Kratom Feasibility Report Supplement

Senate Bill 22-120:
Regulation of Kratom Processors

Report Supplement
Mark Ferrandino
Executive Director
State Licensing Authority
Colorado Department of Revenue1
View the Kratom Feasibility Report
January 4, 2023
This supplement contains background information for the Kratom Feasibility Report, including
specifics of stakeholder engagements, survey results, and public comments. Any stakeholder
perspectives included herein should not be construed as the Department’s position or reflective
of the Department’s recommendations.
1
Staff for the Department of Revenue Liquor Enforcement Division and Marijuana Enforcement Division
contributed to the research and contents of this report supplement.
SB 22-120 Concerning Regulation of Kratom Processors
DOR FEASIBILITY REPORT AND RECOMMENDATIONS - SUPPLEMENT
TABLE OF CONTENTS
Appendix 1. Stakeholder Engagement 3
Department Outreach 3
Operator Site Visits - Kratom Retailer and Kratom Processor 3
Targeted Consultations 5
Appendix 2. Public Comments 7
Appendix 3. Review of Regulatory Structures Across the Country 71

● Arizona 71
● Georgia 71
● Illinois 71
● Nevada 72
● Oklahoma 72
● Oregon 72
● South Dakota 73
● Tennessee 73
● Utah 73
Appendix 4. Analytes and Action Limits for Proposed Testing 75
Appendix 5. Consumer Survey Results - Kratom Dosing 83
Appendix 6. Consumer Survey Results - Use 86
Appendix 7. ISO 9001/ ISO 22000 Documentation 90
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Appendix 1. Stakeholder Engagement

