Senate Standing Committee on Health

Good afternoon. Today we will be discussing kratom and 7-OH with the focus on public health risk and regulatory gaps here in California. Both the FDA and the California Department of Public Health consider Kratom and 7-OH products to be unlawful.

Yet you can still find these items on the shelves of smoke shops, vape stores, gas stations, convenience stores throughout this state. There have been bills attempting to regulate kratom over the last few years. One of those bills, AB 1088 by Assemblymember Baines, will be considered in this Committee later this year.

These bills have been at the center of conflicting claims about kratom and 7-OH safety and its potential for abuse. I hope that today's hearing will clarify what scientific evidence supports as well as the medical community's perspective on these products.

As legislators, our responsibility is to carefully weigh the risk and potential benefits of kratom containing products and determine whether stronger safeguards are needed to protect Californians. I look forward to hearing from the expert witness testifying today who will help make us move our decisions forward.

After our panelists have presented, we will have a maximum of up to one hour of public comment. With that, we will proceed with our first presenter, Dr. Igor Koturbash . Hopefully I pronounced your last name correctly who will be providing us an overview of kratom and its psychoactive alkaloids. Over Zoom.

Chair Senators, ladies and gentlemen, thank you for the opportunity to speak with you today. My name is Sega Koturbash and I'm a professor at University of Arkansas for Medical Sciences and I study chemistry, toxicology and health risk or botanical products including kratom and kratom derived compounds. So what kratom is? It's a plant.

Latin name is Mitragyna speciosa and it is native to Southeast Asia. The plant contains many naturally occurring chemicals that are called Alkaloids. In plain terms, these are plant chemicals that can act like drugs when they get into our body. The most common plant alkaloid in Creatum is Mitragynine.

There is another one called 7 hydroxymitragynine, often shortened to 7-OH and usually 7-OH is present in the natural leaf at extremely low levels. These levels can increase during the processing, for example drying of the leaves. Some amount of metrogynine can also be converted to 7-0H by human liver after metrogynine ingestion.

What is important to understand is that these two compounds, mitragine and 7-OH are not really equal and their opioid like effects both can act on the main opioid receptor in the brain which is called the new opioid receptor, but nitrogenin is a much weaker it has probably it will be correct to say opioid like activity, while 7-OH is far more potent than that receptor.

So when 7-OH levels rise, the product moves away from what many consumers think of as a traditional plant product and actually towards something that can produce opioid type effects. Those effects follow a very familiar pattern. With repeated use, the brain adapts.

People can develop tolerance dependence, meaning they actually will need much higher doses to get the same effect. They also feel withdrawal when they stop. That withdrawal can include anxiety, insomnia, sweating, muscle aches and many other clinical manifestations.

There are published clinical reports of people who use 7h products daily, who developed opioid like withdrawal, who required medical supervised treatment, including medications used for opioid withdrawal such as buprenorphine and naloxone. The most serious toxicology concern is dangerous slowing of breathing known as respiratory depression, which is actually the same basic mechanism involved in opioid overdose.

The risk rises with higher potency opioid active products when people combine them with alcohol, with sedating medicines, also with cannabinoids and actually when the true dose is not really well understood, which is very prevalent on nowadays market. So this leads to the current product issue.

Many newer products are not loosely for traditional extracts that actually been used for a long time in Southeast Asia. They are tablets, gummies, shots, liquids and very often marketed directly as 7-0H. These formats make frequent redosing easy. It may feel those dose feel simple and predictable, but actually it is often not.

Labels are often incomplete, inconsistent and in most cases consumers just have no way to verify what is actually inside the product. So what I want to be clear is I'm not saying that traditional kratom leaf products are risk free. They are not.

But the key point is that a low 7-OH Leaf product and high 7-OH 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 7-OH the most relevant comparison is no longer kratom as a botanical.

It is actually an opioid 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 relative compound, specifically 7OH behaves much more like a traditional opioid than most people understand and realize.

And third, that the largest concern right now is the spread and control spread of products that concentrate this compound 7-OH and sell it in an easy to use forms. Thank you for your time and I'll be very happy to answer any questions.

