Kratom Feasibility Report

Senate Bill 22-120:
Regulation of Kratom Processors

Feasibility Report
Mark Ferrandino
Executive Director
State Licensing Authority
Colorado Department of Revenue1
January 4, 2023
1
Staff for the Department of Revenue Liquor Enforcement Division and Marijuana Enforcement Division
contributed to the research and contents of this report. The content of this report reflects recommendations from the
Department of Revenue and should not be deemed the administration’s position.
SB 22-120 Concerning Regulation of Kratom Processors
DOR FEASIBILITY REPORT AND RECOMMENDATIONS
TABLE OF CONTENTS
EXECUTIVE SUMMARY 4
PURPOSE 6
BACKGROUND 7
Current Legal Status of Kratom in Colorado 7
Colorado’s Kratom Market 7
Review of Regulatory Trends 8
Kratom Consumption 8
Product Types 8
Kratom Dosage 9
Uses for Kratom 10
Poly-Substance Use and Adulteration Considerations 10
DEPARTMENT RECOMMENDATIONS FOR THE REGULATION OF KRATOM 11
RECOMMENDATION #1: PROPOSED DEFINITIONS 11
RECOMMENDATION #2: PRODUCTS PERMITTED 13
RECOMMENDATION #3: SALES RESTRICTIONS 13
RECOMMENDATION #4: LABELING REQUIREMENTS 13
RECOMMENDATION #5: MANUFACTURING STANDARDS 14
RECOMMENDATION #6: TESTING REQUIREMENTS 15

Third Party Testing Program 15
Proposed Test Types 16
Elemental Impurities Testing 16
Alkaloid Concentration Testing 16
Microbial Contaminant Testing 17
Pesticide Testing 17
Surveillance Testing Program 17
Adulterant Testing 18
RECOMMENDATION #7: RECORDKEEPING 18
RECOMMENDATION #8: AGENCIES INVOLVED IN REGULATION OF KRATOM 19
RECOMMENDATION #9: FEES 20
2
RECOMMENDATION #10: TAXES 20
ESTIMATED FISCAL IMPACTS 21
TIMELINE FOR REGULATORY IMPLEMENTATION 23
ALTERNATIVES TO REGULATION 24
CONCLUSION 25
REPORT SUPPLEMENT 26
3
EXECUTIVE SUMMARY
Senate Bill 22-120 directs the Department of Revenue (hereinafter referred to as the Department or DOR)
to study the feasibility of regulating kratom processors, kratom retailers, and kratom products in the state
of Colorado and to submit a report including recommendations for legislative action.
Recommendation #1: Proposed Statutory Definitions
The Department recommends the General Assembly adopt statutory definitions for the following terms
to assist the responsible agency(ies) in promulgating rules: Adverse Health Event Reporting, Advertising,
Approved Kratom Delivery Form, Batch, Batch Number, Certificate of Analysis, Third-Party Laboratory,
Kratom, Kratom Processor, Kratom Product, Kratom Retailer, and Processing.
Recommendation #2: Products Permitted
The Department recommends the General Assembly expressly permit kratom product types where the
kratom plant is in its natural botanical form [e.g. leaves in their whole, crushed or powder form,
capsules, tablets, and tea bags with these contents, as well as extracts of the same] and provide
responsible Department(s) with general rulemaking authority to establish appropriate regulations for
kratom products as necessary for occupational and consumer safety.
Recommendation #3: Sales Restrictions
The Department recommends the General Assembly maintain the existing statutory restriction
regarding the sale of kratom products to persons under 21 years of age.
Recommendation #4: Labeling Requirements
The Department recommends the General Assembly provide rulemaking authority to responsible
agency(ies) to establish labeling requirements for kratom products to include: the list of ingredients,
batch number, identity and address of manufacturer, no health or medical claims, potency test results, and
other requirements for consumer awareness and public health and safety.
Recommendation #5: Manufacturing Standards
The Department recommends the General Assembly require kratom processors to meet standards
similar to manufacturers of dietary supplements. This helps ensure the facility maintains sanitation
standards and safe practices for employees, and can trace products if an adverse health event necessitates
a recall. This involves applying minimum standards comparable to current 21 CFR Part 111, Current
Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, as well as ISO 9001 (Quality Management System), and ISO 22000 (Food Safety).
Recommendation #6: Testing Requirements
The Department recommends the General Assembly provide rulemaking authority to establish minimum
testing requirements (including potency, microbial contamination, elemental impurities, and pesticides
testing) and allow kratom processors to use third-party laboratories (certified by the Department of
Public Health and Environment) for testing compliance.
4
Recommendation #7: Record Keeping

Consistent with Recommendation #5, the Department recommends the General Assembly require kratom
processors to maintain records consistent with 21 CFR Part 111 and for ISO certification, which
address testing results and traceability requirements (for adverse health events). This involves applying
minimum standards comparable to current 21 CFR Part 111, (Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplement), as well as ISO
9001 (Quality Management System), and ISO 22000 (Food Safety).
Recommendation #8: Agencies Involved in Regulation of Kratom