Department Outreach
On July 29, 2022, the Department collected contact information for stakeholders who were interested in
engaging in this process. The Department sent out an email to MED licensees and MED and LED tobacco
stakeholders. 324 individuals responded to express interest.
On September 9, 2022, the Department distributed a survey to the new kratom stakeholder list, to gain
more information to inform this feasibility report. The survey asked stakeholders to respond by first
identifying their affiliation with or interest in kratom, which informed their specific set of questions. We
received responses from retailers, processors, testing laboratories, consumers, healthcare providers, public
health officials, law enforcement, and local municipalities.
Following the survey, and after reviewing and analyzing the results of the survey, the Department held a
focus group meeting to discuss the existing kratom market in Colorado and potential regulation of kratom
with over 30 participants on October 6, 2022. The Division discussed its findings to date and asked for
direct stakeholder input and feedback in several areas.2 Manufacturing, testing, common types of
contaminants, labeling, and other topics were discussed.
Operator Site Visits - Kratom Retailer and Kratom Processor
On September 29, 2022, two members of the Marijuana Enforcement Division (MED) and a member of
the Liquor Enforcement Division (LED) met with a business owner and two associates of a kratom retail
store located in Lakewood.
This visit to an operational retail location included descriptions of the establishment’s sales, sourcing, and
testing of its kratom products. In terms of sales, the retail establishment owner reported that a majority of
sales are conducted at retail with a smaller percentage of sales occurring online. The business owner also
described that kratom may be sold in a powder form, in capsules, or in tinctures or extracts with three
main strains: green, white, and red. The owner reported that kratom in a powder form may have
mitragynine levels around 1.3-1.8% while the business’s extracts can have mitragynine levels of 40-50%,
which is actually a lesser percentage of mitragynine than that found in other extracts which the business
owner reports can have mitragynine levels as high of 70-80%.
When discussing customers, the owner described that most customers indicate using kratom for pain
relief. However, the owner did note that kratom could be addictive like other substances if used at high
dosage levels over twenty-five (25) grams per serving.
As Colorado law had not required regulation of kratom before this proposed legislation, the
establishment’s owner described looking to other sources of authority such as the Colorado Department of
Agriculture’s food regulations as well as Utah and Oregon’s Departments of Agriculture’s kratom
regulations to create standards for their business. These informed standards include having food handling
certificates, having stainless steel appliances, following certain cleanliness standards, and requiring
camera footage to document waste disposal.
When sourcing their kratom products, the retail business looks to whether a vendor is AKA or GMP
certified. As some kratom may be adulterated with heavy metals, extracts, additional powder, or
2
The agenda for this focus group meeting, as well as the recording of the meeting, can be reviewed on the Department’s Kratom
Feasibility webpage.
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pesticides, the owner described the importance of finding a vendor who provides proof of sterilization or
radiation and assigns batch identification for pallet boxes to be tracked.
The retail establishment owner also chronicled how the business works with a certain laboratory that tests
for multiple adulterants including alkaloids, heavy metals, microbials, and residual solvents and that has
password-protected results.
Two members of MED and a member of LED visited and toured a kratom processing operation located in
Colorado Springs on November 17, 2022. The processor has a retail location in Castle Rock and also sells
their products through other retail establishments. In contrast to the visit of the retail business, the
processor stated that its online sales accounted for much more of its total sales noting, by estimation, retail
sales account for 60% of all sales while online sales account for 40% of all sales. The processor’s online
sales come largely from out-of-state with their point-of-sale system prohibiting purchases where the credit
card zip code is from a location that prohibits the sale or use of kratom.
The business owner described that some consumers use kratom for anxiety or as a substitute for coffee,
some consumers use it to assist in chronic pain and improve their quality of life, and other consumers use
kratom to assist in the withdrawal or cessation of another substance.
The owners described in detail the process they undergo to provide kratom products to consumers. They
described sourcing products from Indonesia where their vendor provides certificates of analysis (COAs)
that the product has been tested and sanitized with microwaves. After receiving the raw kratom product,
the owner explained a process they call “homogenization.” This involves taking large amounts of each
strain and placing it in a large grinder or mill. After being ground, the kratom product is then blended in a
blade mixer and placed in large barrels that are sterilized and lined with food-grade, BPA-free plastic
bags. The owner stated that once the kratom product is inside the barrel, the barrel is locked until test
results certify the product has met their standards.
The processor noted this is important as they are currently licensed by the CDPHE as a retail food
establishment and must maintain these standards for licensure. When asked about adverse health events,
the owner reported that they have received six to eight reports of adverse health events in their time as a
processor and that they reported these events to the health department. The owner also discussed having a
Standard Operating Procedure (SOP) requiring a recall if the processor receives more than 15 adverse
health event reports on a given product.
Some unique kratom products are made available by the processor as one owner described attempting to
use carbon dioxide (CO2) extraction on some kratom products, as well as, how their concentrates have
mitragynine levels of 4-5%, 10 times less the amount of mitragynine than the retail establishment
described above. At the facility, the processor also makes kratom lemonade where water and kratom are
heated and then added to lime juice and citric acid. This lemonade and other concentrates are dispensed
using semi-automatic liquid dispensers.
Interestingly, though not connected to the production of the processor, the owner described finding
products at retail shops labeled as kratom that tested positive for methadone and Tianeptine. The owners
described their concern that adulterated products may already be in the market as well as extracts with
high levels of mitragynine, which may have undesirable or unintended effects.
4
Targeted Consultations
The Department consulted directly with several stakeholders, including but not limited to, the CDPHE,
the CDA, the AKA, the Utah Department of Agriculture, and public health officials throughout Colorado.
These consultations focused on subject areas and matters that were within the scope of SB 22-120’s
direction and within each stakeholder group’s expertise. The Department gained valuable insight and
feedback from the stakeholders including but not limited to, suggestions for recommendations around
testing requirements, manufacturing requirements, product availability, regulatory responsibilities and
challenges, and components of adverse health event reporting.
As it regards kratom products, during the Department’s virtual meeting with the AKA, representatives
gave support and recommendations concerning the types of kratom products that should be available on
the market. The AKA supports a ban on any products that have over a 2% potency level of
7-hydroxymitragynine or anything that is beyond the natural 7-hydroxymitragynine potency level of the
Kratom plant. They strongly oppose synthesized or concentrated 7-hydroxymitragynine as it poses a
health risk and it should be banned, similar to that as concentrated caffeine is banned by the FDA.
Furthermore, the AKA supports a ban on extraction methods that are not FDA approved and all Kratom
products that are adulterated with any controlled substance. However, the AKA would oppose regulation
of extracts that are non-adulterated, properly extracted with FDA approved food-grade processes, and
created from the original form. The AKA believes that the processes for creating extracts may eliminate
some microbial contaminants that exist in powder form. For naturally derived product combinations, the
AKA supports these product combinations unless/until there has been an adverse health event supported
by scientifically driven data that states otherwise. The AKA also supports a ban of all product forms that
appeal to children, specifically mentioning the use of animal shapes in gummies as an example. Overall,
the AKA supports science based Kratom products and is opposed to any ban or limitation on naturally
derived product types.
Contrary to AKA’s recommendations, during the Department’s targeted consultation with public health
officials, they recommended that no Kratom products are safe for human consumption, citing concerns for
the lack of research, lack of FDA approval, and the insufficiency of regulatory oversight due to the
importation of Kratom from outside the U.S. Specifically, Tri-County Health Department in partnership
with additional local public health agencies expressed concerns about regulating kratom for public safety
in cases of adverse events and contamination and considering the limited scientific information and
research available. The local partnering agencies asserted their belief that the regulation of kratom will
allow unproven medical claims on kratom products that could cause increases in the sale and consumption
of kratom that may also lead to increased risks of adverse health outcomes. Also, these local agencies and
the FDA expressed concerns with kratom leading to risks of addiction, abuse, and dependence in relation
to other opioid receptor agonists such as morphine.
Public health agencies represented by MDPH, including Denver Department of Public Health and
Environment, Boulder County Public Health, Broomfield County Public Health and Environment,
Jefferson County Public Health, Douglas County Health Department, Tri-County Health Department, and
the Public Health Institute at Denver Health, provided a list of recommendations on what a minimum
regulatory framework should include from a public health perspective. The Department’s
recommendations largely cover MDPH’s recommendations. Specifically, they suggested that a regulatory
framework should:
● Require product safety labeling, developed in collaboration with medical and scientific experts,
that explain that kratom products may pose a health risk, including death, and could negatively
interact with alcohol or other drugs, and has addictive potential.
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● Prohibit labeling or marketing of kratom with a claim to treat a medical or health condition.
● Prohibit the sale of kratom in food, using language similar to Utah’s statute, expressly prohibiting
the sale of kratom in certain forms, including “Any form that is intended to be added to food or
selling kratom already mixed in food for human consumption...”3
● Establish a retail license to monitor sales, fund compliance efforts, create effective penalty and
suspension structures for repeated violations, and regulate the location and density of retailers.
● Develop a confidential, accessible mechanism for the reporting of adverse events, coupled with
appropriate staff capacity to respond and investigate consumer complaints when indicated.
● Ensure capacity and ability to conduct other regulatory activities such as investigating outbreaks
of disease or product contamination.
● Ensure product traceback, with no restrictions from industry such as ‘trade secrets’.
● Ensure monitoring prevalence of kratom use and whether retail sales approved by the state leads
to an increase or decrease in adverse events or other unintended consequences.
● Ensure advisory or working groups to address kratom have significant representation from public
health and medical experts.
3
“Approved Kratom Delivery Form" means a kratom product in raw leaf, capsule, tablet, powder, liquid tincture, tea bag,
concentrated, or extract forms. Any form that is combustible or intended to be used for vaporization is not an approved kratom
delivery form. Any form that is intended to be added to food or selling kratom already mixed in food for human consumption is
not an approved kratom delivery form.” https://ag.utah.gov/wp-content/uploads/2021/06/R70-580-06.28.21.pdf.
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Appendix 2. Public Comments