Thank you so much. Dr. Koturbash, I do have a few questions and I also want to point out that you are joining us from the University of Arkansas Medical Science Department. But how similar is Metragynine and 7-OH to the classical opioid receptors activity as far as like their dependence potential and also the risk for respiratory depression?

Yeah, so once again, metrogynine does not really have a very strong opioid receptor effect. Right. It's not really strong opioid Opioid receptor agonist. Right. It's kind of more opioid like. Right. Although there are some cases being described in literature.

You know, when consumed in a high concentrations, for example, those herbal products can also lead to opioid like effects. 7-OH on the other hand, this is the product that the chemical alkaloid that has a very high potential. It's actually very important. Mutual 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 a higher doses, effects can be reversed by naloxone, which is a classical case of opioids. Right.

There is also accumulating evidence in SC literature published in the case reports when people occasionally or intentionally consumed concentrated 7-OH products and they displayed classical opioid like 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 of several lethal cases being published, including a few that happened in in California.

Does naloxone work as well with reversing the effects of 7-OH as it does with other opioids?

Yes, according. Once again, according to the animal studies and also according to a few clinical cases, when with 7-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 revive the patient.

You mean a few doses of the naloxone?

Naloxone. Yes.

And to your knowledge, can chemical testing currently accurately identify kratom products that have been supplemented with 7-OH?

I would say that most of the forensic laboratories have that capacity to do that. The problem is that 7-OH was never considered something that forensic laboratories would look into. So Mitragynine was a principal component for forensic laboratories to look into.

So technically, once again, labs can do that because it's the same equipment needed, but a certain standard need to be developed for 7-OH in order to be able to quantify it in a laboratory settings.

And of course, if we're talking about emergency department's clinical, there is no way at this moment to tell unless the patient admits that they actually used a 7h product.

So you were saying yes in labs, but if a patient shows up in the emergency room, those labs don't have the capacity to differentiate between the two.

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 cyber. So what you need to do is actually develop, obtain or develop the standards, validate the method and then laboratory can do that.

But it's not a routine panel across the country in the forensic toxicology labs.

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?

Well, emergency rooms is always very difficult to do that because you don't have much time. Right. As an equal clinician, your thought is to save the patient or who is unresponsive, you know, respiratory depression and so on. And usually naloxone in this cases can reverse the effects in terms of confirming that this is a 7oh intoxication. Right.

So you need the biological specimen from a patient and it obviously will take some time to run the analysis. So as an md, as a clinician, you just don't have the luxury of time. But in order to confirm this, the samples can be sent to forensic psychology labs.

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 7-OH both in biological samples as well as retail samples, you know, for those pills and shots and tablets and gummies and you name it.

So technically it's probably just a matter of several months. However, I think 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 7OH in biological samples.

Wow. And just for clarification, when we're talking about screening for 7-OH , is that a urine or a serum?

Well, it can be urine, it can be blood, and blood probably is the best would be, but urine is Also possible.

Okay. And my final question for you. How detrimental do you think as a, as a researcher would it be to biomedical research if California were to schedule kratom or 7-OH as a schedule 1 or 2 controlled substance?

I probably will be biased because I am a scientist and I have worked with Schedule 1 substances before and I know how painful it is in order to obtain all the licenses and certificates and when you have to go, you know, through all this bureaucracy, are you afraid that such move will de.

Incentivize the research which is so much needed? So I would not want to say, I would not want to 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, if scheduling it as Schedule 1, that will disincentivize a lot of researchers who would otherwise would love to do that work.

Okay, thank you. And one more question. I'm sorry.

So I'm going to 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 7-OH as a schedule 1 or 2 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?

You know, 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 implement tomorrow.

I afraid that abrupt ban will have a lot of negative consequences because first of all, it's just going to push the demand on the black market to the black market.

And you know, when we push it into the black market, it results in even more poor substandard products, less control, even higher contamination risks and less opportunity just to monitor the harm effects. Right. I 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 solution what we will do with them tomorrow when those products will just be probably not available to them.

I think it is probably the decision has to come, you know, from a more balanced approach developed with regulatory scientists, pharmacologists, toxicologists, Clinicians, public health experts, law enforcement, you know, that the decision could be taken 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.

