HomeMy WebLinkAbout09 PROPOSED ORDINANCE NO. 1571 PROHIBITING THE SALE OF KRATOM PRODUCTSDocusign Envelope ID: 7573C612-77F6-4535-B95E-2F8B74E33879
. . . . . . . AGENDA REPORT
MEETING DATE
TO
• 1/
OCTOBER 21, 2025
ALDO E. SCHINDLER, CITY MANAGER
DAVID KENDIG, CITY ATTORNEY
JASON MCEWEN, ASSISTANT CITY ATTORNEY
Agenda Item 9
Reviewed: n�
City Manager u
Finance Director
SUBJECT: PROPOSED ORDINANCE NO. 1571 ADDING CHAPTER 10 TO ARTICLE
6 OF THE TUSTIN CITY CODE PROHIBITING THE SALE OF KRATOM
PRODUCTS
SUMMARY:
The City Attorney's office has prepared proposed amendments to Article 6 of the Tustin
City Code to add a ban on the sale, distribution, and advertisement for sale of kratom
products within the City.
The proposed ordinance would ban the sale, distribution, and advertisement for sale of
any product containing any part of the leaf of the plant Mitragyna speciosa (more
commonly known as the kratom plant). The purpose of the ordinance is to protect the
public health and welfare against the sale and distribution of products which the U.S.
Food and Drug Administration has identified as having opioid-like characteristics, and
which pose a threat to the health and safety of the American Public.
RECOMMENDATION:
Introduce and conduct first reading by title only of Ordinance No. 1571 adding Chapter
10 (Prohibition on the Sale and Distribution of Kratom Products) to Article 6 (Public
Welfare) of the Tustin City Code and schedule the adoption for the City Council's next
scheduled regular meeting.
FISCAL IMPACT:
Minimal fiscal impact associated with efforts to enforce the prohibition by the City's code
enforcement and/or law enforcement personnel.
CORRELATION TO THE STRATEGIC PLAN:
Tustin's Strategic Plan Goal A: Economic and Neighborhood Development calls for the
City to "enhance the vibrancy and quality of life of in all neighborhoods and areas of the
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community." Goal B: Public Safety and Protection calls for the City to "Ensure Tustin is
an attractive, safe and well -maintained community in which people feel pride."
BACKGROUND AND DISCUSSION:
According to a report issued by the U.S. Food and Drug Administration (`FDA") in July of
2025, a chemical compound found within the leave of the kratom plan "is a potent opioid
that poses an emerging public health threat, especially when considering the increasing
availability of enhanced or concentrated 7-OH products in the marketplace." (7-
Hydroxymitragynine (7-OH): An Assessment of the Scientific Data and Toxicological
Concerns Around an Emerging Opioid Threat, U.S. Food and Drug Administration, July
29, 2025 (hereinafter "FDA Report"). According to a survey conducted by the Substance
Abuse and Mental Health Service Administration, approximately 1.7 million Americans
aged 12 and older used kratom products in 2021.
The kratom plant (scientific name Mitragyna speciosa) is a tropical evergreen native to
the wetlands of southeast Asia. Historically, the whole leaves of the kratom plant have
been used to treat headaches, diarrhea, insomnia, anxiety, opioid use withdrawal. More
recently, kratom products have been used for recreational purposes with users reporting
feelings of euphoria per the FDA's Report. According to the FDA, there are no FDA -
approved drugs containing kratom or kratom-derived drug substances such as 7-
Hyrdoxymitragynine (" 7-OH") or mitragynine, two substances found within the kratom leaf
which produce psychoactive effects.
As reported by the FDA, "many of the products available today, which are often
associated with or advertised as kratom, no longer resemble botanical kratom. Instead,
the contain `enhanced' or concentrated amounts of 7-OH and are formulated as powders,
capsules, and liquid extracts designed to generate stronger effects on users." (FDA
Report at p. 5) Specifically, 7-OH produces respiratory depression, physical
dependence, and withdrawal symptoms characteristic of classical opioids, such as
morphine, fentanyl, oxycodone, and hydrocodone." (Id. at p. 4)
There are no FDA -approved uses for kratom and it is not legally marketed in the United
States as an additive to any food product, a dietary supplement, or as an ingredient in
any drug. Nonetheless, kratom products are being sold throughout the country with little
or no regulation. As a result, several states and local governments have adopted
regulations pertaining to the sale of kratom products. In fact, several states, such as
Alabama, Arkansas, Indiana, Louisiana, Rhode Island, Vermont, and Wisconsin have
taken steps to ban kratom products. On the other hand, the State of California does not
yet regulate kratom products in any manner.
Locally, the cities of San Diego, Newport Beach, and Huntington Beach have adopted
ordinances prohibiting the sale and distribution of kratom products, and the County of
Orange has adopted regulations which ban the sale of products containing specified
levels of 7-OH and regulated all other kratom product sales.
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If adopted, this ordinance would prohibit all sales, distribution, and advertising for sale of
any product containing kratom, as well as the sale, distribution, and advertising for sale
of any product which is marketed in any way as being a kratom product.
In the event the City Council approves the proposed ordinance, staff will implement a
notice and education campaign to businesses in the City, including but not limited to social
media posts and emailing of informational flyers to licensed businesses, to alert them to
the new prohibition on the sale, distribution, and advertising for sale of any product
containing kratom.
Violations of the ordinance would be punishable pursuant to the General Penalty
provisions of the Tustin City Code. (Tustin City Code sections 1121, 1122, 1123 and
1162.) Specifically, at the discretion of enforcement officers and/or the City Attorney, a
violation of the ordinance could be cited as a criminal misdemeanor or infraction offense,
abated by civil action, and/or subject to issuance of civil administrative citations.
Attachment:
1. U.S. Food and Drug Administration Report: 7-Hydroxymitragynine (7-OH): An
Assessment of the Scientific Data and Toxicological Concerns Around an
Emerging Opioid Threat (July 2025)
2. Ordinance 1571 adding Chapter 10 (Prohibition on Sale and Distribution of Kratom
Products) to Article 6 (Public Welfare) of the Tustin City Code.
