*HB1500.2*
Reprinted
February 21, 2023
HOUSE BILL No. 1500
_____
DIGEST OF HB 1500 (Updated February 20, 2023 6:03 pm - DI 92)
Citations Affected: IC 24-4; IC 35-48; IC 35-52.
Synopsis: Kratom. Defines "kratom product" as a food product or
dietary ingredient that: (1) is derived from the leaf or extract of
mitragyna speciosa and has a level of residual solvent that is not more
than permitted by USP 467; (2) does not contain a level of 7-
hydroxymitragynine in the alkaloid fraction that is greater than 1% of
the overall alkaloid composition of the product; and (3) does not
contain any synthetic alkaloids including synthetic mitragynin,
synthetic 7-hydroxymitragynine, or any other synthetic compound of
a kratom plant. Establishes requirements for the manufacture, labeling,
and sale of kratom products. Specifies that a kratom product is not a
controlled substance.
Effective: July 1, 2023.
Morrison, Lucas, Morris
January 17, 2023, read first time and referred to Committee on Commerce, Small Business
and Economic Development.
February 16, 2023, amended, reported — Do Pass.
February 20, 2023, read second time, amended, ordered engrossed.
HB 1500—LS 6758/DI 149 Reprinted
February 21, 2023
First Regular Session of the 123rd General Assembly (2023)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in this style type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
between statutes enacted by the 2022 Regular Session of the General Assembly.
HOUSE BILL No. 1500
A BILL FOR AN ACT to amend the Indiana Code concerning trade
regulation.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 24-4-23 IS ADDED TO THE INDIANA CODE AS
2 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
3 1, 2023]:
4 Chapter 23. Distribution of a Kratom Product
5 Sec. 1. The following definitions apply throughout this chapter:
6 (1) "Certificate of analysis" means a certificate from an
7 independent testing laboratory describing the results of the
8 laboratory's testing of a sample.
9 (2) "Independent testing laboratory" means a laboratory:
10 (A) with respect to which no person having a direct or
11 indirect interest in the laboratory also has a direct or
12 indirect interest in a facility that:
13 (i) processes, distributes, or sells a kratom product, or a
14 substantially similar substance in another jurisdiction;
15 or
16 (ii) cultivates, processes, distributes, dispenses, or sells a
17 kratom product; and
HB 1500—LS 6758/DI 149 2
1 (B) that is accredited as a testing laboratory to
2 International Organization for Standardization (ISO)
3 17025 by a third party accrediting body such as the
4 American Association for Laboratory Accreditation
5 (A2LA) or Assured Calibration and Laboratory
6 Accreditation Select Services (ACLASS).
7 (3) "Kratom product" has the meaning set forth in
8 IC 35-48-1-17.6.
9 (4) "MBR" refers to a manufacturing batch record.
10 (5) "USP 467" has the meaning set forth in IC 35-48-1-28.
11 Sec. 2. (a) A person may distribute a kratom product in Indiana
12 only if the distributor maintains a MBR that documents all of the
13 following:
14 (1) Batch to batch uniformity.
15 (2) That each batch conforms to kratom raw material
16 specifications.
17 (3) That each batch record shows that each step of the MBR
18 was performed.
19 (4) That the product processes, controls, and tests ensure
20 reliable, reproducible results.
21 (5) That the finished kratom product meets each specification
22 before the product is released for distribution.
23 (b) The distributor must maintain records of MBR testing on all
24 finished kratom products as identified by lot or batch number, and
25 each MBR must include all the following information:
26 (1) The lot or batch identification number of the tested
27 product.
28 (2) The date received.
29 (3) The date of testing completion.
30 (4) The method of analysis for each test conducted.
31 (5) The name and address of the kratom processor that
32 manufactured the product.
33 (6) The name and address where the MBR records are
34 maintained and available for inspection.
35 Sec. 3. A person may distribute a kratom product in Indiana
36 only if the distributor has a certificate of analysis prepared by an
37 independent testing laboratory showing both of the following:
38 (1) That the kratom product is the product of a batch subject
39 to the MBR maintained by the distributor and describes the
40 results of the laboratory's analytical testing of a sample by the
41 independent testing laboratory.