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 can come up.

We have Meral Farsi, deputy Director, Office of Legislative and Government affairs at CDPH Amy Mullin or Dr. Mullin, Mullen, Mullin, I was right. Who's a professor of emergency medicine. She's the chief of division of addiction medicine at UC Davis. Dr. Oday, He's a chief medical examiner at the county of Los Angeles.

Dr. 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 probably the first time I've had so many fellow physicians in front of me. And so we will start with Meral.

Hello. All right, thank you. Chair, Dr. Weber Pierson 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 kratom.

My name is Maral Farsi and I'm here on behalf of Assistant Health Director Dr. Rita Nguyen, who's unfortunately ill today. We apologize. I'd like to begin by sharing some of our data around Kratom use, which was something that you guys wanted to hear about.

So in 2022-2023, an estimated 169,000 Californians ages 12 and older, which is about one half a percent of the population, reported using kratom in the past year. So the Department is aware of 362 kratom related overdose deaths in California between 2019 and 2023, with a steady increase from 38 in 2019 up to 92 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 7-OH. CDPH is also aware of 15 drug related overdose deaths in California between the same time period, 2019 to 2023, where 7-OHwas 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 7-0H. As mentioned by the prior speaker, Kratom has a complex pharmacological profile with the potential for sedative, stimulant and opioid effects.

7 hydroxymidrogynine, or 7-OH is a potent opioid that usually makes up a very small percentage of Kratom leaf but can be concentrated and added to products increase their activity.

What we have observed is that both whole leaf kratom products and 7-OH have a high potential for addiction, particularly among people with existing substance use disorders, and that overdose risk is substantially elevated when 7-OH 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 7-OH. We have issued two press releases to the media about the risks of kratom and 7-OH leading to addiction, serious harms, overdose or death. Last month, CDPH issued a statewide California health advisory to healthcare 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 7-OH.

And in January, CDPH sent a letter to licensed tobacco retailers to inform them that retail and online sale of kratom and 7OH 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 7-OH from retail facilities selling to consumers and from manufacturing locations.

We've taken enforcement actions across the state, including two manufacturers, 22 wholesalers and distributors, and a about 50 retailers. We are not able to discuss the specifics of our investigations, but just general information. Kratom 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 7-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 7-OH. We stand that the most protective, the most health protective policy is the one that we have in place now that kratom and 7-OH 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. Thank you.

Thank you so much. I'm Amy Moulin. 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 hydroxy mirtagenine 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 healthcare 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 7 hydroxy mirtin 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 7 hydroxy mirtagenine.

Most of the 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 7-OH 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 7oh 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 7-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 7-OH 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 safe. Thank you. Thank you.

Dr. Odey Ukpo, 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 of 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 7-OH. 7-OH was predominantly in white men that were suffering from either anxiety, depression, or insomnia.

When we discovered this agent, it was 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 and that. So I just want to be clear that that's how we make our determination is based off of deductive reasoning of nothing else is reasonable that can explain this death. And that's how we came across initially six cases.

And we continue 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. And Madam Chair, I yield for his discussion.

Thank you.

Good afternoon. Thank you, Dr. Pierson 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 7-OH.

7-OH, 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 7-OH 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 7-OH products.

As of January 23rd of this year, we visited 2,882 sites and 357 of them were identified to have kratom and 7oh 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 is sort of stretched our existing workforce because we're not currently structured or funded to monitor for kratom and 7-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 kratom and 7-OH in the community, we've advised the community the safest course of action is to avoid using Kratomin 7.0h products. And we provided risk reduction guidance, including having naloxone on hand. We have community health stations where we distribute naloxone.

Now, people who use kratomin and 7-OH , 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 safeguard lives. Now, 7oh is more potent than unmodified mitragynine. 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 7-OH.

I myself have worked with a patient who is using 7-OH through his treatment with injectable extended release naltrexone, an opioid antagonist that blocks the opioid receptor. And his experience is that 7-OH 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 help. 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 7-OH. I'm happy to answer any questions at the end of the panel. Thank you.

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 is taking kratom or was it kratom or 7-OH?

7-OH, which is a. An agonist. And so was able to overcome the antagonistic force of the.

