatory decision, right, to have those laboratories forensic toxicology laboratories, analyze among the other drugs of abuse, the presence of potential presence of SEP7 Oh in biological samples.
Speaker 1
Wow. And just for clarification, when we're talking about screening for seven zero eight, is that a urine or a serum test?
Speaker 2
Well, it can be urine. It can be blood. And it's blood probably is the best would be, but your urine is also possible.
Speaker 1
Yeah. Okay. And my final question for you. How detrimental do you think, as researcher, would it be to biomedical research if California were to schedule kratom or seven zero eight as a schedule one or two controlled substance?
Speaker 2
I will probably will be biased because I am a scientist. And I have worked with schedule one substances before, and I know how painful it is in order to obtain also licenses and certificates and the when you have to go, you know, through all this bureaucracy. I afraid that such move will de de incentivize the research, which is so much needed. So I would not wanna say I I would not wanna say once again that this or that decision needs to be implemented. But I afraid from if you're asking me from the scientific standpoint, scheduling it as schedule one, that's will disincentivize a lot of researchers who would otherwise would love to do that work.
Speaker 1
Okay. Thank you. And one more question. I'm sorry. I'm going have you because I see you have a PhD and MD, so I'm going to have you put on your MD hat and ask you if you think if we were to schedule kratom or seven zero H, and as a Schedule I or II control substance, do you think that that would potentially decrease the amount of individuals that we see that have side effects or death as a result of these substances?
Speaker 2
You know, it it is a very hard question. And in general, I don't think, you know, there is a rapid solution, you know, that we can just discuss here and and, implement tomorrow. I afraid that abrupt ban will have a lot of negative consequences because first of all, it's it's just gonna push the demand on the black mark to the black market. And, you know, when we push it into the black market, it results in even poor more poor or substandard products, less control, even higher contamination risks, and less opportunity just to monitor the harm effects. Right?
I'm afraid that if I think that just rapid ban would not really improve what are we seeing today. We need to understand there are tens of thousands of people who use it regularly, And we don't have a diss a solution what we will do with them tomorrow when those products would just be probably not available to them. I think, you know, it is probably the decision has to come, you know, from a more balanced approach, you know, developed with regulatory scientists, pharmacologists, toxicologists, clinicians, public health expert, law enforcement, you know, that the decision could be taken. The the one the decision that will cause the minimum harm and will incentivize further research, I think that what kind of a decision we all need to think about.
Speaker 1
Well, thank you so much for joining us. Really appreciate your expertise and giving us the background with the pharmacology and toxicology of this substance. We will now move to our first in person panel and talk about the state and local perspectives and public health impacts. We will start, and all of you can come up. We have Maral Farsey, Deputy Director and Office of Legislative and Government Affairs at CDPH Amy Mullen, or Doctor.
Mullen? Mullen. Mullen, I was right, who's a professor of emergency medicine. She's the chief of the division of Addiction Medicine at UC Davis. Doctor.
Odeh Okpo, he's the chief medical examiner at the County Of Los Angeles. Doctor. Hurley, Medical Director from the Bureau of Substance Abuse Prevention and Control at Los Angeles County Department of Public Health. And Farrah Ting, who is the Deputy Director for County Health Executive Association of California. Thank you all so much for being here.
I think this is probably the first time I've had so many fellow physicians in front of me. And so we will start with Merle.
Speaker 3
Hello. All right. Thank you, Chair Doctor. Weber Pearson. And team, thank you so much to your team for putting all of the work into this.
We appreciate the invitation for the Department of Public Health to participate in this hearing and to provide our perspectives on CRADIM. My name is Maral Farsey, and I'm here on behalf of Assistant Health Director Doctor. Rita Winn, who's unfortunately ill today. We apologize. I'd like to begin by sharing some of our data around creatine use, which was something that you guys wanted to hear about.
So in 2022 to 2023, an estimated one hundred and sixty nine thousand Californians ages 12 and older, which is about half a percent of the population reported using kratom in the past year. So the department is aware of three sixty two kratom related overdose deaths in California between 2019 and 2023, with a steady increase from thirty eight in 2019 up to ninety two in 2023. So this is likely an underestimate because we're just doing a text search through our death certificates. And this estimate specifically excludes 70H. CDPH is also aware of fifteen drug related overdose deaths in California between the same time period 2019 to 2023, where 70H was included as a cause of death substance on the death certificate.
And we're not able to identify the number of drug overdose deaths caused specifically by products containing only 70H. As mentioned by the prior speaker, creatine has a complex pharmacological profile with the potential for sedative, stimulant, and opioid effects. Seven hydroxymitrogynine or seven Oh is a potent opioid that usually makes up a very small percentage of kratom leaf, but can be concentrated and added to products to increase their activity. What we have observed is that I'm sorry, both whole leaf kratom products and seven zero H have a high potential for addiction, particularly among people with existing substance use disorders. And that overdose risk is substantially elevated when seven zero H is taken alongside other intoxicants, particularly alcohol, benzodiazepines, and or other unregulated street drugs.
So let's talk about what CDPH is doing about this. First and foremost, education. CDPH continues to provide information and warnings to the public about the harms of kratom related products, including seven zero h. We have issued two press releases to the media about the risks of kratom and seven zero h leading to addiction, serious harms, overdose, or death. Last month, CDPH issued a statewide California health advisory to health care providers.
On multiple occasions, our department has met with and informed local health officers in California about enforcement actions that may be within their authority to protect the public from being able to gain access to kratom and seven zero H. And in January, CDPH sent a letter to licensed tobacco retailers to inform them that retail and online sale of kratom and seven zero H products for consumption is unlawful. We're also taking enforcement actions. You guys probably are aware that the department has been conducting investigative work associated with kratom, and we continue to take action to remove products and raw materials containing Kratom or seven zero eight from retail facilities, selling to consumers and from manufacturing locations. We've taken enforcement actions across the state, including two manufacturers, 22 wholesalers and distribute distributors, and about 50 retailers.
We are not able to discuss the specifics of our investigations, but just general information. Cradle products are placed under embargo and voluntarily destroyed at several locations, and regulatory letters are issued outlining corrective actions. In most cases, embargoes remain in place until next steps such as civil cases, civil penalties, injunctions, or condemnation orders are pending. And then additionally, CDPH is partnering with California Department of Alcoholic Beverage Control and with the California Department of Tax and Fee Administration to educate consumers and retailers that products containing kratom or seven Oh are considered adulterated, are not legal to sell for consumption, and are associated with addiction, serious harm, overdose, and death. So we recognize and appreciate that the legislature is interested in doing more to protect Californians from the potential dangers of kratom and seven zero eight.
We stand that the most protective the most health protective policy is the one that we have in place now, that Kratom and seven zero h are not legal to be manufactured or sold for consumption. This stance limits the proliferation of such products, and a path towards legalizing or regulating would further public confusion that these products are somehow legal to be sold for consumption or are safe to consume. So that concludes my comments. Thank you for your time. I'm happy to take questions when the time is appropriate.
Speaker 4
Thank you. Thank you so much. I'm Amy Mullen. I'm an emergency physician, also addiction medicine physician, and really appreciate the opportunity to share with you what I am seeing on the ground in my own emergency department, but also from my colleagues across the state. Seven hydroxymertogenin acts at the opioid mu receptor in a way that causes dependence, withdrawal symptoms, and addiction.
We are seeing this play out in patients who come to the emergency department and other health care settings seeking help for their withdrawal, dependence, and addiction. Those patients we end up treating in the same pathways as we do for fentanyl. People who've been using seven hydroxymortagenine require high dose buprenorphine treatments in the same way as patients with fentanyl, and we have even seen patients who require methadone treatment for their dependence on seven hydroxymortagenine. Most of
Speaker 4
patients feel like they have been misled by the way that this is sold and marketed at gas stations over the counter. And I just wanted to share with you some of the patient stories of people that I have taken care of, because they're emblematic of what is happening across the state. One was a pregnant patient who started taking seven zero eight because it was supposed to help her with pregnancy induced nausea. We saw her repeatedly for pregnancy induced nausea, which turned out to be withdrawal symptoms, until we figured out that she had been using seven Oh on a daily basis. She required treatments with buprenorphine for her withdrawal symptoms.
And I also think if we had continued to miss this, there would have been negative outcomes, not only for her, for her pregnancy, and her unborn child. Another patient was she felt, I just wanted to say, very angry and upset because she had been misled by the labeling of this product. That is a common theme. I had a veteran who had spent many years struggling with substance use, many years in recovery, and then was marketed seven Oh as a treatment for his PTSD. Ended up again dependence, withdrawal, addiction, and back in treatment.
Felt very taken advantage of because he was then, what he felt, tricked back into addiction and had to go through that again. And I wanted to share with you, I had a 40 year old female who started taking seven zero eight for symptoms of anxiety and insomnia. And when she ended up experiencing withdrawal requiring treatment, she was also very upset. And what she said to me really stuck with me. And she said, This is like vitamin C.
I thought that this was healthy. And when we have substances that are psychoactive, that act at the brain in a way that it activates the opioid mu receptor, but we sell it like a dietary supplement, like vitamin C, that is not fair. And people feel very upset because of what is happening. And I just wanted to say, if you will hear that this is safe, because we are not seeing large numbers of overdose deaths. And if we are waiting for large numbers of people to die, that is not what we should be considered
Speaker 5
Doctor. Odeokbo, Chief Medical Examiner of the County Of Los Angeles. Deaths unexplained can happen. They do. But whenever there's an increase in the number of unexplained deaths, that signals that there's an emerging threat for the community.
What we saw in June and July 2025 was an increase in unexplained deaths in young folks from 19 as young as 19 to 40 years old. The autopsy did not reveal any cause of death related to injury or natural disease. We then had to expand our toxicology testing to find another agent that may be causing this death that is not commonly seen before. And that's when we discovered the common factor that was shared amongst all these cases was seven Oh. The seven zero eight was predominantly in white men that were suffering from either anxiety, depression, or insomnia.
When we discovered this agent, the only reasonable conclusion that we could make was that the toxin caused the death. The medical examiner does not characterize these as overdoses. Actually, the death is caused by this agent because we don't know if there's a safe level for this agent to be used. Overdose implies also that it can be prescribed, clinical trials in that. So I just want to be clear that that's how we make our determination.
It's based off of deductive reasoning of nothing else gets reasonable that can explain this death. And that's how we came across initially six cases, and we continued to see new cases in the county. This is when we alerted our partners in the county of Los Angeles, the Department of Public Health that has joined with me today. Madam Chair, I yield for his discussion.
Speaker 6
Thank you. Good afternoon. Thank you, Doctor. Pearson and committee members. I'm Brian Hurley.
I'm an addiction psychiatrist, and I'm the medical director for the Los Angeles County Department of Public Health's Bureau of Substance Abuse Prevention and Control. We've worked closely with our county medical examiner when we learned about overdose fatalities associated with seven zero H. Seven zero H, as was mentioned, has been associated with overdoses in individuals between the ages of 18 and 40. And based on these pattern of overdoses, we put out notifications to the community beginning in September. We put out a health alert to our healthcare providers.
And in November, we alerted retailers to essentially stop selling both Kratom and 7OH products. Because there is a wide variability in packaging and labeling conventions, our health our environmental health inspectors don't have an easy ability without testing of differentiating Kratom from seven Oh products. As of January 23, we visited 2,882 sites, and three fifty seven of them were identified to have Kratom and seven zero eight products, which the retailers removed from shelves. But we don't have a food and drug laboratory like the State Department of Public Health. So our current enforcement of the Sherman Food, Drug, and Cosmetic Law is currently supported by the existing licensing and permit fees, enforcement specific fees, and administrative fines and licensing fees, but these fees cannot exceed the reasonable cost of providing the enforcement at the current level.
