ARIZONA STATE SENATE

RESEARCH STAFF

 

CHERIE STONE

LEGISLATIVE RESEARCH ANALYST

HEALTH & HUMAN SERVICES COMMITTEE

Telephone: (602) 926-3171

 

TO:                  MEMBERS OF THE SENATE

                        APPROPRIATIONS COMMITTEE

DATE:            March 29, 2019

SUBJECT:      Strike everything amendment to H.B. 2550, relating to regulation; kratom products


 


Purpose

Establishes requirements and prohibitions related to the preparation, distribution and sale of kratom products. Authorizes the Director of the Department of Health Services (DHS) to impose a civil penalty against a kratom product dealer who violates prescribed regulations.

Background

Mitragyna speciosa, commonly known as kratom, is a tropical plant native to Southeast Asia whose main constituent alkaloids are mitragynine and 7-hydroxymitragynine. The kratom plant's leaves, if consumed or ingested, can produce both stimulant and sedative effects in different doses (U.S. DEA).

Kratom qualifies as a dietary ingredient under the Federal Food, Drug and Cosmetic Act and is regulated by the U.S. Food and Drug Administration (U.S. FDA) as a dietary supplement. Kratom has not been approved by the U.S. FDA for any medical use and is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (U.S. FDA Import Alert
54-15
; 21 U.S.C. §§ 321; 342; and 350).

There is no anticipated fiscal impact to the state General Fund associated with this legislation.

Provisions

1.      Requires a dealer that prepares, distributes, sells or exposes for sale a food product that is represented to be a kratom product to disclose the factual basis on which the representation is made on the product label.

2.      Establishes that a dealer who violates the kratom product disclosure requirement is guilty of a class 2 misdemeanor.

3.      Prohibits a dealer from preparing, distributing, selling or exposing for sale a kratom product that:

a)      does not conform to the product label disclosure requirements;

b)      is adulterated or contaminated with a dangerous nonkratom substance;

c)      contains a level of 7-hydroxymitragynine in the alkaloid fraction that that is greater than two percent of the product's alkaloid composition;

d)      contains any synthetic alkaloid, including synthetic mitragynine, synthetic 7‑hydroxymitragynine or any other synthetically-derived compounds of the kratom plant; or

e)      does not include the amount of mitragynine and 7-hydroxymitragynine contained in the product on the package or label.

4.      Specifies that a kratom product is:

a)      adulterated with a dangerous nonkratom substance if the product is mixed or packed with a nonkratom substance that affects the quality or strength of the product to a degree that renders the product injurious to a consumer; and

b)      contaminated with a dangerous nonkratom substance if the product contains a poisonous or deleterious nonkratom substance, including any controlled substance included in the Uniform Controlled Substance Act.

5.      Prohibits a dealer from distributing, selling or exposing for sale a kratom product to an individual who is under 18 years of age.

6.      Authorizes the Director of DHS to impose the following civil penalties against a dealer who prepares, distributes, sells or exposes for sale a kratom product that is adulterated with a dangerous nonkratom substance:

a)      not more than $500 for the first offense; and

b)      not more than $1,000 for the second offense.

7.      Permits a dealer who is subject to a civil penalty to request a civil hearing with the Office of Administrative Hearings.

8.      Permits a person aggrieved by a violation of kratom product requirements to bring a private cause of action in a court of competent jurisdiction for damages, including economic, noneconomic and consequential damages, resulting from the violation.

9.      Stipulates that a dealer does not violate prescribed kratom product requirements and prohibitions if the court finds by a preponderance of the evidence that the dealer relied in good faith on the representation of a manufacturer, processor, packer or distributor that the food was a kratom product.

10.  Cites this legislation as the Kratom Consumer Protection Act.

11.  Defines relevant terms.

12.  Becomes effective on the general effective date.