7-OH.

Yeah. The antagonist is a monthly injection of naltrexone. It's roughly 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 7-OH on top of that antagonist and having an opioid effect.

Interesting. Okay, thank you.

Thank you, Madam Chair Weber Pierson and Members. I'm Farrah Mc Daid Ting. I'm here, 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 7-OH 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 laboratory in the future and how California will deal with those.

While the science of kratom and 7-OH 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 7-OH 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 19 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 acknowledgement 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, an attempt 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 bailiwake. 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 7-OH 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 non food 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 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 SOVA and zero can ensure that labeling, manufacturing, disposal of the products, testing and even, you know, 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 for LA 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 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 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 1 in 70 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 Chiak to testify today.

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. Dr. Ukpo, thank you so much for your presentation. How were you able to determine that it was 7-OH and not kratom?

Great question. So as the other speaker, I think Dr. Koturbash was talking about that the measurement of 7-OH the standardization to allow to quantify it has not been established. However, there was a presence of mitragynine in these cases, very small level of mitragynine.

And that triggered sort of this unusual sort of ratio where it was very low metragynine but high 70 which is very odd sort of mix because what you expect is that you'll have a good amount of metragynine and some of the byproduct is 7-OH.

And so we saw that sort of odd sort of comparison of those two and 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 that 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 like 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.

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?

Yes. So medical examiners have actually asked us questions because we are at the forefront of this. Like, how did you do that? How were you able to make the 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. So we're actually being asked questions, essentially.

And given what you found, has testing for kratom become a part of the routine toxicology report for unexplained deaths in LA County?

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, like methamphetamine. 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 mitragynine come up. We have since shifted from that to testing for mitragynine. Even in cases where fentanyl and methamphetamine are present, we do see those cases that have fentanyl and methamphetamine.

However, the cases that have metragynine alone, we see about those two to three cases per year of just metragynine, which is kratom alone, for causing death. So it has become part of our testing.

Okay, thank you so much. And Dr. Moulin, I was wondering if you. If you could give a sense of the timeline of when you started becoming aware that this was a increasing problem.

Yeah, I think this is very. This is at least as far as we are seeing the. We have seen kratom for a long time. 7-OH 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 7-OH addiction withdrawal symptoms, and trying to figure out how to treat it.

So this has escalated, I would say, over the past 12 months. Thank you for that.

Maral Farsi, 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 you know, 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?

Thank you for the question, Chair. So to be clear, the stance of 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 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.

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 7-OH, how challenging do you think that would become for CDPH to actually enforce?

Well. I guess I can't speak to how that enforcement would take effect because but 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 the response that the user is looking for.

So I'm being a little vague here intentionally, but 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 in the dose potentially makes the poison.

And so you would you could end up having the same result anyway, even though it's we're looking at a potentially different substance. They're not.

Okay. Thank you. Yeah. Dr. Hurley, in your experience, is there a legitimate use for 7-OH to treat opioid addiction.

There are many community Members who have reached out to the county and saying that they're finding 7-OH helpful for various conditions. But 7-OH 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 a, you know, addiction physician and if I was talking to one of my patients who is using 7-OH 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 based on your medical experience, why would a patient choose to use 7-OH over one of the FDA approved products?

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 Dr. Muller and I have worked very hard to make medications for opioid use disorder 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 7-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 7-OH is it's not part of a medical treatment, it's something people can go buy.

Thank you Senator Perez.

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?

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 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 medical 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 are 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 healthcare. And that is not something we've achieved at this moment. Does that make sense? I wanted to make that distinction.

Yeah, 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 you know, I know we had heard from, you know, those advocates and from people that use kratom, that use 7-OH 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's 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 in, not just here in the state of California, but across the country around dosage in particular, what dosages are good use for treatments? I heard people talk about using it as 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.

At this moment? There are states across the country that have various levels of regulations around both Kratom and 7-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? 7-OH 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 7-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.

Can I just. I apologize. I just wanted 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 7-OH is there's no backstop. Right. So they will end up using escalating doses of 7-OH. 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, 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, you know, and John Hopkins University, looking at some of the impacts and benefits from that, you know, 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 like 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 that our research institutions are constantly exploring these things.