With appropriate statutory authority and resources, the following agencies are well suited to support and
coordinate in the implementation and administration of a kratom regulatory framework in Colorado:
Department of Revenue - Duties include licensing processors & retailers, investigations (e.g. underage
checks, adverse events), test sample collection, and compliance education.
Department of Public Health & Environment - Duties include certification of testing laboratories,
adverse health event reporting, and administration of a testing surveillance program. Paired with
Recommendation #6, a testing surveillance program specific to kratom offers reinforcing public health
measures by enabling the public health department to monitor and support investigations involving
kratom testing compliance and adverse health events. This involves random inspections and sample
collection, where testing can be conducted at the state public health laboratory for contaminants,
including elemental impurities (e.g. lead, nickel), pesticides, microbial contaminants (e.g. mold,
salmonella), and adulterants (e.g. morphine or hydrocodone).
Additionally, the regulation of kratom in Colorado may warrant the creation of a separate division and
cash fund within the department the General Assembly assigns primary regulatory responsibilities. Recent
developments specific to intoxicating hemp and psilocybin may also inform the overall structure (for
example, to consider opportunities to employ existing resources if/where appropriate).
Recommendation #9: Fees
The Department recommends the General Assembly authorize the responsible agency to collect fees for
the application and licensing of kratom processors and retailers. Such fees should be deposited into a
specific kratom fund for annual appropriation and fees should be reasonable to cover the direct and
indirect costs of the program. To support initial implementation, the General Assembly should dedicate
general funds to cover the expenses of the start up of the regulatory program through the first year and
establish an enterprise fund under article X section 20 of the Colorado Constitution.
Recommendation #10: Taxes
The Department recommends that kratom products continue to be subject to the statewide sales tax laws
and accompanying regulations. Based on the Department’s research, most states regulating kratom do
not impose special tax requirements on kratom products.
5
PURPOSE
On May 26, 2022, Governor Polis signed Senate Bill 22-120, Concerning the Regulation of Kratom
Processors. Effective July 1, 2024, Senate Bill 22-120 established statutory restrictions on the sale of
kratom products under section 44-1-105(3), C.R.S., and established criminal liability for the sale of
kratom products to a person under twenty-one years of age under section 18-13-132(1)(a), C.R.S.
Senate Bill 22-120 further directs the Executive Director/CEO of the Colorado Department of Revenue
(“Executive Director”) to submit a report that analyzes the feasibility of regulating kratom products,
kratom processors, and kratom retailers on or before January 4, 2023. As directed by the bill under section
44-1-105(2), C.R.S., the feasibility report must identify, consider, and recommend legislative action
addressing several subjects, including:
● The appropriate state agency or agencies to regulate the manufacture, sale, offering for sale,
possession, or use of kratom products;
● Appropriate definitions of terms including “processing,” “selling,” “advertising,” “kratom,” and
“kratom products;”
● Appropriate age restrictions for kratom purchasing and consumption;
● Feasibility and enforcement of underage compliance checks;
● A testing program for identifying kratom products;
● An evaluation of the competencies and capabilities of existing private third-party laboratories to
manage kratom testing;
● The appropriate standards for laboratory accreditation and performance;
● Testing requirements for identifying kratom that is offered for sale to a Colorado consumer;
● Consideration of types of kratom products that are available as food, including tea powders,
gummies, beverages, pills, capsules, and extracts;
● The types of kratom products that should not be permitted to be sold or offered for sale;
● Serving sizes and related restrictions;
● Labeling requirements including a prohibition on unproven health or medical benefit claims;
● Manufacturing processes and requirements for processors;
● Current good manufacturing process requirements under regulations promulgated by the federal
drug administration for any vendor processing kratom;
● Adverse health-event reporting requirements and product recalls;
● Advertising requirements, limitations, and prohibitions;
● Tax and fee considerations;
● Recordkeeping;
● Traceability;
● Criminal and administrative penalties for violations;
● Recommendations regarding an operable timeline for implementation of a regulatory framework
for kratom;
● Fiscal impacts and resource requirements for implementation and ongoing administration of a
regulatory program for kratom; and
● Alternatives, including consumer protection requirements such as liability insurance
requirements, prohibitions, and criminal penalties, to state regulation of kratom.
Lastly, the bill directs the Executive Director to engage kratom processors, kratom consumers, kratom
retailers, public health officials, legislative members, relevant state agencies with expertise in similar
6
regulatory fields, local governments, and other interested stakeholders in conducting the feasibility study
and compiling the final report and recommendations.
BACKGROUND
Current Legal Status of Kratom in Colorado
This recommended regulatory structure, if implemented, would commence regulation of kratom in the
state of Colorado. Current state law does not expressly permit or prohibit the commercial production or
sale of kratom in Colorado. At the local level, two Colorado localities have made express prohibitions
against the sale of kratom products: Parker and Monument. Additionally, Denver established labeling
requirements and Castle Rock imposed age limitations.2
● Denver - The Denver Environmental Health (DEH) Public Health Inspections Division issued a
release on November 20, 2017 restricting the sale or serving of kratom for human consumption.3
The release described how Denver retailers selling kratom for non-consumptive use must affix a
consumer advisory to each package describing the risks and that the product is not intended for
human consumption. The release also directs that retailers cannot provide consumers with
guidance for dosage or consumption.
● Parker - Parker’s Ordinance number 5.83 § 1 describes that, “[n]o person shall sell or offer to sell
at retail within [Parker] any kratom products intended for human consumption.”4 The ordinance
defines kratom as any product, material, compound, mixture, or preparation derived from the
plant Mitragyna speciosa, or containing any quantity of the 7-Hydroxymitragynine, mitragynine,
and Epicatechin.
● Monument - Monument similarly created Ordinance number 35-2019 under chapter 8.34 of its
municipal code defining kratom and prohibiting the sale of any kratom product at retail for human
consumption.5
Colorado’s Kratom Market

● Retailers - Department research indicates there are approximately 282 physical stores in Colorado
that either have kratom in their name, advertise that they sell kratom, or have online reviews from
the public mentioning their purchase of kratom at the retailer. The total number of kratom
retailers is unknown, however. Kratom products can be found in brick-and-mortar locations
dedicated to the sale of kratom products, as well as smoke shops, gas stations, and liquor and
tobacco stores. As it regards tobacco stores, as of December 28, 2022, there were 4,048 licensed
tobacco retailers in the state. Kratom products are also widely available online.
2
Town of Castle Rock, Notice of Adopted Ordinance, Ordinance No. 2019-011, (June 5, 2019),
https://www.crgov.com/ArchiveCenter/ViewFile/Item/2230 (Accessed December 6, 2022).
3
City and County of Denver Statement, Denver Environmental Health Restricts the Sale or Serving of Kratom for Human
Consumption (Nov. 20, 2017),
https://www.denvergov.org/content/dam/denvergov/Portals/771/documents/PHI/11.20.17%20Kratom%20Press%20Release.pdf.
4
PARKER, CO., REV. ORDINANCES ch. 6.07, § 10 (2019).
5
MONUMENT, CO., REV ORDINANCES ch. 8.34 §§ 10-30 (2019).
7
● Processors & Laboratories - Through the Department’s survey of stakeholders, only two (2)
laboratories (both located in Colorado) indicated they test kratom products. During our targeted
consultation, the American Kratom Association (AKA) relayed that they are aware of at least ten
(10) processors in Colorado, and one (1) testing facility in Colorado that is offering testing
services for potency (alkaloid concentration testing), metals (elemental impurities), and microbial
contaminants. Other stakeholders we spoke with believed there are between ten (10) and 15
processors in the state.
Review of Regulatory Trends

