C:\147_01.txt

First Regular Session

Seventy-fourth General Assembly

STATE OF COLORADO

INTRODUCED

LLS NO. 23-0660.02 Sarah Lozano x3858

SENATE BILL 23-147

Senate Committees House Committees

Finance

A BILL FOR AN ACT

ONCERNING THE REGULATION OF PROCESSORS OF KRATOM101

PRODUCTS.102

Bill Summary

(Note: This summary applies to this bill as introduced and does

not reflect any amendments that may be subsequently adopted. If this bill

passes third reading in the house of introduction, a bill summary that

applies to the reengrossed version of this bill will be available at

http://leg.colorado.gov

Effective July 1, 2024, the bill:

! Establishes the minimum standards and labeling

requirements for kratom products;

! Requires that, prior to selling or offering for sale any

kratom product, the processor of the kratom product

SENATE SPONSORSHIP

Sullivan and Ginal,

HOUSE SPONSORSHIP

(None),

Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.

Capital letters or bold & italic numbers indicate new material to be added to existing law.

Dashes through the words or numbers indicate deletions from existing law.

(processor) register the kratom product with the department

of revenue (department) and provide a certificate of

analysis for the kratom product to the department;

! Requires a processor to notify the department if an adverse

event report is submitted to the federal food and drug

administration for any of the processor's kratom products;

and

! Allows the department, if there is a reasonable basis, to

require a test for compliance of a processor's kratom

product by a third-party laboratory, to coordinate with a

third-party laboratory to conduct the test, and to require the

processor to pay the department's cost for the test.

The executive director of the department is required to promulgate

rules to administer and enforce the bill and is authorized to impose fines

on processors that violate the bill.

