REQUIRES TWO-THIRDS MAJORITY VOTE EXEMPT
(§§ 6, 6.5)
(Reprinted with amendments adopted on June 3, 2023)
THIRD REPRINT A.B. 322
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ASSEMBLY BILL NO. 322–ASSEMBLYMEN NGUYEN, YEAGER,
GONZÁLEZ; BROWN-MAY, DICKMAN, D’SILVA AND GALLANT
MARCH 16, 2023
____________
JOINT SPONSORS: SENATORS HANSEN; AND NGUYEN
____________
Referred to Committee on Commerce and Labor
SUMMARY—Revises provisions relating to kratom products.
(BDR 52-763)
FISCAL NOTE: Effect on Local Government: Increases or Newly
Provides for Term of Imprisonment in County or City
Jail or Detention Facility.
Effect on the State: Yes.
~
EXPLANATION – Matter in bolded italics is new; matter between brackets [omitted material] is material to be omitted.
AN ACT relating to public health; prohibiting a person from selling
or offering to sell a kratom product to an end user unless
the kratom product has been registered with the Division
of Public and Behavioral Health of the Department of
Health and Human Services; setting forth requirements
for the registration of a kratom product with the Division;
requiring a person who registers a kratom product to pay
certain expenses and report certain information relating to
the kratom product to the Division; authorizing the
Division to adopt certain regulations governing kratom
products; revising provisions establishing certain
prohibited acts relating to kratom products; exempting a
person who engages in certain acts relating to kratom
products from certain criminal or legal penalties if certain
substances in those products are designated as controlled
substances; providing penalties; making an appropriation;
and providing other matters properly relating thereto.
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Legislative Counsel’s Digest:
Existing law defines “kratom product” to mean, in general, any product or 1
ingredient containing any part of the leaf of the Mitragyna Speciosa plant if the 2
plant contains the alkaloid mitragynine or 7-hydroxymitragynine, or any synthetic 3
material that contains the alkaloid mitragynine or 7-hydroxymitragynine. Existing 4
law prohibits a person from: (1) selling or offering to sell any material, compound, 5
mixture or preparation containing a kratom product to a child under the age of 18 6
years; (2) preparing, distributing, advertising, selling or offering to sell a kratom 7
product that is adulterated with certain substances; and (3) selling a kratom product 8
that does not have a label that meets certain requirements. Existing law provides for 9
the imposition of a civil penalty of not more than $1,000 against a person who 10
violates those prohibitions. (NRS 597.998) 11
Section 5 of this bill revises the definition of kratom product to mean food 12
containing any part of the leaf of the Mitragyna Speciosa plant. Section 9 of this 13
bill revises the prohibited acts relating to kratom products set forth under existing 14
law to revise: (1) requirements relating to the type of kratom products that a person 15
is prohibited from preparing, distributing, advertising, selling or offering to sell; 16
and (2) the information that must be included on a label for a kratom product. 17
Section 9 eliminates the civil penalty imposed for engaging in such prohibited acts 18
and section 8.7 of this bill instead provides for the imposition of administrative 19
fines by the Division of Public and Behavioral Health of the Department of Health 20
and Human Services for certain violations relating to kratom products. 21
Section 6 of this bill prohibits a person from selling or offering to sell a kratom 22
product to an end user unless the kratom product has been registered with the 23
Division. Section 6 sets forth certain requirements for a person to register a kratom 24
product with the Division. 25
Sections 6.5 and 8 of this bill set forth circumstances under which the Division 26
may require a person who registers a kratom product to submit the kratom product 27
to a laboratory for certain additional testing. Section 7.5 of this bill requires a 28
person who registers a kratom product to submit to the Division a copy of certain 29
reports concerning the kratom product that are required to be submitted to the 30
United States Food and Drug Administration. 31
Section 7 of this bill authorizes the Division to adopt certain regulations to 32
carry out the provisions of this bill. Section 9.8 of this bill makes an appropriation 33
from the State General Fund to the Division for personnel, travel, operating, 34