There are currently nine (9) states that regulate kratom. The regulation of kratom spans administrative
departments from state-to-state and varies in complexity and extent of regulatory and/or law enforcement
oversight. Please see Appendix 3 – Review of Regulatory Structures Across the Country for a listing of the
states along with their corresponding enforcement and labeling requirements as applicable.
The Department’s research has also revealed international perspectives from drug policy experts who
argue against banning kratom products while also noting that the expansion of the international kratom
market and the variety of products marketed as either an herbal medicine, health supplement, or for
recreational purposes warrants regulatory attention.6 Indeed, other countries have changed course from
strict bans and enforcement to more recently decriminalizing traditional uses of kratom. Specifically, in
Thailand, as of 2021, individuals can manufacture kratom products if they have a permit from the Thai
Food and Drug Administration. 7 This informs the Department’s recommendations regarding the
regulation of kratom in Colorado and highlights the importance of ensuring responsible agencies are
provided sufficient resources and rulemaking authority to establish appropriate regulatory standards,
mitigate and quickly respond to public health risks/events, and evolve regulations as more research
becomes available.
Kratom Consumption
Product Types
Currently there are several kratom products that exist on the market today. One study reports that the
most common method of consumption is by liquid, but the use of powders in food and beverage is also
predominant.8 Smith et al, reported that 37% of respondents in a study conducted by Garcia-Romeu et al,
consumed kratom as a prepared beverage, 43.6% ingested it as a raw powder, and 18.9% ingested it as a
capsule9. The DEA reports users ingesting kratom via tablet, capsules, or extracts. They also report that
kratom leaves may be chewed or crushed into powder and used as a tea.10
6
Jelsma, Martin, transnational institute. Kratom: the creation of a threat, a policy commentary on the WHO pre-review of
kratom. Oct. 8, 2021. https://www.tni.org/en/publication/kratom-the-creation-of-a-threat.
7
Jelsma, Martin. Kratom: the creation of a threat, a policy commentary on the WHO pre-review of kratom. Oct. 8, 2021.
8
Veltri, Charles, and Oliver Grundmann. “Current perspectives on the impact of Kratom use.” Substance abuse and rehabilitation
vol. 10 23-31. 1 Jul. 2019, doi:10.2147/SAR.S164261 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612999/.
9
Smith, Kirsten Elin, et al. "Searching for a signal: self-reported kratom dose-effect relationships among a sample of US adults
with regular kratom use histories." Frontiers in pharmacology (2022): 445.
https://www.frontiersin.org/articles/10.3389/fphar.2022.765917/full.
10
https://www.dea.gov/sites/default/files/2020-06/Kratom-2020.pdf.
8
As it relates to kratom concentrates, based on the Department’s research and feedback from public health
officials, there is not enough information available on dosage, serving size, or interactions with other
drugs, both legal and illicit, to determine appropriate regulations for certain product types such as
concentrates. Furthermore, concentrates offer a far greater ability to intake high dosages. According to the
AKA, overconsumption of kratom in its natural form is nearly impossible due to the fact that at certain
levels of intake it causes gastrointestinal distress, especially nausea and vomiting. It is unknown whether
this natural mechanism to protect against overdose could be bypassed in concentrated products. However,
kratom products that have been extracted by FDA approved food-grade extraction processes pose a
significantly reduced risk in regard to contaminants such as Lead and Microbials. This serves as an
example of where delegated rulemaking authority can allow agencies to evolve regulations as more
research becomes available.
Kratom Dosage
There is little research into kratom dosing and its corresponding effects. According to Prozialeck et al.,
low to moderate doses (1-5 grams) of Kratom leaves produce mild stimulant effects, while moderate to
high doses (5-15 grams) produce opioid-like effects. Very high doses (>15 g) produce sedative effects.11
Smith et al., reported that data collected on kratom users in the U.S. found the typical dose of kratom was
1-3 grams (49%) or 4-6 grams (33.4%), with most respondents reporting daily kratom use. The most
beneficial effects were observed when taking 1-3 grams 2-3 times per day, with adverse effects occurring
at doses higher than 8 grams, 4-5 times a day. The most widely reported adverse effects when consuming
kratom are nausea, vomiting, constipation, and headaches. Other effects reported include increased
anxiety, nervousness, and somatic symptoms such as dehydration or rashes. Regarding withdrawal effects,
57.5% reported zero negative withdrawal effects at 12, 24, and 48 hour intervals after ceasing
consumption of kratom. For those who did experience withdrawal symptoms, they were rarely noted as
being severe.12
Per different online kratom forums, users report an onset of effects within 5-15 minutes that last from 2-5
hours. The doses vary per person and tolerance level, as well as the type of product and potency. 13 Smith
et al., reported that 82.9% of kratom users felt the effects within minutes and 11.6% felt the effects within
hours. 91.5% of kratom users reported effects dissipating after a few hours.14
11
Prozialeck, Walter C., Jivan, Jateen K. and Andurkar, Shridhar V.. "Pharmacology of Kratom: An Emerging Botanical Agent
With Stimulant, Analgesic and Opioid-Like Effects" Journal of Osteopathic Medicine, vol. 112, no. 12, 2012, pp. 792-799.
https://doi.org/10.7556/jaoa.2012.112.12.792.
https://www.degruyter.com/document/doi/10.7556/jaoa.2012.112.12.792/html#j_jaoa.2012.112.12.792_ref_020.
12
13
https://www.erowid.org/plants/kratom/kratom_dose.shtml.
14
9
Uses for Kratom

Review of scientific journals indicates that kratom has been increasingly used to manage pain and
management of opioid withdrawal.15 Garcia-Romeu conducted a survey on 2,798 kratom users and found
that 91.3% of users advocated for using kratom as pain relief and to treat mood related disorders such as
anxiety (67.2%) and depression (64.2%). 40.9% of respondents reported using kratom to stop the use of
prescription or illicit opioids.16 Smith et al., further reported that the kratom use is evolving within the
U.S., leaving the need for frequent evaluations on the motivations behind kratom use. In Southeast Asia,
kratom use consists of medicinal, cultural, recreational, and energy-enhancing purposes.17
Resources provided to the Department by the American Kratom Association do indicate the following
positive aspects in regard to harm reduction and comparison to other opioids. “Mitragyna speciosa, also
known as kratom, has the potential [to] meet the need for pain medications that lack the addictiveness and
overdose risk of classical opioid analgesics, such as morphine. This need is urgent because opioid
addiction and overdose deaths have risen throughout diverse segments of U.S. society. Some opioid
addicts have found relief in kratom preparations. The use of kratom as an analgesic has been validated by
historical accounts and contemporary pharmacological research. Although kratom is a promising source
of analgesic candidates, it is a euphoriant with potential for both abuse and addiction. However, kratom
appears to be less addictive and to have milder withdrawal symptoms than opioid drugs. Thus, there is a
need to balance the potential medical benefits and abuse of M. speciosa.”18
Poly-Substance Use and Adulteration Considerations
Poly-substance abuse has been cited as a contributing factor in the majority of reported kratom-related
deaths. Kratom consumption combined with substances such as fentanyl, heroin, benzodiazepines, and
prescription opioids were the most frequently found co-occurring substances. The U.S. Centers for
Disease Control (CDC) reported 152 kratom related deaths that occurred from July 2016 to December
2017 in 27 states.19 “Kratom was determined to be a cause of death (i.e., kratom-involved) by a medical
examiner or coroner for 91 (59.9%) of the 152 kratom-positive decedents, including seven for whom
kratom was the only substance to test positive on postmortem toxicology.” A 2019 article in the New
15
Prozialeck, Walter C., Jivan, Jateen K. and Andurkar, Shridhar V.. "Pharmacology of Kratom: An Emerging Botanical Agent
With Stimulant, Analgesic and Opioid-Like Effects" Journal of Osteopathic Medicine, vol. 112, no. 12, 2012, pp. 792-799.
https://www.degruyter.com/document/doi/10.7556/jaoa.2012.112.12.792/html#j_jaoa.2012.112.12.792_ref_020.
16
Garcia-Romeu, Albert et al. “Kratom (Mitragyna speciosa): User demographics, use patterns, and implications for the opioid
epidemic.” Drug and alcohol dependence vol. 208 (2020): 107849. doi:10.1016/j.drugalcdep.2020.107849.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423016/.
17
18
Halpenny, Genevieve M. “Mitragyna speciosa: Balancing Potential Medical Benefits and Abuse.” ACS medicinal chemistry
letters vol. 8,9 897-899. 8 Aug. 2017, doi:10.1021/acsmedchemlett.7b00298
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5601368/
19
Olsen EO, O’Donnell J, Mattson CL, Schier JG, Wilson N. Notes from the Field: Unintentional Drug Overdose Deaths with
Kratom Detected — 27 States, July 2016–December 2017. MMWR Morb Mortal Wkly Rep 2019;68:326–327. DOI:
http://dx.doi.org/10.15585/mmwr.mm6814a2.
10
England Journal of Medicine noted 15 kratom related deaths in Colorado between 1999-2017;20 however,
14 of these cases were ultimately determined attributable to multidrug ingestion such as fentanyl and there
was insufficient blood for confirmatory testing in the one remaining case.
Currently, kratom itself and ingredients used to further process kratom products are not considered
potentially hazardous by food safety standards. Meaning, these are products that do not require
temperature control (cold holding < 41 ℉, hot holding >135℉) to maintain their integrity and/or do not
pose an imminent health hazard to the public. While kratom itself is not considered potentially hazardous
by food safety standards, introduction of other substances whether through adulteration or poly-substance
use presents public health concerns that can be addressed through appropriate regulatory measures.
DEPARTMENT RECOMMENDATIONS FOR THE