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FDA
7-Hydroxymitragynine (7-OH):
An Assessment of the Scientific Data and
Toxicological Concerns Around
an Emerging Opioid Threat
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7-Hydroxymitragynine (7-OH):
An Assessment of the Scientific Data and
Toxicological Concerns Around
an Emerging Opioid Threat
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FDA Center for Drug Evaluation and Research
Authors
Chad J. Reissig, PhD, Supervisory Pharmacologist, Controlled Substance Staff (CSS), CIDER
Dominic Chiapperino, PhD, Director, CSS, CDER
Amy Seitz, PhD, MPH, Team Lead for Nonmedical Drug Use Team 3, Division of Epidemiology II
(DEPI), Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and
Epidemiology (OSE), CDER
Regina Lee, Pharm.D., Safety Evaluator, Division of Pharmacovigi lance II, OPE, OSE, CDER
Rose Radin, PhD, Associate Director for Science, DEPI, OPE, OSE, CDER
Jana McAninch, MD, MPH, MS, Associate Director for Public Health Initiatives, OSE, CDER
Acknowledgments
Matthew Daubresse, DrPH, MHS, Epidemiologist, DEPI, OPE, OSE, CDER
Tamra Meyer, PhD, MPH, Associate Director for Nonmedical Drug Use, DEPI, OPE, OSE, CDER
Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health,
CDER
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Table of Contents
EXECUTIVESUMMARY............................................................................................................................4
INTRODUCTION......................................................................................................................................... 5
The Context for 7-OH Concerns......................................................................................................5
ContemporaryOutlook......................................................................................................................5
ANALYSIS OF DATA ON 7-HYDROXYMITRAGYNINE(7-OH).............................................................7
7-OH Sources and Products vs. Kratom.........................................................................................7
Patterns of 7-OH Use, Human Exposures, and Law Enforcement Data.....................................9
Preclinical Data Characterizing 7-OH Pharmacology..................................................................13
CONCLUSIONS........................................................................................................................................18
REFERENCES...........................................................................................................................................19
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EXECUTIVE SUMMARY
Recent reports indicate increased availability and marketing of 7-hydroxymitragynine (7-OH) in
the U.S., raising public health concerns due to its pharmacology. This report provides an
overview on the chemical, pharmacological, and epidemiological data on 7-OH. It focuses on the
characterization of 7-OH-containing products in the marketplace, the evidence of increasing
human exposures, and the extensive body of preclinical studies in the scientific literature that
indicate the predominant mu opioid agonist pharmacology of 7-OH. These data sources
indicate that 7-OH is a potent opioid that poses an emerging public health threat, especially
when considering the increasing availability of enhanced or concentrated 7-OH products in the
marketplace.
7-OH is a naturally occurring substance in the kratom plant (Mitragyna speciosa), but only a
minor constituent that comprises less than 2% of the total alkaloid content in natural kratom
leaves. However, 7-OH demonstrates substantially greater mu-opioid receptor potency than
kratom's primary alkaloid constituent mitragynine, as well as other classical opioids such as
morphine. In vitro studies reveal 7-OH exhibits high binding affinity for mu-opioid receptors (Ki =
7.2-70 nM), with functional activity as a mu agonist. Animal behavioral studies demonstrate its
rewarding effects from self -administration and conditioned place preference methods,
consistent with its opioid properties. Critically, 7-OH produces respiratory depression, physical
dependence, and withdrawal symptoms characteristic of classical opioids, such as morphine,
fentanyl, oxycodone, and hydrocodone.
Recently, there has been a concerning proliferation of concentrated 7-OH products that are sold
over the counter and online. The enhanced amount of 7-OH in these products is likely
synthetically derived through oxidate chemical conversion of mitragynine isolates or kratom
extracts. Given the trace amounts of 7-OH that are naturally present in kratom, direct extraction
of 7-OH from plant material would simply be unfeasible economically.
Surveillance data from multiple sources, including America's Poison Centers National Poison
Data System (NPDS), Drug Enforcement Administration toxicology testing programs, and social
media monitoring, suggest increasing human exposure to these concentrated 7-OH products.
Clinical presentations include euphoria, sedation, respiratory depression, and opioid-like
withdrawal syndromes, with users acknowledging its significant addiction potential.
The pharmacological profile, abuse liability, and emerging patterns of non -medical use establish
7-OH as a dangerous substance. Current regulatory gaps have enabled widespread availability
of these products despite their opioid-like properties and necessitate immediate policy
intervention to address this emerging threat to American public health.
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INTRODUCTION
The Context for 7-OH Concerns
7-Hydroxymitragynine (7-OH) is a component of the plant kratom (Mitragyna speciosa), a
tropical evergreen tree in the Rubiaceae family that grows in the wetlands of Southeast Asia
(Brown et al., 2017). Kratom leaves contain over 50 alkaloids, with mitragynine and 7-OH being
the primary psychoactive constituents (Warner et al., 2016). Its leaves, consumed as a tea or in
dry leaf form, have been used for centuries in both medicinal and recreational settings, largely
due the properties of its alkaloids mitragynine and 7-OH. Typically, 7-OH occurs in botanical
kratom in amounts no more than—.01-.04 percent by dry weight (Heywood et al., 2024).
Medicinally, kratom has been used to treat headaches, diarrhea, insomnia, anxiety, opioid use
withdrawal, and more, while in recreational use cases, it has been associated with feelings of
euphoria (Hill et al., 2025). Currently, there are no FDA -approved drugs containing kratom or
kratom-derived drug substances such as 7-OH for any therapeutic indications.
Kratom products have grown in popularity since the mid-2000's; however, kratom, mitragynine,
and 7-OH have faced regulatory scrutiny in the United States due to concerns about their safety
and potential for abuse. None of these substances are lawful when added to conventional foods,
as dietary supplements, or as ingredients in any FDA -approved drug, and yet, these substances
are still sold in various markets. At the state level, some jurisdictions have implemented
restrictions on their sale and use. Until now, 7-OH has not been the sole target of a regulatory
response but has always been addressed alongside the kratom plant and mitragynine.
FDA issued its first import alert for kratom in 2012. At the time, kratom was being marketed in
various forms for human consumption despite a lack of approved drug uses or established
safety as a dietary ingredient. In the years since, additional import alerts have been issued by
the Agency. The Drug Enforcement Administration (DEA) and the Department of Health and
Human Services (HHS) had given consideration to kratom, as well as its constituents,
mitragynine and 7-OH, to determine whether these substances should be recommended for
control under the Controlled Substances Act (CSA). Those actions were ultimately suspended
in 2018, with the Assistant Secretary for Health at that time stating that the science was
incomplete, and the available data were not adequate to support a recommendation to control
these substances under the CSA.
Contemporary Outlook
Given the concerning trends with 7-OH and other kratom-related products, FDA has now
determined that a more comprehensive assessment of available scientific and medical data on
7-OH is warranted. Many of the products available today, which are often associated with or
advertised as kratom, no longer resemble botanical kratom. Instead, they contain "enhanced" or
concentrated amounts of 7-OH and are formulated as powders, capsules, and liquid extracts
designed to generate a stronger effect on users. Other products are explicitly advertised as 7-
OH-containing products. One analysis of websites selling 7-OH products found that most (82.2
%) were formulated as chewable/sublingual tablets, shots, or gummies and marketed specifically
as 7-OH only products (92%). The mean cost per recommended dose/serving was $3.97 (Hill et
al., 2025).
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As described below, research has shown that 7-OH is a potent mu-opioid receptor agonist,
demonstrating pharmacological characteristics that define classical opioids like morphine and
fentanyl. Based on its opioid pharmacology, there is significant potential for abuse of 7-OH. In
fact, in various preclinical studies it has demonstrated greater potency than classical opioids.
For example, 7-OH produces respiratory depression with more than 3-fold greater potency than
morphine. Since the substance's therapeutic and psychoactive effects are mediated through the
same mu-opioid receptor pathways as classical opioids, it can be considered to have opioid
properties warranting similar regulatory consideration (Hill et al., 2025; Obeng et al., 2021).
