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.