REGULATION OF KRATOM
Kratom products are currently available throughout the state of Colorado, without required testing,
manufacturing standards, recordkeeping or labels that could support traceability were an adverse health
event to occur, as has been observed in other states. The Department believes kratom could be feasibly
regulated pursuant to the below recommendations. It is the Department’s position that a regulatory
framework allowing responsible operators to make regulated kratom products available in Colorado could
greatly reduce the risks to public safety of unregulated kratom in Colorado and prevent harms that may
result from broadly prohibiting kratom in Colorado. Through the licensing of kratom processors and
retailers, rulemaking authority that allows agencies to keep pace with evolving research and data, and
requirements for testing, manufacturing, and recordkeeping, along with commensurate enforcement
mechanisms, kratom can remain available to Colorado consumers while accomplishing the state’s goal to
protect public health, safety, and welfare.
RECOMMENDATION #1: PROPOSED DEFINITIONS

The Department recommends the following new or amended statutory definitions. If the Department is
delegated responsibilities for the regulation of kratom, defined terms can be added to article 1 of title 44
in a new statutory section for defined terms specific to kratom:
“Adverse Health Event” means any untoward health condition or occurrence
associated with the use of kratom - this could include any unfavorable and
unintended sign (including a hospitalization, emergency department visit,
medical visit, abnormal laboratory finding, outbreak, non-motor vehicle-related
death), symptom, or disease temporally associated with the use of a kratom
product, and may include concerns or reports on the quality, labeling, or possible
adverse reactions to a specific kratom product.
“Advertising” means the act of providing consideration for the publication,
dissemination, solicitation, or circulation, of visual, oral, or written
20
Gershman K, Timm K, Frank M, Lampi L, Melamed J, Gerona R, Monte AA. Deaths in Colorado Attributed to Kratom. N
Engl J Med. 2019 Jan 3;380(1):97-98. doi: 10.1056/NEJMc1811055. PMID: 30601742; PMCID: PMC6688840.
https://www.nejm.org/doi/full/10.1056/NEJMc1811055.
11
communication, to directly induce any person to patronize or purchase from a

particular kratom retailer or kratom processor.
“Approved Kratom Delivery Form" means a kratom product in raw leaf,
capsule, tablet, powder, or tea bag forms. The following are not an approved
kratom delivery form:
a) any form that is combustible or intended to be used for vaporization;
b) any form that is intended to be added to food;
c) any form that mimics a candy product, gummy, or other confection, or
is manufactured, packaged, or advertised in a way that appeals to
children; or
d) any concentrate, unless otherwise permitted by rule.
“Batch” means a uniform group of products produced/manufactured at the same
time and by the same process. This can also be called a ‘lot.’
“Batch Number” means any distinctive group of letters, numbers, or symbols,
or any combination of them, from which the complete history of the
manufacturing, packaging, labeling, and/or holding of a Batch or lot of dietary
supplements can be determined.
“Certificate of Analysis” or (COA) means a certificate from a third-party
laboratory describing the results of the laboratory’s testing of a sample.
“Third-party Laboratory” means a laboratory that has no direct interest in a
processor, retailer, or importer of kratom or a kratom product that is capable of
performing mandated testing utilizing validated methods.
“Kratom” means any parts of the plant Mitragyna speciosa, whether growing or
not, and any compound, manufacture, salt, derivative, mixture, or preparation of
that plant, including but not limited to mitragynine and 7-hydroxymitragynine.
“Kratom Processor” means a person who sells, prepares, distributes,
wholesales, or maintains a kratom product, or advertises, represents, or holds
oneself out as selling, preparing, distributing, wholesaling or maintaining a
kratom product. Processor does not include a kratom retailer.
“Kratom Product” means any product or ingredient containing any part of the
leaf of the Mitragyna speciosa plant if the plant contains the alkaloid mitragynine
or 7-hydroxymitragynine.21
“Kratom Retailer” means a person who sells or distributes a kratom product to
consumers or advertises, represents, or holds oneself out as selling or distributing
a kratom product to consumers.
“Processing” means selling, preparing, or maintaining a kratom product.
Processing includes but is not limited to mixing, homogenizing, grinding,
milling, formulating, modifying, manipulating, labeling, and packaging.
21
This proposed definition amends the existing statutory definition to exclude synthetics.
12
RECOMMENDATION #2: PRODUCTS PERMITTED

We recommend expressly permitting kratom product types where the kratom plant is in its natural
botanical form, including leaves (in their whole, crushed or powder form), capsules, tablets, and tea bags
with these contents, as well as extracts of the same.
The Department also recommends the General Assembly provide general rulemaking authority to
promulgate appropriate regulations for kratom products as necessary for occupational and consumer
safety. For example, kratom products may require rules on manufacturing practices, prohibited ingredients
and solvents, testing requirements, serving size and dosage, and packaging and labeling. Regulations for
certain product categories may also require consideration of peer-reviewed research and should take into
account the intended use/method of consumption to inform approvals and rule requirements, and areas in
which the FDA has a distinct role (for example, any category of product that is considered a “medical
device” requiring specific FDA approval, for which Colorado regulations should not conflict).
RECOMMENDATION #3: SALES RESTRICTIONS

The Department recommends maintaining the age restriction already established in SB22-120 for the
purchase of kratom in Colorado. This approach aligns three other states that regulate kratom: Oregon,
South Dakota, and Tennessee.22
If the General Assembly maintains the age restriction in SB22-120, kratom retailers should be subject to
underage compliance monitoring. The Marijuana Enforcement Division (MED) and Liquor Enforcement
Division (LED) are housed within the Department and both divisions are responsible for underage
compliance monitoring and enforcement. The MED licenses and regulates the commercial marijuana
industry (including the cultivation, manufacture, testing, and sale of cannabis products). The LED licenses
and regulates businesses involved in the sales of alcoholic beverages and tobacco and nicotine products. If
the Department is assigned regulatory responsibilities for kratom, absent the establishment of a separate
division for dedicated resources specific to kratom, the LED and MED’s existing processes can inform
how licensure, regulation, and enforcement specific to kratom can be effectively apportioned (including
underage compliance) within the Department.
RECOMMENDATION #4: LABELING REQUIREMENTS

Senate Bill 22-120 established two requirements for labels affixed to kratom products: (1) the identity and
address of the manufacturer; and (2) the full list of ingredients in the product. We recommend the
following also apply to kratom products sold in Colorado:
● License number and name of kratom processor
● Batch number
● Net contents
● Potency test results
● Ingredients
● Expiration/use-by date
22
It should be noted that five other states (Arizona, Nevada, Utah, Oklahoma, and Georgia) only restrict sales to those eighteen
(18) years of age and older. See Appendix 3 – Review of Regulatory Structures Across the Country.
13
● Storage conditions
● Font size - No smaller than 1/16 of an inch
● A statement that reads "This product has not been evaluated for safety or efficacy. This
product is not intended to diagnose, treat, cure, or prevent any disease.”
● Labels must be unobtrusive and conspicuous
● Labels must be reflected in the English language at a minimum (however, this should not
prohibit or otherwise restrict the use of other languages)
● No trademark infringement
Legislation should also provide that labels (and associated advertising/marketing) cannot be designed to
appeal to children and cannot reflect false or misleading statements or health and benefit claims. These
recommendations were informed by consult with the Colorado Department of Public Health and
Environment (CDPHE), the FDA’s labeling requirements2324 for dietary supplements, and labeling for
certain cannabis products in statute25 and rule26.
RECOMMENDATION #5: MANUFACTURING STANDARDS