42 (2) That the independent testing laboratory determined that
HB 1500—LS 6758/DI 149 3
1 the tested batch contained:
2 (A) an extract from a kratom product that has a level of
3 residual solvent that is not more than permitted by USP
4 467;
5 (B) a kratom product that does not contain a level of
6 7-hydroxymitragynine in the alkaloid fraction that is
7 greater than one percent (1%) of the overall alkaloid
8 composition of the product; and
9 (C) a kratom product that does not contain any synthetic
10 alkaloids including synthetic mitragynine, synthetic
11 7-hydroxymitragynine, or any other synthetic compound
12 of a kratom plant.
13 Sec. 4. A kratom product must be distributed in packaging that
14 contains the following information:
15 (1) A scannable bar code or QR code linked to a document
16 that contains information with respect to the manufacture of
17 the kratom product, including all the following:
18 (A) The batch identification number.
19 (B) The product name.
20 (C) The batch date.
21 (D) The batch size.
22 (E) The total quantity produced.
23 (F) The ingredients used in the product, including the:
24 (i) ingredient name;
25 (ii) name of the company that manufactured the
26 ingredient;
27 (iii) company or product identification number or code,
28 if applicable; and
29 (iv) ingredient lot number.
30 (G) The download link for a certificate of analysis for the
31 kratom product.
32 (2) The batch number.
33 (3) The Internet address of a website to obtain batch
34 information.
35 (4) The expiration date.
36 (5) A recommended serving size.
37 (6) The manufacturer.
38 (7) The fact that the product:
39 (A) contains an extract from a kratom product that has a
40 level of residual solvent that is not more than permitted by
41 USP 467;
42 (B) does not contain a level of 7-hydroxymitragynine in the
HB 1500—LS 6758/DI 149 4
1 alkaloid fraction that is greater than one percent (1%) of
2 the overall alkaloid composition of the product; and
3 (C) does not contain any synthetic alkaloids including
4 synthetic mitragynine, synthetic 7-hydroxymitragynine, or
5 any other synthetic compound of a kratom plant.
6 (8) The label of each kratom product marketed as a dietary
7 supplement shall include the following text prominently
8 displayed:
9 "This product has not been evaluated by the Food and
10 Drug Administration. This product is not intended to
11 diagnose, treat, cure, or prevent any disease.".
12 (9) The following statement: "If you are pregnant or
13 breastfeeding, please ask a health professional before using a
14 kratom product.".
15 (10) If there is not sufficient room on the kratom product
16 label, the kratom product shall display on the label a
17 scannable bar code, QR code, or web address linked to a
18 document containing the required information.
19 Sec. 5. A person who distributes a kratom product in violation
20 of this chapter commits a Class B infraction. However, the offense
21 is a Class A infraction if the person has a prior unrelated judgment
22 for a violation of this chapter. These penalties are in addition to
23 any criminal penalties that may be imposed for unlawful possession
24 or distribution of a controlled substance.
25 SECTION 2. IC 24-4-24 IS ADDED TO THE INDIANA CODE AS
26 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
27 1, 2023]:
28 Chapter 24. Kratom Product Sales
29 Sec. 1. As used in this chapter, "kratom product" has the
30 meaning set forth in IC 35-48-1-17.6.
31 Sec. 2. This chapter does not apply to the sale of a product that
32 has been approved by the federal Food and Drug Administration
33 or the federal Drug Enforcement Agency as a prescription or over
34 the counter drug.
35 Sec. 3. (a) A person may sell a kratom product at retail only if
36 the packaging complies with the requirements of IC 24-4-23-4.
37 (b) A person who violates subsection (a) commits a Class C
38 infraction. However, the violation is a Class B infraction if the
39 person has one (1) prior unrelated judgment for a violation of
40 subsection (a), and a Class A infraction if the person has two (2) or
41 more prior unrelated judgments for a violation of subsection (a).
42 These penalties are in addition to any criminal penalties that may
HB 1500—LS 6758/DI 149 5
1 be imposed for unlawful possession or distribution of a controlled
2 substance.
3 Sec. 4. (a) A person may not sell, barter, exchange, provide, or
4 furnish a kratom product to a minor.
