Indiana 2023 Regular Session

Indiana House Bill HB1500 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	HB1500.2
2		-	Reprinted
3		-	February 21, 2023
	1	+	HB1500.1
	2	+	February 16, 2023
4	3		HOUSE BILL No. 1500
5	4		_____
6		-	DIGEST OF HB 1500 (Updated February 20, 2023 6:~~03 pm~~ - DI 92)
	5	+	DIGEST OF HB 1500 (Updated February 16, 2023 10:34 am - DI 75)
7	6		Citations Affected: IC 24-4; IC 35-48; IC 35-52.
8	7		Synopsis: Kratom. Defines "kratom product" as a food product or
9	8		dietary ingredient that: (1) is derived from the leaf or extract of
10	9		mitragyna speciosa and has a level of residual solvent that is not more
11	10		than permitted by USP 467; (2) does not contain a level of 7-
12	11		hydroxymitragynine in the alkaloid fraction that is greater than 1% of
13	12		the overall alkaloid composition of the product; and (3) does not
14	13		contain any synthetic alkaloids including synthetic mitragynin,
15	14		synthetic 7-hydroxymitragynine, or any other synthetic compound of
16	15		a kratom plant. Establishes requirements for the manufacture, labeling,
17	16		and sale of kratom products. Specifies that a kratom product is not a
18	17		controlled substance.
19	18		Effective: July 1, 2023.
20	19		Morrison, Lucas, Morris
21	20		January 17, 2023, read first time and referred to Committee on Commerce, Small Business
22	21		and Economic Development.
23	22		February 16, 2023, amended, reported — Do Pass.
24		-	February 20, 2023, read second time, amended, ordered engrossed.
25		-	HB 1500—LS 6758/DI 149 Reprinted
26		-	February 21, 2023
	23	+	HB 1500—LS 6758/DI 149 February 16, 2023
27	24		First Regular Session of the 123rd General Assembly (2023)
28	25		PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
29	26		Constitution) is being amended, the text of the existing provision will appear in this style type,
30	27		additions will appear in this style type, and deletions will appear in this style type.
31	28		Additions: Whenever a new statutory provision is being enacted (or a new constitutional
32	29		provision adopted), the text of the new provision will appear in this style type. Also, the
33	30		word NEW will appear in that style type in the introductory clause of each SECTION that adds
34	31		a new provision to the Indiana Code or the Indiana Constitution.
35	32		Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
36	33		between statutes enacted by the 2022 Regular Session of the General Assembly.
37	34		HOUSE BILL No. 1500
38	35		A BILL FOR AN ACT to amend the Indiana Code concerning trade
39	36		regulation.
40	37		Be it enacted by the General Assembly of the State of Indiana:
41	38		1 SECTION 1. IC 24-4-23 IS ADDED TO THE INDIANA CODE AS
42	39		2 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
43	40		3 1, 2023]:
44	41		4 Chapter 23. Distribution of a Kratom Product
45	42		5 Sec. 1. The following definitions apply throughout this chapter:
46	43		6 (1) "Certificate of analysis" means a certificate from an
47	44		7 independent testing laboratory describing the results of the
48	45		8 laboratory's testing of a sample.
49	46		9 (2) "Independent testing laboratory" means a laboratory:
50	47		10 (A) with respect to which no person having a direct or
51	48		11 indirect interest in the laboratory also has a direct or
52	49		12 indirect interest in a facility that:
53	50		13 (i) processes, distributes, or sells a kratom product, or a
54	51		14 substantially similar substance in another jurisdiction;
55	52		15 or
56	53		16 (ii) cultivates, processes, distributes, dispenses, or sells a
57	54		17 kratom product; and
58	55		HB 1500—LS 6758/DI 149 2
59	56		1 (B) that is accredited as a testing laboratory to
60	57		2 International Organization for Standardization (ISO)
61	58		3 17025 by a third party accrediting body such as the
62	59		4 American Association for Laboratory Accreditation
63	60		5 (A2LA) or Assured Calibration and Laboratory
64	61		6 Accreditation Select Services (ACLASS).
65	62		7 (3) "Kratom product" has the meaning set forth in
66	63		8 IC 35-48-1-17.6.
67	64		9 (4) "MBR" refers to a manufacturing batch record.
68	65		10 (5) "USP 467" has the meaning set forth in IC 35-48-1-28.