There is an extensive body of research looking at. You mentioned a few psychedelics and empathogens. 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 mitragynine and 7 hydroxymetragine, it is not nearly to the same extent.

Thank you so much, Senator. I had a couple questions as well. Start with Senator, 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 70 different counties approach it already very differently. So there's no standardization.

Isn't that alone creating difficulty of enforcement or. Yeah, or approach. When you say different counties are approaching, what are they approaching differently? Different 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 Department?

Well, I 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.

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 Department, how are the counties right now able to put local ordinances that legalize some of these products?

I don't know enough. Sorry. And I'm a stand in, by the way, but I don't think I know enough about like the jurisdictional differentiation.

What we have done, as I said during my testimony, is that we have provided information to local health officers, 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 healthcare 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 that was before. Some of those actions have 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 our local partners and going along that.

Is it in the stance of the Department that if the state were to, 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.

So. The state's stance is that this is not a product, according to the FDA, that can be legally sold in the state.

So if you, 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.

Thank you. My next question is going to be to the deputy Director that. And I was trying to, if you can. 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?

So our point is Sherman law is enforced statewide by CDPH, 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 LA 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 three that have some delegated authority have never played in the manufactured food space. And so that is also a differing patchwork.

Would the extension of those to all 58 counties that authority help with reducing some of the incidents we're having?

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. 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.

It would be adding on a new duty for our local environmental health inspectors in the non Sherman counties. Got it. Thank you.

Senator Padilla.

just briefly 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 if you maybe to counsel, but if we were to clarify or remove the limitation on investigation 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, you 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, you know, 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 some, hasn't there been some coordinated effort here prior to this? I mean, 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?

Madam Chair, I'll take a stab at that, not being a lawyer nor a doctor with my esteemed 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 kind of 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, 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, you know, 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.

Understand that. Thank you.

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. Three bills that have touched on kratom and or 7-OH. And when we're thinking about different policies, the issue of age requirement just came up.

So I just wanted to ask, Dr. Akbo, of those who had passed and you were doing the evaluation, how many of those were under the age of 18?

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. 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.

40 was the oldest, so youngest was 19. Oldest was 40.

Okay. Senator Perez.

I really appreciated your question. Chair I do we. 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 creative morse 7-OH.

So overdose is not a term that medical examiner uses when we certify 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. Then they try it on the patients that have the condition you're trying to treat.

So 708s 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 the 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, aha, it's above this, therefore, it caused the death.

So we don't speak in terms of.

Dosage, but in terms of when the medical examiner is looking at somebody who has died as a result of kratom or 7-OH there's not like a, you know, assessment of how much substance the individual took to, like, document any of that.

It is documented, but I think that it's often interpreted as, well, that was the amount. So it is quantified. And it's limited how much we can quantify for 7-OH given it's a new substance. So we don't make the determination based off of that.

Thank you.

Dr. Hurley, what is it that you would like to see from the California Legislature?

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 kratom from 7oh products based on packaging alone. Right. There's no reliable way of doing that.

So if you created a framework around packaging rules, it would help our environmental health to potentially distinguish between unmodified mitragynine or just sort of kratom products and 7oh products. I also think it's clear from our medical examiner that 7oh products have a unique risk. Right.

These are clearly driving fatalities that end up in the medical examiner differently than Kratom 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 kratom products and 7oh products, which we're currently not resourced to do.

So just following up on that. How. Would you distinguish between a product that has, you know, 95% kratom 708 and 5% 70? I mean, we don't have the research, we don't have the data to say a certain threshold of 70 is not harmful. So how would packaging help you?

There is a convention in place right now which is 2%. Right. Products where the total alkaloid percentage of 7oHs over 2% are considered to be concentrated 7oH 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, that we're aware of and it's actually in the background paper as a, as a threshold. So one could then adopt and that. And there are other counties that have created that. Riverside as just one example of a 2% percentage of alkaloid to separate 7OH products from kratom products.

There 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 Kratom brownie from a gas station and testing it to see if it's 2%.

So someone could essentially put it on their packaging label, but there's no way to verify that that's actually the case.