We recommend kratom processors be subject to standards applicable to dietary supplements, as reflected
in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplement. And to avoid conflicts with the U.S. Department of
Agriculture, these standards could be duplicated into legislation instead of simply referencing 21 CFR
Part 111. This approach is consistent with Utah’s model and based on feedback from the AKA. We also
recommend applying basic food safety standards, ISO 9001 (Quality Management System) and ISO
22000 (Food Safety). In addition, the Department recommends the following manufacturing standards:
● Good Manufacturing Practices - A licensed processor’s operations should be comparable to or
exceed Current Good Manufacturing Practices (cGMP). These practices are intended to prevent
an imminent health hazard to the public. This is generally aligned with the AKA’s GMP
Standards Program.27
● Standard Operating Procedures & Training - In accordance with Good Manufacturing Practices,
processors should have Standard Operating Procedures (SOPs) implemented and available to
staff. This should include staff training on processes and equipment, documented training logs,
and recurring staff competency checks to support a safe and compliant operation.
● Equipment & Materials - Processors should utilize equipment, tools and materials made in a
design, fabrication and/or construction that meets food grade standards and requirements for
cleaning and sterilization purposes.
23
U. S. Food and Drug Administration, Dietary Supplement Labeling Guide: Chapter I. General Dietary Supplement Labeling,
Questions 1 and 2 (2005).
https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-c
hapter-i-general-dietary-supplement-labeling#1-2.
24
U. S. Food and Drug Administration, Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling (2005).
https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide-c
hapter-iv-nutrition-labeling.
25
44-10-501(2)(a), C.R.S.
26
Colorado Marijuana Rules, Rules 3-1005 and 3-1010, 1 CCR 212-3.
https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=10507.
27
American Kratom Association, Good Manufacturing Standards Program.
https://www.americankratom.org/gmp-standards-program.
14
● Process & Inventory Controls - Processors should document the flow of kratom and kratom
products through their facility with internal inventory tracking systems, from initial receipt
(whether through importation or transfer from an out-of-state business) to sale, utilizing
ingredient batch numbers.28 See the report’s section on recordkeeping for a list of documentation
that should be maintained.
RECOMMENDATION #6: TESTING REQUIREMENTS

Kratom is known to have a possibility of certain contaminants that can pose public health risks, such as
Lead and Nickel. Based on a survey conducted by the Department, 77% of kratom consumers (27/35
respondents) indicated daily use of kratom. Considering the potential for contaminants and the frequency
of consumption reported,29 regulation of kratom warrants the establishment of a testing program to
promote consumer and occupational safety, with minimum requirements based on known risks and for
consumer awareness. The Department recommends the following:
● Third-Party Laboratory Testing Program. A third-party testing program allows kratom
processors to use private laboratories to demonstrate compliance with minimum testing standards
(consistent with other testing programs, private laboratories must be certified by the CDPHE).
Required testing at minimum should include alkaloid concentration, elemental impurities,
microbial contaminants, and pesticides and should apply to all lots or production batches of
kratom products.
● Surveillance Testing Program. Legislation should also provide rulemaking authority to establish
a surveillance testing program that enables the Department to collect samples for testing by the
state public health laboratory. This allows the state to further monitor testing compliance for
kratom products (for the categories of tests noted above), in addition to enabling the state to
screen for adulterants such as opioids.
The following paragraphs provide more detail regarding these recommendations.
Third Party Testing Program

Testing standards should apply to all lots or production batches of kratom products, where testing can be
carried out by private third party laboratories, similar to testing for Industrial Hemp, Industrial Hemp
Products, and Regulated Marijuana. Additional elements of a third-party testing program, which can be
further established in statute or via delegated rulemaking authority, include:
● Require processors to maintain records to verify compliance with testing for each batch (for
example, certificates of analysis (COA) , a copy of the label, photo of test samples, and associated
batch numbers).
28
U.S. Food and Drug Administration, Good Manufacturing Practices for the 21st Century for Food Processing (2004 Study)
Appendix E: Comparison of Food GMPs to Quality Systems and Other GMPs (2004).
.https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements/good-manufacturing-prac
tices-21st-century-food-processing-2004-study-appendix-e-comparison-food-gmps.
29
15
● Private third party laboratories would provide the testing services paid for by the kratom
processor or retailer.
● CDPHE currently certifies Industrial Hemp, clinical, forensic toxicology, drinking water and milk
testing labs in accordance with applicable Board of Health rules and federal regulations. CDPHE
also currently has several Laboratory Certification Scientists on staff who perform audits and
recommend certification of private third party laboratories based on meeting the standards of
Colorado Regulated Marijuana rules. This could be expanded to cover kratom labs and there will
likely be substantial overlap in laboratories that want to offer these services. The CDPHE would
establish certification requirements under their authority in 25-1.5-101(1)(f), C.R.S. and would
certify third-party laboratories by performing audits to assess their ability to meet established
testing requirements.
● Laboratories performing testing on kratom would be required to comply with ISO/IEC
17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories
accreditation. This mirrors requirements for other Colorado testing programs and third-party
laboratories would have the ability to choose the accrediting body such as A2LA, ANAB, or
PJLA (who would then perform periodic audits assessing the laboratories ability to fulfill and
maintain ISO/IEC requirements).
Proposed Test Types

Elemental Impurities Testing
Lead and Nickel contamination in kratom products has been attributed to soil conditions in Southeast Asia
where the plant is predominantly grown and harvested, in addition to processing equipment used,
including industrial grinders formerly used for ammunition purposes during World War II. For these
reasons, the Department recommends testing for Lead, Nickel, Arsenic, Cadmium, and Mercury with
action limits based on U.S. Pharmacopeia Chapters 223230 and 232,31 addressing elemental impurities in
dietary supplements and in drug products, respectively.
Alkaloid Concentration Testing
Mitragynine and 7-hydroxymitragynine are the main active alkaloids present in kratom and are primarily
responsible for its pharmacological action. The best method for identifying kratom is a test for these
compounds with action limits based on the natural alkaloid composition of the kratom plant, Mitragyna
speciosa, with 7-hydroxymitragynine only being present at levels below 1% of the total alkaloid content.
The biochemical pathway resulting in 7-hydroxymitragynine production has not been discovered, and is
not thought to exist. The presence of this compound in kratom products is attributable to degradation of
kratom plant material throughout the time of processing and shipping and can be minimized for the most
part. This category of testing is also important due to reports of suspected adulteration of kratom products
with synthetic 7-hydroxymitragynine.32
30
USP-NF, General Chapter <2232> Elemental Contaminants in Dietary Supplements (2012).
https://www.uspnf.com/notices/general-chapter-elemental-contaminants-dietary-supplements
31
USP-NF, USP 39, <232> ELEMENTAL IMPURITIES—LIMITS.
https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/key-issues/c232-usp-39.pdf
32
Lydecker, Alicia G et al. “Suspected Adulteration of Commercial Kratom Products with 7-Hydroxymitragynine.” Journal of
medical toxicology : official journal of the American College of Medical Toxicology vol. 12,4 (2016): 341-349.
doi:10.1007/s13181-016-0588-y. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5135684/.
16
Microbial Contaminant Testing

Microbial contamination is a known risk with these products due in part to the climates and nature of
processing that occurs in the countries of origin. One outbreak of Salmonella infections in the U.S. was
linked to contaminated kratom which involved 199 affected patients in 41 states during 2018,33 although
the American Kratom Association informed this 2018 outbreak was an isolated incident. According to
Department research, a common drying technique includes laying the kratom outdoors on tarps where it is
exposed to bird droppings among other sources of microbial contaminants such as E. coli, aspergillus,
yeast and mold. To mitigate the public health threats related to microbial contamination of kratom
products, the Department recommends testing for several microbial contaminants of concern as outlined
in the American Herbal Products Association guidelines. 34
Pesticide Testing
Limiting dietary exposure to pesticides is important to public health and safety. Currently, Utah tests for
59 pesticides in kratom, just as they do with cannabis. DOR recommends testing for the same pesticides
required for Industrial Hemp Products in Colorado. This alignment would simplify testing for both public
and private laboratories.
Residual Solvent Analysis
Residual solvent analysis is necessary to determine that all solvents used during extractions have been
removed to a safe level. This type of testing would only be required for extracted product types. Solvents
to be tested for and action limits would be based on accepted food safety standards such as USP. The
Department recommends it be granted rulemaking authority to determine the appropriate solvents and
action limits.
Surveillance Testing Program