69	66		11 Sec. 2. (a) A person may distribute a kratom product in Indiana
70	67		12 only if the distributor maintains a MBR that documents all of the
71	68		13 following:
72	69		14 (1) Batch to batch uniformity.
73	70		15 (2) That each batch conforms to kratom raw material
74	71		16 specifications.
75	72		17 (3) That each batch record shows that each step of the MBR
76	73		18 was performed.
77	74		19 (4) That the product processes, controls, and tests ensure
78	75		20 reliable, reproducible results.
79	76		21 (5) That the finished kratom product meets each specification
80	77		22 before the product is released for distribution.
81	78		23 (b) The distributor must maintain records of MBR testing on all
82	79		24 finished kratom products as identified by lot or batch number, and
83	80		25 each MBR must include all the following information:
84	81		26 (1) The lot or batch identification number of the tested
85	82		27 product.
86	83		28 (2) The date received.
87	84		29 (3) The date of testing completion.
88	85		30 (4) The method of analysis for each test conducted.
89	86		31 (5) The name and address of the kratom processor that
90	87		32 manufactured the product.
91	88		33 (6) The name and address where the MBR records are
92	89		34 maintained and available for inspection.
93	90		35 Sec. 3. A person may distribute a kratom product in Indiana
94	91		36 only if the distributor has a certificate of analysis prepared by an
95	92		37 independent testing laboratory showing both of the following:
96	93		38 (1) That the kratom product is the product of a batch subject
97	94		39 to the MBR maintained by the distributor and describes the
98	95		40 results of the laboratory's analytical testing of a sample by the
99	96		41 independent testing laboratory.
100	97		42 (2) That the independent testing laboratory determined that
101	98		HB 1500—LS 6758/DI 149 3
102	99		1 the tested batch contained:
103	100		2 (A) an extract from a kratom product that has a level of
104	101		3 residual solvent that is not more than permitted by USP
105	102		4 467;
106	103		5 (B) a kratom product that does not contain a level of
107	104		6 7-hydroxymitragynine in the alkaloid fraction that is
108	105		7 greater than one percent (1%) of the overall alkaloid
109	106		8 composition of the product; and
110	107		9 (C) a kratom product that does not contain any synthetic
111	108		10 alkaloids including synthetic mitragynine, synthetic
112	109		11 7-hydroxymitragynine, or any other synthetic compound
113	110		12 of a kratom plant.
114	111		13 Sec. 4. A kratom product must be distributed in packaging that
115	112		14 contains the following information:
116	113		15 (1) A scannable bar code or QR code linked to a document
117	114		16 that contains information with respect to the manufacture of
118	115		17 the kratom product, including all the following:
119	116		18 (A) The batch identification number.
120	117		19 (B) The product name.
121	118		20 (C) The batch date.
122	119		21 (D) The batch size.
123	120		22 (E) The total quantity produced.
124	121		23 (F) The ingredients used in the product, including the:
125	122		24 (i) ingredient name;
126	123		25 (ii) name of the company that manufactured the
127	124		26 ingredient;
128	125		27 (iii) company or product identification number or code,
129	126		28 if applicable; and
130	127		29 (iv) ingredient lot number.
131	128		30 (G) The download link for a certificate of analysis for the
132	129		31 kratom product.
133	130		32 (2) The batch number.
134	131		33 (3) The Internet address of a website to obtain batch
135	132		34 information.
136	133		35 (4) The expiration date.
137	134		36 (5) A recommended serving size.
138	135		37 (6) The manufacturer.
139	136		38 (7) The fact that the product:
140	137		39 (A) contains an extract from a kratom product that has a
141	138		40 level of residual solvent that is not more than permitted by
142	139		41 USP 467;
143	140		42 (B) does not contain a level of 7-hydroxymitragynine in the
144	141		HB 1500—LS 6758/DI 149 4
145	142		1 alkaloid fraction that is greater than one percent (1%) of
146	143		2 the overall alkaloid composition of the product; and
147	144		3 (C) does not contain any synthetic alkaloids including
148	145		4 synthetic mitragynine, synthetic 7-hydroxymitragynine, or
149	146		5 any other synthetic compound of a kratom plant.