In this report, FDA presents its new assessment of the available scientific data and literature on
7-OH, as well as more recent law enforcement data and the rapidly evolving trends in kratom-
related products. FDA still has concerns about the safety of kratom products more broadly and
the unlawful marketing of them under several regulated product categories in the Federal Food,
Drug, and Cosmetic Act. However, there is a recognized need for more immediate action to
address 7-OH because it is a substance with potent mu opioid agonist properties and significant
abuse liability.
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ANALYSIS OF DATA ON 7-HYDROXYMITRAGYNINE (7-OH)
7-OH Sources and Products vs. Kratom
The alkaloid 7-hydroxymitragynine (7-OH) is a naturally occurring substance in the kratom plant
(Mitragyna speciosa), but only a minor constituent, described as early as 1994, when it was
reported to comprise about 1.6% of the total alkaloid content of kratom leaves (Ponglux et al.,
1994). This early reported value is in agreement with more recent assessments that have
consistently demonstrated 7-OH as comprising less than 2% of the total alkaloid content in
natural kratom as noted below.
7-OH has the chemical structure shown in Figure 1. Its IUPAC name is methyl (E)-2-
[(2S,3S,7aS,12bS)-3-ethyl-7a-hydroxy-8-methoxy-2,3,4,6,7,12b-hexahydro-1 H-indolo[2,3-
a]quinolizin-2-yl]-3-methoxyprop-2-enoate, and it has the molecular formular C23113oN205, with a
molecular weight of 414.40 amu.
N u111\
\ DN
HO
Figure 1. 7-Hydroxymitragynine Chemical Structure
Although details are not well-known, 7-OH is present in some products in amounts far exceeding
its natural levels in the kratom plant. The 7-OH in these products is likely derived from the
kratom plant. These 7-OH-enhanced products likely involve additional chemical synthetic steps
by the producers of these products, converting the more abundant plant alkaloid mitragynine
into 7-OH via chemical oxidation.
Data are available regarding 7-OH as a percentage of the total alkaloid content in kratom, and
also as a percentage of dried botanical kratom leaf material and other kratom-derived products
in the U.S. marketplace. One recent review reports 7-OH as comprising 2% of the total alkaloid
content in kratom (Hossain et al., 2023) and this result can be extended to samples of kratom
grown in the U.S. (Leon et al., 2009). In another analysis of 13 commercial products purported
to contain kratom, the 7-OH content by weight ranged from 0.01-0.04% (Kikura-Hanajiri et al.,
2009) a finding in agreement with others that have reported 7-OH to account for less than 0.05%
by weight, substantially lower than reported mitragynine amounts (Kruegel et al., 2019). A more
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recent study used ecological momentary assessment to evaluate the motivations and patterns of
use of adult U.S. kratom consumers (Smith, Panlilio, Feldman, et al., 2024; Smith, Panlilio,
Sharma, et al., 2024). As part of the study, subjects provided samples for quantitative testing of
their own kratom products that they obtained and were self-administering. Across the 341
samples, the 7-OH content (expressed as a percentage by weight/weight or weight/volume, as
indicated) ranged from below the limit of quantitation (< 0.005%) to a maximum of 0.21 % with a
mean of 0.01 % (Sharma et al., 2025). These data suggest 7-OH is present in botanical kratom
(i.e., leaf) at relatively low or trace amounts and may be a postharvest oxidative derivative of
mitragynine (Karunakaran et al., 2024).
Common forms of kratom sold online include powders, capsules, resin extracts, crushed leaves,
and tablets, although loose powder and prepared capsules have been reported to be the most
frequently used formulations (Garcia-Romeu et al., 2020; Smith, Panlilio, et al., 2024). While
kratom use characteristics are complicated by the diversity of products in the marketplace,
survey studies have reported on consumption patterns. Garcia-Romeu collected data from
regular kratom users and found that most users reported using 1-3g (49%) or 4-6g (33.4%) of
botanical kratom per consumption (Garcia-Romeu et al., 2020). In other survey studies, the self -
reported average consumption of kratom powder was 4-5 g per serving with serving sizes
ranging between 2.6- 7.5 g (Rogers et al., 2024; Smith et al., 2022). When quantifying the
amount of mitragynine consumed through the use of kratom, individuals self -reported
consuming an average of 31.3 mg of mitragynine/serving and a range of 78.3 - 134.6 mg of
mitragynine per day (Sharma et al., 2025).
Mitragynine, as the most abundant alkaloid in kratom, accounts for about 66% of the total
alkaloid content of kratom and less than 2% of dried leaf content by weight, although there are
reports of regional and seasonal variability in the tree's alkaloid composition (Arndt et al., 2011;
Leon et al., 2009; Sengnon et al., 2023). For example, Chear and colleagues collected fresh
kratom leaves from different locations in Peninsular Malaysia and determined their alkaloid
profiles. The mitragynine concentration ranged from 9.38 to 18.85 mg/g or 0.38% to 1.89% of
dried leaf weight while the 7-OH concentration ranged from 0.05 to 0.15 mg/g or 0.005% to
0.015% (Chear et al., 2021).
Despite the low amounts of 7-OH in botanical kratom, there are reports of its more -enhanced
presence in commercial kratom-related products (Grundmann et al., 2024), although some
products have been identified in reports from nearly a decade ago. For example, Lydecker and
colleagues tested eight commercially available kratom products for their alkaloid content(s). In
seven of the eight products tested, they found levels of 7-OH to be 109-509% higher than
expected, based on naturally occurring levels of 7-OH reported in the kratom plant (Lydecker et
al., 2016). More recently, the Tampa Bay Times purchased twenty kratom-derived products from
local stores. One of those products consisted of pressed pills and contained 15 mg/pill of 7-OH,
an amount far greater than observed in any botanical kratom preparation to date (Ogozalek,
2023). In addition to the verified amounts of 7-OH in the products obtained by Lydecker et al.
and the Tampa Bay Times, other products labeled and/or purported to have high levels of 7-OH
appear to be readily available for purchase online.
In summary, the low amounts of 7-OH in natural botanical kratom products is well -established as
a percentage of alkaloid content, as a percentage of dried kratom leaf material, and in products
representing other dosage forms made from natural kratom and consistent with its natural
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composition. However, there are also a concerning and increasing number of products being
sold that have unexpectedly and unnaturally high levels of 7-OH. This poses a threat to public
health that is more clearly understood based on the pharmacological properties and effects of 7-
OH, discussed in the preclinical data section below, and also in the limited information available
on known patterns of human use and resulting harms discussed below. These sections will
present and discuss the evidence in the available data that establishes the mu opioid agonist
pharmacology associated with 7-OH in particular.
Patterns of 7-01H Use, Human Exposures, and Law Enforcement Data
There are several sources of information to characterize the current patterns of 7-OH use and
the resulting harms to individuals who knowingly or unknowingly are exposed to 7-OH at
significant doses from 7-OH-enhanced products, as described in the subsections below.