The Department is recommending rulemaking authority to establish a statewide sampling and surveillance
testing program. Kratom retailers and processors would be subject to random inspection and sample
collection of products to be submitted to and tested by the state public health laboratory for the test types
described above and included in Appendix 4 - Analytes and Action Limits for Proposed Testing.
This model is currently used for the collection of Regulated Marijuana samples by the Colorado
Department of Agriculture (CDA) inspectors for pesticide testing at the CDA Biochemistry Laboratory. It
also mirrors the testing program for kratom currently being conducted in the state of Utah, with sampling
duties assumed by the Utah Department of Agriculture and Food, and testing of kratom products at the
Utah State Laboratory.
While both the CDPHE and the CDA laboratories have the instrumentation and capabilities required for
this proposed testing and both departments expressed a willingness to fill this role, the Department
recommends that the CDPHE be responsible for the testing portion of the sampling and surveillance
33
Nsubuga, Johnson et al. “Multistate Outbreak Investigation of Salmonella Infections Linked to Kratom: A Focus on Traceback,
Laboratory, and Regulatory Activities.” Journal of food protection vol. 85,5 (2022): 747-754. doi:10.4315/JFP-21-319.
https://pubmed.ncbi.nlm.nih.gov/35114689/.
34
American Herbal Products Association, AHPA Guidance Policies. https://www.ahpa.org/ahpa_guidance_policies.
17
program. Having the CDPHE perform the recommended testing would benefit the lab certification work,
as it would allow the CDPHE to understand any challenges that private third party laboratories may
encounter, as well as giving the CDPHE better capability to evaluate test methods or lab issues when third
party test results are in question. It would also give the CDPHE the capability to test products as part of
adverse health event investigations.
Adulterant Testing
Due to the action of mitragynine on opioid receptors in addition to its potential use in harm reduction of
opioid use disorder, a major concern voiced by the AKA and other stakeholders relates to kratom products
that have been found to be adulterated by opiates and opioids such as morphine and hydrocodone35.
Testing for adulterants such as these requires either a license from the DEA to handle controlled
substances standards (this is called targeted screening), or advanced instrumentation that uses digital
compound libraries36 to identify substances (this is called non-targeted screening). Under the
recommended surveillance testing program, non-targeted screening offers advantages in the ability to
screen for hundreds of adulterants without the need for DEA licensing or the handling of controlled
substances standards, however this method requires advanced instrumentation (High Resolution Mass
Spectrometry) that is prohibitively expensive for private labs. The CDPHE (as well as the CDA) have
these instruments and the capability to perform non-targeted screening for hundreds of possible
adulterants.37 CDPHE also possesses a DEA license for handling controlled substances, so targeted
screening would also be possible. The testing for adulterants would be a component of the surveillance
testing program.
RECOMMENDATION #7: RECORDKEEPING

The Department recommends recordkeeping and traceability requirements, which can be established via
delegated rulemaking authority or incorporated in legislation. This should include requirements for on-site
records and enables agencies to verify compliance with statutory and regulatory requirements (for
example, to verify accurate labels that, in accordance with Senate Bill 22-120, must contain the identity
and address of the manufacturer, or to identify specific Batch Numbers associated with products to verify
testing compliance or trace products in the event of a report of an adverse health event). Additionally,
processors should be required to maintain records required under 21 CFR Part 111 and for ISO
certification, pursuant to the manufacturing section of this report.
35
Acute Renal Insufficiency Associated With Consumption of Hydrocodone- and Morphine-Adulterated Kratom (Mitragyna
Speciosa) LeSaint, Kathy T. et al. Journal of Emergency Medicine, Volume 63, Issue 1, e28 - e30.
https://doi.org/10.1016/j.jemermed.2022.02.004.
36
U.S. Centers for Disease Control, High-Resolution Mass Spectral Libraries for Opioid Analysis (2022).
https://www.cdc.gov/nceh/dls/erb_hrms_libraries.html.
37
Knolhoff AM, Croley TR. Non-targeted screening approaches for contaminants and adulterants in food using liquid
chromatography hyphenated to high resolution mass spectrometry. J Chromatogr A. 2016 Jan 8;1428:86-96. doi:
10.1016/j.chroma.2015.08.059. Epub 2015 Aug 31. PMID: 26372444. https://pubmed.ncbi.nlm.nih.gov/26372444/.
18
RECOMMENDATION #8: AGENCIES INVOLVED IN

REGULATION OF KRATOM
Article 1 of title 44, as adopted in SB 22-120, contemplates and authorizes the Department’s Executive
Director to promulgate rules necessary for the administrative enforcement of the prohibition against
preparing, distributing, advertising, selling or offering to sell an adulterated kratom product, against
selling a kratom product that does not meet statutory labeling requirements, and against preparing,
distributing, advertising, selling, or offering to sell a kratom product to a person under twenty-one years
of age in section 44-1-105(3), C.R.S. Given this direction, and taking into consideration the existing
administrative expertise of other state agencies, the Department recommends the following for the
regulation of kratom processors, retailers, and products.
The CDPHE possesses the expertise and instrumentation necessary to manage the recommended testing
programs. The CDPHE also possesses the expertise necessary to audit and certify private third-party
laboratories (similar to their current testing facility certification program and processes for industrial
hemp testing laboratories and licensed marijuana testing facilities). However, implementation is expected
to require resources and interagency support and coordination with the agency assigned primary
regulatory responsibilities. Considering the Department’s experience in licensing and regulating the
liquor, tobacco, and marijuana industries, and its longstanding interagency relationship with the CDPHE
in the regulation of these other products, the Department is well suited to lead and support the
establishment of a regulatory framework for kratom in coordination with partner agencies and
stakeholders.
Specifically, the Department recommends the General Assembly authorize and direct the following:
● Kratom processors and kratom retailers in the state of Colorado are required to obtain licenses (or
registrations) issued by the Department in order to operate.
● The Executive Director will promulgate rules necessary for the fair and efficient regulation of
kratom processors, kratom retailers, and kratom products, including requirements for licensure,
testing, manufacturing, recordkeeping, and labeling.
● Authorize the Department to establish licensing or registration requirements and create
applications and forms for purposes of implementing article 1 of title 44;
● Authorize the Department to establish a schedule of application fees, licensing fees, and
disciplinary actions up to and including fines, license suspension, and license revocation for
purposes of implementing and enforcing article 1 of title 44;
● Direct the Department to coordinate with local law enforcement for the purpose of enforcing the
age restriction on kratom sales and purchases;
● Direct the CDPHE to ensure third-party testing laboratories are certified in a manner consistent
with the statutory provisions and/or rule provisions for the purpose of testing kratom products and
to advise on appropriate regulations for the labeling, packaging, and advertising of kratom
products, in coordination with the Department;
● Grant the Department(s) both general and specific rulemaking authority. This includes authority
to establish a surveillance sampling and testing program, to manage and conduct surveillance
19
testing of kratom products in coordination with the CDPHE to protect the public health, safety,
and welfare.
● Authorize the Department and the CDPHE to coordinate on adverse health event reporting and
investigation.
The Department also recognizes that its experience in regulating other products (liquor, tobacco, and
marijuana) does not mean all requirements that apply to these industries should by default apply to a
kratom regulatory framework. The Department recognizes the value of diverse stakeholder engagement,
which has been critical to informing reasonable regulations informed by the perspectives and subject
matter expertise of industry members, consumers, local partners, and other members of the community.
Further, the Department’s approach to regulation is guided by the following principles, which we believe
should apply consistently to all programs for which the Department is responsible: Rules should be (1)
Transparent, such that they clearly articulate expectations; (2) Systematic, such that compliance can be
planned; (3) Operable, with the ability for licensees to integrate requirements into their business
processes; and (4) Defensible, such that rules are grounded in law.
RECOMMENDATION #9: FEES