150	147		6 (8) The label of each kratom product marketed as a dietary
151	148		7 supplement shall include the following text prominently
152	149		8 displayed:
153	150		9 "This product has not been evaluated by the Food and
154	151		10 Drug Administration. This product is not intended to
155	152		11 diagnose, treat, cure, or prevent any disease.".
156	153		12 (9) The following statement: "If you are pregnant or
157	154		13 breastfeeding, please ask a health professional before using a
158	155		14 kratom product.".
159	156		15 (10) If there is not sufficient room on the kratom product
160	157		16 label, the kratom product shall display on the label a
161	158		17 scannable bar code, QR code, or web address linked to a
162	159		18 document containing the required information.
163	160		19 Sec. 5. A person who distributes a kratom product in violation
164	161		20 of this chapter commits a Class B infraction. However, the offense
165	162		21 is a Class A infraction if the person has a prior unrelated judgment
166	163		22 for a violation of this chapter. These penalties are in addition to
167	164		23 any criminal penalties that may be imposed for unlawful possession
168	165		24 or distribution of a controlled substance.
169	166		25 SECTION 2. IC 24-4-24 IS ADDED TO THE INDIANA CODE AS
170	167		26 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY
171	168		27 1, 2023]:
172	169		28 Chapter 24. Kratom Product Sales
173	170		29 Sec. 1. As used in this chapter, "kratom product" has the
174	171		30 meaning set forth in IC 35-48-1-17.6.
175	172		31 Sec. 2. This chapter does not apply to the sale of a product that
176	173		32 has been approved by the federal Food and Drug Administration
177	174		33 or the federal Drug Enforcement Agency as a prescription or over
178	175		34 the counter drug.
179	176		35 Sec. 3. (a) A person may sell a kratom product at retail only if
180	177		36 the packaging complies with the requirements of IC 24-4-23-4.
181	178		37 (b) A person who violates subsection (a) commits a Class C
182	179		38 infraction. However, the violation is a Class B infraction if the
183	180		39 person has one (1) prior unrelated judgment for a violation of
184	181		40 subsection (a), and a Class A infraction if the person has two (2) or
185	182		41 more prior unrelated judgments for a violation of subsection (a).
186	183		42 These penalties are in addition to any criminal penalties that may
187	184		HB 1500—LS 6758/DI 149 5
188	185		1 be imposed for unlawful possession or distribution of a controlled
189	186		2 substance.
190	187		3 Sec. 4. (a) A person may not sell, barter, exchange, provide, or
191	188		4 furnish a kratom product to a minor.
192	189		5 (b) A person who recklessly, knowingly, or intentionally violates
193	190		6 subsection (a) commits a Class B misdemeanor. However, the
194	191		7 offense described in subsection (a) is a Class A misdemeanor if the
195		-	8 person has a prior unrelated conviction under this section.
	192	+	8 person has a prior unrelated conviction under this section.".
196	193		9 SECTION 3. IC 35-48-1-9, AS AMENDED BY P.L.153-2018,
197	194		10 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
198	195		11 JULY 1, 2023]: Sec. 9. (a) "Controlled substance" means a drug,
199	196		12 substance, or immediate precursor in schedule I, II, III, IV, or V under:
200	197		13 (1) IC 35-48-2-4, IC 35-48-2-6, IC 35-48-2-8, IC 35-48-2-10, or
201	198		14 IC 35-48-2-12, if IC 35-48-2-14 does not apply; or
202	199		15 (2) a rule adopted by the board, if IC 35-48-2-14 applies.
203	200		16 (b) The term does not include:
204	201		17 (1) low THC hemp extract (as defined by IC 35-48-1-17.5); or
205	202		18 (2) kratom product (as defined by IC 35-48-1-17.6).
206	203		19 SECTION 4. IC 35-48-1-17.6 IS ADDED TO THE INDIANA
207	204		20 CODE AS A NEW SECTION TO READ AS FOLLOWS
208	205		21 [EFFECTIVE JULY 1, 2023]: Sec. 17.6. "Kratom product" means
209	206		22 a substance or compound that:
210	207		23 (1) is a food product or dietary ingredient;
211	208		24 (2) is derived from the leaf or extract of mitragyna speciosa;
212	209		25 (3) has an extract that has a level of residual solvent that is
213	210		26 not more than permitted by USP 467 (as defined by
214	211		27 IC 35-48-1-28);
215	212		28 (4) does not contain a level of 7-hydroxymitragynine in the
216		-	29 alkaloid fraction that is greater than ~~one~~ percent (1%) of the
	213	+	29 alkaloid fraction that is greater than two percent (2%) of the
217	214		30 overall alkaloid composition of the product;
218	215		31 (5) does not contain any synthetic alkaloids including
219	216		32 synthetic mitragynin, synthetic 7-hydroxymitragynine, or any
220	217		33 other synthetic compound of a kratom plant; and
221	218		34 (6) contains no other controlled substances.