1) Metro Denver Partnership for Health (MDPH)4 email and letter received November 3, 2022:
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MDPH’s mission is to “is to improve population health regionally with collective action” and it “is led by seven metro Denver
public health partners (LPHAs) — Boulder County Public Health, Broomfield Department of Public Health and Environment,
Denver Department of Public Health & Environment, Douglas County Health Department, Jefferson County Public Health, the
Public Health Institute at Denver Health, and Tri-County Health Department — that serve Adams, Arapahoe, Broomfield,
Boulder, Denver, Douglas, and Jefferson counties.”
https://www.coloradohealthinstitute.org/research/metro-denver-partnership-health.
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2) Email received from Joshua Millier on December 28, 2022:
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3) American Kratom Association email and attachments received December 30, 2022.
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4) Additional comments received from the American Kratom Association on January 3, 2023:
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5) Public comment received from Jason Smith on December 21, 2022:
I have bulging discs and kratom helps me get through without near as much pain
6) Public comment received from Kate Robare, who identified as a consumer, on December 21,
2022:
Kratom has been my lifesaver. I wish I would’ve found it sooner and it would’ve save me
from months of jail time , time away from my family and a lot of money. Kratom came
about as an important part of my life when my doctor disagreed with me taking less of my
narcotics and ending treatment abruptly. A terrifying and humiliating place to be.
I have used Kratom for my chronic pain as well as for the extreme withdrawals I had
from Percocet and MS Contin that my doctor prescribed.
I finally am not held in a prescription prison where I can’t go anywhere unless I have
enough medication. I had to be sure that I keep all appointments perfectly straight the
testing done right and I don’t miss a dose. If any of those fails to happen, the pain clinics
are quick to discharge you as they’re not making the money they expect.
I have only experienced two purchases of Kratom that seemed either old or possibly not
what they said it was. Knowing the amount of milligrams of active components I am
consuming is vital to tapering off of it as well as effective dosage. I’m hoping this
legislature will allow that.
With this essential tool it provides a safe alternative from buying illegal and often
dangerous products effectively keeping crime low. Removal of Kratom from those of us
that need the substance will make a cause and effect of more crime, overdoses, suicides &
murders.
This substance saves lives for those that need it for the withdrawal and can’t wait the
months or even years to get into treatment facilities, or they will be treated less than
human and labeled as worthless. The chronic pain & embarrassment of having to be a
“drug seeker” just to live a normal life. I hope in this time we live in that we are finally ,
looking to more alternatives to work with the oddities of the mind and make a person
whole rather than strip them down into what society wants to call a successful person.
7) Public comment received from Colorado State Senator Joann Ginal on December 22, 2022:
NA
8) Public comment received from Travis Radtke, of Coglassco, on December 28, 2022:
I think putting regulation on small store sales of Kratom is not the right answer for the
situation Kratom being federally legal you can just buy it online so the only thing putting
regulation on local Kratom would be doing would be hurting small businesses. I think the
police have enough to deal with with the legalization of mushrooms and legalization of
weed there’s no reason to try to make Kratom illegal I think the voters would agree with
leaving Kratom alone…
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9) Public comment received from Terry Behrman, of Mary Janes Glass Haberdasher, on December
28, 2022:
i feel so much regulation and licenses is getting so burdensome, I have to have a tobacco
distribution lic, a tobacco lic, a non tobacco lic a state lic a city lic and now a bag fee
that is taxed...how much more do we have to do to stay in business…
10) Public comment received from Stevie Day, of Smok N Bra, on December 28, 2022:
Hey there, I'm Stevie Day. As a retail business owner of kratom and working at the
Coroner's office here, I see more deaths from other substances and mixing substances
together causing the initial death. It allso doesnt have any psychoactive effect and not
many ways of testing. This needs more science to establish regulations. Noone just dies
from kratom. I agree with regulating age and labeling, and lab testing, but I just don't
want to see small businesses going out of business because of the licensing and taxing.
Businesses like mine, already have more than one tax license. It truly makes it more work
on us seperating all the items, that we could focus on more things like educating and
expanding. You've already been getting the tax money as is, so why change it to another
license and fees for us small businesses? Do you have a special license to buy caffeine, or
any other natural stimulants or kava? Are you going to regulate that next? Or any other
indigenous culture, herb, or sacred plant material? Is this disrespecting the indigenous
culture of us picking them out and taxing us more? Kratom is not a new plant or herbal
supplement, it's been around longer than you know.
11) Public comment received from Ryan Connelly, of Murray-Brown Labs, on December 29, 2022:
Here are some notes I have on the proposed limits.
Metals
The lead limit of 0.4ppm will remove a very large percentage of kratom from the market
(~65 - 80%). Most kratoms will yield a lead concentration between 0.4 - 0.8ppm. The
other metal limits you have set will not affect the vast majority of kratom. I would
recommend reducing the mercury limit to 0.2ppm.
APC of 10,000,000 CFU/g is quite high but the other indicators look good. While we
don't see Staph aureus often in this product, we do recommend that it is tested. Here are
our proposed indicator limits that we have helped kratom vendors develop:
APC: < 100,000 - 1,000,000 CFU/g
Yeast/Mold: < 50,000 - 100,000 CFU/g
Coliform/Gram Negative: < 5000 - 10,000 CFU/g
Staph: < 100 CFU/g
Yeast/Mold will be significantly higher than 100,000 CFU/g in fermented strains. I would
recommend either looking into the safety of these types of products directly or outlaw the
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sale of these. I've seen Y/M levels from 200,000 - 500,000 in these types. Commonly,
fermented strains are of the red variety.
E. coli/STEC limit is recommended to be Negative in 25g to mirror that of Salmonella.
We would likely receive a lot of pushback from other stakeholders but a Salmonella
sample size of 375g would result in a lot more of the ""hot spots"" being found in product.
Salmonella is by far the most prevalent microbial risk in kratom. Other options to
monitor its presence would be to lower the batch size requirement for testing. An entire
pallet of one lot of material should warrant more than one lab test as there can be
significant variation in both the metal content and microbial profile.
Some of the pesticide limits will be difficult to hit. For reference, we use C18 SPE
cleanup with ACN for elution. LC-MS/MS for detection. All sample matrices are spiked
with 100ng of each pesticide for recovery/control purposes.
Dichlorvos: We are unable to recover this pesticide currently in kratom. This pesticide
would warrant further investigation in order to state absence.
Carbaryl: This pesticide yields a 15 - 20% recovery. The limit of 0.050 is a little
aggressive so I would recommend 0.100 if this limit is acceptable healthwise.
Propoxur: Similar to carbaryl. A 0.100 limit is more applicable based on recovery.
Spiroxamine: Similar to carbaryl. The proposed limit of 0.100 should be achievable.
With respect to the legality of extracts which came up in yesterday's meeting:
I back the decision to allow for extraction based products to be legal within reason. The
microbial and metal contaminants are nearly completely removed during the extraction
process. This is going to be the safest way to consume kratom. I don't recommend that
pure extracts be available for sale to the public. I would recommend extracts to be sold to
processors which would use them to make finished products following GMP processes
(similar to CBD tinctures/drinks or tablets/pills). The sale of extracts directly to
consumers will likely increase the frequency of adverse events (taking too high of
doses/getting sick). I am not an expert on the dosing of this material so I would defer to
others on the specifics.
If extract products are to be legal, a residual solvent analysis should be added to the
testing requirements.
The exact definition of mitragynine concentration should be set in stone so there is less
confusion with potency results. Currently there are two concentrations depending on the
adequacy of separation used in the potency analysis:
Mitragynine fully separated from paynantheine
Mitragynine unresolved from paynantheine
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These two compounds cannot be separated with a C18 column. A potency calculated from
this kind of analysis will be between 0.2 - 0.4% higher than one that fully resolves the two
compounds.
Please reach out to me directly for clarification or discussion on any of these points.
Sincerely,
Ryan Connelly
12) Public comment received from Travis Radtke, of Coglassco, on January 2, 2023:
Hi this is Travis Radtke I had one more or actually many more concerns but one that
came to the top of my head is when small businesses in Colorado by Kratom from
vendors out of state there is going to be no way to make sure that the out-of-state vendors
are licensed with the state of Colorado I don’t think there’s any way to make out-of-state
vendors get a Colorado license to sell some sort of approved Kratom so it will hurt local
vendors and not change anything. If local vendors aren’t allowed to sell out of state
create them because the out-of-state companies aren’t going to get a Colorado license
then the small business won’t be able to sell it legally but your average person can still
easily buy it online because there is no regulation federally once again in the end with
this proposal small business will Lose. This will force Kratom sales online which can’t be
enforced. This will also create a black market for Kratom which will just drive up price
and interest when some thing is unattainable people seem to want to obtain it.
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Appendix 3. Review of Regulatory Structures Across the Country