Be it enacted by the General Assembly of the State of Colorado:1

SECTION 1. In Colorado Revised Statutes, repeal 44-1-105.2

SECTION 2. In Colorado Revised Statutes, add article 15 to title3

44 as follows:4

ARTICLE 155

Colorado Kratom Consumer Protection Act6

44-15-101. Short title. T

HE SHORT TITLE OF THIS ARTICLE 15 IS7

THE "COLORADO KRATOM CONSUMER PROTECTION ACT".8

44-15-102. Definitions. A

S USED IN THIS ARTICLE 15, UNLESS THE9

CONTEXT OTHERWISE REQUIRES:10

(1) "C

ERTIFICATE OF ANALYSIS" MEANS A CERTIFICATE OF11

ANALYSIS:12

(a) F

ROM A THIRD-PARTY LABORATORY SHOWING THAT A KRATOM13

PRODUCT DOES NOT VIOLATE SECTIONS 44-15-103 (2)(b) AND (2)(c); AND14

(b) T

HAT INCLUDES A BATCH NUMBER OR LOT NUMBER FOR THE15

APPLICABLE KRATOM PRODUCT.16

SB23-147-2-

(2) "FUND" MEANS THE KRATOM CONSUMER PROTECTION CASH1

FUND CREATED IN SECTION 44-15-108 (1).2

(3) "K

RATOM EXTRACT" MEANS A PRODUCT CONTAINING ANY3

PART OF THE LEAF OF THE PLANT MITRAGYNA SPECIOSA THAT HAS BEEN4

EXTRACTED THROUGH AN EXTRACTION PROCESS THAT MEETS THE5

STANDARDS SET BY THE UNITED STATES PHARMACOPEIA.6

(4) "K

RATOM PRODUCT" OR "PRODUCT" MEANS ANY PART OF THE7

LEAF OF THE PLANT MITRAGYNA SPECIOSA, OR A KRATOM EXTRACT,8

MANUFACTURED AS A FOOD, POWDER, CAPSULE, PILL, BEVERAGE, OR ANY9

OTHER EDIBLE PRODUCT.10

(5) "L

OCAL GOVERNMENT" MEANS A HOME RULE OR STATUTORY11

COUNTY, MUNICIPALITY, OR CITY AND COUNTY.12

(6) (a) "P

ROCESSOR" MEANS A PERSON THAT:13

(I) S

ELLS, PREPARES, OR MAINTAINS A KRATOM PRODUCT; OR14

(II) A

DVERTISES, REPRESENTS, OR HOLDS ITSELF OUT AS SELLING,15

PREPARING, OR MAINTAINING A KRATOM PRODUCT.16

(b) "P

ROCESSOR" DOES NOT INCLUDE A RETAILER.17

(7) "R

ETAILER" MEANS A PERSON THAT SELLS, OFFERS FOR SALE,18

OR DISTRIBUTES A KRATOM PRODUCT TO INDIVIDUALS FOR PERSONAL19

CONSUMPTION.20

44-15-103. Prohibited acts - labeling requirements -21

enforcement - penalties. (1) A

PERSON SHALL NOT:22

(a) K

NOWINGLY PREPARE, DISTRIBUTE, ADVERTISE, SELL, OR OFFER23

TO SELL A KRATOM PRODUCT THAT IS ADULTERATED WITH FENTANYL OR24

ANY OTHER CONTROLLED SUBSTANCE LISTED IN PART 2 OF ARTICLE 18 OF25

TITLE 18;26

(b) S

ELL A KRATOM PRODUCT THAT DOES NOT HAVE A LABEL THAT27

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CLEARLY SETS FORTH:1

(I) T

HE IDENTITY AND ADDRESS OF THE MANUFACTURER; AND2

(II) T

HE FULL LIST OF INGREDIENTS IN THE KRATOM PRODUCT;3

NOWINGLY PREPARE, DISTRIBUTE, ADVERTISE, SELL, OR OFFER4

TO SELL A KRATOM PRODUCT TO A PERSON UNDER TWENTY-ONE YEARS OF5

AGE; OR6

(d) D

ISPLAY OR STORE KRATOM PRODUCTS IN A RETAIL LOCATION7

IN A MANNER THAT WILL ALLOW THE PRODUCTS TO BE ACCESSED BY8

INDIVIDUALS UNDER TWENTY-ONE YEARS OF AGE.9

(2) A

PROCESSOR SHALL NOT ADVERTISE, DISTRIBUTE, SELL, OR10

OFFER FOR SALE:11

(a) A

KRATOM PRODUCT TO A PERSON UNDER TWENTY-ONE YEARS12

OF AGE;13

(b) A

KRATOM PRODUCT THAT:14

(I) I

S MIXED OR PACKED WITH A NONKRATOM SUBSTANCE THAT15

AFFECTS THE QUALITY OR STRENGTH OF THE KRATOM PRODUCT TO SUCH16

A DEGREE AS TO RENDER THE KRATOM PRODUCT INJURIOUS TO A17

CONSUMER;18

(II) C

ONTAINS A POISONOUS OR OTHERWISE HARMFUL19

NONKRATOM INGREDIENT, INCLUDING ANY SUBSTANCE LISTED IN PART 220

OF ARTICLE 18 OF TITLE 18;21

(III) H

AS A LEVEL OF 7-HYDROXYMITRAGYNINE IN THE ALKALOID22

FRACTION THAT IS GREATER THAN ONE PERCENT OF THE OVERALL23

ALKALOID COMPOSITION OF THE KRATOM PRODUCT; OR24

(IV) H

AS SYNTHETIC ALKALOIDS, INCLUDING SYNTHETIC25

MITRAGYNINE, SYNTHETIC 7-HYDROXYMITRAGYNINE, OR ANY OTHER26

SYNTHETICALLY DERIVED COMPOUNDS OF THE PLANT MITRAGYNA27

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SPECIOSA; OR1

KRATOM EXTRACT WITH LEVELS OF RESIDUAL SOLVENTS2

THAT ARE HIGHER THAN ALLOWED BY CHAPTER 467 OF THE UNITED3

TATES PHARMACOPEIA.4

(3) (a) A

NY KRATOM PRODUCT ADVERTISED, DISTRIBUTED, SOLD,5

OR OFFERED FOR SALE IN THE STATE MUST INCLUDE A LABEL OR A QUICK6

RESPONSE CODE OR A WEBSITE ADDRESS FOR A WEBSITE THAT:7

(I) C

ONTAINS THE NAME AND ADDRESS OF THE KRATOM8

PROCESSOR;9

(II) I

NCLUDES ADEQUATE DIRECTIONS, INCLUDING THE TOTAL10

RECOMMENDED SERVING SIZE OF THE KRATOM PRODUCT AND THE NUMBER11

OF SERVINGS IN THE CONTAINER OR PACKAGE OF THE KRATOM PRODUCT;12

(III) D

ESCRIBES THE FACTUAL BASIS UPON WHICH THE PROCESSOR13

REPRESENTS THE KRATOM PRODUCT AS FOOD, INCLUDING:14

(A) A

PRODUCT FACT PANEL LISTING ALL INGREDIENTS THAT ARE15

EXPRESSED BY NUMERICAL COUNT OR IN VOLUME OR WEIGHT; AND16

(B) T

HE AMOUNT OF MITRAGYNINE AND 7-HYDROXYMITRAGYNINE17

CONTAINED IN THE KRATOM PRODUCT OR PRODUCTS CONTAINED IN A18

CONTAINER OR PACKAGE, SO LONG AS THE LEVEL OF19

HYDROXYMITRAGYNINE IN THE ALKALOID FRACTION DOES NOT EXCEED20

ONE PERCENT OF THE OVERALL ALKALOID COMPOSITION OF THE KRATOM21

PRODUCT;22

(IV) I

DENTIFIES A BATCH NUMBER OR LOT NUMBER THAT MATCHES23

THE BATCH OR LOT NUMBER ON THE CERTIFICATE OF ANALYSIS SUBMITTED24

FOR THE KRATOM PRODUCT PURSUANT TO SECTION 44-15-104 (1)(b);25

(V) I

NCLUDES A DISCLAIMER THAT STATES: "THIS PRODUCT HAS26

NOT BEEN EVALUATED BY THE UNITED STATES FOOD AND DRUG27

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ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT,1