National Drug Early Warning System (NDEWS)
The National Drug Early Warning System (NDEWS) provides real-time surveillance from sentinel
sites across U.S. to detect early signals of potential drug epidemics using novel (e.g., street
reporting, web monitoring) and traditional data sources (e.g., OD deaths, treatment admissions).
NDEWS analyzed Reddit posts mentioning 7-OH during January to September 2024 and found
that posts increased over this time. These posts are broad and can vary in content but have
included warnings from Reddit users about respiratory depression, potency, dependence and
long-lasting withdrawal (NDEWS, 2024).
Social Media
A variety of social media outlets were assessed for mentions and/or discussions of 7-OH.
Websites included:
• erowid.org - a member -supported organization providing access to information about
psychoactive plants, chemicals, and related issues;
• bluelight.org - an international message board that educates the public about
responsible drug use by promoting free discussion, advocating harm reduction, and
attempting to eliminate misinformation;
• reddit.com - online forum that functions as a vast collection of user -driven communities,
known as sub-Reddits, each centered around specific topics.
It is important to note that all considerations of these social media sources are, at best,
anecdotal in considering the risks and abuse potential associated with 7-OH products.
However, it is clear that there is fairly widespread understanding of the availability of products
specifically targeting high levels of the substance 7-OH, distinct from kratom products generally.
In analyzing these social media posts, some relevant themes have been identified and include
mention of the following: euphoria and an opioid-like "buzz"/high as motivation for consuming 7-
OH; availability of "candy -like" formulations which users acknowledge as having a risk of
overconsumption to their own detriment; perceptions of therapeutic value of 7-OH in self -
treating pain and anxiety; concerns over loss of access to these products if they were to be
banned; acknowledgement that use of these products could lead to overdose and serious
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outcomes including death; and acknowledgement that use could lead to addiction and has
caused users to experience withdrawal symptomology much like that produced by other
commonly abused opioids.
Drug Enforcement Administration Toxicology Testing Program (DEA TOX)
The Drug Enforcement Administration Toxicology Testing program (DEA TOX) conducts
analyses of voluntarily submitted leftover or previously collected biological samples from drug
overdose victims to identify novel psychoactive substances (NPS) and other drugs of abuse in
subjects with fatal and nonfatal overdose. The DEA TOX database was queried for reports of
mitragynine, 7-OH, or mitragynine pseudoindoxyl from 2019-2025. A total of 103 cases, some
fatal and some non -fatal, were identified in this selected sample; this database does not include
all overdose cases, and the number of samples voluntarily submitted for analysis may vary year
to year based on unknown factors.
It is notable that the utility of the DEA TOX data is limited because it generally cannot be
discerned whether deaths are related to mitragynine, 7-OH, or mitragynine pseudoindoxyl, or
some combination thereof. In addition, although 7-OH and mitragynine pseudoindoxyl are not
typically found in appreciable amounts in fresh kratom leaves (Hill et al., 2025), both are
metabolites of mitragynine, complicating forensic assessments of causality (Kamble et al., 2020).
These are significant limitations in making inferences from these data; however, the number of
fatal overdose cases in which one or more of these substances were detected for 2023 to 2025
are approximately three -fold higher than for the years 2019 through 2022, coinciding with the
more recent entry of more -concerning kratom-related products in the marketplace, such as 7-
OH.
Human Exposures in Pharmacokinetic Studies
Pharmacokinetic (PK) data for 7-OH are sparse, as to our knowledge, no clinical studies have
been performed using isolated or purified 7-OH. Nonetheless, there are 7-OH PK data derived
from a small number of studies using botanical kratom. Most available clinical PK data for 7-OH
are variable, which may be for several reasons such as genetic differences in kratom plants,
different formulations (e.g., teas, capsules, etc.), and methods of analysis. Much of the data is
also from non -controlled studies making it difficult to interpret the results. Huestis and
colleagues conducted a randomized, between -subject, double-blind, placebo -controlled dose
escalation study of 500-4000 mg encapsulated dried kratom leaf powder corresponding to
mitragynine doses of 6.65-53.2 mg. Twelve subjects enrolled in the study (n=12). Blood plasma
levels of mitragynine and 7-OH were assessed after a single dose, and then again after 15 days
of continuous dosing. According to the study authors, peak plasma levels of 7-OH (i.e.,
Cmaxvalues) and exposure (i.e., area under the curve, (AUC)) were lower than mitragynine but
increased in a dose proportional manner and ranged from 3.6 to 22.7 ng/mL while the time to
peak plasma levels (i.e.,T, ax values) ranged from 1.2 — 1.8 h. The half-life of 7-OH increased
with increasing dose and ranged from a mean of 1.7 to 4.7 hours. During the multiple dose
phase of the study, 7-OH steady state was reached in about 7 days (Huestis et al., 2024).
In another study examining the PK properties of 7-OH, sixteen healthy subjects (n=16) received
kratom tea containing 23.6 mg of mitragynine. Subjects were administered tea in two sessions:
once with tea alone, and in a second session following pretreatment with itraconazole, a
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CYP3A4 inhibitor. The 7-OH Cr was 12.81±3.39 ng/mL which occurred 1.7 h after
administration (Tm,.). In the second session after pretreatment with itraconazole (200 mg), the
Cma,, decreased 56% with a concomitant 43% decrease in AUC. These data describe the PK of
7-OH and demonstrate that the metabolism of mitragynine to 7-OH is heavily dependent on
CYP3A4 (Mongar et al., 2024).
Tanna et. al., assessed the PK of a single orally administered dose of kratom (2 g), in the form of
a tea, to healthy adult subjects (n = 5 completers). According to the authors, there were only
trace amounts of 7-OH (< LOQ) in the starting product, therefore, the assumption was made that
7-OH was generated from the metabolism of mitragynine in vivo. The authors identified a PK
difference between enantiomers of kratom alkaloids in either the 3S or 3R configuration. 7-OH
has a 3S configuration which, according to the authors, leads to a shorter Tma,,, lower exposure
(AUC), longer terminal half-life, and a higher volume of distribution during the terminal phase
compared to the 3R alkaloids. Measured 7-OH in plasma samples demonstrated that 7-OH had
a Cmex = 16.1 nM, Tmax = 1 h, half-life = 5.67h, and an AUCO-120h = 103nM x h.(Tanna et al.,
2022).
Epidemiological Data Sources
Limitations with the Epidemiological Data Sources
Because 7-OH appears to be a novel, emerging public health threat, the ability of public health
surveillance systems to monitor 7-OH specific risks may be limited. For example, large national
surveys such as the National Survey on Drug Use and Health include questions about use of
kratom, but not 7-OH. Additionally, there may be a lack of awareness among consumers of
kratom-related products that they are obtaining 7-OH enhanced products, and thus use of 7-OH
would likely be underreported in data collected using self -report. Many forensic laboratories
test for mitragynine as a marker of kratom use. In these cases, 7-OH overdose cases and
fatalities may incorrectly be classified as kratom and/or mitragynine-related (Smith, Boyer, et al.,
2024). Furthermore, toxicology reports documenting presence of 7-OH are difficult to interpret,
because 7-OH is a known metabolite of mitragynine in humans. All of these issues complicate
the real -world assessment of risks associated with use of 7-OH containing products as distinct
from risks associated with kratom and other mitragynine-containing products.