equipment and information services expenses to carry out the provisions of this bill. 35
Existing law sets forth the Uniform Controlled Substances Act, which 36
establishes various provisions relating to controlled substances, including, without 37
limitation, provisions establishing certain offenses concerning controlled 38
substances and the penalties for those offenses. (NRS 453.011-453.348) 39
Existing law authorizes the State Board of Pharmacy to adopt regulations to 40
add, delete or reschedule substances as controlled substances in schedules I, II, III, 41
IV or V pursuant to the Uniform Controlled Substances Act. (NRS 453.146) 42
Section 8.3 of this bill provides that if mitragynine or any of its constituent 43
alkaloids is added to a schedule of controlled substances, a person who engages in 44
the possession, delivery, production, sale or use of a kratom product that meets the 45
requirements of this bill and who confines his or her activities to those authorized 46
by this bill does not commit a violation of any law, ordinance, rule or regulation of 47
this State or any political subdivision of this State and any such conduct must not 48
constitute the basis for any investigation, detention, search, seizure, arrest, 49
prosecution or other legal penalty against the person. Section 9.7 of this bill 50
provides that the Uniform Controlled Substances Act and certain other provisions 51
governing controlled substances do not apply to the extent that they are inconsistent 52
with the provisions of sections 2-9 of this act. 53
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Sections 2.5-4.5 of this bill define certain other words and terms for the 54
purposes of this bill. 55
THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN
SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:
Section 1. Chapter 597 of NRS is hereby amended by adding 1
thereto the provisions set forth as sections 2 to 8.7, inclusive, of this 2
act. 3
Sec. 2. As used in NRS 597.998 and sections 2 to 8.7, 4
inclusive, of this act, unless the context otherwise requires, the 5
words and terms defined in sections 2.5 to 5, inclusive, of this act 6
have the meanings ascribed to them in those sections. 7
Sec. 2.5. “Certificate of analysis” means a document 8
produced by a laboratory describing the results of the laboratory’s 9
testing of a kratom product. 10
Sec. 3. “Division” means the Division of Public and 11
Behavioral Health of the Department of Health and Human 12
Services. 13
Sec. 4. “Food” means any food, food product, food 14
ingredient, dietary ingredient, dietary supplement or beverage 15
intended for ultimate human consumption. 16
Sec. 4.5. “Kratom extract” means a kratom product 17
containing any part of the leaf of the Mitragyna Speciosa plant 18
that has been extracted and concentrated to provide a dosage that 19
is more standardized. 20
Sec. 5. “Kratom product” means food containing any part of 21
the leaf of the Mitragyna Speciosa plant, or an extract thereof, 22
which is manufactured as a powder, capsule, pill or other edible 23
form. 24
Sec. 6. 1. A person shall not sell or offer to sell a kratom 25
product to an end user unless the kratom product has been 26
registered with the Division pursuant to this section. 27
2. A person who wishes to register a kratom product must 28
submit to the Division: 29
(a) An application on a form prescribed by the Division. 30
(b) A fee in an amount established by the Division by 31
regulation. 32
(c) A certificate of analysis for the kratom product which: 33
(1) Is produced by an independent laboratory that meets 34
any requirements set forth in regulations adopted by the Division 35
pursuant to section 7 of this act. Such requirements may include, 36
without limitation, a requirement that the independent laboratory 37
meet any accreditation standards required by the Division relating 38
to the testing of food. 39
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(2) Provides sufficient information about the kratom 1
product to enable the Division to determine whether the kratom 2
product complies with the provisions of NRS 597.998 and sections 3
2 to 8.7, inclusive, of this act. 4
(d) Any other information and documentation that the 5
Division deems necessary to ensure that the kratom product meets 6
the requirements of NRS 597.998 and sections 2 to 8.7, inclusive, 7
of this act and the regulations adopted pursuant thereto. 8
3. A registration issued pursuant to this section expires 1 year 9