CURE, OR PREVENT ANY DISEASE."; AND2

(VI) D

OES NOT INCLUDE ANY CLAIMS THAT THE KRATOM PRODUCT3

IS INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY MEDICAL4

CONDITION OR DISEASE.5

(b) T

HE PROCESSOR SHALL PROVIDE THE INFORMATION DESCRIBED6

IN SUBSECTION (3)(a) OF THIS SECTION IN ENGLISH. THE PROCESSOR MAY7

ALSO PROVIDE THE INFORMATION IN ANOTHER LANGUAGE.8

(4) A

PROCESSOR THAT VIOLATES SUBSECTION (2) OR (3) OF THIS9

SECTION OR FAILS TO COMPLY WITH SECTION 44-15-104 (1) IS SUBJECT TO10

A FINE OF NO MORE THAN FIVE HUNDRED DOLLARS FOR THE FIRST OFFENSE11

AND NO MORE THAN ONE THOUSAND DOLLARS FOR THE SECOND OR ANY12

SUBSEQUENT OFFENSES.13

(5) T

HE EXECUTIVE DIRECTOR SHALL TRANSMIT ALL PENALTIES14

COLLECTED UNDER THIS SECTION TO THE STATE TREASURER, WHO SHALL15

CREDIT THEM TO THE FUND.16

44-15-104. Registration of kratom products - certificate of17

analysis - fees - rules. (1) P

RIOR TO ADVERTISING, DISTRIBUTING,18

SELLING, OR OFFERING TO SELL ANY KRATOM PRODUCT IN THE STATE,19

EACH PROCESSOR SHALL:20

(a) R

EGISTER AND MAINTAIN CURRENT REGISTRATION OF THE21

KRATOM PRODUCT WITH THE DEPARTMENT;22

(b) P

ROVIDE TO THE DEPARTMENT A CERTIFICATE OF ANALYSIS FOR23

THE KRATOM PRODUCT AT THE PROCESSOR'S OWN EXPENSE; AND24

AY AN INITIAL REGISTRATION FEE AND, THEREAFTER, AN25

ANNUAL RENEWAL FEE IN THE AMOUNT DETERMINED BY THE EXECUTIVE26

DIRECTOR BY RULE.27

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(II) THE AMOUNT OF THE FEES MUST REFLECT THE ACTUAL AND1

DIRECT COSTS INCURRED BY THE DEPARTMENT IN IMPLEMENTING THIS2

ARTICLE 15.3

(2) (a) I

F THE DEPARTMENT RECEIVES CREDIBLE NOTICE THAT A4

KRATOM PRODUCT VIOLATES SECTION 44-15-103 (2)(b) OR (2)(c), THE5

EXECUTIVE DIRECTOR SHALL REQUIRE THE PROCESSOR OF THE KRATOM6

PRODUCT TO SUBMIT TO THE DEPARTMENT A CURRENT CERTIFICATE OF7

ANALYSIS, AT THE PROCESSOR'S OWN EXPENSE, FOR THE KRATOM PRODUCT8

WITHIN A PERIOD DETERMINED BY THE EXECUTIVE DIRECTOR BY RULE.9

(b) I

F THE PROCESSOR DOES NOT SUBMIT A CURRENT CERTIFICATE10

OF ANALYSIS TO THE DEPARTMENT WITHIN THE REQUIRED PERIOD, THE11

DEPARTMENT MAY REVOKE THE PROCESSOR'S REGISTRATION FOR THE12

APPLICABLE KRATOM PRODUCT.13

(3) T

HE EXECUTIVE DIRECTOR SHALL TRANSMIT ALL FEES14

COLLECTED UNDER THIS SECTION TO THE STATE TREASURER, WHO SHALL15

CREDIT THEM TO THE FUND.16

44-15-105. Adverse event reporting - third-party laboratory17

testing - rules. (1) (a) I

F AN ADVERSE EVENT REPORT IS SUBMITTED TO18

THE FEDERAL FOOD AND DRUG ADMINISTRATION FOR ANY OF A19

PROCESSOR'S KRATOM PRODUCTS, THE PROCESSOR SHALL SUBMIT A COPY20

OF THE ADVERSE EVENT REPORT TO THE DEPARTMENT WITHIN A PERIOD21

DETERMINED BY THE EXECUTIVE DIRECTOR BY RULE.22

(b) I

F THE PROCESSOR FAILS TO SUBMIT A COPY OF AN ADVERSE23

EVENT REPORT WITHIN THE REQUIRED PERIOD, THE DEPARTMENT MAY24

REVOKE THE PROCESSOR'S REGISTRATION FOR THE KRATOM PRODUCT FOR25

WHICH THE ADVERSE EVENT REPORT WAS FILED.26

(2) (a) I

F THE DEPARTMENT HAS A REASONABLE BASIS TO REQUIRE27

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A TEST OF A PROCESSOR'S KRATOM PRODUCT BY A THIRD-PARTY1