FDA's Adverse Event Reporting System
Although FDA's Adverse Event Reporting System (FAERS) has documented cases reporting
adverse events (13 cases, including 2 deaths) suspected to involve 7-OH, ambiguity about the
contributory role of 7-OH from uncharacterized products or concomitant medications and
underlying disease limits interpretation. Therefore, we do not include further analysis of these
FAERS cases here.
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America's Poison Centers, National Poison Data System
National Poison Data System (NPDS) receives near real-time data from the nation's poison
centers (PC), providing information and assistance to callers on exposures to prescription drugs,
over-the-counter medications, unapproved products, and other substances. PC healthcare
professionals systematically follow up on exposure cases to document medical and clinical
effects. Quality control measures are used to ensure data accuracy and completeness. Notably,
7-OH specific NPDS codes were only recently added (Feb -May 2025), and therefore the NPDS
reporting period is limited to 2/1/2025-4/30/2025. As shown below, there were a total of 53
exposure cases involving 7-OH during this time period, the majority of which involved abuse -
related reasons for use (i.e., "intentional abuse"). Most single -substance 7-OH exposure cases
resulted in minor or moderate clinical outcomes, with several documented has having major
clinical outcomes.
Table 1. National Poison Data System Closed Human Exposure Cases*,
2/1 /2025-4/30/2025
Total cases involving 7-OH
Number of
••
cases**
53
ingle
Numberof SSingle substance
abuse substance
cases** exposure cases
1 24 1 37 1 16
Reason
Adverse drug reaction
4
2
Intentional- abuse
24
16
Intentional- misuse
4
3
Intentional - Suspected suicide
2
0
Other — Withdrawal
8
6
Unintentional — general
4
4
Unintentional- misuse
1
1
Unintentional therapeutic error
4
3
Unknown reason
2
2
Related clinical outcomes
Minor
6
3
Moderate
13
6
Major
3
1
Not followed, minimal clinical
effects possible
5
3
Unable to follow, judged as
potentially toxic exposure
1
0
Age
<18 years
6
1
5
0
>_ 18 years
46
23
32
16
Unknown age
1
0
0
0
*Excludes cases classified as'confirmed non -exposure'
**Cases may involve other substances, besides 7-OH
Related clinical outcomes include cases with clinical effects deemed "related" to exposure based on timing,
severity, and assessment of clinical effects by Poison Center Specialists. Definitions available from America's
Poison Centers: NPDS Full Report 2023. Page 235.
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Note: This analysis used the case listing data in NPDS to identify and characterize cases documented as involving
7-OH. As of July 2025, an in-depth review NPDS case narrative data was ongoing; this further review may yield
different numbers from those presented here.
Summary of Epidemiological Data and 7-OH Concerns
Available surveillance data indicate that abuse of 7-OH is occurring and is associated with
serious harms; however, as noted previously, it is difficult to quantify the public health burden
because surveillance systems do not provide estimates for the prevalence of 7-OH use and are
only beginning to track the specific involvement of 7-OH enhanced products in exposure cases
and overdoses. The current epidemiologic data on 7-OH exposures often lack sufficient detail to
distinguish with confidence involvement of botanical kratom products from 7-OH enhanced
products.
Preclinical Data Characterizing 7-OH Pharmacology
Although there are limited data from human studies to characterize effects of 7-OH in humans,
as noted above, there is a large body of in vitro and animal studies that provide extensive
evidence of 7-OH as a potent mu opioid agonist, as described in below subsections.
In Vitro Data
Receptor Binding Studies
7-OH has been shown to have affinity and activity at mu opioid receptors. In a study using
human embryonic kidney (HEK) cells with cloned, human opioid receptors, 7-OH demonstrated
high affinity for the mu opioid receptor (Ki = 47 nM) relative to kappa (Ki = 188 nM) and delta
opioid receptors (Ki = 219 nM) (Kruegel et al., 2016). In a second study using HEK 293 cells
expressing human mu and other opioid receptors, 7-OH demonstrated high affinity for mu opioid
receptors (Ki = 16 ± 1 nM) and its affinity was greater than mitragynine (Ki = 238 ± 28 nM) and
lower than morphine (Ki = 1.50 ± 0.04 nM) (Todd et al., 2020). Using an in vitro radioligand
binding assay with CHO cells expressing murine-derived opioid receptors, 7-OH demonstrated
relatively high affinity for mu-opioid receptors (Ki = 37 ± 4 nM), relative to mitragynine (Ki = 230
± 47 nM), although its affinity was lower than morphine (Ki = 4.6 ± 1.8 nM) (Varadi et al., 2016).
Other studies conducted using whole brain homogenates of guinea pig brain tissue have also
demonstrated that 7-OH has high affinity at mu opioid receptors (Ki = 8.0 nM) relative to kappa
(Ki = 6.7 nM) and delta opioid receptors (Ki = 6.8 nM) (Matsumoto et al., 2004). Obeng and
colleagues evaluated the binding affinity of 7-OH using human recombinant HEK 293 cells
expressing mu opioid receptors. Their results are in agreement with the data presented above
where the authors found that 7-OH binds with high affinity (Ki = 7.2 nM) to mu opioid receptors
relative to delta (Ki = 236 nM) and kappa (Ki = 74.1 nM) receptor subtypes (Obeng et al., 2020).
A number of additional binding studies are in keeping with the data described above,
demonstrating the affinity of 7-OH for mu opioid receptors across a variety of binding assays
(Chakraborty et al., 2021; Matsumoto et al., 2008; Obeng et al., 2021; Takayama et al., 2002).
The results of the receptor binding studies with 7-OH are in keeping with in silico receptor
binding models that suggest 7-OH has high affinity for the mu opioid receptor. The in silico
modeling results were subsequently confirmed with a radioligand binding assay where 7-OH
demonstrated high affinity for cloned, human mu opioid receptors (K; = 70 nM). (Ellis et al.,
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2020). Collectively, the available receptor binding data demonstrate the affinity and binding of
7-OH to mu opioid receptors.
Functional Studies
Many of the studies referenced above performed additional assessments of 7-OH to determine
its functional activity after binding (i.e., agonist or antagonist effects). These studies have
consistently demonstrated that 7-OH produces mu-opioid agonist effects. For example, Kruegel
and colleagues examined the functional activity of 7-OH and mitragynine in HEK cells
expressing opioid receptors using a bioluminescence resonance energy transfer (BRET) assay.
Both mitragynine and 7-OH functioned as partial agonists, producing Emax values of 34% and
47% respectively and EC50 values of 339 ± 178 nM and 34.5 ± 4.5 nM (Kruegel et al., 2016).