222	219		35 SECTION 5. IC 35-48-1-28 IS ADDED TO THE INDIANA CODE
223	220		36 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
224	221		37 1, 2023]: Sec. 28. "USP 467" means general chapter 467 (residual
225	222		38 solvents) of the United States pharmacopeia (USP).
226	223		39 SECTION 6. IC 35-52-24-20.5 IS ADDED TO THE INDIANA
227	224		40 CODE AS A NEW SECTION TO READ AS FOLLOWS
228	225		41 [EFFECTIVE JULY 1, 2023]: Sec. 20.5. IC 24-4-24-4 defines a crime
229	226		42 concerning kratom products.
230	227		HB 1500—LS 6758/DI 149 6
231	228		COMMITTEE REPORT
232	229		Mr. Speaker: Your Committee on Commerce, Small Business and
233	230		Economic Development, to which was referred House Bill 1500, has
234	231		had the same under consideration and begs leave to report the same
235	232		back to the House with the recommendation that said bill be amended
236	233		as follows:
237	234		Page 2, between lines 8 and 9, begin a new line block indented and
238	235		insert:
239	236		"(4) "MBR" refers to a manufacturing batch record.".
240	237		Page 2, line 9, delete "(4)" and insert "(5)".
241	238		Page 2, delete lines 10 through 42, begin a new paragraph and
242	239		insert:
243	240		"Sec. 2. (a) A person may distribute a kratom product in
244	241		Indiana only if the distributor maintains a MBR that documents all
245	242		of the following:
246	243		(1) Batch to batch uniformity.
247	244		(2) That each batch conforms to kratom raw material
248	245		specifications.
249	246		(3) That each batch record shows that each step of the MBR
250	247		was performed.
251	248		(4) That the product processes, controls, and tests ensure
252	249		reliable, reproducible results.
253	250		(5) That the finished kratom product meets each specification
254	251		before the product is released for distribution.
255	252		(b) The distributor must maintain records of MBR testing on all
256	253		finished kratom products as identified by lot or batch number, and
257	254		each MBR must include all the following information:
258	255		(1) The lot or batch identification number of the tested
259	256		product.
260	257		(2) The date received.
261	258		(3) The date of testing completion.
262	259		(4) The method of analysis for each test conducted.
263	260		(5) The name and address of the kratom processor that
264	261		manufactured the product.
265	262		(6) The name and address where the MBR records are
266	263		maintained and available for inspection.
267	264		Sec. 3. A person may distribute a kratom product in Indiana
268	265		only if the distributor has a certificate of analysis prepared by an
269	266		independent testing laboratory showing both of the following:
270	267		(1) That the kratom product is the product of a batch subject
271	268		to the MBR maintained by the distributor and describes the
272	269		results of the laboratory's analytical testing of a sample by the
273	270		HB 1500—LS 6758/DI 149 7
274	271		independent testing laboratory.
275	272		(2) That the independent testing laboratory determined that
276	273		the tested batch contained:
277	274		(A) an extract from a kratom product that has a level of
278	275		residual solvent that is not more than permitted by USP
279	276		467;
280	277		(B) a kratom product that does not contain a level of
281	278		7-hydroxymitragynine in the alkaloid fraction that is
282	279		greater than one percent (1%) of the overall alkaloid
283	280		composition of the product; and
284	281		(C) a kratom product that does not contain any synthetic
285	282		alkaloids including synthetic mitragynine, synthetic
286	283		7-hydroxymitragynine, or any other synthetic compound
287	284		of a kratom plant.
288	285		Sec. 4. A kratom product must be distributed in packaging that
289	286		contains the following information:
290	287		(1) A scannable bar code or QR code linked to a document
291	288		that contains information with respect to the manufacture of
292	289		the kratom product, including all the following:
293	290		(A) The batch identification number.