So, this additional enforcement just sort of stretched our existing workforce because we're not currently structured or funded to monitor for Kratom and seven Oh products. Were, at Los Angeles County, to create a local ordinance, we would need additional resources in order to be able to enforce such an ordinance. And given the potential under recognition of the risk of creatinine seven Oh in the community, we've advised the community the safest course of action is to avoid using creatinine seven Oh products. And we've provided risk reduction guidance including naloxone on hand. We have community health stations where we distribute naloxone.
Now, people who use creatinine seven zero eight, as has been previously commented on, can experience opioid dependence and opioid withdrawal. So, we've advised individuals at risk for opioid withdrawal to consider medications such as methadone or buprenorphine which can reduce the risk of overdose and save lives. Now, seven Oh is more potent than unmodified metragidine, right? It's associated with a higher risk of dependency and a higher tolerance. So, we've seen instances where people require higher doses of methadone, higher doses of buprenorphine, and repeated administrations of naloxone in order to reverse an overdose involving seven zero H.
I myself have worked with a patient who is using seven zero H through his treatment with injectable extended release naltrexone, an opioid antagonist that blocks the opioid receptor. And his experience is that seven zero eight is activating his opioid receptors through that antagonism, which speaks to the potency of this product. Now, we offer a no wrong door policy for anyone who is Medi Cal eligible or otherwise uninsured. We operate a county helpline. We have a universal access to addiction medications policy.
But we do wanted to highlight both the public health risks and some of the complexities with local health jurisdictions trying to conduct enforcements without a statewide sort of infrastructure around regulating kratom products and regulating seven zero eight. I'm happy to answer any questions at the end of the panel. Thank you.
Speaker 1
I'm sorry. Before you go, I just wanted to clarify. You said that you had a patient that or an individual who was taking something that was an antagonist. Correct. And also was taking Kratom or was it Kratom or seven zero eight?
Speaker 1
Seven zero which is an agonist, and so it was able to overcome the antagonistic force of the
Speaker 6
Yeah, antagonist is a monthly injection of naltrexone. It's a four week It's administered every four weeks. It's injected into the gluteal muscle and provides a steady stream of a relatively high potency opioid antagonist. And my experience with him is that he was using seven zero eight on top of that antagonist and having an opioid effect.
Speaker 8
Thank you, Madam Chair Weber Peterson and members. I'm Farrah McDade Ting. I'm here representing the County Health Executives Association of California today. We represent the local health departments throughout California on policy matters. And local health departments, as many of you know I'm speaking to the choir here serve as the backbone of community health in California.
Our members carry out life saving functions, including responding to health threats such as infectious diseases, natural disasters and bioterrorism, helping children get a healthy start by supporting pregnant people, newborns, and adolescents, providing medical care to indigent adults, and building diverse community partnerships to address health disparities. Environmental health is a branch related to public health that implements statutory and regulatory requirements for safe, prepared foods, drinking water and water quality, on-site sewage disposal, solid and medical waste disposal, and hazardous materials management. We appreciate the opportunity to speak before the committee today on this topic, and want to note that Kratom and seven zero H are not the first in the list of substances that are potentially harmful, and we expect other substances in the future. So while we're discussing this compound today, we also want to take a lens of thinking of all the substances that exist already and that may be, frankly, cooked up in a lab in the future and how California will deal with those. While the science of kratom and seven zero eight is still emerging, the public health impacts on the communities, as you have just heard, are becoming apparent.
Should you, as policymakers, determine that the regulation of kratom and or seven zero eight is required, it's important to align the regulatory framework with the mission and expertise of those who will enforce it. And, of course, it's important to ensure the appropriate resources to do so. Since the COVID-nineteen pandemic, more and more issues have been identified as public health threats. People are more aware of public health, which we celebrate. We also appreciate the acknowledgment of the multitude of factors impacting the health of our communities.
That's public health's bread and butter, and we love that people know about it now. But public health or environmental health is not always best positioned to address all the public health dangers. Local health departments are being asked also to do more and more with less. In fact, you know, with the effects of HR1, the significant medical care and fiscal impacts on locals. We just had federal grant funding and attempts to cut off federal grant funding yet again here in California last month.
Local health agencies are struggling to get through these rough seas already. And we have fielded many questions about whether local health departments can regulate kratom. What we say for local health departments and environmental health is that our local health inspectors focus on prepared foods. They don't regulate cannabis, intoxicating hemp, infused edibles, alcohol, prescription drugs, or even scheduled narcotics like cocaine and heroin. That's not our bailiwick.
Asking environmental health inspectors to take on a quasi law enforcement role for substances is not only outside of their scope of expertise, but could also, in some instances, threaten their safety on the job. As lawmakers, you get to decide whether Kratom and seven zero eight require a comprehensive enforcement framework. And if the answer is yes, then we ask to look to California's robust and centralized regulation of substances that fall outside of food safety standards. As mentioned before, the Departments of Cannabis Control, Alcoholic Beverage Control, Department of Justice, Tax and Fee Administration all specialize in regulating and enforcing the parts of manufacturing, the ingredients, the testing, the labeling, and sales of nonfood substances. And yes, there's always challenges for enforcement, no matter what level of government is tasked with it, as we heard in last night's JLAC and Assembly Business and Professions hearing, where the Department of Cannabis Business Control is really struggling to keep up with cannabis products marketed at children.
Whoever does the enforcement and regulation, it's not going to be a panacea, and it's not going to fix everything, but it's worth a try. And a similar state led approach on kratom and so on and Oh can ensure that labeling, manufacturing, disposal of the products, testing, and even age restrictions or what other regulatory framework you want to put in place is enforced statewide. Right now, for those jurisdictions with local ordinances, those ordinances can only be enforced within their jurisdiction. So, L. A.
County, if LA County were to pass a local ordinance, they could only enforce it in the unincorporated areas of the county, not the city areas. And so, we have had a couple counties and a couple cities do kratom ordinances, but really, it's a patchwork. Of course, our local health inspectors can serve as the eyes and ears on the ground. As they make their rounds to any place that sells prepared food, some gas stations do, but not all, Of course, restaurants and other food preparation places they can look for these products on sale during their routine inspections and report them to whatever the centralized state authority is. In fact, right now, that is what is happening, especially with CDPH's stepped up enforcement and willingness to field these calls, and also their education campaign has helped a lot.
Local public health departments can also partner with the state enforcement agency on education and outreach efforts, because we're good at that, and surveillance efforts. So as more deaths are seen, more testing is done, we can keep track of those and help inform the framework. These local efforts fit within our local expertise and allow environmental health workers to continue to focus on their core food, water, and environmental health safety mission. While we don't know what the next substance may be, rest assured there will be many more. Kratom is the one in seven zero eight is what we're talking about today, but it won't be the last.
Building on the state level efforts and expertise in regulating various substances statewide will be key in managing these challenges. Thank you for allowing Chiek to testify today.
Speaker 1
Thank you for being here. I will now open it up to see if any of the other members of the committee have any questions. So, I will start. Doctor. Akpo, thank you so much for your presentation.
How were you able to determine that it was 708 and not Kratom?
Speaker 5
Great question. As the other speaker, I think Doctor. Koturbesh, was talking about that the measurement of seven zero eight, the standardization to allow to quantify it, has not been established. However, there was a presence of metraginine in these cases, a very small level of metraginine. And that triggered this unusual ratio where it was very low metraginine, but high seven zero eight, which is a very odd sort of mix.
Because what you expect is that you'll have a good amount of metrogynine and some of the byproduct is seven zero eight. And so we saw that sort of odd comparison comparison of of those those two. Two. And And that's that's what alerted us to say something's unusual here. And we also went back to our case.
Actually, in our morning conferences, we saw these strange pills. Were just like, what are they? They had this powder. They had this packaging that was very nondescript and variable. Also, the pills had some suggestion that you're supposed to quarter them.
So it would have the markings of quartering, and yet the pills are missing three at one time or something like that. So we started to say, this is not a coincidence. That this substance that is labeled on the product is being found in the system with no other explanation for the death.
Speaker 1
Thank you for that. And have you spoken with medical examiners across other counties to discuss your findings and see whether or not they have been testing or thinking of this as well?
Speaker 5
Questions So because we are at the forefront of this, like how did you do that? How were you able to make that determination? And so I've had questions about what our lab does and trying to get to where we are today in testing in that regard. I am aware of other states that it has been happening already. I believe Montana was one of the first states to report numerous deaths.
And so right now, we're kind of like in the forefront now of this as we certify these deaths. We're actually being asked questions, essentially.
Speaker 1
And given what you've found, has testing for kratom become a part of the routine toxicology report for unexplained deaths in LA County?
Speaker 5
Yeah, absolutely. So what happens is if we have the usual substances that can explain death that are powerful and have a high prevalence of causing death, methamphetamine or fentanyl, if we find that, we don't go doing further testing because those are agents we know are well established and potent and can cause sudden death. Cases where we have nothing are more likely to have metraginine come up. We have since shifted from that to testing for metraginine, even in cases where fentanyl and methamphetamine are present. We do see those cases that have fentanyl and methamphetamine.
However, the cases that have metrogynine alone, we see about those two to three cases per year of just metraginine, which is kratom, alone for causing death. So it has become part of our testing.
Speaker 1
Okay. Thank you so much. And Doctor. Mullen, I was wondering if you could give a sense of the timeline of when you started becoming aware that this was an increasing problem.
Speaker 4
Yeah. I think this is very this is, at least as far as we are seeing, we have seen kratom for a long time. Seven zero eight has definitely escalated over the past year. I have to say this feels to me very like fentanyl in 2020, when we started seeing a lot more severe opioid withdrawal. And I started reaching out to colleagues, and folks were like, I am seeing this new thing.
How are you treating it? And we are right at the beginning, where everyone I talk to is seeing a lot more people with seven point zero H addiction withdrawal symptoms, and trying to figure out how to treat it. So, this has escalated, I would say, over the past twelve months. Thank you for that.
Speaker 1
Maral Farcy, I was wondering, you spoke about some of the efforts that CDPH is doing and the stance that the department takes as to neither one of these products should be marketed, or manufactured or sold. How effective do you think those strategies have been? And when you go into, like, say, a gas station and they remove all of the products, Is there ever a follow back to see in a week, two weeks, are those products back on the shelf?
Speaker 3
Thank you for the question, Chair. So to be clear, the stance that the department is taking just I know you know this, but to reiterate, is coming from the FDA. The FDA has made the statement. And under the Sherman Law, we're complying with that. I don't have the figures on follow-up readily available.
But I will say, and I think you've heard this, that our peace officers and enforcement team are also have a certain capacity. And so what we focus on primarily is on the manufacturers and the distributors and often provide support to our local public health departments and health officers when necessary. But the focus when we're alerted to issues, we respond. And we do investigative work, obviously, to track down some of these manufacturers and wholesalers. So we can get back to you on whether we've seen follow-up, but I'm not aware that we I don't have that information, at least readily available.
Speaker 1
Thank you. And one other question. So we know the FDA's official position, and you reiterated that. But if we in the legislature were to pass some kind of law that distinguishes between traditional kratom and seven zero eight, how challenging do you think that would become for CDPH to actually enforce?