Activation of the mu opioid receptor pathway was also investigated using forskolin-stimulated
cyclic adenosine monophosphate (cAMP) accumulation in Chinese Hamster Ovary (CHO) cells
expressing mu opioid receptors. In this assay, 7-OH produced a maximal activation (Emax) of
85.9%, a value similar to that produced by the positive control comparators DAMGO (86.2%)
and morphine (86.9%). These data suggest 7-OH acts a full mu opioid agonist (Todd et al.,
2020). Similarly, Matsumoto and colleagues concluded that 7-OH was "found to have an opioid
agonist property on p- and/or K-opioid receptors" based on its ability to inhibit contraction of
isolated guinea pig ileum. In this assay, 7-OH displayed approximately 13-fold greater potency
than morphine and 46-fold greater potency than mitragynine. The inhibition was reversed by
naloxone, suggesting the effects are mediated via mu opioid receptors (Matsumoto et al., 2004).
Other functional assays produced results that are aligned with Matsumoto and colleagues. For
example, using a cAMP mobilization assay as a measure of functional effects, 7-OH acted as a
full agonist with an EC50 of 7.6 nM, and was more potent than mitragynine (EC50307.5 nM)
(Obeng et al., 2020). Likewise, when evaluating the agonist activity of 7-OH in an electrically
stimulated guinea pig ileum, 7-OH acted as a full agonist and was more potent than morphine
(Takayama et al., 2002). Finally, using a [35S] GTPyS functional assay, 7-OH produced an Emax
of 77% with an EC50 of 53.4 nM, further demonstrating its agonist effects (Varadi et al., 2016).
Animal Data on Behavioral and Physiological Effects
Conditioned Place Preference
Conditioned place preference (CPP) is a commonly utilized animal model to study the rewarding
effects of drugs. In this paradigm, an animal is conditioned to associate a particular environment
with a drug treatment, and an alternative environment with a non -drug condition. After repeated
sessions, the animal is then observed under non -drug conditions to determine which
environment the animal prefers. CPP is established if the animal spends more time in the drug -
paired compartment vs. the vehicle -paired compartment (Mombelli, 2022; Prus et al., 2009).
Many drugs of abuse produce CPP, though notably, it is not a direct measure of reinforcing
effects.
Using the CPP paradigm, several studies have demonstrated the ability of 7-OH to produce
rewarding effects and that it does so more potently than morphine. Gutridge and colleagues
employed C57BL/6 mice and demonstrated the development of CPP after 3 mg/kg 7-OH. CPP
was observed after both doses although 7-OH required more sessions (4 sessions) whereas
morphine (6 mg/kg) was able to establish CPP in two sessions (Gutridge et al., 2020). Similarly,
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other studies have demonstrated the ability of 7-OH (2 mg/kg) to produce CPP, and that it does
so with greater potency than morphine (Matsumoto et al., 2008).
Drug Discrimination
Drug discrimination is an experimental method in which animals identify whether a test drug
produces interoceptive effects similar to those produced by a drug to which the animals are
trained to differentiate from placebo, and which has known pharmacological properties. If the
known drug is one with abuse potential, drug discrimination methods can be used to predict if a
test drug will have abuse potential in humans (Balster & Bigelow, 2003; Solinas et al., 2006).
For abuse assessment purposes, an animal is trained to press one bar when it receives a known
drug of abuse (the training drug) and another bar when it receives placebo. A challenge session
with the test drug determines which of the two bars the animal presses more often as an
indicator of whether the test drug is more like the known drug of abuse or more like placebo. A
test drug is said to have "full generalization" to the training drug when the test drug produces
bar pressing >80% on the bar associated with the training drug (Ator & Griffiths, 2003;
Swedberg, 2016; Walker, 2018; Young, 2009). A test drug that generalizes to a known drug of
abuse will likely be abused by humans (Balster and Bigelow, 2003).
Male Sprague Dawley rats were trained to discriminate morphine (5.0 mg/kg i.p.) from saline
using a 30 min pretreatment time and FR10 schedule of reinforcement. After successful
training, substitution tests with 7-OH (0.3, 1.0 and 3.0 mg/kg) were performed. The highest dose
of 7-OH (3.0 mg/kg) produced complete substitution for the morphine stimulus cue. Moreover,
pretreatment with naloxone significantly reversed the 7-OH substitution and resulted in saline -
like responding. Notably, in this study, 7-OH was more potent than morphine (Harun et al.,
2015).
In a second study, the discriminative stimulus effects of 7-OH were examined in separate groups
of rats trained to discriminate either morphine (3.2 mg/kg i.p., 15 min pretreatment) or
mitragynine (32 mg/kg i.p., 30 min pretreatment) from saline. After successful acquisition of
discrimination training 7-OH was administered in substitution tests. 7-OH was administered i.p.,
with a 15 min pretreatment time in a dose range of 0.1-17.8 mg/kg. In the morphine -trained rats,
7-OH produced complete substitution at doses above 0.56 mg/kg, with the 1.0 mg/kg dose
producing 100% drug -lever -appropriate responding and a resultant ED50 of 0.28 mg/kg. Notably,
the dose -response curve was shifted to the left, demonstrating an increased potency of 7-OH
relative to morphine. In addition, pretreatment with 0.032 mg/kg naltrexone shifted the dose -
response curve to the right suggesting substitution was mediated via mu-opioid receptors
(Obeng et al., 2021). Taken together, the drug discrimination data demonstrate the ability of 7-
OH to substitute and mimic the stimulus effects of morphine, and that 7-OH is more potent in
doing so. These data are a strong indication that 7-OH produces subjective effects in humans
that are similar to opioids, along with an associated abuse potential.
Self -Administration
Self -administration is a method that assesses whether a drug produces reinforcing effects that
increase the likelihood of behavioral responses in order to obtain additional drug (i.e., whether
an animal will press a lever for a drug injection). Drugs that are self-administered by animals are
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likely to produce rewarding effects in humans, which is indicative of abuse potential. Generally,
a good correlation exists between those drugs that are self-administered by animals and those
that are abused by humans (Balster & Bigelow, 2003; Brady et al., 1987; Johanson & Schuster,
1981; Panlilio & Goldberg, 2007). It is notable that self -administration is a behavior that is
produced by drugs that have been placed into every schedule of the CSA. Additionally, rates of
self -administration for a particular drug will go up or down if the available drug dose or the work
requirement (bar pressing for drug) is altered. Positive results from a self -administration study
provide an abuse potential signal, suggesting that a drug has rewarding properties, but not
necessarily that it produces more rewarding effects than another drug in humans.
7-OH produces reinforcing effects and is self-administered by rodents. In the study, rodents
were trained to self-administer morphine (100 pg/infusion) and faded to 50 pg/infusion once
stable responding was achieved. Thereafter, extinction sessions were performed to confirm
acquisition of the self -administration training prior to substitution tests. Substitution tests were
performed with 7-OH doses of 2.5, 5, 10 and 20 pg/infusion. In the substitution tests, 7-OH
produced an inverted U-shaped curve and the number of infusions for 5 and 10 pg/infusion of 7-
OH were significantly greater than vehicle, demonstrating the reinforcing effects of 7-OH
(Hemby et al., 2019).