294	291		(B) The product name.
295	292		(C) The batch date.
296	293		(D) The batch size.
297	294		(E) The total quantity produced.
298	295		(F) The ingredients used in the product, including the:
299	296		(i) ingredient name;
300	297		(ii) name of the company that manufactured the
301	298		ingredient;
302	299		(iii) company or product identification number or code,
303	300		if applicable; and
304	301		(iv) ingredient lot number.
305	302		(G) The download link for a certificate of analysis for the
306	303		kratom product.
307	304		(2) The batch number.
308	305		(3) The Internet address of a website to obtain batch
309	306		information.
310	307		(4) The expiration date.
311	308		(5) A recommended serving size.
312	309		(6) The manufacturer.
313	310		(7) The fact that the product:
314	311		(A) contains an extract from a kratom product that has a
315	312		level of residual solvent that is not more than permitted by
316	313		HB 1500—LS 6758/DI 149 8
317	314		USP 467;
318	315		(B) does not contain a level of 7-hydroxymitragynine in the
319	316		alkaloid fraction that is greater than one percent (1%) of
320	317		the overall alkaloid composition of the product; and
321	318		(C) does not contain any synthetic alkaloids including
322	319		synthetic mitragynine, synthetic 7-hydroxymitragynine, or
323	320		any other synthetic compound of a kratom plant.
324	321		(8) The label of each kratom product marketed as a dietary
325	322		supplement shall include the following text prominently
326	323		displayed:
327	324		"This product has not been evaluated by the Food and
328	325		Drug Administration. This product is not intended to
329	326		diagnose, treat, cure, or prevent any disease.".
330	327		(9) The following statement: "If you are pregnant or
331	328		breastfeeding, please ask a health professional before using a
332	329		kratom product.".
333	330		(10) If there is not sufficient room on the kratom product
334	331		label, the kratom product shall display on the label a
335	332		scannable bar code, QR code, or web address linked to a
336	333		document containing the required information.".
337	334		Page 3, delete lines 1 through 28.
338	335		Page 4, delete lines 3 through 12, begin a new paragraph and insert:
339	336		"Sec. 3. (a) A person may sell a kratom product at retail only if
340	337		the packaging complies with the requirements of IC 24-4-23-4.
341	338		(b) A person who violates subsection (a) commits a Class C
342	339		infraction. However, the violation is a Class B infraction if the
343	340		person has one (1) prior unrelated judgment for a violation of
344	341		subsection (a), and a Class A infraction if the person has two (2) or
345	342		more prior unrelated judgments for a violation of subsection (a).
346	343		These penalties are in addition to any criminal penalties that may
347	344		be imposed for unlawful possession or distribution of a controlled
348	345		substance.
349	346		Sec. 4. (a) A person may not sell, barter, exchange, provide, or
350	347		furnish a kratom product to a minor.
351	348		(b) A person who recklessly, knowingly, or intentionally violates
352	349		subsection (a) commits a Class B misdemeanor. However, the
353	350		offense described in subsection (a) is a Class A misdemeanor if the
354	351		person has a prior unrelated conviction under this section.".
355	352		Page 4, after line 42, begin a new paragraph and insert:
356	353		"SECTION 6. IC 35-52-24-20.5 IS ADDED TO THE INDIANA
357	354		CODE AS A NEW SECTION TO READ AS FOLLOWS
358	355		[EFFECTIVE JULY 1, 2023]: Sec. 20.5. IC 24-4-24-4 defines a crime
359	356		HB 1500—LS 6758/DI 149 9
360	357		concerning kratom products.".
361	358		Renumber all SECTIONS consecutively.
362	359		and when so amended that said bill do pass.
363	360		(Reference is to HB 1500 as introduced.)
364	361		MORRIS
365	362		Committee Vote: yeas 10, nays 3.
366		-	_____
367		-	HOUSE MOTION
368		-	Mr. Speaker: I move that House Bill 1500 be amended to read as
369		-	follows:
370		-	Page 5, line 8, delete "section."." and insert "section.".
371		-	Page 5, line 29, delete "two percent (2%)" and insert "one percent
372		-	(1%)".
373		-	(Reference is to HB 1500 as printed February 16, 2023.)
374		-	MORRISON
375	363		HB 1500—LS 6758/DI 149