Speaker 3
Well, I guess I can't speak to how that enforcement would take effect? Because I know that we have examples of other substances in California where we've had to watch how a potentially legal substance can be concentrated or modified to achieve the same outcomes in in the response that the user is looking for. So I'm I'm being a little vague here intentionally, but I I think without knowing what that enforcement construct would look like, it would be really challenging to posit. But I think what we have seen historically is people take products and you can take kratom and you can concentrate it and the dose potentially makes the poison. And so you could end up having the same result anyway, even though we're looking at a potentially different substance.
They're not.
Speaker 1
Okay. Thank you. Yeah. Doctor. Hurley, in your experience, is there a legitimate use for seven zero eight to treat opioid addiction?
Speaker 6
There are many community members who have reached out to the county and saying that they're finding 70 helpful for various conditions. But seven zero H has not been approved by the Food and Drug Administration for any medical purpose. And we have FDA approved medications such as methadone and buprenorphine that can treat opioid use disorder, that have analgesic properties. And so as an addiction physician, and if I was talking to one of my patients who was using seven zero eight, I would be making treatment recommendations that rely on validated treatments, not on sort of self reported help from products that haven't been validated or tested for safety. So
Speaker 1
based on your medical experience, why would a patient choose to use seven zero eight over one of the FDA approved products?
Speaker 6
The FDA approved products are regulated and essentially gatekeeped through medical providers. You have to make an appointment, you have to go in, and we've worked actually, Doctor. Mullen and I have worked very hard to make medications for opioid use sort of more universally accessible in emergency departments, in primary care practices, in county behavioral health services. And we're still not at the point of universal access. We should be, but we're not across the state, and that is an effort that we continue to work on.
Because seven Oh products currently aren't regulated, you don't have to make an appointment. If you have enough money to be able to go purchase it from a retailer that sells it, you can just go buy it. And so that could be one of the reasons why people are choosing seven zero eight is it's not part of a medical treatment. It's just something people can go buy.
Speaker 9
Thank you, Senator. I appreciate it. I just had a follow-up question, actually, to something that you said and then some additional questions. You said that we lack universal access. When you say universal access, did you mean for methadone and other treatments in the state for is that what you're referring to?
Speaker 6
So, the current state law requires every drug Medi Cal certified and AOD licensed program to offer addiction medications directly or through referral. That's the current state law. That does not extend it to every primary care practice, to every hospital, to every emergency room, to every street medicine program, to every, you know, like that is a specific program. In LA, we're focused on making our drug Medi Cal program and state designated alcohol and other drug programs more accessible, but we recognize that actually only a fraction of the people who could benefit from these services were actually receiving them. So to really, when I say universal access, I don't just mean in state regulated alcohol and other drug licensed facilities.
I'm talking about throughout the entire continuum of health care, and that is not something we've achieved at this moment. Does that make sense? I wanted to make that distinction.
Speaker 9
Yeah. And I appreciate that. I think, you know, I was in the public safety hearing when we had taken up a bill, particularly on these two topics. And I know we had heard from those advocates and from people that use Kratom, that use seven zero H, that rely on it as a product. And I'll be honest, I was very unfamiliar with it before we even took this bill up.
But I am very sensitive to, I think, folks that are struggling with opiate based addiction. I've lost three family members to opiate based addiction, and I understand how difficult it is to overcome that. And so when you hear from folks that say that there is a tool out there for them that's helping them, that is a positive thing. I want to learn more because it is such a hard addiction to be. And for anybody that's ever had a loved one go through it, you know just how difficult it is.
Is there any research that's been done here, not just here in the state of California, but across the country, around dosage, in particular? And what dosages are good use for treatments? I heard people talk about using it a pain treatment as well. I know that because it's publicly available in gas stations, that there is no age restrictions. Has there been research done around age restrictions?
And do we have any of that data? Is there any of that data beginning to be gathered?
Speaker 6
At this moment, I'm so there are states across the country that have various levels of regulations around both Kratom and seven Oh, but I don't know of any study then looking at the association between those policies and the public health impacts, right? You know, this is when the regulations went into effect and what do we see in terms of overdose trends and use trends. Seven zero eight has not been validated as a treatment for any medical condition. So that is to say, I as a prescribing physician have no guidance on this is the starting dose, this is the medium dose, this is the max dose, which I do have for many other FDA approved medications. And so, when I talk to people who say I'm using seven Oh and finding, you know, this is why I'm taking it, I'm typically pivoting the conversations of how else can we get those needs met with validated, safe medications.
Speaker 4
Can I just I apologize, just want to say one thing? As an addiction medicine physician, there is a difference between having someone buy something over the counter in an unsupervised, unregulated way versus being able to treat someone with a medication where I know the dose and can see how that person is responding, versus someone who and what I will see from my folks who have been taking seven zero H is there's no backstop, right? So they will end up using escalating doses of seven zero H, and there is no one to say, Hey, we should look at this. We need to back off. We need to think about how this is affecting the rest of your life.
I have highly effective treatments for opioid use disorder in buprenorphine, and can prescribe them in a way that is safe, and then can also address some of the other factors that go along with the substance use disorder that you cannot do if someone is self treating in an unmonitored setting. Yeah. And I ask, and I recognize that this hasn't been regulated by the FDA yet,
Speaker 9
but I know that there are oftentimes research institutions that will go ahead and begin exploring these topics before FDA approval. And whether that's been psilocybin and John Hopkins University looking at some of the impacts and benefits from that, or MDMA, and doing these kinds of exploratory studies to see whether or not there are some sort of health benefits there to actually validate what folks are saying, and if this is even a treatment worth looking into for targeted populations. I'd be interested to know whether or not that's happening. And I recognize that those you know, are very sensitive studies, but
Speaker 6
There is an extensive body of research looking at you mentioned a few psychedelics and in pathogens, right, as a potential treatment for, I'll call it psychiatric and other conditions. They're not yet these haven't crossed the FDA approval line, right, but there's an extensive body of research. While there has been research involving metraginin, the seven hydroxymetraginin, it is not nearly to the same extent.
Speaker 11
Thank you so much, Senator. I had a couple questions as well. I'll start with CDPH. You answered the chair's question regarding maybe the potential well, vaguely the potential difficulty if the state were to enact anything separating Kratom, how we treat Kratom and seven Oh. Different counties approach it already very differently, so there's no standardization.
Isn't that alone creating difficulty of enforcement or, yeah, our approach?
Speaker 3
When you say different counties are approach what are they approaching differently specifically?
Speaker 11
Counties have enacted their own local ordinances, whether it's by age or complete illegal ban. If we're doing it piecemeal, doesn't that alone create difficulty more for the
Speaker 3
department? Well, mean, it definitely creates difficulty in the perception of whether it's permitted to be consumed or that it's safe to be consumed or sold. I would agree with that. But I don't think I mean, the state's stance is that these products can't be sold and they should not be consumed because the FDA has stated that.
Speaker 11
You know, I've always known that counties can be more can be tighter, more restrictive, but cannot be less than the state. If that's the stance of the department, how are the counties right now able to put local ordinances that legalize some of these products?
Speaker 3
I I don't know enough. Sorry. And I'm I'm a stand in, by the way. But I don't think I know enough about the jurisdictional differentiation. What we have done, as I said during my testimony, is that we have provided information to local health officers that the products are not legal to be sold, that they're not safe for use.
We've issued our statewide health advisory to health care providers. So our role has been to get out information, educate, and additionally, also to enforce where we can within our space. So yeah, I don't know why localities would be taking more limited stances. And I think some of those actions had been taken before this really started picking up. And because of what we have seen with the data around overdoses and use and all of that, the state has responded in kind by providing that education to
Speaker 11
our local partners. And going along that, is it then the stance of the department that if the state would, example, put an age requirement. And in doing so, while we're looking to protect our children, we're also legalizing something that has not been legalized by FDA.
Speaker 3
So the state's stance is that this is not a product, according to FDA, that can be legally sold in the state. So if there was legislation introduced and the governor potentially signed it that said there would be age limitations, we would see that as a conflict between the federal advice and the federal stance and what the state should be doing.
Speaker 11
Thank you. My next question is gonna be to the deputy director. And I was trying to if you can I I might have gotten lost in the last part of your remarks where you felt that it shouldn't fall under Sherman law? Was that your point?
Speaker 8
So our point is Sherman law is enforced statewide by CDPH Yes. Food drug manufacturing. Local environmental health typically only enforces food prepared foods. However, there are three counties, as outlined in the background paper, which is very comprehensive and great, L. A.
Being one of them, that have some delegated authority from the state to enforce some of Sherman, meaning the manufacturing piece of food. And so CDPH's stance comes from their experience with having the Sherman authority, whereas the counties other than the the three that have some delegated authority have never played in the manufactured food space. And so that is also a differing patchwork.
Speaker 8
I don't know if it would help reduce incidences. What I do know is that there aren't resources for those jurisdictions to do so. Okay. And so any enforcement effort, whether it is local, state, federal, you name it, would have to come with resources to be able to do it. Would be adding on a new duty for our local environmental health inspectors in the non Sherman Counties.
Got it. Thank you.
Speaker 12
Just briefly, Madam Chair, triggered a question. Thanks to the panel for your testimony. Is it or would it be and you may not be the right people from CDPH to even address this question, so maybe to counsel. But if we were to clarify or remove the limitation on enforcement away from just retail establishments and expand that? Would we be in seizure and removal enforcement as we speak?
And trying to begin an alternative review? I mean, you have a product that's basically know, whether you accept preemption or the FDA's determination or you look at Sherman, this is an unlawful adulterated agreement. Ingredients shouldn't be on the shelf anywhere if you look at it from a public health standpoint. From a technical legal standpoint, the enforcement scope only extends to retail establishments. It's a glaring hole obviously being taken advantage of by industry and consumers who end up sometimes in an ED presenting with other issues.
And clearly, whether it's on the pathology or it's on the clinical intervention, the level of intervention that's now being required, as we had testimony about, it's pretty clear that there's a distinction between the derivative here. Right? And so we have a bunch of issues presented. So I guess what I'm asking is, A, why isn't there been some coordinated effort here prior to this? Is this data that new?
And if in fact we close that loophole around the distinction between retail and other types of settings where this product is sold and consumed, would we be in enforcement action today seizing and removing this product?
Speaker 8
Doctor. Madam Chair? I'll take a stab at that, not being a lawyer, nor a doctor with my esteem colleagues here. CDPH's stance that kratom is unlawful to be manufactured as a consumable is rock solid rock solid ground. However, it is not currently illegal to possess kratom.
That's where we're not seeing the federal help and structure that we kinda need. We're feeling around in the dark, and that's why it's very complicated. Who enforces? How do you do it? Would you seize it if, you know, it can the state go to all the places where it's being sold?
It's not just being sold in places where food is prepared, which is where our local environmental health inspectors go. Corner gas stations with no food but dispensaries and others. And so, really, there's a lot of gray area about what kratom is, and the science is we just say it's emerging. Local public health directors, we're agnostic on the substance itself, because the science there still needs to be more science. We have very strong indicators that it could be a harmful substance.
And once the FDA or another statewide regulatory agency says, no, this is definitely bad, We would welcome a statewide framework to figure out who's going to enforce, who's going to seize, and how we're going to take care of that. But we're in the initial stages of feeling our way around this new substance.
Speaker 1
Thank you. So this is an issue that the legislature, as I said at the beginning, has been tackling. I think there's been at least three bills that have touched on Kratom and or seven zero eight. And when we're thinking about different policies, the issue of age requirement just came up. So I just wanted to ask Doctor.
Akbou, of those who had passed and you were doing the evaluation, how many of those were under the age of 18?
Speaker 5
One was 19, and that's the youngest. So nobody younger than 18. However, it doesn't exclude the possibility that it would cause death in younger ages.