5 (b) A person who recklessly, knowingly, or intentionally violates
6 subsection (a) commits a Class B misdemeanor. However, the
7 offense described in subsection (a) is a Class A misdemeanor if the
8 person has a prior unrelated conviction under this section.
9 SECTION 3. IC 35-48-1-9, AS AMENDED BY P.L.153-2018,
10 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
11 JULY 1, 2023]: Sec. 9. (a) "Controlled substance" means a drug,
12 substance, or immediate precursor in schedule I, II, III, IV, or V under:
13 (1) IC 35-48-2-4, IC 35-48-2-6, IC 35-48-2-8, IC 35-48-2-10, or
14 IC 35-48-2-12, if IC 35-48-2-14 does not apply; or
15 (2) a rule adopted by the board, if IC 35-48-2-14 applies.
16 (b) The term does not include:
17 (1) low THC hemp extract (as defined by IC 35-48-1-17.5); or
18 (2) kratom product (as defined by IC 35-48-1-17.6).
19 SECTION 4. IC 35-48-1-17.6 IS ADDED TO THE INDIANA
20 CODE AS A NEW SECTION TO READ AS FOLLOWS
21 [EFFECTIVE JULY 1, 2023]: Sec. 17.6. "Kratom product" means
22 a substance or compound that:
23 (1) is a food product or dietary ingredient;
24 (2) is derived from the leaf or extract of mitragyna speciosa;
25 (3) has an extract that has a level of residual solvent that is
26 not more than permitted by USP 467 (as defined by
27 IC 35-48-1-28);
28 (4) does not contain a level of 7-hydroxymitragynine in the
29 alkaloid fraction that is greater than one percent (1%) of the
30 overall alkaloid composition of the product;
31 (5) does not contain any synthetic alkaloids including
32 synthetic mitragynin, synthetic 7-hydroxymitragynine, or any
33 other synthetic compound of a kratom plant; and
34 (6) contains no other controlled substances.
35 SECTION 5. IC 35-48-1-28 IS ADDED TO THE INDIANA CODE
36 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
37 1, 2023]: Sec. 28. "USP 467" means general chapter 467 (residual
38 solvents) of the United States pharmacopeia (USP).
39 SECTION 6. IC 35-52-24-20.5 IS ADDED TO THE INDIANA
40 CODE AS A NEW SECTION TO READ AS FOLLOWS
41 [EFFECTIVE JULY 1, 2023]: Sec. 20.5. IC 24-4-24-4 defines a crime
42 concerning kratom products.
HB 1500—LS 6758/DI 149 6
COMMITTEE REPORT
Mr. Speaker: Your Committee on Commerce, Small Business and
Economic Development, to which was referred House Bill 1500, has
had the same under consideration and begs leave to report the same
back to the House with the recommendation that said bill be amended
as follows:
Page 2, between lines 8 and 9, begin a new line block indented and
insert:
"(4) "MBR" refers to a manufacturing batch record.".
Page 2, line 9, delete "(4)" and insert "(5)".
Page 2, delete lines 10 through 42, begin a new paragraph and
insert:
"Sec. 2. (a) A person may distribute a kratom product in
Indiana only if the distributor maintains a MBR that documents all
of the following:
(1) Batch to batch uniformity.
(2) That each batch conforms to kratom raw material
specifications.
(3) That each batch record shows that each step of the MBR
was performed.
(4) That the product processes, controls, and tests ensure
reliable, reproducible results.
(5) That the finished kratom product meets each specification
before the product is released for distribution.
(b) The distributor must maintain records of MBR testing on all
finished kratom products as identified by lot or batch number, and
each MBR must include all the following information:
(1) The lot or batch identification number of the tested
product.
(2) The date received.
(3) The date of testing completion.
(4) The method of analysis for each test conducted.
(5) The name and address of the kratom processor that
manufactured the product.
(6) The name and address where the MBR records are
maintained and available for inspection.
Sec. 3. A person may distribute a kratom product in Indiana
only if the distributor has a certificate of analysis prepared by an
independent testing laboratory showing both of the following:
(1) That the kratom product is the product of a batch subject
to the MBR maintained by the distributor and describes the
results of the laboratory's analytical testing of a sample by the
HB 1500—LS 6758/DI 149 7
independent testing laboratory.