● Arizona
Statute A.R.S. § 36-795
Enforcement Includes both civil and criminal penalties.

Violations include:
● Sale of adulterated kratom;
● Synthetic kratom;
● Kratom containing more than 2% 7-hydroxymitragynine; and
● Sales to individuals under eighteen (18).
Labeling Labels must contain the amount of mitragynine and 7-hydroxymitragynine contained
in the product.
● Georgia
Statute Ga. Code Ann. § 16-13-120 (2019).
Enforcement Includes criminal penalties for sale to persons under eighteen (18).
Labeling Labels must include:

● Clearly labeled ingredients;
● A warning that the sale or transfer possession of kratom to another person
under 18 years of age is prohibited;
● The amount of mitragynine and 7-hydroxymitragynine contained in such
product;
● The amount of mitragynine and 7-hydroxymitragynine contained in the
packaging for such product;
● The common or usual name of each ingredient used in the manufacture of
such product, to be listed in descending order of predominance;
● The name and the principal mailing address of the manufacturer or the person
responsible for distributing such product;
● Clear and adequate directions for the consumption and safe and effective use
of such product; and
● Any precautionary statements as to the safety and effectiveness of such
product.
● Illinois
Statute 720 ILCS 642/1
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Enforcement Includes criminal penalties.
Labeling N/A
● Nevada
Statute N.R.S. 597.998
Enforcement Includes both civil and criminal penalties for sales to individuals under eighteen (18).
Labeling Label "clearly sets forth the ingredients and directions for the safe and effective use of
the kratom product."
● Oklahoma
Statute 63 Okla. Stat. § 63-142.1 (2014).