Speaker 1
Right. Yeah. But what we've seen right now is that it's been fatal mainly in adults that we know of. And so I if we do some kind of age restriction, we have to recognize that it's impacting adults as well.
Speaker 9
I really appreciated your question, Chair. I know I've asked about this research question. Do we happen to have an idea of what a fatal dose even looks like and what the indicators are of that? Is there any commonality in some of the cases where we've seen folks that have died as a result of creatine morphine Oh?
Speaker 5
So overdose is not a term that the medical examiner uses when we certify a death. When you have a substance that hasn't undergone clinical trials to establish safety, whether it goes from animal models then to healthy patients. They try it on the patients that have the condition they're trying to treat. 70H did not go through that process. When a medical examiner certifies a death, it comes from the fact that, one, an injury didn't cause a death.
Natural disease did not cause a death. We understand that these substances can cause a random event that normally the person would have taken in the past, but for some reason this time it caused death. There's no clear understanding about one or the other, so then we don't look at a dose and say, Uh-huh, it's above this, therefore it caused the death. So we don't speak in terms of dosage.
Speaker 9
But in terms of when the medical examiner is looking at somebody who has died as a result of Kratom or seven Oh, there's not like a assessment of how much substance the individual took to document any of that?
Speaker 5
It is documented, but I think that it's often interpreted as, well, that was the amount.
Speaker 5
it is quantified, and it's limited how much we can quantify for seven zero eight given it's a new substance. So we don't make the determination based off of that.
Speaker 1
Doctor. Hurley, what is it that you would like to see from the California legislature?
Speaker 6
I think the California legislature could help local county health departments, that's the hat I'm wearing now, through creating, I'll call it some sort of infrastructure building around packaging rules, right, because right now our health jurisdiction has no way of differentiating creatum from seven zero eight products based on packaging alone, right? There's no reliable way of doing that, right? So if you created a framework around packaging rules, it would help our environmental health to potentially distinguish between unmodified metraginin or just, I'll call it, sort of kratom products and seven Oh products. I also think it's clear from our medical examiner that seven Oh products have a unique risk, right? These clearly driving fatalities that end up in the medical examiner differently than creative products are ending up in the medical examiner.
But local ordinances, to the point was made earlier, vary from jurisdiction to jurisdiction. You know, if you cross from Riverside into LA County, all of a sudden, like, packaging rules are different. That's not going to be a helpful way of being able to create a standard. And then, if there was then some infrastructure for how we would enforce and there was resourcing for health departments, we could then look at enforcing some distinction between querum products and seven Oh products, which we're currently not resourced to do.
Speaker 1
So, just following up on that, How would you distinguish between a product that has, you know, 95% Kratom seven zero eight and five percent seven zero eight? I mean, we don't have the research, we don't have the data to say a certain threshold of seven zero H is not harmful. So, how would packaging help
Speaker 6
you? There is a convention in place right now which is 2%, right? Products where the total alkaloid percentage of seven OHs over 2% are considered to be concentrated seven OH products and less than 2% aren't. That is a convention and I don't I did not come prepared to sort of litigate that percentage. I'll just sort of say that's a convention that we're aware of and it's actually in the background paper as a threshold.
So one could then adopt and there are other counties that have created that. Riverside is just one example of a 2% percentage of alkaloid to separate seven zero eight products from creative
Speaker 8
we go. Thank you. My apologies. I will note there is no local public health lab testing capacity for these substances. Our local public health labs test for pathogens, communicable diseases.
They do not have any experience in testing for substances. The medical examiner's office obviously has other scientific testing experience. Our understanding is that the state lab may have this ability, but for those counties that have explored ordinances and said, hey, we think 2% convention is good, they have no way of actually taking a krait and brownie from a gas station and testing it to see if it's 2%.
Speaker 1
So someone could essentially put it on their packaging label, but there's no way to verify that that's actually the case?
Speaker 1
Yeah. Thank you. Mrs. Ting, what because I think you mentioned this a little bit in your presentation, but what lessons can we learn from California's experience with legalizing industrial hemp and the subsequent challenges that California is facing to prohibit intoxicating forms of industrial hemp?
Speaker 8
Yeah. Intoxicating hemp, or industrial hemp issue, I think CDPH has been a great partner on that issue. And one lesson we've learned, and a kratom is another great example, is that there will be new substances that scientists and doctors and others will have to catch up with. It took us a little bit to catch up with intoxicating hemp and the potential impacts of that. The structure, folding it under, having enforcement being done a little bit by the Department and a little bit by cannabis control and others is something we support, having that statewide enforcement.
The science on intoxicating hemp, again, had to catch up with what people were experiencing in the field. And to the extent that the science can be accelerated in some form or fashion to understand if a substance is potentially harmful or could cause overdose or death, That'd be helpful. Typically, the federal research apparatus and university systems would help a lot in that, and that has been hampered by lack of funding currently. So we're hampered in that way. But having a statewide department that is keeping an eye out for these substances, that can maybe test for them, maybe can do some research on these or partner with the university to do that, is something we'd love to see, because right now, we're always reacting.
Speaker 1
Well, with no further questions, I want to thank each member of this panel. It was very informative. I think, you know, Doctor. Moulin, you pointed out something that we should all take very seriously, which is this feels to you and your colleagues in this area like what you felt and saw at the beginning of the fentanyl outbreak. And I think that we all know that we could have done better in protecting people's lives and communities.
And so my hope is that we take that to heart when we're dealing with this current issue and the other ones that will come up in the future. So thank you all so much.
Speaker 1
We will now move to our next panel, perspectives from Kratom and seven zero eight advocates. I would like to call forward Matthew Lowe. He's the executive director for Global Kratom Coalition. Sheldon Bradshaw, FDA Regulatory Council, Botanicals for Better Health and Wellness. Jackie Subic, Executive Director for Seven Hope Alliance Foundation and Michelle Ross, principal Doctor.
Michelle Ross, excuse me, Principal Scientist for Infuse Partners. And we will begin with Matthew Lowe.
Speaker 14
Thank you. My name is Matthew Lowe. I'm the Executive Director of the Global Kratom Coalition. We are a coalition of scientists, natural kratom industry leaders and consumers fighting to protect access to natural kratom leaf products. Natural kratom leaf is a botanical from Southeast Asia.
It's been consumed there for centuries. And I want to be clear, it's been consumed in The United States for at least fifty years, since the 1970s. Natural kratom leaf is a complex botanical. It's made up of 50% fiber, 25% antioxidants and 50 different alkaloids that give it its unique effect. Mitragyanin, as we've discussed today, is the most abundant alkaloid.
70H is found in trace, trace, trace amounts in dried leaf cratom. On the other hand, isolated concentrated synthetic seven zero H products use chemical synthesis to concentrate seven zero H from 100 to 1,000 times more than what is found in natural cratom leaf. These are not the same products. They are different exposure classes entirely. Let me give you an analogy.
Appleseeds contain trace amounts of amygdalin. When you eat an apple, your body produces a tiny amount of cyanide from that amygdalin, too small to harm you. Now imagine a company extracts the amygdalin, processes it chemically to produce cyanide and sell cyanide tablets and calls them apples. When regulators express concern, they say, this is safe. Look at the safety profile of apples.
These are not the same thing. That's what's happening here today. I want to bring your attention to something that happened in Kansas City these last two weeks. They unanimously passed an ordinance to ban concentrated synthetic 7OH and regulate natural kratom leaf. This is what other localities in California have done as well that we've discussed today.
Why does this matter to California? Well, because Kansas City is ground zero for this debate. It's home to Vint Sanders and American Shaman. They're the largest manufacturers of concentrated synthetic seven zero eight in the country. Kansas City's star investigative journalist David Hudnall has been covering the story over the last year.
He's covered the warning letters put out about concentrated synthetic 70H in July 2025. One of those letters went to Vin Sanders. What followed was the FDA's recommendation that was made on the July 29 to schedule concentrated synthetic 70H. The Missouri AG has started an investigation into the seven zero eight industry, and in December, the Feds raided Vinsander's operation and seized a whole lot of products. After the raid, this was discussed in Kansas City, and Huddle, who's written these pieces on this industry, wrote, The council was wise enough to distinguish natural kratium leaf from a lab concentrated alkaloid pressed into tablets sold as a quick hit.
Treating those as the same would have been misguided. California has that same choice to make today. This choice will impact more than 3,000,000 consumers that use natural creatum leaf for its functional benefits and, again, have done so for fifty years. The federal government has already drawn this line through their recommendation to schedule concentrated synthetic 7OH. 13 other states have passed regulations similar to what has been proposed today.
These regulations regulate natural kratom leaf, age gate, appropriate labeling and prohibit these synthetic derivatives. That's the right thing to do. I want to further press the point that Florida and Kentucky have taken action to schedule concentrated synthetic 7OH. They set a limit of 400 parts per million on a dried weight basis. So that's the distinction between what is found naturally and what is synthesized and concentrated.
I just want to say that, and you'll probably hear this today, that this is a market share war. This is not a market share war. Since 2019, states driven by scientists and the natural kratom leaf industry have put this cap on the amount of seven Oh that can be found in a Kratom product. That cap aligns with what's found naturally. Any Kratom or natural Kratom company could have gotten into the $7.00 8 industry.
They have not. Why? Because it's morally reprehensible and it's dangerous. In recent news articles, a reporter asked Sanders, who's the inventor of these products, so seven zero eight hasn't had any human trials for regulations or anything like that. He said, that is correct.
The human trials are that are choosing to use it. That unbridled sale of concentrated synthetic seven zero H is a mass uncontrolled human experiment conducted on the American population. That kind of drug development is the purview of pharmaceutical companies and FDA approval. Studies show concentrated synthetic 7OH causes morphine like respiratory depression. Natural kratom leaf does not.
Unlike natural kratom, concentrated synthetic 7OH has no ceiling effect. Higher doses mean more risk of respiratory depression. You'll hear that they've reduced opioid deaths. That claim is based on zero clinical trials and zero observational studies. It's a temporal correlation presented as causation.
What actually reduced opioid deaths, and we know this so well, is the widespread distribution of NARCAN. And perhaps most disturbing, and I believe you'll hear this today as well, is this claim being made that seventeen percent of surveyed concentrated synthetic 7OH consumers said if these products were banned, they would commit suicide or consider committing suicide. That's not a safety argument or argument to keep these products on the market. That's an indictment. A product that's been on the market for less than two and a half years has created such profound dependence that seventeen percent of those users would want to commit suicide if it was gone is a real problem.
You scale that up by another year or two years, the absolute number starts to increase. So we don't need to reinvent the wheel here. The FDA has drawn this line and they've been very, very clear. We want to focus on concentrated synthetic seven Oh. We want to preserve access to natural kratom leaf.
What California needs to do, in my humble opinion, is what AB ten eighty eight is doing and proposes: regulate natural kratom leaf, age restricted, make sure that it's labeled appropriately, make sure it's not adulterated and make sure that safe for use. Prohibit these seven zero eight products. Let's protect consumers and let's also protect their right to choose a natural substance. And again, I want to reiterate fifty years of use in The United States. It's very concerning to us that a question around potentially prohibiting kratom, natural kratom leaf is coming up because of what's being done through these synthetic concentrates that are masquerading as natural kratom.
Thank you for your time. I'm happy to answer any questions.
Speaker 7
Can you hear me? Is my mic on all right? Thank you. Thank you, Madam Chair, and members of the committee who are here today and who have afforded me the opportunity to testify. My name is Sheldon Bradshaw, and I'm the FDA Regulatory Counsel for Botanics for Better Health and Wellness.