Within the Department, the divisions that are responsible for the regulation of liquor, tobacco, and
marijuana are authorized to collect fees for the licensing and administration of their respective regulatory
programs. The monies collected through these fees are deposited into designated cash funds (for example,
the Marijuana Cash Fund) and are subject to annual appropriation by the General Assembly to the
Department for the direct and indirect costs associated with implementing the regulatory program. If the
General Assembly moves forward with adopting a regulatory structure for kratom processors, kratom
retailers, and kratom products, the agency responsible for licensing and regulatory oversight should be
authorized to promulgate rules requiring licensing (or registration) fees that cover the direct and indirect
costs of administering the regulatory program. Such fees should similarly be deposited into a designated
cash fund and subject to annual appropriation. The Department also recognizes the importance of
ensuring a fee structure is not prohibitive for industry participants and that fees are reasonable to enable
participation in a regulated kratom program.
RECOMMENDATION #10: TAXES

In Colorado, products (or tangible personal property) offered for consumer sales are generally taxed at a
2.9% sales tax rate;38 whereas, products including, but not limited to, alcohol, tobacco, and marijuana are
subject to special excise and/or sales taxes.39 Kratom products for sale in Colorado should currently be
subject to the 2.9% sales tax as tangible personal property.40 While there may be an interest in imposing a
special excise and/or sales tax as seen in other age restricted products, imposing any additional or
different tax would likely require a TABOR (Taxpayer Bill of Rights) vote. Generally based on the
Department’s research, most states that are regulating kratom processors and kratom products do not
38
See section 39-26-106, C.R.S.
39
See e.g. Colo. Const., Art. XVIII, sec. 16; Colo. Rev. Stat. title 39, articles 28-28.8.
40
Defined as “all goods, wares, merchandise, products and commodities, and all tangible or corporeal things and substances that
are dealt in and capable of being possessed and exchanged.” Section 39-26-102(15)(a)(I), C.R.S.
20
impose special tax requirements on kratom products. Therefore, the Department recommends that kratom
products continue to be subject to the statewide sales tax laws and accompanying regulations.
ESTIMATED FISCAL IMPACTS

The below estimates are based upon the Department’s recommendations and may differ from estimates
provided during the legislative process depending on any proposed statutory provisions. The below
estimates also include fiscal impact considerations that contemplate CDPHE’s involvement in the
program. As the Department continues to evaluate fiscal impacts of establishing the program, it will do so
with an eye towards opportunities for cost savings and efficiencies in administration of the program
(including by considering existing programs within the Department to inform regulatory streamline
opportunities, where appropriate). The Department also recognizes the importance of ensuring a fee
structure is not prohibitive for industry participants and that fees are reasonable to enable participation in
the regulatory program.
ONE-TIME COSTS:
In consultation with CDPHE, the Department identifies the following one-time estimated fiscal impacts:
Agency Unit Need Estimate

Licensing One-Time Operating $14,000
Investigations One-Time Operating $21,000
DOR
Analysis and Resolution One-Time Operating $7,000
Testing One-Time Operating $14,000
GC/MS/MS $300,000
Refrigerators $12,000
CDPHE LIMS Development $20,000
Reference Lab
One-time Operating Expenses $35,000
Total $423,000
ONGOING COSTS:
In consultation with CDPHE, the Department identifies the following ongoing estimated fiscal impacts:
Agency Unit Need Estimate

1.0 FTE Administrator IV $76,919
1.0 FTE Administrative Assistant III $54,664
Licensing
DOR On-Going Operating $1,470
Central Appropriations $33,902
1.0 FTE Compliance Investigator II $76,919
Investigations
21
2.0 FTE Criminal Investigator II $173,952

On-Going Operating $2,205
1.0 FTE Legal Assistant II $76,919
Analysis and On-Going Operating $735
DOR Resolution
Central Appropriations
$17,952
2.0 FTE Life/Social Science Researcher IV $153,838
Testing On-Going Operating $1,470
Fleet Three (3) PHEV Fleet $13,688
1.0 FTE Health Professional IV $61,140.00
Adverse Health Event 1.0 FTE Statistical Analyst III $72,744.00
Monitoring
Contract expansion with Rocky Mountain Poison
and Drug Safety $30,000
Lab Certification* 1.0 FTE Physical Scientist Researcher/Scientist IV $85,620
CDPHE 1.0 FTE Physical Scientist Researcher/Scientist IV $85,620
1.0 FTE Physical Scientist Researcher/Scientist II $68,460
Reference Lab Operating Budget $100,000
Ongoing Operating Expenses $3,675
Total $1,500,527
*Assumes travel costs are charged as a fee, not covered by the program.
Other possible considerations that may be necessary depending upon final Department recommendation
and legislation include courier services and lab space build out.
Department of Revenue Fiscal Impact Details:
Licensing Staff:
● Office Manager / Licensing Specialist - Administrator IV Position - (1.0 FTE**) - This position
would be responsible for managing all of the kratom staff and coordinating members of the team
to carry out necessary tasks. This position would also be responsible for managing and reviewing
registration/licensing applications and processes. This position would be the primary contact for
all human resources, hiring, and budget responsibilities.
● Administrative Assistant III - (1.0 FTE**) - This position would be primarily responsible for
managing intake for new and renewal of registrations/licenses, and other intake as needed.
22
Investigations Staff:
● Compliance Investigator II (1.0 FTE**) - This position would be primarily responsible for
conducting registration/license investigations and compliance investigations.
● Criminal Investigator II (1.0 FTE**/1.0 FTE***) - These positions would be primarily
responsible for conducting compliance investigations, including but not limited to conducting
underage compliance checks.
Analysis and Resolution:
● Legal Assistant II (1.0 FTE***) - This position would be primarily responsible for managing and
coordinating any administrative actions and enforcement actions against a registered/licensed
kratom business.
Testing:
● Life/Social Science Researcher IV (1.0 FTE***) - This position would be primarily responsible
for supporting registration/license investigations, including but not limited to products, the testing
program, and adverse health event reports.
● Life/Social Science Researcher IV (1.0 FTE**) - This position would be primarily responsible for
establishing testing standards, requirements, and processes specific to the legislative direction
regarding kratom and kratom products and establishing a testing process, including ensuring there
are laboratories capable of testing these products.
**The Department anticipates requiring the identified 5.0 FTE to be hired on or before January 1, 2024, in order to
adopt rules, establish forms, applications, and processes, and to begin accepting applications as recommended in
this report.
*** The Department anticipates requiring the additional 3.0 FTE to be hired on or before July 1, 2024, in order to
continue program management and begin compliance oversight and enforcement.
Non-standardized costs:
Each field investigator team requires a vehicle to conduct their investigations. The Department will lease
three (3) of the required PHEV (plugin Hybrid Electric Vehicle) or BEV (Battery Electric Vehicle)
vehicles from the state fleet, which is managed by the DPA. Each vehicle is estimated to cost $4,630
annually for a total of $13,688 per year.
Colorado Department of Law:
The Department and the CDPHE may require legal services to conduct extensive rulemaking for the
program, to handle administrative cases that arise, and general counsel. At a minimum, the Department
anticipates 1.0 FTE for legal services, as informed by further attorney general’s office analysis.
TIMELINE FOR REGULATORY IMPLEMENTATION