Not currently without a framework and resources to do so. Yeah.

Okay, thank you. And. 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?

Yeah, the intoxication 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 would 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.

Well. With no further questions, I want to thank each Member of this panel. It was very informative, I think, you know, Dr. 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 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.

Thank you.

We will now move to our next panel, perspectives from kratom and 7oh 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 Subek, Executive Director for Seven Hope alliance foundation, and Michelle Ross, principal Dr. Michelle Ross, excuse me, principal scientist for Infuse Partners.

And we will begin with Matthew Lowe.

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 50 years, since the 1970s. Natural kratom leaf is a complex botanical. It's made up of 50% fibre, 25% antioxidants and 50 different alkaloids that give it its unique effect.

Mitragynine, as we've discussed today, is the most abundant alkaloid. 7-OH is found in trace, trace, trace amounts in dried leaf kratum. On the other hand, isolated concentrated synthetic 7-OHproducts use chemical synthesis to concentrate 7-OH from 100 to a thousand times more than what is found in natural kratom leaf. These are not the same products.

They are different exposure classes entirely. Let me give you an analogy. Apple seeds contain trace amounts of amygdalin. When you eat an apple, it 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 sells 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 this last two weeks. They unanimously passed an ordinance to ban concentrated synthetic 7-OH 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 Vin Sanders and American Shaman. They're the largest manufacturers of concentrated synthetic 7-OH in the country. Kansas City 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 7-OH.

In July 2025. 1 of those letters went to Vince Sanders. What followed was the FDA's recommendation that was made on the 29th of July to schedule concentrated synthetic 7-OH. The Missouri HG started an investigation into the 7-OH industry. And in December, the feds raided Vin Sanders operation and seized a whole lot of products after the raid.

This was discussed in Kansas City And Hadnall, who's written these pieces on this industry, wrote the council was wise enough to distinguish natural kratom 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 million consumers that use natural kratom leaf for its functional benefits and again have done so for 50 years. The Federal Government has already drawn this line through their recommendation to schedule concentrated synthetic 7-OH. Thirteen 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 7-OH. 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 7-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-OH 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 7-OH hasn't had any human trials for regulations or anything like that. He said, that is correct. The human trials are people that are choosing to use it.

That unbridled sale of concentrated synthetic 7-OH 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 7-OH causes morphine like respiratory depression. Natural kratom leaf does not, unlike concentrate. Unlike Natural kratom, concentrated synthetic 7-OH 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 17% of surveyed concentrated synthetic 7-OH consumers said if these products were banned, they would commit suicide or consider committing suicide. That's not a safety argument. An 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 17% of those users were would want to commit suicide if it was gone is a real problem. You scale that out 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 7-OH. We want to preserve access to natural kratom leaf. What California needs to do, in my humble opinion is, is what AB1088 is doing and proposes.

Regulate natural kratom leaf age, restrict it, make sure that it's labeled appropriately, make sure it's not adulterated, and make sure that it's safe for use. Prohibit these 7-OH products. Let's protect consumers and let's also protect their right to choose a natural substance.

And again, I want to reiterate from 50 years of use in the United States, it's very concerning to us that a question around potentially prohibiting 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.

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 7 hydroxymitrigynine or known as 7-OH and support common sense regulations on rather than a ban of the natural botanical kratom.

Such regulations would include age, gating, testing, packaging and labeling requirements, particularly testing regarding the quantity of 7-OH in the product, and very clear requirements that that has to be indicated on the package and 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 semisynthetic 7-OH is not a natural botanical and is not kratom. Importantly, the two can be distinguished.

First, the misconception that 7-OH is kratom was perpetuated by the 7-OH 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 7-OH to kratom. Second, when kratom leaves are first harvested, they do not contain 7-OH. Post harvest, trace amounts of mitragynine convert to 7-OH due to oxidation.

Realizing this, entrepreneur chemist that I like to call bathtub chemists began exposing mitragynine to toxic oxidizing chemicals. Think of the chemicals found in things like bleach, Drano, pulse shock. These are oxidizing agents. They're taking these toxic agents, exposing them to mitragynine, and then converting that into a brand new chemical entity. Synthetic or semi synthetic?