Violations include:
Labeling Kratom products shall be accompanied by a label, or a quick response (QR) code on
the product label linked to a website, bearing the following information prior to its
sale in this state:
● A list of the ingredients, which shall include the common or usual name of
each ingredient used in the manufacture of the product, listed in descending
order of predominance;
● The amount of mitragynine and 7-hydroxymitragynine contained in the
product;
● The amount of mitragynine and 7-hydroxymitragynine contained in
packaging for the product;
● The name and the principal street address of the vendor or the person
responsible for distributing the product;
● The suggested use of the product;
● Any precautionary statements as to the safety and effectiveness of the
product; and
● That the sale or transfer of kratom to a person under eighteen (18) years of
age is prohibited;
● Oregon
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Statute TBD, HB 4010
Enforcement Includes civil penalties for not registering with the Department of Revenue before
selling, distributing, or exposing Kratom for sale.
Labeling Label "clearly sets forth the ingredients and directions for the safe and effective use of
the kratom product."
● South Dakota
Statute SDCL 34-20B-115
Enforcement Includes criminal penalties.
Labeling N/A
● Tennessee
Statute TN Code § 39-17-452 (2019).
Enforcement Includes criminal penalties for sales to individuals under twenty-one (21).
Labeling "Labeled” means a label containing the manufacturer's information and a warning that
includes, at a minimum, the following: “Warning: Do not use if you are pregnant or
nursing. It is illegal to possess Kratom if under 21 years of age. Consult your
healthcare professional before using. Do not combine with alcohol or medication.
Consult a doctor prior to usage if you have any heart disease, liver disorder, high
blood pressure, or medical condition or take medication.”
● Utah
Statute Utah Code § 4-45-101 - § 4-45-108

Violations include:
● Sale of adulterated kratom;
● Synthetic kratom;
Labeling Labels must include the amount of mitragynine and 7-hydroxymitragynine contained
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in the packaged kratom product.
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Appendix 4. Analytes and Action Limits for Proposed Testing

Alkaloid Concentration Testing
Analytes Action Limits
Mitragynine n/a
7-hydroxymitragynine <1% Total Alkaloids
Elemental Impurities
Lead <0.80 ppm*
Cadmium <0.40 ppm*
Arsenic <1.2 ppm*
Mercury <1.2 ppm*
Nickel <16 ppm**
*Based on 12.5 g/day max intake and USP 2232 Limits

**Based on 12.5 g/day max intake and USP 232 Limits
Microbial Contaminants
Total Aerobic Microbial Count NMT <10,000,000 cfu/g
Total Combined Yeast and Mold NMT <100,000 cfu/g
Total Bile-tolerant Gram-negative Bacteria NMT <10,000 cfu/g
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Salmonella spp. Absence in 25g
E. coli Absence in 10g
Total Aflatoxins (B1 + B2 + G1 + G2)) 20 ppb
Ochratoxin A 20 ppb
Adulterants
Fentanyl Not Detectable
Hydrocodone Not Detectable
Morphine Not Detectable
*Non-targeted screening would allow for the detection of many additional adulterants
Pesticides
Analytes Action Limits (ppm)
Abamectin 0.100
Acephate 0.020
Acequinocyl 0.030
Acetamiprid 0.100
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Aldicarb 1.00
Allethrin 0.200
Atrazine 0.025
Azadirachtin 1.00
Azoxystrobin 0.020
Benzovindiflupyr 0.020
Bifenazate 0.020
Bifenthrin 1.00
Boscalid 0.020
Buprofezin 0.020
Carbaryl 0.050
Carbofuran 0.020
Chlorantraniliprole 0.020
Chlorfenapyr 0.050
Chlorpyrifos 0.040
Clofentezine 0.020
Clothianidin 0.050
Coumaphos 0.020
Cyantraniliprole 0.020
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Cyfluthrin 0.200
Cypermethrin 0.300
Cyprodinil 0.250
Daminozide 0.100
Deltamethrin 0.500
Diazinon 0.020
Dichlorvos 0.100
Dimethoate 0.020
Dimethomorph 0.050
Dinotefuran 0.100
Diuron 0.125
Dodemorph 0.050
Endosulfan sulfate 0.050
Endosulfan-alpha 0.200
Endosulfan-beta 0.050
Ethoprophos 0.020
Etofenprox 0.050
Etoxazole 0.020
Etridiazole 0.030
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Fenhexamid 0.125
Fenoxycarb 0.020
Fenpyroximate 0.020
Fensulfothion 0.020
Fenthion 0.020
Fenvalerate 0.100
Fipronil 0.060
Flonicamid 0.050
Fludioxonil 0.020
Fluopyram 0.020
Hexythiazox 0.010
Imazalil 0.050
Imidacloprid 0.020
Iprodione 1.00
Kinoprene 0.500
Kresoxim-methyl 0.020
(Lambda) Cyhalothrin 0.250
Malathion 0.020
Metalaxyl 0.020
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Methiocarb 0.020
Methomyl 0.050
Methoprene 2.00
Mevinphos 0.050
MGK-264 0.050
Myclobutanil 0.020
Naled 0.100
Novaluron 0.050
Oxamyl 3.00
Paclobutrazol 0.020
Parathion-methyl 0.050
Permethrin 0.500
Phenothrin 0.050
Phosmet 0.020
Piperonyl butoxide 0.200
Pirimicarb 0.020
Prallethrin 0.050
Propiconazole 0.100
Propoxur 0.020
80
Pyraclostrobin 0.020
Pyrethrins 0.050
Pyridaben 0.050
Pyriproxyfen 0.010
Quintozene 0.020
Resmethrin 0.100
Spinetoram 0.020
Spinosad 0.100
Spirodiclofen 0.250
Spiromesifen 3.00
Spirotetramat 0.020
Spiroxamine 0.100
Tebuconazole 0.050
Tebufenozide 0.020
Teflubenzuron 0.050
Tetrachlorvinphos 0.020
Tetramethrin 0.100
Thiabendazole 0.020
Thiacloprid 0.020
81
Thiamethoxam 0.020
Thiophanate-methyl 0.050
Trifloxystrobin 0.020
82
Appendix 5. Consumer Survey Results - Kratom Dosing