If the General Assembly moves forward with a regulatory structure, the Department and the CDPHE will
require time for the onboarding of resources and to establish processes and rules to implement the
program. Considering the current statutory age restriction on sales of kratom, effective July 1, 2024, and
assuming some or all recommendations are adopted through legislation during the 2023 legislative session
and signed into law with a petition clause, the Department believes the following timeline is reasonable:
● On or before January 1, 2024: Agency build out for regulatory program, including but not
limited to hiring, rulemaking, acquiring and installing testing instrumentation, and test method
validation, as well as CDPHE certification of third-party laboratories.
23
● January 1, 2024: Applications become available for retailers/processors.

● On or before July 1, 2024: Hiring and training staff required for administration of the program.
● July 1, 2024: The Department begins regulation and any necessary enforcement activities.
ALTERNATIVES TO REGULATION
The Department is also tasked with considering alternatives to regulation.
1. The General Assembly could take no action. Pursuant to Senate Bill 22-120, criminal liability for
the sale of kratom products to a person under twenty-one years of age under section
18-13-132(1)(a), C.R.S. will be effective July 1, 2024. That would outline expectations for
retailers as it regards sales, and would allow an enforcement mechanism for violations. Local law
enforcement agencies could conduct underage compliance checks as some currently do for liquor
or marijuana. In conjunction with that, and in lieu of regulation, the General Assembly could also
prohibit certain types of kratom products and attach criminal liability to the sale of those
products, whether it would target products containing above a certain amount of the active
ingredients, or products in a certain form, such as synthetic products, edibles or drinks,
concentrates, and so forth.
The Department does not recommend this approach for three primary reasons: 1) Under this
alternative, local law enforcement would not have the state’s support through either resources or
expertise to ensure compliant sales of kratom products. 2) This approach opens the door for local
jurisdictions to create divergent and potentially contradictory standards for sales and/or product
requirements that could challenge overall compliance within the state. 3) This approach would
not protect public health and safety by ensuring that kratom products are not adulterated with
other substances and chemicals.
2. The General Assembly could allow for limited scope regulation under the Department, simply
tasking the Department with enforcement of the age restriction on sales via underage compliance
checks of retailers. Retailers could be licensed by the Department with no manufacturing
standards or testing provisions that have been outlined in this report. It should be noted that
Senate Bill 22-120 currently allows for the Executive Director of the Department to promulgate
rules to this end.
The Department does not recommend this approach because it fails to address the primary
concern raised by stakeholders throughout the 2022 Legislative Session and the Feasibility
Report outreach, which is to ensure that kratom products are not adulterated with other
substances and chemicals. Manufacturing and testing standards will play a critical role in
protecting the public health and safety in Colorado while maintaining access to kratom products.
3. The General Assembly could establish a public health and medical advisory committee, as
recommended by the MDPH earlier in this report, and task the committee with studying kratom
from a scientific, medical, and public health perspective, to inform a future regulatory structure, if
any. Additional funding may need to be allocated to support this work.
The Department recognizes the value in establishing a committee to further the studies and
scientific evidence needed to inform the regulatory structure; however, while such a committee
could be a valued addition to a regulatory structure, it would not replace the need for one. The
24
Department recommends that any statutory provisions adopted incorporate flexibility for the
Department and other state agencies to adapt to this evolving market.
4. The General Assembly could impose a liability insurance requirement on retailers, processors, or
both, to serve as consumer protection, giving the consumer an avenue of recourse if injured by a
kratom product they purchased.
The Department does not recommend this approach as a standalone avenue to address the
current primary concerns around the sale of kratom products - sales to minors and adulteration
of products. Generally, the Department supports providing consumers pathways for recourse, but
without state regulatory oversight, this approach will encounter challenges around collecting
data and information to support these consumer efforts.
CONCLUSION
Nine other states currently regulate kratom and, based on stakeholder outreach conducted by the
Department, an appetite exists in this state for legislative action. The vast majority of industry
stakeholders that the Department communicated with support regulation. The science behind the effects
and safety of kratom products for consumers has not been definitively established and research is
ongoing. Therefore, the Department believes the recommendations contained in this report strike a
balance between the viewpoints of various stakeholders and represent an appropriate initial regulatory
structure while providing the Department and other state agencies authority to adapt to the emerging and
evolving kratom market.
25
REPORT SUPPLEMENT
The Report Supplement contains the following appendices:
Appendix 1. Stakeholder Engagement

Appendix 2. Public Comments
Appendix 3. Review of Regulatory Structures Across the Country
Appendix 4. Analytes and Action Limits for Proposed Testing
Appendix 5. Consumer Survey Results - Kratom Dosing
Appendix 6. Consumer Survey Results - Use
Appendix 7. ISO 9001/ ISO 22000 Documentation
26

Kratom Feasibility Report

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Senate Bill 22-120:

Regulation of Kratom Processors

DEPARTMENT RECOMMENDATIONS FOR THE REGULATION OF KRATOM 11

RECOMMENDATION #1: PROPOSED DEFINITIONS 11

RECOMMENDATION #2: PRODUCTS PERMITTED 13

RECOMMENDATION #3: SALES RESTRICTIONS 13

RECOMMENDATION #4: LABELING REQUIREMENTS 13

RECOMMENDATION #5: MANUFACTURING STANDARDS 14

RECOMMENDATION #6: TESTING REQUIREMENTS 15

RECOMMENDATION #7: RECORDKEEPING 18

RECOMMENDATION #8: AGENCIES INVOLVED IN REGULATION OF KRATOM 19

RECOMMENDATION #9: FEES 20

RECOMMENDATION #10: TAXES 20

ESTIMATED FISCAL IMPACTS 21

TIMELINE FOR REGULATORY IMPLEMENTATION 23

Recommendation #7: Record Keeping

Recommendation #8: Agencies Involved in Regulation of Kratom

Colorado’s Kratom Market

Review of Regulatory Trends

Uses for Kratom

DEPARTMENT RECOMMENDATIONS FOR THE

RECOMMENDATION #1: PROPOSED DEFINITIONS

communication, to directly induce any person to patronize or purchase from a

RECOMMENDATION #2: PRODUCTS PERMITTED

RECOMMENDATION #3: SALES RESTRICTIONS

RECOMMENDATION #4: LABELING REQUIREMENTS

RECOMMENDATION #5: MANUFACTURING STANDARDS

RECOMMENDATION #6: TESTING REQUIREMENTS

Third Party Testing Program

Proposed Test Types

Microbial Contaminant Testing

Surveillance Testing Program

RECOMMENDATION #7: RECORDKEEPING

RECOMMENDATION #8: AGENCIES INVOLVED IN

RECOMMENDATION #9: FEES

RECOMMENDATION #10: TAXES

ESTIMATED FISCAL IMPACTS

Agency Unit Need Estimate

Agency Unit Need Estimate

2.0 FTE Criminal Investigator II $173,952

TIMELINE FOR REGULATORY IMPLEMENTATION

● January 1, 2024: Applications become available for retailers/processors.

Appendix 1. Stakeholder Engagement

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