RELATING TO CONSUMER PROTECTION.

HB717

HOUSE OF REPRESENTATIVES

H.B. NO.

717

THIRTY-THIRD LEGISLATURE, 2025

STATE OF HAWAII

A BILL FOR AN ACT

relating
to consumer protection
.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

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SECTION
1.
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Chapter 328, Hawaii Revised Statutes,
is amended by adding a new part to be appropriately designated and to read as
follows:

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Part .
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Hawaii Kratom consumer protection act

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328-A
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Short title.
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This part shall be known and may be cited as
the Hawaii Kratom Consumer Protection Act.

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328-B
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Definitions.
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As used in this chapter:

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"Attractive
to children" means kratom products manufactured in the shape of cartoons
or animals or is manufactured or packaged in a form that bears any reasonable
resemblance to an existing candy product that is familiar to the public as a
widely distributed, branded food product such that a product could be mistaken
for the branded product, especially by children.

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"Independent
testing laboratory" means a laboratory accredited by a third-party
accrediting body as a competent testing laboratory pursuant to standard 17025
of the International Organization for Standardization and International
Electrotechnical Commission specialized system for worldwide standardization,
commonly abbreviated as ISO/IEC 17025.

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"Kratom"
means the plant Mitragyna speciosa or any part of that plant, including all
components present in the natural plant.

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"Kratom
extract" means a substance or compound obtained by extraction of the
Mitragyna speciosa leaf, intended for ingestion, containing more than trace
amounts of Mitragyna speciosa and contains other alkaloids of the kratom plant,
which does not contain any controlled substances or levels of residual solvents
greater than is allowed in the U.S. Pharmacopeia General Chapter 467.

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"Kratom
food service establishment" means a person who sells kratom as a beverage
prepared on-site, or sells pre-packaged kratom beverages or finished kratom
products, at a food service establishment licensed by the department.

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"Kratom
product" means a food, food ingredient, dietary ingredient, dietary
supplement, or beverage intended for human consumption that contains any part
of the leaf of the plant Mitragyna speciosa or an extract of the Mitragyna
speciosa leaf and is manufactured or served as a powder, capsule, pill,
beverage, liquid, or other edible form.

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"Synthesized
material" means an alkaloid or alkaloid derivative that has been created
by chemical synthesis or biosynthetic means, including fermentation,
recombinant techniques, yeast derived, and enzymatic techniques, rather than
traditional food preparation techniques, such as heating or extracting, that
synthetically alters the composition of any kratom alkaloid or constituent.

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328-C
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Kratom products; limitations.
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(a)
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No
person shall sell, offer for sale, advertise, distribute, produce, or
manufacture any of the following:

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(1)
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A kratom product that contains:

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(A)
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A level of 7-hydroxymitragynine in the
alkaloid fraction that is more than two per cent of the alkaloid composition of
the kratom product; provided that any product that contains a level of 7-hydroxymitragynine
in the alkaloid fraction more than two per cent of the alkaloid composition cannot
be marketed, labeled, or contain any reference on its packaging, that it is a
kratom product or referenced that it is derived from the alkaloid mitragynine;

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(B)
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Kratom extract and that contains levels of
residual solvents greater than is allowed in the U.S. Pharmacopeia General
Chapter 467; or

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(C)
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Dangerous psychoactive compounds, including
but not limited to synthetic cannabinoids or synthetic cathinones, or any other
compound that significantly alters the safety profile of the kratom product;

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(2)
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A kratom product that is adulterated;

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(3)
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A kratom product produced or manufactured in a
manner that is attractive to children;

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(4)
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A kratom product in any form that is
combustible, intended to be used for vaporization, or injectable; or

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(5)
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A product that contains any part of the leaf
of the plant Mitragyna speciosa or an extract of the Mitragyna speciosa leaf and
that does not conform to the definition of kratom product.

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(b)
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For purpose of this section, a kratom product
shall be deemed adulterated if:

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(1)
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The kratom product contains a poisonous or
otherwise deleterious non-kratom ingredient, including but not limited to
substances listed as a controlled substance under federal law or chapter 329;

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(2)
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The kratom product contains any synthesized
material or alkaloids or other plant constituents that have been isolated or
manipulated to artificially increase their potency through a method other than
traditional food preparation techniques, unless the manufacturer has safety
data to support the increased potency according to the conditions for use on
the label in the populations the data supports; or

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(3)
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A kratom product is combined with another
compound that is known to inhibit key cytochrome P450 enzymes, including CYP3A4
and CYP2D6, unless such specific product mixtures are scientifically validated
as safe under the intended conditions of use and are specifically permitted by
the department by rules adopted pursuant to chapter 91.

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328-D
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Kratom product registration; required.
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(a)
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No
person shall place a kratom product into commerce in the State unless the
person has registered the kratom product with the department on a form
prescribed by the department with a fee as provided under subsection (b) and
the sworn certifications under subsection (d).

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(b)
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The registration fee shall be determined by
department by rule adopted pursuant to chapter 91.
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The fee shall be adjusted annually to cover
all administrative costs for processing and administering the registration,
including the necessary personnel and the publication and maintenance of a
kratom registration webpage as provided in this section.