The self -administration of 7-OH was blocked by both a mu opioid antagonist (naloxonazine) and
a delta opioid antagonist (naltrindole), suggesting its reinforcing effects are mediated via opioid
receptors. In addition, peak morphine self -administration occurred at 50 pg/infusion while peak
7-OH infusions occurred at 5 pg/infusion, demonstrating a substantially increased potency of 7-
OH relative to morphine.
There are some pharmacokinetic (PK) data available from animal studies involving the
administration of isolated, i.e., single entity, 7-OH. Following a single oral dose (1 mg/kg 7-OH)
to beagle dogs, absorption was rapid, with a peak plasma concentration (i.e., Cmax) of 56 ± 1.6
ng/mL 15 minutes post -dose. The elimination half-life was slower, producing a mean of 3.6 ±
0.5 h. No AEs were observed, and no abnormal laboratory findings were reported (Maxwell et
al., 2021). In adult male and female mice, the PK parameters of 7-OH were investigated after a
single oral dose of 50 mg/kg 7-OH. The tissue distribution of 7-OH was observed in descending
order: liver > kidney > spleen > lung > brain. Plasme Cmax values were 0.6 and 09 pg/mL in
males and females with a T max value of 0.5 hr. Area under the curve (AUC) values over 48
hours (AUCO-48 hr* pg/mL) were 1.4 and 2.9 in male and female mice (Berthold et al., 2022).
Antinociceptive Effects
The antinociceptive effects of 7-OH were investigated in mice using the tail flick and hot plate
tests. These tests are commonly used to examine pain and analgesic effects in rodents
(D'Amour & Smith, 1941). In these tests, rodents are subject to a heat stimulus and timed for
the duration it takes to move their tail (i.e., tail flick) or produce a response such as jumping,
licking, or shaking of limbs (i.e., hot plate).
In the tail flick test, subcutaneous administration of 7-OH (2.5 — 10 mg/kg) produced both time
and dose -related antinociceptive effects. Notably, the dose -effect curve for 7-OH was shifted to
the left, indicating a greater potency than the positive control comparator, morphine. Similar
results were observed in the hot plate test, and when morphine and 7-OH were administered
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orally. Naloxone (2 mg/kg s.c.) inhibited the effects of 7-OH and morphine in both tests
(Matsumoto et al., 2004; Matsumoto et al., 2008). Concurrent results were observed by Obeng
and colleagues using the hot plate test. In their study, 7-OH (0.0032 — 3.2 mg/kg, i.v.) produced
maximum antinociceptive effects and was more potent morphine but less potent than fentanyl
when administered intravenously. Likewise, naltrexone (0.1 mg/kg) reversed the antinociceptive
effects of 7-OH suggesting the antinociception was mediated via mu opioid receptors (Obeng et
al., 2020).
Respiratory Depression
A major risk of opioid exposure and cause of opioid-induced death is respiratory depression
(Baldo & Rose, 2022; Bateman et al., 2023). To examine the respiratory effects of 7-OH in
rodents, whole body plethysmography was used in freely moving, awake rats. Both morphine
(10 and 32 mg/kg, im.) and 7-OH (1, 3.2, and 10 mg/kg, im.) induced significant respiratory
depression as assessed by minute volume, tidal volume, and breathing frequency. The mu-
opioid agonist naloxone (1.0 mg/kg i.v.) reversed these effects, a finding consistent with the mu
opioid effects of 7-OH (Zuarth Gonzalez et al., 2025). These data highlight a potential risk factor
of 7-OH exposure and suggest 7-OH may expose individuals to similar risks as classic opioids,
including respiratory depression.
Physical Dependence and Withdrawal
It is well -established that chronic administration of opioids leads to the development of tolerance
and physical dependence that may culminate into a withdrawal syndrome. In parallel with some
of the hot plate tests described above, the ability of 7-OH to produce physical dependence and
withdrawal was examined. Mice were treated with subcutaneous 7-OH (10 mg/kg b.i.d.) or
morphine (10 mg/kg b.i.d.) for five days. Tolerance was assessed as a reduction of analgesia in
the hot plate test. After five days of treatment, both morphine and 7-OH showed a decreased
analgesic response on the hot plate test, demonstrating the development of tolerance. In
addition, cross -tolerance was also observed between morphine and 7-OH suggesting a similar
mechanism of action between the drugs. Finally, after five days of escalating doses of 7-OH and
morphine (8-45 mg/kg b.i.d.) the development of withdrawal was assessed with a 3 mg/kg s.c.,
dose of naloxone injected two hours after 7-OH administration. Both morphine and 7-OH
treatment produced signs of withdrawal such as jumping, rearing, urination, ptosis, forepaw
tremor, and diarrhea (Matsumoto et al., 2005).
Summary of Preclinical Data
From the studies described above, 7-OH has high affinity for mu opioid receptors and functional
activity as an agonist at these receptors. Consistent with this pharmacological activity, 7-OH is
self-administered by animals, substitutes for morphine in drug discrimination studies, produces
antinociception, and physical dependence leading to withdrawal when administered to rodents.
Moreover, 7-OH has consistently demonstrated an increased potency relative to morphine in
preclinical rodent studies. These observations suggest 7-OH has pharmacological properties
representative of a full mu opioid agonist and an associated high potential for abuse.
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CONCLUSIONS
The data described in this report indicate that 7-OH has a significant potential for abuse and
associated harms. Conclusively, 7-OH has high affinity and agonist activity at mu opioid
receptors. Consistent with this pharmacological mechanism of action, 7-OH demonstrates
rewarding effects in that it is self-administered by animals and also produces conditioned place
preference, two well -established animal behavioral models measuring rewarding effects as a
predictor of abuse potential in humans. In animal drug discrimination studies, 7-OH substitutes
for morphine with full generalization. 7-OH is also demonstrated to produce antinociception
consistent with opioid pharmacology, and to produce physical dependence when administered
to rodents, as evidenced by a classic set of withdrawal signs associated with opioid withdrawal
upon discontinuation of opioid administration. Moreover, 7-OH in all above models has
consistently demonstrated an increased potency relative to morphine.
Due to the fact that 7-OH is both a metabolite of mitragynine and naturally present in low
amounts in botanical kratom, using toxicology results to identify 7-OH as a primary or sole
contributor in human exposures is challenging. There is also a need for improved clinical
awareness and population surveillance to better characterize patterns of 7-OH use, the products
that people are obtaining, and individual treatment needs following 7-OH exposure. Additionally,
questions on 7-OH are not generally included in national surveys, and other data sources that
rely on self -reported use of 7-OH likely underestimate the number of 7-OH exposure cases, as
individuals may be unaware of the distinction from kratom products. Nonetheless, since specific
codes were added earlier this year to document 7-OH exposure cases, U.S. poison centers have
identified multiple single -substance cases of 7-OH exposure resulting in serious adverse clinical
outcomes. Also, although anecdotal, social media and online forums indicate growing awareness
and use of 7-01-1, and many testimonials of the negative opioid-mediated effects users have
experienced, including 7-OH dependence, associated withdrawal syndrome, and addiction.