I am an FDA Regulatory Attorney and previously served as the Chief Counsel of the United States Food and Drug Administration. Our organization advocates for evidence based regulation of plant derived products. As a result, we support efforts to ban chemically manipulated synthetic drugs that masquerade as botanicals such as seven hydroxymitrogynine, known as seven Oh, and support common sense regulations on, rather than a ban of, the natural botanical kratom. Such regulations would include age gating, testing, packaging, labeling requirements, particularly testing regarding the quantity of seven zero eight in the product, and very clear requirements that that has to be indicated on the packaging labeling of the product. And perhaps most importantly, a requirement that these products comply with all FDA regulations governing the marketing of dietary supplements.
Kratom is a botanical in the coffee family that has been safely used for centuries in Southeast Asia. It contains at least 50 unique alkaloids, the most predominant of which is Mitragynine. At the outset, it's critical to understand that synthetic and semi synthetic seven zero eight is not a natural botanical, and is not kratom. Importantly, the two can be distinguished. First, the misconception that seven zero H is kratom was perpetuated by the seven zero H industry, which often used vignettes of kratom leaves on their packaging, along with claims that their products were natural or contained kratom.
The purpose of this canard was threefold. One, to mislead consumers who thought they were using a natural botanical with a long history of safe use. Two, to falsely suggest that the two products have the same safety profile. And three, to shift the blame for adverse events from seven zero eight
Speaker 7
kratom. Second, when kratom leaves are first harvested, they do not contain seven Oh. Post harvest trace amounts of mitraginin convert to seven Oh due to oxidation. Realizing this, entrepreneur chemists, that I like to call bathtub chemists, began exposing Mitragyne to toxic, oxidizing chemicals. Think of the chemicals found in things like bleach, Drano, pull shock.
These are oxidizing agents. They're taking these toxic agents, exposing them to metrogynine, and then converting that into a brand new chemical entity, synthetic or semi synthetic seven Oh. A simple analogy nicely illustrates why synthetic seven Oh is not kratom. Imagine if a chemist isolated the primary alkaloid in coffee, which is caffeine, and then exposed the caffeine to toxic chemicals that converted it into a brand new chemical entity. I do not believe that anyone in this room would call that new chemical entity coffee.
Similarly, semi synthetic seven zero eight is not kratom. To achieve the twin goals of banning seven zero eight and placing common sense regulations on kratom, our organization encourages the State of California to join numerous other states in enacting laws that are frequently called kratom consumer protection acts. These laws would ban seven zero eight and place guardrails around the sale of natural kratom. In doing so, would align California law with FDA's science based efforts in this space. Those efforts have resulted in FDA recently calling for the scheduling of seven zero eight, which it has specifically identified as illegal, addictive, and dangerous, while simultaneously allowing access to the botanical kratom.
But importantly, and despite some suggestions that I've heard say to the contrary, FDA has not banned kratom. FDA has not deemed kratom to be unlawful or illegal. When FDA took steps in July 2025 to initiate the scheduling of the synthetic drug seven zero eight, the agency took great pains to explicitly note that its actions were not focused on the natural kratom leaf products. Similarly, when FDA Commissioner Marty Makary recently warned consumers about products containing seven zero eight, he's again specifically stated that they bear no resemblance to the botanical kratom that people have consumed for centuries. A decade earlier, FDA and the DEA considered whether kratom should be scheduled based on the eight factor test set forth in the Federal Controlled Substances Act?
The answer, it should not. FDA, with the encouragement of Congress, the Department of Health and Human Services, and the National Institute of Drug Abuse, abandoned the idea. Subsequent analyses of the eight factors have resulted in the same conclusion. Creatine has beneficial effects with a relatively low risk of harm, and therefore does not meet the criteria to be scheduled. I think there are some statements on FDA's website that entities who think mistakenly that FDA has banned kratom, including, I believe, the California Department of Public Health, have viewed these isolated statements on the FDA's website that are a relic from the time period a decade ago when the FDA was considering and then abandoned the idea of scheduling kratom.
And what's important is to note that this issue has come up in several court cases where FDA and Department of Justice lawyers have gone into federal court and had to explain its position on kratom. In 2003, in a federal case here in California, FDA and DOJ took the position that FDA does not have evidence that Kratom was dangerous. A year later, in 2024, DOJ lawyers stated in federal court that the statements that the California Department of Health is relying upon were informal. I heard I heard them saying that's the official view of the FDA, but FDA, under oath in federal court, said that those views were informal, nonbinding, and did not go through any internal review. Those are the those are the official views of the United States Food and Drug Administration as explained under oath to a federal judge.
Of note, FDA is actively studying the botanical. FDA's first study of Kratom, which was completed in 2024, showed that the botanical was well tolerated in study subjects even at high doses. The ascending dose study was in an adult population and used up to one hundred and forty milligrams of metrogynine, which is seven times the amount of metrogynine in a typical serving of a commercial kratom product. Today, kratom is used by 23,000,000 Americans to increase focus and energy to provide a mild boost in mood and relief from minor aches and pains associated with physical activity. Researchers from numerous academic institutions, including John Hopkins, Columbia, Ohio State, and the University of Florida, have found that kratom has beneficial effects with a relatively low potential for harm.
Only yesterday, Doctor. Chris McCurdy, a renowned academic at the University of Florida, revealed the results of an NIH study that was just conducted and it found that, not to their surprise, that seven zero eight induced respiratory depression and that Narcan was successful in dealing with individuals who had overdosed on seven Oh, it found something very interesting about kratom. It found that it actually increased respiratory depression and was unaffected by Narcan because Kratom does not work on opioid receptors and cause respiratory depression like seven o h. I would welcome the opportunity to answer any questions you may have.
Speaker 16
There we go. Hello. Good afternoon, honorable chair and committee members. My name is Jackie Subic. I'm the executive director of Seven Hope Alliance, a nonprofit dedicated to public education, advocacy, and science on seven hydroxymetranidine, also known as seven point zero, and Kratom.
I'm here today to protect access for the millions of Californians who are seven point zero and Kratom consumers. Thank you for holding this informational hearing today. This is exactly what is needed. Thoughtful study sessions and more research not rushing to bans. As we all know, drug policy is complex and public health decisions can have unintended consequences.
2,400,000 Californians are using Kratom and seven point products. We are working adults, parents, veterans, teachers, and health care professionals, many of whom struggle with great pain. Madam Chair, you asked us last year for clinical research on seven point zero, and we listened. A recent research study of fifteen twenty one seven point zero consumers shows that seventy four percent use it specifically to manage their chronic pain, often as a safer alternative to more dangerous prescription or opus treat opioids. And further, many more are using these products as harm reduction tools to reduce alcohol use or transition away from illicit drugs or pain pill addictions.
The average seven-zero consumer is a 41 year old working man, often a father, trying to maintain balance, stay employed, and take care of his family. We must put the impacted communities front and center. We are not talking about a hypothetical population. We're talking about Californians who have built a stable wellness routine around these products. When the government abruptly takes away a wellness tool that people rely on, the consequences are not abstract.
They are real. Mr. Lowe was correct that you would hear this statistic today, that 17% of seven point zero consumers said that if these products were banned, they would consider suicide. And, in fact, the American Kratom Association's survey in 2016, long before seven point zero was even on the market, said the exact same thing. Also, for seven point consumers, 41 said they would seek it illegally if it was banned, 25% said they would turn to illicit drugs, And 12% said they would go back to alcohol abuse.
That is not public safety. That is predictable harm. We are in an age of misinformation, so I'd like to set the record straight on a few headlines. Seven-zero deaths are not happening everywhere. Poison control calls are not up.
Emergency room visits are not up. This is a manufactured crisis, plain and simple. And even worse is that information released by health agencies is confusing to consumers. When they release data linking seven point to polysubstance deaths, when it is clear from the medical examiner reports that each of these people had serious substance abuse and mental health disorders. Kratom and seven point zero are not separate issues.
While they are different products, they are both naturally derived from the exact same plant. Kratom's primary alkaloid, metronome, is naturally metabolized to 7OH. Every single human being who consumes Kratom will have 7O in their body within the hour. You cannot separate Kratom from 7O, nor can you separate Kratom consumers from 7O consumers. Think cannabis flower and cannabis gummies.
Same consumers, same plant. Prohibition is not a public health strategy. And so no matter what is said here today, banning one alkaloid in the kratom plant does not solve anything and is only going to make things worse, likely resulting in an entirely new health crisis for Californians. We have decades of evidence from The US war on drugs that prohibition does not eliminate demand. It eliminates safety.
And we're already seeing this dynamic play out. When the state of Florida banned seven point zero last year, overdoses rose by three hundred percent in the first month alone. That is what happens when lawmakers remove a low risk product from a community that still has pain, still has addiction, and still has demand. The demand doesn't disappear. It just relocates.
We do not need to repeat that here, and we do not need to add more crimes to California's books. I want to put risk into context. California regulates products that have real Tylenol kills hundreds of people per year. Alcohol kills millions. And even laundry detergent pods injure thousands of people every year.
We do not ban everything that carries risk. We regulate it. We label it. And we package it safely and keep it away from children. Our government should not punish people for how they survive, especially when they're trying to avoid overdose or relapse.
Our number one mission is consumer safety. Same as public health, but their current approach of prohibition by enforcement memo has only hurt consumers by removing access to products they need and rely on. We support immediate and responsible regulations for seven point zero and Kratom, the whole plant, including 21 age gating and at point of sale, child safety protections, milligram caps, labeling and packaging restrictions, and mandatory testing. This is a complex issue, and it deserves a thoughtful response grounded in evidence and social reality, not a rushed return to a Reagan era war on drugs. California should lead with responsible regulation and compassion, not criminalization.
This is one plant, one community, and one clear pathway. Regulate the whole Cradle plant for safety. Thank you.
Speaker 17
Well, thank you, Chair Doctor. Weber Pearson and members of the Senate Health Committee. My name is Doctor. Michelle Ross. I'm an addiction scientist and court qualified expert on Kratom and seven zero H.
I'm the principal scientist at Infuse Partners, author of the book Kratom as Medicine, and I also advise the nonprofit Seven Hope Alliance. Five minutes is not long enough to discuss the science and potential of the kratom alkaloid seven Oh, which is an analgesic, anti inflammatory, and antioxidant compound that even has therapeutic activity against HER2 positive breast cancer. As a plant derived partial opioid agonist, seven Oh is safer than other full opioid agonist, not more dangerous. I'd also like to clarify, some of the things that have been said today, some of the misinformation that's been spread about kratom and seven zero H. For example, I really do think that even kratom risk in seven zero eight is being blown out of proportion.
The federal database, the pseudoRS database, S U D O R S, has statistics about what percentage of fatal overdoses in The United States, and even by state, is associated with kratom on board. And this doesn't mean kratom, for example, is a cause of death. It's just on board. Every year, 2020, 'twenty one, 'twenty two, 'twenty three, and 'twenty four, only two percent of fatal overdoses, those descendants had kratom, and very clearly here, metrogynine in their system. And by the way, since twenty four percent of metrogynine in kratom is converted into seven Oh, Every single one of these deaths where kratom was acknowledged, obviously they would have seven Oh in their system, as well as a metabolite.
The number has not gone up over years, even though in 2023 isolated seven Oh products were introduced and would have been considered kratom products because, again, the differentiator between seven zero eight products and kratom products is actually a false one defined by the kratom industry, not by the science. So I'd like to say that again. Sort of what we're seeing here is sort of a manufactured crisis. And it might be in part because there's a lot of confusion over the data. There's a lot of confusion over the papers out there.