after issuance and may be renewed by submitting to the Division 10
an application for renewal and the same fees and materials 11
required by paragraphs (b), (c) and (d) of subsection 2 for an 12
initial registration. 13
Sec. 6.5. 1. If the Division has reasonable cause to believe 14
that the information contained on the label of, or the certificate of 15
analysis for, a kratom product is inaccurate, the Division may 16
require the person who registered the kratom product to send the 17
kratom product to a laboratory selected by the Division to conduct 18
testing on the kratom product. 19
2. After the testing conducted pursuant to subsection 1 is 20
completed, the Division shall send the person who registered the 21
kratom product a bill for the costs of the testing. If the person fails 22
to pay those costs within a period of time after the receipt of the 23
bill established by the Division by regulation, the Division shall 24
revoke the registration of the kratom product. 25
Sec. 7. The Division may adopt regulations as it determines 26
to be necessary or advisable to carry out the provisions of NRS 27
597.998 and sections 2 to 8.7, inclusive of this act. 28
Sec. 7.5. 1. If a person submits to the United States Food 29
and Drug Administration a report pursuant to 21 U.S.C. § 379aa-1 30
concerning a serious adverse event involving a kratom product 31
that the person has registered pursuant to section 6 of this act, the 32
person shall send a copy of that report to the Division by certified 33
mail within a period of time established by the Division by 34
regulation. 35
2. Failure to send to the Division a copy of the report 36
described in subsection 1 within the time required by subsection 1, 37
constitutes grounds for the revocation of the registration of the 38
kratom product about which the report relates. 39
Sec. 8. 1. Any person may report to the Division on a form 40
prescribed by the Division a suspected violation of NRS 597.998 or 41
sections 2 to 8.7, inclusive, of this act. 42
2. If the Division determines that the allegations in a 43
complaint are credible and relate to the content or labeling of, or a 44
certificate of analysis for, a kratom product, the Division shall 45
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require the person who committed the alleged violation to obtain 1
and provide to the Division, within a period of time prescribed by 2
the Division by regulation, a new certificate of analysis which 3
complies with paragraph (c) of subsection 2 of section 6 of this act 4
for the kratom product. 5
3. If a person fails to provide the Division with a certificate of 6
analysis pursuant to subsection 2, the Division shall revoke the 7
registration for the kratom product. 8
Sec. 8.3. Notwithstanding any other provision of law, if 9
mitragynine or any of its constituent alkaloids are added to 10
schedule I, II, III, IV or V by the State Board of Pharmacy by 11
regulation pursuant to NRS 453.146, a person who engages in the 12
possession, delivery, production, sale or use of a kratom product 13
that meets the requirements of NRS 597.998 and sections 2 to 8.7, 14
inclusive, of this act and who confines his or her activities to those 15
authorized by NRS 597.998 and sections 2 to 8.7, inclusive, of this 16
act does not violate any law, ordinance, rule or regulation of this 17
State or any political subdivision of this State and such conduct 18
may not constitute the basis for any investigation, detention, 19
search, seizure, arrest, prosecution or other legal penalty against 20
the person. 21
Sec. 8.7. 1. A person who violates any provision of NRS 22
597.998 and sections 2 to 8.7, inclusive, of this act is subject to an 23
administrative fine in an amount not to exceed $500 for a first 24
offense and $1,000 for a second or subsequent offense. 25
2. Upon the request of a person to whom an administrative 26
fine is issued, the Division shall provide notice of and conduct a 27
hearing in accordance with the provisions of chapter 233B of 28
NRS. 29
Sec. 9. NRS 597.998 is hereby amended to read as follows: 30
597.998 1. A person shall not knowingly distribute, sell or 31
offer to sell any material, compound, mixture or preparation 32
containing a kratom product to a child under the age of 18 years. 33
2. A person shall not knowingly prepare, distribute, advertise, 34
sell or offer to sell a kratom product that [is] : 35
(a) Is adulterated , as defined in 21 U.S.C. § 342, or combined 36
or packaged with [a] : 37
(1) A controlled substance or a dangerous drug, as defined 38