The Department’s survey asked, among other questions, respondents to identify the kratom
products that they manufactured, sold, or consumed, and provided the following options:
● Pills/capsules
● Tablets ● Extracts
● Gum ● Edibles
● Tinctures ● Powder
Respondents had the opportunity to select as many responses as they wanted to. The following table
includes the survey results for the product type question.
Product Type Dose at one time Doses per day
Extracts, Powder approx. 7-9 grams for the last 4 times a day for the last four
four years without increase. years without increase
Extracts, Powder 2 grams 3-4
Pills/Capsules 1.8G twice daily
Pills/Capsules 2 grams 1-2
Pills/Capsules, Extracts, Powder 3.5-5 grams 1-3
Pills/Capsules, Extracts, Powder 4gs 2
Pills/Capsules, Powder 2 grams 2-3
Pills/Capsules, Powder 3.5 - 4 grams of regular powder 1
Pills/Capsules, Powder 4-8 grams 4
Pills/Capsules, Powder 7 caps. Been the same for 5 5

years
83
Pills/Capsules, Powder . 28 oz 3
Pills/Capsules, Powder 2-4 grams One
Pills/Capsules, Tinctures, 1-4g 1-2

Extracts, Powder
Powder 2-3 grams 2-3
Powder Anywhere from 1 - 6 grams Varies, anywhere from 0 to 3

generally
Powder 6g 3 doses a day
Powder Tablespoon 6 to 8
Powder 3 flat and level kitchen 4-5

measuring tsp
Powder 1 oz 4 to 6 oz a day
Powder ~ 1.5 teaspoons 4-6
Powder 2 tbsp 1
Powder teaspoon 3
Powder 7 - 10 grams Four
Powder .5-1 Teaspoon (2-4 grams) 1
Powder 5mg daily 5
Powder 1 teaspoon 4
84
Powder 2-3 grams. 1-3 times a day, depending on

my work and workout schedule.
Like a cup of coffee.
Powder <5g 2
Powder 2 grams 4
Powder 2-3 grams 3 to 4
Powder 2 grams Two to three
Powder, mix the powder with teaspoon every 2 to 3 hours for Teaspoon every 2 to 3 hours for
water over a year now over a year now
Powder, prepared as a tea, and 1 to 1.5 Tbsp (9 - 13.5 grams) 1

filtered through a micro-fine
strainer ("Finum" brand).
Remaining powder is tossed in
the trash.
Tablets, Powder 1-2 Grams 2
Tinctures, Extracts, Powder 3 to 4 grams of powder every 2 5 - 8

to 4 hours
85
Appendix 6. Consumer Survey Results - Use

The Department’s survey asked, among other questions, respondents to describe their reason for
consuming kratom or kratom products. Respondents were given two options: 1) Health Reason(s) or 2)
Recreational, with the opportunity to add a narrative description. The following table includes the
responses to this question:
Reason Explanation for use
Health Reason(s) I have completely stopped using opiates and

other opioids besides kratom. Besides my health
this has saved me hundreds of dollars a month.
Health Reason(s) It has greatly improved and lessens the pain I

have daily and it's been a godsend for my
anxiety
Health Reason(s) It has helped me to medicate my ADHD without

the need for stronger stimulants like adderall
and has also aided in getting off substances that
have not been great for my health like
gabapentin.
Health Reason(s) It has eliminated my use for large amounts of

over the counter painkillers like Advil
Health Reason(s) Kratom has freed me from the shackles of

prescription opiates, as well as prescription
"maintenance" drugs for opiate dependance
(Suboxone, Methadone, Subutex, etc.)
Health Reason(s) Significantly improved my health
Health Reason(s) It gives me energy during and eliminates my