7-OH A simple analogy nicely illustrates why synthetic 7-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 semisynthetic 7-OH is not kratom. To achieve the twin goals of banning 7oh 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 7-OH and place guardrails around the cell of natural Kratom and 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 7-OH, 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 of 2025 to initiate the scheduling of the synthetic drug 70 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 Macari recently warned consumers about products containing 7-OH he 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.

Kratom 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 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 them saying that's the official view of the FDA. But FDA, under oath in federal court, said that those views were informal, non binding, and did not go through any internal review. 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 140 milligrams of Metrogynine, which is seven times the amount of mitrigynine in a typical serving of a commercial Kratom product.

Today, Kratom is used by 23 million 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, Dr. Chris McCurdy, 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 7-OH induced respiratory depression and could be and that Narcan was successful in dealing with individuals who had overdosed on 7-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 7-OH. I would welcome the opportunity to answer any questions you may have.

Thank you. Here we go.

Oh, there we go. Hello. Good afternoon, honorable Chair and Committee Members. My name is Jackie Subak. I'm the Executive Director of 7hope Alliance, a nonprofit dedicated to public education, advocacy and science on 7 hydroxy mitragynine, also known as 7-OH and kratom. I'm here today to protect access for the millions of Californians who are 7-OH 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 and public health decisions can have unintended consequences. 2.4 million Californians are using kratom and 7-OH products.

We are working adults, parents, veterans, teachers and healthcare professionals, many of whom struggle with great pain. Madam Chair, you asked us last year for clinical research on 7-OH and we listened.

Our recent research study of 1,521 7-OH consumers shows that 74% 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 7-OH 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 7-OH 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 7-OH was even on the market, said the exact same thing. Also for 7-OH 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. 7-OH 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 7-OH 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 7-OH are not separate issues.

While they are different products, they are both naturally derived from the exact same plant. Kratom's primary alkaloid, metragynine is naturally metabolized to 7-OH . Every single human being who consumes kratom will have 7-OH in their body within the hour. You cannot separate kratom from 7-OH, nor can you separate kratom consumers from 7-OH.

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 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 7-OH last year, overdoses rose by 300% 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 priority that have real harm. 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 the consumers by removing access to products they need and rely on.

We support immediate and responsible regulations for 7o and kratom, the whole plant including 21 plus 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 regulation 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 Kratom plant for safety. Thank you.

Well, thank you Chair Dr. Weber Pearson and Members of the Senate Health Committee. My name is Dr. Michelle Ross. I'm an addiction scientist and court qualified expert on kratom and 7-OH. I'm the principal scientist at Infuse Partners, author of the book Kratom as Medicine and I also Advise the nonprofit 7 Hope Alliance.

Five minutes is not long enough to discuss the science and potential of the Kratom Alkaloid 70 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, 7-OH is safe, safer than other full opioid agonists, 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 7-OH. For example, I really do think that the even kratom risk in 7-OH is being blown out of proportion.

The federal database, the Sudors 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, 21, 22, 23 and 24, only 2% of fatal overdoses those descendants had Kratom and very clearly here metrogynine in their system.

And by the way, since 24% of Metrogynine in kratom is converted into 7-OH every single one of these deaths where kratom was acknowledged, obviously they would have 7-OH in their system as well as a metabolite. The number has not gone up over years.

Even though in 2023 isolated 7-OH products were introduced and would have been considered kratom products because, again, the differentiator between 7-OH 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, this is sort of what we're seeing here, 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 7-OH from kratom and portraying 7-OH as uniquely dangerous while labeling kratom leaf as safe and natural.

The background analysis and even the 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 7-OH 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 7-OH and kratom literature.

So I really want to say that all these bans that you're hearing about in Orange County, Riverside, Fresno, et cetera, 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 frustrating.

This is the third 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 7-OH is somehow different than kratom.

Instead of actually exploring how do we make safe regulations for the people of California, again, over 2.4 million 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 mitrogynine or 7-OH. These are not separate products. Seven zero 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. It's also found in isolated products. So it's not some Franken alkaloid that does not exist in nature.