And I have to say that this is a false narrative separating seven zero eight from kratom and portraying seven zero eight as uniquely dangerous while labeling kratom leaf as safe and natural. The background analysis and even expert materials cited in this debate rely on falsified research that has required publication corrections and this is rare, by the way publication corrections for failing to meet editorial standards. So things like lying about how potent seven zero eight is compared to morphine, one of the things that you'll hear that is 13 times more potent than morphine, or that it binds to the opioid receptor more strongly than morphine, or that even most of the products in the market are sublingual, or they bypass first pass metabolism. They go straight into the bloodstream. These are all faucets that have actually been corrected in the scientific literature by addiction experts.
So it's not just me, or it's not like industry experts. These are independent addiction experts that are going, the publications are wrong. There's something here. And there's also an ongoing investigation, an ethics investigation, at the major Kratom Research Institute in the country right now. Taken together, this reflects a troubling pattern of scientific distortion in the seven zero eight and Kratom literature.
So I really want to say that all these bans that you're hearing about in Orange County, Riverside, Fresno, etcetera, they're reporting some of these inaccurate claims verbatim. This is serious and this is wrong. Californians deserve legislation grounded in accurate science, not in flawed or corrected research. It's also really time that California has tried to, you know, work on kratom policy, and I think it's really important that we do have a regulatory framework. However, it comes back to the same thing over and over again, that 07/2008 is somehow different than kratom.
Instead of actually exploring how do we make safe regulations for the people of California, again, over 2,400,000 that choose to use these products. So let's have a serious policy discussion instead. The scientific consensus is that there are three categories of kratom products: whole leaf kratom products, like powder or capsules full spectrum kratom extract products and kratom alkaloid products, such as isolates, including metronogenin or seven Oh. These are not separate products. Seven Oh is not a synthetic opioid.
It is exactly the same whether it is found in the kratom leaf, and it is actually found there are many papers that state this it is found in the body as a metabolite, and it's also found in isolated products. So it's not some franken alkaloid that does not exist in nature. It is real, and it is the same chemical structure no matter where it comes from. Oxidation can happen oxygen, via heat, via age. By the way, if you test old kratom, it will have elevated levels of seven Oh, and also another metabolite called metronome pseudoindoxyl.
So that's a little snippet for you. Each of these categories of products has distinct regulatory considerations, but none is inherently risk free, right? All products either contain seven zero eight or metabolized into seven zero eight in the body. Physical dependence, withdrawal symptoms, and adverse effects occur across all three categories of products, particularly with high dose, frequent use, or riskier routes of administration, such as drinks, vapes, and sublingual films. It's not the alkaloid that defines risk, especially because metronome is converted into seven Oh in the body.
Again, every kratom product turns into seven Oh. So, if you're trying to protect Californians by just banning seven Oh or capping products off at 2%, it really doesn't prevent them from exposure. And in fact, again, if there's all these Californians that have already been taking it, millions of Americans taking kratom products that convert into seven Oh in the body, if you think that seven Oh is the problem, you would have seen deaths, overdoses, and ER crisis long before now. I really hope you take this into account and think, you know, what is causing this narrative? And more facts about seven Oh, while it's important for pain relief, it has poor bioavailability.
So if you take an oral tablet, only about two point five percent of that seven Oh actually gets in the body to be used. Then it actually is less likely to cross the blood brain barrier than metronidin. Metronidin cross es it very easily. 7OH doesn't. And so what you're having is a substance that actually can't cross the blood brain barrier into the parts of the brain, like the brain stem, that actually impact respiratory depression.
So there's a whole bunch of fishy science being thrown about how 70H is actually really bad and is going to cause respiratory depression. This comes from IV rodent studies, not from humans. Now, I will not discount the fact that there are some case studies of people who were highly abusing these products, and even riskier versions, like, for example, sublingual films, which I do not believe should be sold at all. But for the most part, people taking oral tablets, and especially responsible amounts of them, do not experience respiratory depression, and that's also something we saw with our research. Okay, so the most pressing public health issue you hear is actually adulterated products.
And I know we may differ with the CDPH on what the definition of that actually is. But an adulterated product, in our opinion, would be a kratom product that actually has other food ingredients in it. For example, a kava and kratom product, or a kratom product that has yohimbine, which is a stimulant. These combinations actually increase toxicity and addiction risk. You might have heard like the little blue bottles of Feel Free, etcetera.
Here's, for example, another brand. They come in little shots, right? Easy to drink, really, that increases the addiction risk, etcetera. These are often marketed as alcohol alternatives. Some have been the subject of substantial legal settlements for deceptive marketing, fooling customers into thinking that there are health drinks marketed on Facebook ads for people with alcohol abuse issues.
And they didn't disclose that habit forming kratom leaf were in them. Those are the products that merit regulatory attention. Yet, we're not really discussing them. We're only talking about kratom leaf and seven zero eight. Why is no one talking about these multi ingredient kratom products?
Well, the two advocates that were representing the kratom industry today are, in fact, representatives of the adulterated kratom drinks. And their organizations are responsible for the false narrative that seven zero eight products are unsafe to deflect from the dangerous and improperly marketed products that their own vendors sell. Notice how the conversation has been kratom lethal safe and seven zero eight is bad, yet no one is talking about kratom extracts or these adulterated products. It's by design. They've hijacked and manipulated the scientific, media, and policy narrative around kratom, including pushing forward AB ten eighty eight.
That bill narrowly targets 7OH while avoiding comprehensive regulation of extracts in multi ingredient formulations. That selective focus does not align with the pharmacology or risk assessment. The goal is consumer protection. We need comprehensive regulation, mandatory third party testing of COAs, accurate alkaloid labeling, defined serving sizes, restrictions on high risk routes of administration, and enforcement against adulterated products. Okay.
And then I just want to mention that it's not the mere presence of seven zero eight that determines risk. It's how product is formulated, labeled, marketed, and consumed. So I really hope that we can have really productive policy discussions in the future that are evidence based. And I want to thank you for your time and your commitment to evidence based public health. So thank you.
Speaker 1
Thank you. And that concludes this panel. I'll see if any of my other colleagues have any questions. If not, I'll go ahead and start. So this is for both Mrs.
Subic and Doctor. Ross, because in your presentation, you were essentially alluding that Kratom and seven zero H are inseparable. They're the same. And so why do we need seven zero H if they're the same as kratom?
Speaker 17
If you don't mind, I'll take that. Okay. So kratom and seven zero eight products are typically taken by people with chronic illness, chronic pain. And a lot of people have issues taking large amounts of kratom powder, whether it's the powder itself or capsules. For example, to get the same pain relief that you might get from a small seven zero eight tablet, you might have to take, say, twelve kratom capsules.
Now, because kratoms, alkaloids, act very similar to NSAIDs, they will burn out your stomach, people that depend on this for pain relief and have to take it multiple times per day because a half life isn't that long, really struggle with stomach pain. And we have consumers that have Crohn's disease, all these different autoimmune disorders, and they go, Okay, well, was working for me, but now I can't take it, and I'm struggling. And when seven zero eight products came along, they were able to just take one little standardized tablet. It doesn't hurt their stomach as much. So it is very helpful.
Also, seven Oh doesn't do exactly the same thing as Kratom. Kratom has 50 alkaloids. It's sort of messy. It's sort of like how CBD activates all these different receptors. Seven Oh is very specific.
And if you just need the pain relief, and you don't need, say, the serotonin activation, the dopamine activation, all these other things, it really is more helpful for people that need that very specific outcome. Some people really like Kratom, and that works for them. Some people really prefer seven zero eight. And we really believe that there should be innovation in this market rather than restrictions not based on science.
Speaker 1
Thank you. So essentially, what I'm hearing is that seven zero eight is more potent because essentially you just said that you'd need to take more kratom to get the same effect as seven zero eight. So there is a difference. They're not the same. So I wanted to make that clear.
The other question that I had for you, Doctor. Ross, you spoke about, I believe, some nationwide autopsy reports from different labs and things like that. How many of those labs actually had the capacity and the forethought to actually test for seven zero eight? Because one of the things that we've been hearing is that most labs don't. Here in California, LA County just started.
So, how many of those labs and those studies actually had the capacity and the foresight to test? Okay. So, I
Speaker 17
would say that I can't tell you the exact number of that. What I can tell you is that many of them have been testing for metrogynine for over five, six years. And one example I'll actually give you is from Orange County. There's a publication that was published in 2023 that looked at metrogynine and its involvement in DUIs in California, specifically Orange County. And so they were testing for both metrogenine and even seven zero eight back in 2018, 2019.
So there have been municipalities that have been looking at this. And by the way, that data actually shows that Kratom is less than zero point two percent of all DUIs, and really, it never is a cause of a DUI by itself. It's always with alcohol. And so, it's just present. So, just saying, it's like there are opportunities to test.
And I do want to state, too, that I have reviewed every single one of the autopsy reports and the overdoses cases. It is disturbing to hear that they say that they can't quantify seven zero eight, but then they say that the levels of the seven Oh were so high compared to the metrogyny, and yet those were not publicly released. And it's we're hearing conflicting evidence. So I understand that it could be the science around this is confusing. The equipment around this may not be available for everyone.
I think it's hard. But in terms of knowing that seven zero eight is a metabolite of kratom, if we know that metronome turns into seven zero eight, I mean, do we really need to test for that, or do we need to acknowledge that any kratom consumption can lead to adverse risk because there is seven zero eight involved as a metabolite, or whether it's present as an isolated product? And I want to say that seven zero eight is not more potent necessarily, because I told you that there is a reduced bioavailability and ability for the seven zero eight to cross the blood brain barrier. There's other things that also contribute to seven zero eight, but it is not necessarily more potent. If you are taking, say, a twenty milligram tablet, and only 2.5% is bioavailable, right, you're not getting all that into your system.
It's not going into the brain, where it's going to activate the pathways for respiratory depression or addiction. And by the way, seven Oh does not activate at all the beta arrestin pathway that is associated with constipation tolerance or respiratory depression. And so that is very different than other opioids. So I think that there's still I can't explain all the science in five minutes, or even in these questions here. I mean, I would love to be able to answer as many questions as is needed here.
I have many different documents, including an A factor analysis as well, with some of the signs showing why it shouldn't be scheduled. But I think that there are risks, but it's not as potent, as dangerous, etcetera, as stated. And if anything, if seven zero eight is dangerous, Kratom is dangerous. I mean, in my humble opinion, I would say if you think that seven zero eight products are so dangerous that they shouldn't be sold, then Kratom products shouldn't be sold.
Speaker 1
Well, know, I'm not saying whether either one should be sold, I don't think that there is a similarity based on the things that I've read, the things that we've heard today, the things that we've heard from providers who are actually on the ground seeing patients, taking care of patients
Speaker 1
our coroner's office who have seen an uptick in not only cases, but in deaths. So, I wouldn't necessarily say that this is a manufactured crisis, which is something that I did hear both of you speak about. But I will go and ask a question right now of either Mr. Lowe or Mr. Bradshaw.
If labs currently are unable most labs are unable to test for a percentage of seven zero eight, you know, if you take a Kratom product. How would you propose that we allow for the continued sale of Kratom, but we can't actually do widespread testing to ensure that there is no seven or a higher dose of seven zero eight in there.
Speaker 7
Thank you. Thank you. I was turning it off every time you turned it on. I just want to clarify. There are two different types of testing.
You've heard testimony earlier today about how easy it is to test for the presence of metronidin or seven hydroxymetronidin in blood as a part of like a toxicology report or as a part of an autopsy. And the point was made that that's sometimes difficult to do in certain environments. But there actually that isn't an issue when you're testing the raw material. There is an approved assay for that. And so if you have a product, say you're marketing a Kratom product, you would, if you're following FDA rules and regulations, be using a manufacturer that follows FDA's good manufacturing practices.
