AB322A - Revises provisions relating to kratom products. (BDR 52-763)

REQUIRES TWO-THIRDS MAJORITY VOTE EXEMPT (§§ 6, 6.5) (Reprinted with amendments adopted on June 3, 2023) THIRD REPRINT A.B. 322 - *AB322_R3* 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. – 2 – - *AB322_R3* 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 – 3 – - *AB322_R3* 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 – 4 – - *AB322_R3* (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 – 5 – - *AB322_R3* 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 – 6 – - *AB322_R3* 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 [Text truncated for display. Full text available on LegiScan.]