In the current marketplace in the U.S., 7-OH is increasingly being marketed over-the-counter
and online, in concentrated forms or sufficient doses to cause harms to those individuals
engaging, knowingly or unknowingly, in use of 7-01-1. Based on demonstrated pharmacology,
repeated or prolonged use of 7-OH would lead to tolerance, physical dependence, and
potentially to opioid addiction— typical of mu opioid agonist drugs of abuse. This public health
threat is troubling and requires immediate and impactful policies to educate consumers and take
regulatory action that limits access to 7-OH containing products.
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A'1"1'ACHMENT 2
ORDINANCE NO. 1571
AN ORDINANCE OF THE CITY COUNCIL OF THE CITY OF
TUSTIN, CALIFORNIA, ADDING CHAPTER 10
(PROHIBITION ON THE SALE AND DISTRIBUTION OF
KRATOM PRODUCTS) TO ARTICLE 6 (PUBLIC
WELFARE) OF THE TUSTIN CITY CODE.
The City Council of the City of Tustin does hereby ordain as follows:
SECTION 1. The City Council finds and determines as follows:
A. The City of Tustin ("City") is empowered pursuant to California Constitution, Article
XI, Section 7, to make and enforce within its jurisdiction all local, police, sanitary,
and other ordinances and regulations not in conflict with general laws.
B. California Health & Safety Code section 101450 empowers the City Council to take
measures necessary to preserve and protect the public health, including adopting
ordinances, regulations, and orders that are not in conflict with general laws.
C. The kratom plant (Migtragyna speciosa) is a tropical evergreen tree native to
Southeast Asia, the leaves of which contain psychoactive constituents, including
the compounds mitragynine, and 7-Hydroxymitragynine (" 7-OH").
D. The U.S. Food and Drug Administration ("FDA") has stated that the increased
availability and marketing of certain products containing kratom leaves and/or their
components poses an emerging public health threat, especially when considering
the increasing availability of enhanced or concentrated kratom products in the
marketplace.
E. The FDA has indicated that 7-OH produces respiratory depression, physical
dependence, and withdrawal symptoms characteristic of classical opioids, such as
fentanyl, oxycodone, and hydrocodone, and that the pharmacological profile,
abuse liability, and emerging patterns of non -medical use establish 7-OH as a
dangerous substance.
F. Despite the fact that the kratom leaf and its chemical components are unlawful
when added to conventional foods, as dietary supplements, or as ingredients in
any FDA -approved drug, there are currently no laws which prohibit sale of these
products.
G. The FDA has confirmed that current regulatory gaps have enabled widespread
availability of kratom products despite their opioid-like properties, which
necessitates immediate policy intervention to address this emerging threat to
American Public Health.
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H. Kratom products are not regulated by the United States government, nor are they
subject to government -mandated safety checks, which has resulted in a lack of
oversight and safety standards for use, regulation of ingredients, purity levels, and
dosage.
I. Various state and local governments have prohibited the sale and distribution of
kratom products in their respective jurisdictions.
J. The City desires to prohibit the sale and distribution of kratom products within the
City in order to protect the public health and welfare of its residents.
SECTION 2. New Chapter 10 (Prohibition on the Sale and Distribution of Kratom
Products) is hereby added to Article 6 (Public Welfare) of the Tustin City Code to read as
follows:
CHAPTER 10 — PROHIBITION ON THE SALE OF KRATOM PRODUCTS
6930 — DEFINITIONS
The following words, terms, and phrases when used in this chapter shall have the
meanings ascribed to them in this section, except when the context clearly indicates a
different meaning:
(1) "Distribute" means to furnish, give away, exchange, transfer, deliver, or supply,
whether or not for monetary gain.
(2) "Kratom Product" means the leaf of the plant Mitragyna speciosa or any food
product, food ingredient, dietary ingredient, dietary supplement, or beverage
intended for human consumption that contains any part of the leaf of the plant
Mitragyna speciosa or any extract, synthetic alkaloid, or synthetically derived
compound of such plant or its leaf, including but not limited to, any powder,
capsule, pill, beverage, or other edible product intended for human consumption.
(3) "Leaf' means any or all parts of the leaf of the plant Mitragyna speciosa that
contains mitragynine or 7-Hydroxymitragynine.
(4) "Sell" or "sale" means to furnish, exchange, transfer, deliver, or supply for monetary
gain.
6931 — SALE AND DISTRIBUTION OF KRATOM PROHIBITED
(a) It is unlawful to sell, advertise for sale, offer for sale, or distribute, directly or
indirectly, any kratom product in the City.
(b) It is unlawful to sell, advertise for sale, offer for sale, or distribute, directly or
indirectly, any product, the packaging for which indicates, implies, or otherwise
4908-0360-5100, v. 1
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suggests that the product contains kratom leaf, mitragynine, 7-
Hydroxymitragynine, or "7-OH."
SECTION 3. Effective Date. This Ordinance shall take effect on the 31st day after its
adoption. The City Clerk or his or her duly appointed deputy shall certify to adoption of
the Ordinance and cause this Ordinance to be published as required by law.
SECTION 4. CEQA Exemption. The City Council finds that this Ordinance is not subject
to the California Environmental Quality Act (CEQA) pursuant to Title 14 of the California
Code of Regulations, Chapter 3, sections 15060, subdivision (c)(2) (the activity will not
result in a direct or reasonably foreseeable indirect physical change in the environment)
and 15060, subdivision (c)(3) (the activity is not a project as defined in section 15378 and
by Public Resources Code section 21065) because it has no potential for resulting in
physical change to the environment, directly or indirectly.
SECTION 5. Severability. If any section, subsection, sentence, clause, phrase or portion
of this Ordinance is for any reason held out to be invalid or unconstitutional by the decision
of any court of competent jurisdiction, such decision shall not affect the validity of the
remaining portions of this Ordinance. The City Council of the City of Tustin hereby
declares that it would have adopted this Ordinance and each section, subsection, clause,
phrase or portion thereof irrespective of the fact that any one or more sections,
subsections, sentences, clauses, phrases, or portions be declared invalid or
unconstitutional.
PASSED AND ADOPTED, at a regular meeting of the City Council for the City of Tustin
on this day of )2025.
AUSTIN LUMBARD, MAYOR
ATTEST:
ERICA N. YASUDA, CITY CLERK
APPROVED AS TO FORM:
DocuSigned by:
DA DIG, CITYATTORNEY
4908-0360-5100, v. 1
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STATE OF CALIFORNIA )
COUNTY OF ORANGE ) ss.
CITY OF TUSTIN )
CERTIFICATION FOR ORDINANCE NO. 1571
Erica N. Yasuda, City Clerk and ex-officio Clerk of the City Council of the City of Tustin,
California, does hereby certify that the whole number of the members of the City Council
of the City of Tustin is five; that the above and foregoing Ordinance No. 1571 was duly
passed, and adopted at a regular meeting of the Tustin City Council held on the _ day
of , 2025, by the following vote:
COUNCILPERSONS AYES:
COUNCILPERSONS NOES:
COUNCILPERSONS ABSTAINED:
COUNCILPERSONS ABSENT:
Erica N. Yasuda, City Clerk
Published:
4908-0360-5100, v. 1