It is real and is the same chemical structure, no matter where it comes from. Oxidation can happen via oxygen, oxygen via heat, via age. By the way, if you test old kratom, it will have elevated levels of 7-OH and also another metabolite called metrogynine 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 7-OH or are metabolized into 7-OH 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 mitrogynine is converted into 7-OH in the body. Again, every kratom product turns into 7-OH.

So if you're trying to protect Californians by just banning 7-OH or, you know, 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 7-OH in the body.

If you think that 7-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 what is causing this narrative. More facts about 7-OH. While it's important for pain relief, it has poor bioavailability.

So if you take an oral tablet, only about 2.5% of that 7-OH actually gets into the body to be used. Then it actually is less likely to cross the blood brain barrier than metrogyny. Metrogyny crosses it very easily. 7-OH doesn't.

And so what you're having is a substance that actually can't cross the blood brain barrier and into the parts of the brain like the brainstem that actually impact respiratory depression. So there's a whole bunch of fishy Signs being thrown about how 7-OH 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 are 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, etc. Here's for example, another brand, they come in little shots, right? Easy to drink, really, that increases the addiction risk, et cetera. 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 were 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 7-OH. 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 7-OH products are unsafe to deflect from the dangerous and improperly marketed products that their own vendors sell. Notice how the conversation has been Kratom Leaf is safe and 7-OH is bad. And 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 1088. That bill narrowly targets seven 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 and 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 7-OH 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. 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. Subak and Dr. Ross, because in your presentation, you were essentially alluding that kratom and 7-OH are inseparable. They're the same.

And so why do we need 7-OH if they're the same as Kratom?

If you don't mind, I'll take that. Okay. So kratom and 7-OH 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 are capsules.

For example, to get the same pain relief that you might get From a small 7oh tablet, you might have to take, say, 12 kratom capsules.

Now, because Kratom's alkaloids act very similar to NSAIDs, where they will burn out your stomach, people that depend on this for pain relief and have to take it multiple times per day because the 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, this was working for me, but now I can't take it and I'm struggling. And when 7-OH 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, 7-OH doesn't do exactly the same thing as kratom. Right. Kratom has 50 alkaloids. It's sort of messy. It's sort of like how CBD activates all these different receptors. 7-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, kratom. You know, some people really like Kratom and that works for them. Some people really prefer 7-OH.

And we really believe that there should be innovation in this market rather than restrictions not based on science.

Thank you. So essentially what I'm hearing is that 7-OH is more potent because essentially you just said that you'd need to take more kratom to get the same effect as 7-OH. And so there is a difference. They're not the same. And so I wanted to make that clear.

The other question that I had for you, Dr. Ross, you spoke about, I believe, some, like, 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 7-OH?

Because one of the things that we've been hearing is that most labs don't here in California, L.A. County, just started. So how many of those labs and those studies actually had the capacity and the foresight to test?

Okay, so I 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 56 years. And one example I'll actually give you is from Orange County.

There's a publication that was published in 2023 that looked MetroGyline and its involvement in DUIs in California, specifically Orange County. And so they were testing for both mitrogynine and even 7-OH 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 0.2% 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 7-OH but then they say that the levels of the 7-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 7-OH is a metabolite of kratom, if we know that mitrogyny turns into 7-OH, 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 7-OH involved as a metabolite, or whether it's present as a isolated product.

And I want to say that 7-OH is not more potent necessarily, because I told you that there is a reduced bioavailability and ability for the 7-OH to cross the blood brain barrier.

There's other things that also contribute to 7-OH but it is not necessarily more potent if you are taking, say, a 20 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, 7-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, you know, 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 eight 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, et cetera, as stated.

And if anything, if 7-OH is dangerous, kratom is dangerous. I mean, in my humble opinion, I would say if you think that 7-OH products are so dangerous that they shouldn't be sold, then kratom products shouldn't be sold.

Well, you know, I'm not saying whether either one should be sold, but I don't think that there is the 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. From.

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 7-OH.

You know, if you take a Kratom product, how would you propose that we allow for the same, the continued sale of Kratom, but we can't actually do widespread testing to ensure that there is no 7 or a higher dose of 7-OH in there.

Quickly clarify your.