And you would test the product both in process while it's being made, and then the finished process, one of the assays that you ought to be using on the finished product is the amount of seven hydroxymetrogynine, and there is such an assay for that. So it actually is very easy. So if you look at a legitimate Kratom product and flip it over, it'll have what's called a supplements facts panel on it because it's being marketed as a dietary supplement, And it will say right on the label how much seven hydroxymitrogynine is in the product. So in fact, it is possible to know. It's very easy to do.
In fact, I will say that just yesterday, the FDA put out a press release announcing that the primary sponsor of their organizations, Vince Saunders from American Shaman, had to recall 70H products because they contained 70H above what was being reported on the label. So that's all very, very easy to do. There's an assay. If you're following and complying with the FDA rules and regulations, you know you don't have a volatile amount of seven hydroxy in your kratom product.
Speaker 19
I wanna thank you all for for your testimony here today. I I I heard the kratom bill seven o h and kratom kratom bill come through public safety. And the testimony in that bill was briefer than you have in a hearing such as this, which is an informational hearing. And I appreciate the discussion and the information. But I have the same feeling.
I don't have a question because, quite frankly, I think that there are more questions than there are answers. And that was part of the challenge with the Public Safety Committee because we were being asked to do something that would make it illegal and would take it off the market entirely. And part of the challenge is that this discussion should be happening very similar as the federal government deals with it at FDA, a real discussion on what are the differences between the two, and what are the impacts of it being unregulated and people doing whatever they want with the products. We jumped into the whole issue of marijuana use and cannabis without knowing what the medical information was that would make us feel comfortable that it was going to be used appropriately produced, and then could be regulated by doctors. Doctors would be prescribing the dosages, and then looking at the effects of it.
And so, while I appreciate the information, there's more questions, I think, than answers. And this is part of why I think this committee had to hold this hearing, and it's important information. It is an informational hearing, so that's good. It means I don't have to vote to ban something that I don't understand fully enough to say people that are suffering from chronic pain ought to have some relief. And if it's better than some of the products on the market right now, then why wouldn't we use it?
Well, we might not use it in all of its form, and there might be a use that makes sense. And so, I'm hoping that at some point we can move towards that kind of a framework. I just really do think there's way too many questions. I appreciate your testimony here today. Didn't solve it for me one way or another.
I was hoping I'd come out thinking, Okay, now I know what we had to do. Thank you, Madam Chair.
Speaker 1
Yeah, thank you. All right, I'd like to thank this panel. And Doctor. Ross, one further thing. Could you please you stated none of the studies cited oh, I'm sorry, that the studies cited had to be corrected and retracted.
Can you please provide that information to my office or the health committee so we can review that? I'd be happy to. Thank you. Thank you all so much. We will now move to our public comment section.
As I stated at the top of the hour, our public comment section will be no longer than one hour, and so each person will have one minute. And if you're interested in making a public comment, please stand and come to the mic. And you will have one minute. You
Speaker 20
may begin. My name is Dionne Evans. And in 2016, with the opioid crisis, all opioids were discontinued for people with chronic pain. I'm a terminal patient, and I have the most painful condition known to humans. I have full body CRPS.
After the opioid crisis and the opioids were removed, I was less than a half an hour away from taking my own life because I couldn't do it anymore. And that's when I found Kratom. Before Kratom, I was bedridden, and I couldn't do anything for myself. I still have a care provider who helps me do everything. But if it weren't for Kratom, I would not be able to be here and testify as to what it's done for me.
It's enabled me to be able to get out of my bed and get here and talk. And it's also, as of November 25, I became a great grandma. I never would have been able to do that if it weren't for Kraton. Thank you.
Speaker 21
Thank you. Good afternoon, chair and members of the committee. My name is Marcel Smith, and I live in Woodland, California. I am a disabled army veteran who uses plain leaf kratom as part of managing chronic pain and supporting my overall stability and well-being. It is not a cure, and it does not eliminate my pain.
I still struggle. But it helps me maintain balance and function in daily life. I have taken the same consistent amount for nearly nine years this April, actually. Let me see. My routine lab work, including liver function tests, has remained normal, and I have not experienced adverse health issues.
I support reasonable regulation that ensures product safety, accurate labeling, and age restrictions. Consumers deserve protection, quality standards, and transparency so they can make informed decisions. As policymakers consider considering this issue, I encourage balanced approach that prioritizes consumer safety while recognizing the real world impact on people who rely on responsibly manufactured products. And, yeah, I just want to talk a little bit real quickly.
Speaker 22
Hello. How's it going? I have a speech impediment, so if I stutter, I apologize. So Kratom's been used in America since soldiers came back from Vietnam. A lot of these issues didn't happen until seven hydroxy came onto the market.
There's actually been over four fifty published studies on Kratom. I think it's higher now, probably around like 500. A lot were done by the University of Florida, Doctor. Chris McCurdy, National Institute of Drug Abuse. So what I'm saying is that the plain leaf is not a new thing whatsoever.
Also in 2016, the DEA had the opportunity to schedule kratom, but they refused to do so. Also, the World Health Organization said that kratom does not meet the criteria for scheduling. Also, too, the FDA in 2024 said kratom appears to be safe. It was published in Bloomberg, I believe it was. Also, too, the FDA commissioners clearly stated that they're not targeting the natural leaf, only the synthetics.
I'm I'm also in the industry itself. I've been approached by several seven o h companies to sell their products, and I have refused to to to do so. The the leaf saved my life. I I was a heroin addict for a very long time, and kratom saved my life. Now I'm married with five kids.
And I've still a lot of people that went down the route of seven O H that wish they never did. I'm sorry to anyone here that gets benefit from it. This is just what I've personally seen in my own life. Seven O H and kratom are two very different things. Seven Oh is not natural to kratom.
It's called seven hydroxymetragenine because it used to be metragenine, but due to oxidation or metabolism, it turns into it. It's not natural
Speaker 24
Hi, my name is Var Richard. I'm very thankful for how considerate you guys have been with everything you've been hearing, and you've been listening to everything said. I use Kratom's as a supplemental with my regular vitamins, because I've had issues with anxiety most of my life. I have six older sisters, so that might be part of it. But I've been taking half a tablespoon for eight years.
Never had to increase it. Still does the same job. I know dozens of people who take kratom. It's not to get high. No one gets high from kratom.
I think the amount get high would probably be pounds. Which no one's going to spend that money and you would throw up before you actually see anything. So please don't throw the baby out with the bathwater. We agree with your position now to schedule leaf kratom. And that's the main thing.
Don't mix the two together with the hydroxy. Thank you.
Speaker 23
Hello, Madam Chair, committee members. My name is Mitchell DeMarty from New Castle, California. I just wanna talk on behalf of Natural Kratom. I'm a Kratom consumer. You hear many people talk about how Kratom helped them with addictions and getting off.
I have never had that addiction, but I do take it for energy, and I take it to focus for work. Also, take it my wife's shop frequently on Amazon, so my garage has become a cardboard recycling center. So as I clean out the cardboard recycling center, I take kratom because it relaxes me a little bit. I believe there are some differences between natural kratom and seven hydroxy. When Spice came into the market years ago, we didn't ban cannabis.
When Delta Products came into the market, we didn't ban cannabis. So I think there's a way to look at regulation on both natural kratom and seven hydroxy. So thank you for your time and consideration.
Speaker 25
Good morning, Madam Chair and members. My name is Twigle Van Pleat. I'm from Sacramento, California, currently living in Fairfield. I'm a health care advocate, and I represent thousands of abandoned pain patients with limited access to care or with barriers to accessing any care at all. And I do utilize both Kratom and seven zero eight.
I am an abandoned pain patient. 2016, I've been on my own ever since. I started utilizing seven zero eight about a year and a half ago. This last year has been the most amazing year, even though I'm limited. I've lived also with complex regional pain syndrome for twenty five years.
It is considered one of the worst pain ever known to man and medicine. It is nicknamed the suicide disease. I am, in fact, a suicide survivor. Please consider regulation of all products instead of prohibition. My grandbabies rely on you.
I thank you for your time and consideration. Thank you. Thank you. Good
Speaker 26
afternoon. I am glad that we are able to have these discussions. I am a state board licensed barber for eight years, and about three, four years ago, I developed what is known as sciatic nerve pain, sciatica. And I wanted to go into I wanted to get a treatment for it, and then I've seen that many people are denied treatment for sciatic nerve pain. And then I found out about kratom, and that helped me.
Although I started getting constipation from the amount of, kratom leaf that I had to take, so I started using seven zero eight as needed, and it it is not as dangerous as people think. I did not experience any withdrawals, and I was using as needed maybe, like, two twice a week, like, whenever I would have a busy day, you know, cutting hair up to, like, eight hours. And it also helped me with depression. My mom passed August 11 from leukemia, and I I I was about to also go to the doctor for antidepressant depressants or treatment for my, you know, being very sad about losing my mother to leukemia last August. And, I remember that that I used this Kratom and seven zero eight to help with, my chronic pain, and I started using it again for my depression, and it has helped me a lot with the and it it it allowed me to continue to work and not file for disability and therefore costing state and county more money.
And, yes, I support regulatory framework for both. Thank you. Thank you.
Speaker 10
My name is Victor Pino. I'm a resident of Castro Valley and a representative from Students for Sensible Drug Policy. For many Californians, Kratom serves as a vital off ramp from dangerous opioids and a tool for managing chronic pain. In our current reality of heightened stigma surrounding opioid addiction, coupled with the ever rising costs of traditional health care channels for treatment, banning this accessible lifeline would potentially push vulnerable individuals back towards prescription painkillers or illicit street drugs. So in that statement, I would just like to support that we do not create new felonies.
We do not create new misdemeanors in California for this. And that we allow people to access this simply, easily, as a method of harm reduction.
Speaker 27
Hi. My name is Alex Wolf. I'm a San Francisco resident, lifetime California native. I'm a creatum consumer, not for harm reduction, not for pain relief, but as a functional supplement. It helps with productivity and mood and energy.
I've tried seven zero eight. I am scared of it. I really see the two as very different, particularly given the use case I have for regular natural kratom use. They are totally distinct. I'm also a member of the industry.
I'm part of a company that does sell a product with natural kratom as an active ingredient. We do not see seven zero eight as competitive. Our customers would never take seven zero eight. We would never sell it. What I think is really dangerous is the conflation of the two in both policy and discourse.
It's created a lot of confusion. So I hope that I think the science clearly differentiates the two. I think that the FDA's recent positions have clearly differentiated the two. 20 other states have differentiated the two. I hope California follows suit with AB ten eighty eight.
Thank you.
Speaker 28
Hi. My name is Justin Wolfe. I'm Alex's brother, actually. I'm co founder and CEO of NewBrew, which is a Los Angeles based brand of social tonics, which use kratom, small servings of natural kratom, as part of
Speaker 28
formulation. First, I want to express appreciation for this committee and for the many experts and public health officials who have spoken out. You're taking a serious and thoughtful look at this issue with a clear goal of protecting public health, and we share that goal. I'm here in strong support of a common sense regulatory framework for natural kratom. I believe we already have the proper solution in AB ten eighty eight, which passed unanimously through the assembly and has the support of law enforcement up and down
Speaker 28
state and is very similar to regulations passed in 20 other states now. The core issue before you is clarity. We are discussing two entirely different things that I really don't think belong in the same conversation to begin with. I'm grateful to the many experts in this meeting who have made that distinction abundantly clear, echoing the FDA's actual statements very recently. The rise in deaths and emergency advisories here in California and beyond directly correlates with the proliferation of these isolated and concentrated seven Oh products.