in chapter 454 of NRS, or any poisonous or deleterious substance; 39
or 40
(2) Any substance that affects the quality or strength of the 41
kratom product to such a degree as to render the kratom product 42
injurious to a consumer [. A person has not violated the provisions 43
of this subsection if he or she can show by a preponderance of 44
evidence that he or she relied in good faith upon the representations 45
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of a manufacturer, processor, packer or distributor of the kratom 1
product. 2
3. A person shall not sell a kratom product that does not have a 3
label that clearly sets forth the ingredients and directions for the safe 4
and effective use of the kratom product. 5
4. A person who violates any provision of this section is 6
subject to a civil penalty of not more than $1,000 for each violation. 7
5. As used in this section, “kratom product” means any product 8
or ingredient containing: 9
(a) Any part of the leaf of the Mitragyna Speciosa plant if the 10
plant contains the alkaloid mitragynine or 7-hydroxymitragynine; or 11
(b) A synthetic material that contains the alkaloid mitragynine 12
or 7-hydroxymitragynine, 13
regardless of whether the product or ingredient is labeled or sold 14
for human consumption.] ; 15
(b) Contains a level of 7-hydroxymitragynine in the alkaloid 16
fraction that is greater than 1 percent of the alkaloid composition 17
of the kratom product; 18
(c) Contains a synthetic alkaloid, including, without limitation, 19
synthetic mitragynine, synthetic 7-hydroxymitragynine or any 20
synthetically derived compound of the Mitragyna Speciosa plant; 21
(d) Does not include a label that complies with any 22
requirements for the labeling of food established by the State 23
Board of Health by regulations adopted pursuant to NRS 439.200 24
or 446.940 and that clearly sets forth: 25
(1) The recommended size of an individual serving; 26
(2) The maximum limits for individual servings per day; 27
(3) The number of servings equal to the size of one 28
recommended individual serving that are contained in the 29
package; and 30
(4) Directions for the safe and effective use of the kratom 31
product. 32
(e) A kratom extract which contains levels of residual solvents 33
that exceed the levels authorized by chapter 467 of the United 34
States Pharmacopeia-National Formulary, published by the 35
United States Pharmacopeial Convention. 36
Sec. 9.5. (Deleted by amendment.) 37
Sec. 9.7. NRS 453.005 is hereby amended to read as follows: 38
453.005 The provisions of this chapter do not apply to the 39
extent that they are inconsistent with the provisions of [title] : 40
1. Title 56 of NRS. 41
2. NRS 597.998 and sections 2 to 8.7, inclusive, of this act. 42
Sec. 9.8. 1. There is hereby appropriated from the State 43
General Fund to the Division of Public and Behavioral Health of the 44
Department of Health and Human Services for personnel, travel, 45
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operating, equipment and information services expenses to carry out 1
the provisions of this act the following sums: 2
For the Fiscal Year 2023-2024 .................................. $121,162 3
For the Fiscal Year 2024-2025 .................................. $140,010 4
2. Any balance of the sums appropriated by subsection 1 5
remaining at the end of the respective fiscal years must not be 6
committed for expenditure after June 30 of the respective fiscal 7
years by the entity to which the appropriation is made or any entity 8
to which money from the appropriation is granted or otherwise 9
transferred in any manner, and any portion of the appropriated 10
money remaining must not be spent for any purpose after 11
September 20, 2024, and September 19, 2025, respectively, by 12
either the entity to which the money was appropriated or the entity 13
to which the money was subsequently granted or transferred, and 14
must be reverted to the State General Fund on or before 15
September 20, 2024, and September 19, 2025, respectively. 16
Sec. 10. 1. This section becomes effective upon passage and 17
approval. 18
2. Section 9.8 of this act becomes effective on July 1, 2023. 19
3. Sections 1 to 9.7, inclusive, of this act become effective: 20
(a) Upon passage and approval for the purpose of adopting any 21
regulations and performing any other preparatory administrative 22
tasks that are necessary to carry out the provisions of this act; and 23
(b) On January 1, 2024, for all other purposes. 24
H