LABORATORY TO DETERMINE IF THE KRATOM PRODUCT VIOLATES SECTION2

44-15-103 (2)(b)

OR (2)(c), THE DEPARTMENT MAY:3

(I) C

OORDINATE WITH A THIRD-PARTY LABORATORY OF THE4

DEPARTMENT'S CHOICE TO CONDUCT THE TEST; AND5

(II) R

EQUIRE THE PROCESSOR OF THE KRATOM PRODUCT TO PAY6

THE COST OF THE TEST TO THE DEPARTMENT WITHIN A PERIOD7

DETERMINED BY THE EXECUTIVE DIRECTOR BY RULE.8

(b) I

F THE PROCESSOR FAILS TO PROVIDE THE COST OF THE TEST TO9

THE DEPARTMENT WITHIN THE REQUIRED PERIOD, THE DEPARTMENT MAY10

REVOKE THE PROCESSOR'S REGISTRATION FOR THE APPLICABLE KRATOM11

PRODUCT.12

44-15-106. Rules. T

HE EXECUTIVE DIRECTOR SHALL PROMULGATE13

RULES AS NECESSARY FOR THE ADMINISTRATION AND ENFORCEMENT OF14

THIS ARTICLE 15.15

44-15-107. Local governments. N

OTHING IN THIS ARTICLE 15 OR16

THE RULES PROMULGATED BY THE EXECUTIVE DIRECTOR PURSUANT TO17

THIS ARTICLE 15 LIMITS A LOCAL GOVERNMENT FROM ENACTING OR18

ENFORCING AN ORDINANCE, RESOLUTION, REGULATION, OR OTHER LAW19

RELATING TO THE MANUFACTURE, SALE, OFFERING FOR SALE, TRANSFER,20

POSSESSION, OR USE OF ANY KRATOM PRODUCT IN THE JURISDICTION OF21

THE LOCAL GOVERNMENT, SO LONG AS THE ORDINANCE, RESOLUTION,22

REGULATION, OR OTHER LAW ENACTED OR ENFORCED BY THE LOCAL23

GOVERNMENT IS NO LESS RESTRICTIVE THAN THE REQUIREMENTS OF THIS24

ARTICLE 15.25

44-15-108. Kratom consumer protection cash fund. (1) T

HE26

KRATOM CONSUMER PROTECTION CASH FUND IS CREATED IN THE STATE27

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TREASURY. THE FUND CONSISTS OF:1

(a) M

ONEY CREDITED TO THE FUND PURSUANT TO SECTION2

44-15-104

(3);3

(b) A

NY PENALTIES COLLECTED PURSUANT TO SECTION 44-15-1034

(5);

AND5

NY MONEY APPROPRIATED OR TRANSFERRED TO THE FUND BY6

THE GENERAL ASSEMBLY.7

(2) T

HE MONEY IN THE FUND, INCLUDING ANY UNEXPENDED AND8

UNENCUMBERED MONEY REMAINING IN THE FUND AT THE END OF A STATE9

FISCAL YEAR, SHALL NOT BE DEPOSITED IN, CREDITED TO, OR10

TRANSFERRED TO THE GENERAL FUND OR ANY OTHER FUND. THE STATE11

TREASURER SHALL CREDIT ALL INTEREST AND INCOME DERIVED FROM THE12

DEPOSIT AND INVESTMENT OF MONEY IN THE FUND TO THE FUND.13

(3) M

ONEY IN THE FUND IS CONTINUOUSLY APPROPRIATED TO THE14

DEPARTMENT FOR COSTS RELATED TO ADMINISTERING AND ENFORCING15

THIS ARTICLE 15.16

SECTION 3. Act subject to petition - effective date -17

applicability. (1) This act takes effect at 12:01 a.m. on the day following18

the expiration of the ninety-day period after final adjournment of the19

general assembly; except that, if a referendum petition is filed pursuant20

to section 1 (3) of article V of the state constitution against this act or an21

item, section, or part of this act within such period, then the act, item,22

section, or part will not take effect unless approved by the people at the23

general election to be held in November 2024 and, in such case, will take24

effect on the date of the official declaration of the vote thereon by the25

governor.26

(2) This act applies to conduct occurring on or after July 1, 2024.27

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