That is not a coincidence. I think a question was asked earlier, you know, if no new law has been passed on Kratom recently, why didn't the health department or other agencies begin enforcement years ago much sooner? And the answer is that, you know, even without the clear regulatory standards that we're pushing for as an industry, natural kratom has not created this kind of public health crisis. In fact, it's been helping millions of Californians. Imagine if we were to implement these very strict standards, right, for packaging, for manufacturing, labeling.
With those guardrails in place, I believe that the already relatively low risks associated with natural kratom consumption would be that much further mitigated.
Speaker 29
Good afternoon, chair and members of the Senate Health Committee. My name is Ethan France. I'm a small business owner in the San Francisco Bay Area. And I ask for your I vote on AB ten eighty eight. I'm speaking to you today both personally and professionally.
Personally, I've used Kratom on and off for about fifteen years, and I've done so in a controlled and intentional way. In my life, it's been meaningfully helpful for pain, anxiety, and depression. And importantly, I've experienced it to be effective while also being easily self manageable. Professionally, I've operated a small business, a medicinal herbal tea business, for also about fifteen years in the Bay Area, where we sell many herbs, including Kratom. Also, just want to say we've never sold seven zero eight products because I know enough to know that they're different products.
The seven zero eight is not Kratom. Over these fifteen years, I've served thousands of Californians from many backgrounds, all ages of adults. I report great benefits from responsible Kratom use. I'm here to do my best to advocate for them as well. I will say I've also been subject to the CDPH's embargo actions, so I could speak to that a little if you have any curiosities about that from a subject of that action.
There was a question earlier that you asked about whether they've had repeat visits to check on whether things are still on shelves, and I can say that they haven't in my business. They've been in twice, but that was regarding the embargo action itself. But no follow-up since then. And that commenced mid November. Their follow-up was mid December.
And, yeah, again, we haven't seen them since then, for whatever that's worth. Again, I really support this AB ten eighty eight action. You know, my heart does go out to the people who use seven zero H. I do think that potentially it fills a gap, but it's too close to a pharmaceutical drug, again, for me personally to sell in my business. And I think to be sold at gas stations, convenience stores, smoke shops, it's too powerful a substance to have there for people to just wander in.
And I've been in and asked a number of these shop owners or the people working there at least, and they don't know what they're selling. You know, I ask questions about it from my point of knowledge and I'm always met with, I can't really tell you much about it. I don't really know much about it. I've never tried it myself.
Speaker 30
Madam Chair, Teri McHale with Aaron Reed and Associates, representing the American Cradle Association. There's been enough advocacy today. I just wanted to say that these are two and a half hours that I would not want back. This is one of the best hearings I've ever heard. I wanted to thank you and the committee for your patience, and to thank your remarkable staff for the scholarship and the patience that they showed in allowing everybody to be heard.
It's an important issue, and we look forward to following up with you later. Thank you very much.
Speaker 13
Hi. Thank you for this hearing today and for hearing from us all. I appreciate what's being said and having the opportunity to speak. My name is Jessica Lawless. I'm a Californian.
I use both Kratom and seven point zero. I am feeling a little confused. At some point along the way, there seemed to be something got heard somewhere about them being one and the same. And I think, from my perspective, what I heard was that they're from the same plant. And so trying to regulate just one part of a plant is kind of how I think about it.
It's difficult and hard to make sense around. I have Crohn's disease. And there's different reasons why I use kratom or why I use seven point zero. And so they're different, but they're coming from the same plant. And to make that distinction, especially as a consumer, is tricky.
So I wanted to name that. And I had some things I wrote that I was going to say, but this is the thing I want to say after this long amount of time. I don't use seven-zero for any other reason but I want to live. And that I'm, in my late 50s, a queer person who's married to a trans gender person in their early 50s. And our community, as you all know, has higher percentages of addiction, of suicide, of making it to elderly.
We're actually rare that we are who we are, and we've made it this long. And seven-zero has been something that I've added into my health regimen. And as I said, the only reason I use it is because I want to live, and I want the opportunity to keep aging with dignity. And I ask of you to not be another government agency that is making our lives more difficult right now. Things are pretty hard for us, and this is one of the things that actually helps me through.
And please keep paying attention and doing more research to understand that we need regulation for the whole plant, seven-zero and Kratom. Thank you.
Speaker 18
Good afternoon, madam chair and members or member. Ryan Sherman with the California Narcotic Officers Association. Just wanted to briefly chime in on our support for AB ten eighty eight and give a little bit of background on our position. After AB 2,365 by Assembly Member Haney failed passage in the 2324 session, the CNOA began working with local governments to accomplish the intent of the Haney bill, to ban on concentrated seven zero H products and regulating natural kratom leaf. As a result of our efforts, over two dozen cities have passed local ordinances to protect their residents from the dangers posed by seven zero H.
The counties of Fresno, Orange, and Riverside have also passed local ordinances to do the same. But I did want to point out at this time, here's the language that the seven o h manufacturers use to warn their own customers about their products. This product is not intended to diagnose, treat, cure, prevent any medical condition or disease, and may be harmful to your health. The FDA has not approved seven zero H for therapeutic uses. Consult your health provider for questions regarding its use.
Do not use this product in combination with any psychoactive, intoxicating, or impairing substance, including other botanical products, alcohol, nicotine, cannabinoids, or illicit products. Do not use this product if you have health conditions, such as high blood pressure, or use prescription medicine, over the counter drugs, or dietary supplements, except under physician supervision. Do not use this product before engaging in dangerous activities or operating machinery or a motor vehicle. This product is not intended to be sold as an alternative to alcohol, nicotine, cannabinoids, prescription medications, or any other substance. This product is not intended to be used or sold for the treatment of any disease, illness, or injury for which physician care should be sought.
And I'd just like to leave that with you and let you know, again, we're here to help and answer any questions that you may have and support ten eighty eight. Thank you.
Speaker 31
Hello. Thank you for having me. My name is Brandy Clark, and I am an authorized distributor for a Kratom product. I think that what I see on the ground, I'm in these shops, I'm in these gas stations, I'm in all these stores, and I see the people that come and buy these products. And I can say that you can definitely see that some of these people need to have these products, because it helps them with anxiety.
It helps them with moderate pain. It helps them with just basically getting through the day. I also noticed that there is a very big difference between the natural creatinine leaf and the seven zero eight. You can see it in the people that are coming for it, that there doesn't seem to be a lot of pain. It's more of like a get high versus getting something that's for chronic pain.
As a person, I have chronic pain. Three years ago, you could not have told me anything about kratom. I had no idea what it was. Until someone had presented it to me, I tried it, and I realized that my anxiety had definitely leveled off to where I can control it. My pain levels with sciatic, with the stuff that I've done to myself, you know, because I was a child of the 80s and the 90s, you know, hey, watch this.
It was very prevalent in my life, and so I've done a lot of things to myself that caused pain that I have forever. So, this helps control that. It doesn't cure it, but it helps me control it and helps me maintain it without going pharmaceutical. Which I'm grateful for. I take a multitude of vitamins every day, I constantly monitor what's going on, and I'm an advocate for my own health.
And that is what, with natural lead kratom, a lot of people that are taking that have already gone through certain steps, that they're going to this because it is helping them, and it's helping them maintain without going into, like, a crazy level where you think you don't have control over what's going on. So I would just say that making the difference between the two is very important. But also, when I see it, there's a lot of companies that are backing, you know, information. And we're trying to make sure that everybody that sells it, that touches it, understands what it is correct dosage, gatekeeping it's over 21. So definitely, I'm in support of the ten eighty eight.
I think it's very important, and I think that it needs to be done. Because in the
Speaker 31
in the business, I have seen it change. And I'm thinking that with the natural leaf kratom, you are definitely in something that's helping people and is definitely a benefit to them, versus something that is not. I mean, there's things that are out there now, that one pill of seven zero eight is two fifty bottles of another product. That is 500 servings. That is what we're talking of the difference.
And it's vast. Thank you.
Speaker 15
Good day. My name is Rob Nichols. I'm a member I'm I live in in Central California, Placerville. When I was in the hospital from an injury one time, I got, I was on Percocet for two days. I thus became addicted to it.
And someone introduced me to Kratom, and I took it for a couple days, and I was off the Percocet. Thank you. A couple years later, I had another injury because I was a laborer in the labor union. I have two steel plates and 50 screws in my body. The doctor says, you get to be on Norcos the rest of your life.
I was like, no. I don't want to be on Norcos the rest of my life. So I went and told my boss about He introduced me to it. I told him, I'm done. I I don't do that kind of stuff anymore and all that.
You know that. I'm thirty two years clean and sober also. Anyway, I took the time, went and studied the plant, came back to him, agreed to give it a try. I came back to him an hour later. I said, come nobody knows about this stuff?
That was fifteen years ago. I still take Kratom. It is a help for me. We need the regulatory framework such as ten eighty eight. Kratom does not take away the pain.
It allows me to function without having to reduce to opiates and get addicted to all that kind of stuff. I took Kratom for a year and a half. I stopped abruptly because I wanted to know. I took a nap for two days, and I was done. There was no addiction with kratom leaf.
Thank you.
Speaker 32
Pam Lopez, on behalf of the Holistic Alternative Recovery Trust, I want to thank the committee for their really thoughtful work on the analysis and their really thoughtful work in putting together this hearing. What is clear coming away from this conversation is that there is some research that is emerging, but there is still a lot that is missing. And what you heard from Doctor. Ross is some of the back and forth between some of the researchers that are currently in the field. Researchers definitely debate with each other and take issue with one another's research.
That's an indicator that there is still a lot in this conversation that is outstanding. What we also see, both anecdotally and from the social science research, is that there are thousands and thousands of Californians whose lives very much will be impacted by this conversation and by the work that legislators do in this space. And so from a very warm place in my heart, on behalf of Hart and I didn't even mean to make a pun but I ask the legislature to proceed with this conversation by centering the reality that there are thousands and thousands of Californians that are impacted by it. And whatever we say about either of the clearly two warring industries who are here today, there are real people whose lives are impacted. And they are deserving of empathy and understanding and moving slowly enough so that we don't unintentionally derail their lives.
Thank you for your work today.
Speaker 1
Thank you. Well, seeing no further public comment, I want to thank all of the panelists who joined us today. It was extremely informative and very, very beneficial. I definitely learned a lot, and I believe my fellow colleagues who were here and those who were watching also learned as well. I want to thank the staff for working on creating this panel and making sure that when we do hear the bill from Assembly Member Baines and any others that may come forward in the future that we are as knowledgeable about this issue as possible.
Understanding that, yes, this is an emerging field, that there are people who are still looking into this, still doing research. And so, though we don't want to just do something quickly, we also don't want to continue seeing overdoses and deaths. And we do not want to move at a snail's pace while we wait for the research to definitively say one way or the other. Because one of the things that we have learned is that even when we have all of the research in the world, you can still have one or two people question that research. I think we're seeing that now with vaccine efficacy.
So, there will always be people within the field that have differing opinions, but when we start seeing a trend in something with the addition of something new, recognizing that whole leaf kratom has been around for a long time, but we are now seeing an uptick in those who have become addicted, those who are succumbing to that addiction through death. It is our duty to look into it and our duty to figure out what is it that we can do to protect the residents here in California, acknowledging the benefits, but also looking at some of the potential harms. And so with that, I thank you all so much for coming and participating, and, look forward to seeing you at our next health informational hearing.
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