(2) That the independent testing laboratory determined that
the tested batch contained:
(A) an extract from a kratom product that has a level of
residual solvent that is not more than permitted by USP
467;
(B) a kratom product that does not contain a level of
7-hydroxymitragynine in the alkaloid fraction that is
greater than one percent (1%) of the overall alkaloid
composition of the product; and
(C) a kratom product that does not contain any synthetic
alkaloids including synthetic mitragynine, synthetic
7-hydroxymitragynine, or any other synthetic compound
of a kratom plant.
Sec. 4. A kratom product must be distributed in packaging that
contains the following information:
(1) A scannable bar code or QR code linked to a document
that contains information with respect to the manufacture of
the kratom product, including all the following:
(A) The batch identification number.
(B) The product name.
(C) The batch date.
(D) The batch size.
(E) The total quantity produced.
(F) The ingredients used in the product, including the:
(i) ingredient name;
(ii) name of the company that manufactured the
ingredient;
(iii) company or product identification number or code,
if applicable; and
(iv) ingredient lot number.
(G) The download link for a certificate of analysis for the
kratom product.
(2) The batch number.
(3) The Internet address of a website to obtain batch
information.
(4) The expiration date.
(5) A recommended serving size.
(6) The manufacturer.
(7) The fact that the product:
(A) contains an extract from a kratom product that has a
level of residual solvent that is not more than permitted by
HB 1500—LS 6758/DI 149 8
USP 467;
(B) does not contain a level of 7-hydroxymitragynine in the
alkaloid fraction that is greater than one percent (1%) of
the overall alkaloid composition of the product; and
(C) does not contain any synthetic alkaloids including
synthetic mitragynine, synthetic 7-hydroxymitragynine, or
any other synthetic compound of a kratom plant.
(8) The label of each kratom product marketed as a dietary
supplement shall include the following text prominently
displayed:
"This product has not been evaluated by the Food and
Drug Administration. This product is not intended to
diagnose, treat, cure, or prevent any disease.".
(9) The following statement: "If you are pregnant or
breastfeeding, please ask a health professional before using a
kratom product.".
(10) If there is not sufficient room on the kratom product
label, the kratom product shall display on the label a
scannable bar code, QR code, or web address linked to a
document containing the required information.".
Page 3, delete lines 1 through 28.
Page 4, delete lines 3 through 12, begin a new paragraph and insert:
"Sec. 3. (a) A person may sell a kratom product at retail only if
the packaging complies with the requirements of IC 24-4-23-4.
(b) A person who violates subsection (a) commits a Class C
infraction. However, the violation is a Class B infraction if the
person has one (1) prior unrelated judgment for a violation of
subsection (a), and a Class A infraction if the person has two (2) or
more prior unrelated judgments for a violation of subsection (a).
These penalties are in addition to any criminal penalties that may
be imposed for unlawful possession or distribution of a controlled
substance.
Sec. 4. (a) A person may not sell, barter, exchange, provide, or
furnish a kratom product to a minor.
(b) A person who recklessly, knowingly, or intentionally violates
subsection (a) commits a Class B misdemeanor. However, the
offense described in subsection (a) is a Class A misdemeanor if the
person has a prior unrelated conviction under this section.".
Page 4, after line 42, begin a new paragraph and insert:
"SECTION 6. IC 35-52-24-20.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2023]: Sec. 20.5. IC 24-4-24-4 defines a crime
HB 1500—LS 6758/DI 149 9
concerning kratom products.".
Renumber all SECTIONS consecutively.
and when so amended that said bill do pass.
(Reference is to HB 1500 as introduced.)
MORRIS
Committee Vote: yeas 10, nays 3.
_____
HOUSE MOTION
Mr. Speaker: I move that House Bill 1500 be amended to read as
follows:
Page 5, line 8, delete "section."." and insert "section.".
Page 5, line 29, delete "two percent (2%)" and insert "one percent
(1%)".
(Reference is to HB 1500 as printed February 16, 2023.)
MORRISON
HB 1500—LS 6758/DI 149