Restless Legs at night.
Health Reason(s) It has saved my life. I was suicidal for decades

from depression and anxiety.
86
Health Reason(s) Its drastically improved my pain and mental

health
Health Reason(s) Helps chronic neck pain after oxycodone

became a no-no from a medical doctor.
Health Reason(s) It has improved my quality of life, and has

probably had a neutral effect on my health
Recreational
Health Reason(s) Greatly helped manage pain & stress, and got
me through physical therapy.
Health Reason(s) Pain management
Health Reason(s) Relieves pain and extreme anxiety
Health Reason(s) Takes away the pain and fatigue
Health Reason(s) Dramatically. My primary care, orthopedic

surgeon and OB/GYN all support my choice.
My labs are done every six months and are
excellent
Health Reason(s) It has eased the pain
Health Reason(s) It not only has helped with back/spine pain and
arthritis pain, but also does wonders for my
mental health.
Health Reason(s) It helped me quit smoking cigarettes. It helps

ease my depression and anxiety. It allows me to
be more productive.
Health Reason(s) Preventative use
87
Health Reason(s) Relief from anxiety depression and arthritic pain
Health Reason(s) I feel like it helps manage my moods and pain in

my body.
Health Reason(s) Lower back pain
Health Reason(s) Kratom has allowed me to control my anxiety

and pain on a level where I can work full time.
Thanks to kratom I am off all medication.
Health Reason(s) Pain relief for back and muscles, less caffeine,
MUCH less anxiety, and made me lose interest
in Drinking.
Health Reason(s) Yes, significantly. Helps with mental and

physical health. Overall wellbeing.
Health Reason(s) less chronic pain of some kinds
Health Reason(s) Pain has significantly decreased, I get a bit more

energy to just get through a day
Health Reason(s) I was prescribed prescription pain medicine and

wanted a better quality of life. I switched to
kratom and am enjoying life more now. My
knee and hip pain and arthritis is much more
manageable when taking kratom vs not.
Recreational I marked recreational, but would have marked

both if possible- it has been incredibly effective
for anxiety, and also occasionally pain
Health Reason(s) helped my mom unbelievably and the one time I

tried it for mouth pain, same
88
Health Reason(s) It has made managing my pain much better! I

have trigeminal neuralgia from a rare nerve
sheath tumor in my skull known as a "trigeminal
schwannoma" (named for the "schwann cell",
the nerve sheath cell type). Additionally, I
developed TMJ/TMD in high-school from
having braces, which aggravates the nerve pain
from the schwannoma. This pain had been
keeping me up at night, and making it very
difficult to sleep.
After discovering kratom, I found that a simple

tea preparation before bedtime alleviated the
pain and helped me sleep.
Health Reason(s) It keeps me from having restless legs.
Health Reason(s) Lets just say without Kratom I would have to

rely on opioids or other cannabis, which would
bankrupt me.
89
Appendix 7. ISO 9001/ ISO 22000 Documentation
Common clauses for both QMS and FSMS are in Black. FSMS clauses are blue
This table cross references between clauses of ISO 22000:2005 and ISO 9001:2015
Section 1
ISO 22000:2005 ISO 9001:2015
Food Safety Management System - FSMS Context of the Organization
4.1 General requirements 4.1 Understanding the organization and its context
4.2 Documentation requirements 7.5 Documented Information
4.2.1 General 7.5.1 General
4.2.2 Control of documents 7.5.2 Creating and Updating
4.2.3 Control of Records 7.5.3 Control of Documented Information
Section 2
ISO 22000:2005 ISO 9001:2015
5 Management Responsibility 5 Leadership
5.1 Management commitment 5.1 Leadership and Commitment
5.2 Food Safety Policy 5.2 Policy
5.2.1 Establishing the Quality Policy
5.2.1 Communicating the Quality Policy
5.3 Food Safety Management System Planning 5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.3 Planning of changes
5.4 Responsibility and authority. 5.3 Organizational roles, responsibilities and authorities
5.5. Food Safety Team Leader 5.3 Organizational roles, responsibilities and authorities
5.6 Communication 5. Leadership.
5.6.1 External Communication 7.2.1 Determination of requirements related to
the product and services.
8.2.1 Customer communication
5.6.2 Internal Communication 5.5.3 Communication
8.5.6 Control of Changes
5.7 Emergency preparedness and response 5.1.2 Customer focus
5.8 Management review 9.3 Management review
5.8.1 General 9.3.1 General
5.8.2 Review Input 9.3.2 Management Review Input
5.8.3 Review Output 9.3.3 Management Review Output
Section 3
ISO 22000:2005 ISO 9001:2015
6 Resource management 7 Support
6.1 Provision of resources 7.1.1 General
6.2 Human resources 7.2 Competence

6.2.1 General 7.2 Competence
6.2.2 Competence, awareness and training. 7.2 Competence.
7.3 Awareness
6.3 Infrastructure 7.1.3 Infrastructure
90
6.4 Work environment 7.1.4 Environment for the operation of processes
Section 4
ISO 22000:2005 ISO 9001:2015
7 Planning and realization of safe products 8 Operation
7.1 General 8.1 Operational Planning and control
7.2 Prerequisite programmes (PRP) 7.1.3 Infrastructure
7.2.1 7.1.4 Environment for the operation of processes
7.2.2 8.5.1 Control of production and service Provision

7.2.3 6.1 Actions to address risks and opportunities
10.3 Continual Improvement
7.3 Primary steps to enable hazard analysis 8.3 Design and development of product and
services
7.3.1 General
7.3.2 Food safety team
7.3.3 Product characteristics 8.4.3 Information for external providers
7.3.4 Intended use

8.2.2 Determination of requirements related to
7.3.5 Flow diagram, process steps and control the product and services
measures
7.4 Hazard Analysis 8.3.2 Design and development planning
7.4.1 General
7.4.2 Hazard identification and determination
of acceptable levels
7.4.3 Hazard assessment
7.4.4 Selection and assessment of control
Measures
7.5 Establishing the operational prerequisite 8.3.3 Design and development inputs
programmes (PRPs)
7.6 Establishing HACCP Plan 8.3.5 Design and development outputs
7.6.1 HACCP Plan 8.5.1 Control of production and service
Provision
7.6.2 Identification of critical control points
(CCPs)
7.6 3 Determination of critical limits for critical

control points
7.6.4 System for the monitoring of critical 9.1.1 General

control points
7.6. 5 Actions when monitoring results exceed 8.7 Control of nonconforming outputs
critical limits
7.7 Updating of preliminary information and 7.5.3 Control of documented information
documents specifying the PRPs and the
HACCP plan
7.8 Verification planning 8.3.5 Design and development controls
91
7.9 Traceability system 8.5.2 Identification and traceability

7.10 Control of Nonconformity 8.7 Control of nonconforming outputs
7.10.1 Corrections
7.10.2 Corrective actions 10.2 Nonconformity and Corrective action
7.10.3 Handling potentially unsafe products
8.7 Control of nonconforming outputs
7.10.4 Withdrawals
Section 5
ISO 22000:2005 ISO 9001:2015
8 Validation, verification and improvement 9 Performance Evaluation
of the food safety management system
8.1 General 9.1.1 General
8.2 Validation of control measure 9.1.3 Analysis and evaluation
combinations 8.3.4 Design and development controls
8.5.1 Control of production and service provision
8.3 Control of monitoring and measuring 7.1.5 Monitoring and measuring resources
8.4. Food safety management system 9.1 Monitoring, measurement, analysis and evaluation
Verification
8.4.1 Internal audit 9.2 Internal audit
8.4.2 Evaluation of individual verification 7.3.4 Design and development review
results 8.2.3 Monitoring and measurement of
processes
8.4.3 Analysis of results of verification 8.4 Analysis of data
Activities
8.5 Improvement 8.5 Improvement
8.5.1 Continual improvement 8.5.1 Continual improvement
8.5.2 Updating the food safety management 8.3.4 Design and development controls
System
92

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Senate Bill 22-120:

Regulation of Kratom Processors

Appendix 2. Public Comments 7

Appendix 3. Review of Regulatory Structures Across the Country 71

Appendix 4. Analytes and Action Limits for Proposed Testing 75

Appendix 5. Consumer Survey Results - Kratom Dosing 83

Appendix 6. Consumer Survey Results - Use 86

Appendix 7. ISO 9001/ ISO 22000 Documentation 90

Appendix 1. Stakeholder Engagement

Operator Site Visits - Kratom Retailer and Kratom Processor

Appendix 2. Public Comments

2) Email received from Joshua Millier on December 28, 2022:

5) Public comment received from Jason Smith on December 21, 2022:

Here are some notes I have on the proposed limits.

APC: < 100,000 - 1,000,000 CFU/g

Yeast/Mold: < 50,000 - 100,000 CFU/g

Coliform/Gram Negative: < 5000 - 10,000 CFU/g

Staph: < 100 CFU/g

E. coli/STEC limit is recommended to be Negative in 25g to mirror that of Salmonella.

Propoxur: Similar to carbaryl. A 0.100 limit is more applicable based on recovery.

Spiroxamine: Similar to carbaryl. The proposed limit of 0.100 should be achievable.

With respect to the legality of extracts which came up in yesterday's meeting:

Mitragynine fully separated from paynantheine

Mitragynine unresolved from paynantheine

Appendix 3. Review of Regulatory Structures Across the Country

Enforcement Includes both civil and criminal penalties.

Labeling Labels must include:

Enforcement Includes criminal penalties.

Enforcement Includes both civil and criminal penalties.

Statute TBD, HB 4010

Enforcement Includes criminal penalties.

Enforcement Includes both civil and criminal penalties.

in the packaged kratom product.

Appendix 4. Analytes and Action Limits for Proposed Testing

Analytes Action Limits

7-hydroxymitragynine <1% Total Alkaloids

Analytes Action Limits

Lead <0.80 ppm*

Cadmium <0.40 ppm*

Arsenic <1.2 ppm*

Mercury <1.2 ppm*

Nickel <16 ppm**

*Based on 12.5 g/day max intake and USP 2232 Limits

Analytes Action Limits

Total Aerobic Microbial Count NMT <10,000,000 cfu/g

Total Combined Yeast and Mold NMT <100,000 cfu/g

Total Bile-tolerant Gram-negative Bacteria NMT <10,000 cfu/g

Salmonella spp. Absence in 25g

E. coli Absence in 10g

Total Aflatoxins (B1 + B2 + G1 + G2)) 20 ppb

Analytes Action Limits

Fentanyl Not Detectable

Hydrocodone Not Detectable

Morphine Not Detectable

Analytes Action Limits (ppm)

Endosulfan sulfate 0.050

(Lambda) Cyhalothrin 0.250

Piperonyl butoxide 0.200

Appendix 5. Consumer Survey Results - Kratom Dosing

Product Type Dose at one time Doses per day

Extracts, Powder 2 grams 3-4

Pills/Capsules 1.8G twice daily

Pills/Capsules 2 grams 1-2

Pills/Capsules, Extracts, Powder 3.5-5 grams 1-3