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(c)
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A person registering a kratom product under
section 328-C(b)(2) or (3) shall pay an additional fee determined by the
department pursuant to chapter 91 based on the costs incurred to retain the
services of qualified experts to review the safety data provided by the person
to allow the department to conduct a review and make a final decision.

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(d)
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Applications for registration shall include
sworn certifications from the kratom product's producer or manufacturer of the
following:

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(1)
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The kratom product was manufactured,
processed, or held in a facility that is in compliance with current good
manufacturing practices that meet requirements of title 21 Code of Federal
Regulations section 111;

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(2)
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A statement that the producer or manufacturer
has a reasonable basis that the product is safe for consumption under the
conditions of use set forth on the label; provided that the person registering
the kratom product shall assume responsibility and liability for the kratom
product; and

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(3)
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A certificate of analysis from a certified
third-party independent testing laboratory showing compliance with the
requirements of this chapter for residual solvents, 7-hydroxymitragynine
content, contaminants, and synthesized materials.

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(e)
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Products that contain identical kratom
ingredients in identical kratom delivery forms shall be included in a single
registration regardless of whether the containers, packages, or volumes are
identical.

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(f)
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Each registration shall expire on December 31
of each year.
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Before December 31 of each
year, the person shall renew the registration on a form prescribed by the
department with a fee as provided under subsection (b).

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(g)
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The department shall publish and maintain a
kratom registration page on the department's website listing all registered
kratom products available to be sold, offered for sale, or distributed in the
State.

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328-E
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Kratom products; labeling.
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A kratom product sold, offered for sale,
advertised, distributed, produced, or manufactured in the State shall have a
label that clearly and conspicuously provides all of the following information
on each retail package:

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(1)
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A statement against the use by individuals who
are under eighteen years of age, who are pregnant, or who are breastfeeding;

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(2)
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A recommendation to consult a health care
professional prior to use;

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(3)
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A statement that kratom may be habit forming;

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(4)
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The following statement: "These
statements have not been evaluated by the United States Food and Drug
Administration.
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This product is not
intended to diagnose, treat, cure, or prevent any disease.";

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(5)
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The name and the address for the place of
business of the registrant; and

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(6)
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Directions for use that includes the following:

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(A)
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A recommended amount of the kratom product per
serving that is:

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(i)
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Clearly described on the label for product
forms, such as capsules, gummies, prepackaged single serving units, and similar
product forms; or

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(ii)
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For beverages, liquids, or loose powders, a
clear instruction or a mark on the package or container that clearly informs
the consumer on the recommended serving size;

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(B)
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A recommended number of servings that can be
safely consumed in a twenty-four-hour period;

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(C)
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A listing of the servings per container;

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(D)
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A listing of kratom alkaloids and other
ingredients in the product, including quantitative not to exceed declarations
of the amount per serving of mitragynine and 7-hydroxymitragynine;

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(E)
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A kratom food service establishment that sells
kratom as a beverage prepared on-site shall provide an equivalent label in card
form or prominently display the required language in a location next to the
point-of-sale device to the customer at the time the beverage is purchased by
the consumer; and

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(F)
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For any kratom product that contains
psychoactive compounds otherwise permitted shall be clearly labeled with a full
disclosure of all active ingredients, the exact concentration of each compound,
and adequate warning statements about the potential interactions and risks
associated with the combined use of these substances.

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328-F
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Enforcement.
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(a)
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Each
kratom product without a valid registration shall be seized and destroyed, and
the costs associated with the enforcement shall be assessed to the person
selling, offering for sale, advertising, or distributing the kratom product.

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(b)
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No person shall sell or offer for sale a
kratom product intended to a person under eighteen years of age.
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A person who knowingly commits a second or
subsequent violation of this subsection within one year after the initial
violation shall be guilty of a misdemeanor.

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(c)
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A person who knowingly sells, offers for
sale, advertises, distributes, produces, or manufactures a kratom product containing
any substance listed as a controlled substance under federal law or chapter 329
shall be guilty of a class C felony.

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(d)
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A person who knowingly sells, offers for
sale, advertises, distributes, produces, or manufactures a kratom product
containing any synthesized material, including synthetic mitragynine, synthetic
7-hydroxymitragynine, or any other synthetically derived compound of the plant
Mitragyna speciosa, or alkaloids or other plant shall constitute a violation of
section 328-C(b)(2).
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A violation of this
subsection shall result in the immediate seizure and destruction of the kratom
products and may result in the penalties under section 328-29.
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Any person who, within five years of the
instant offense, has convictions of two or more violations of this subsection
shall be guilty of a class C felony.

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(e)
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A person who violates section 328-C(b),
except as provided under subsection (d), shall be subject to the penalties
under section 328-29.

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(f)
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Upon receipt of a violation report on any
kratom product sold, offered for sale, advertised, distributed, produced, or manufactured,
the department shall require the person to produce an updated and current
certificate of analysis in a reasonable time frame from a certified third-party
independent testing laboratory showing compliance with the requirements of this
part for safe kratom products.
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If the person
does not provide the certificate of analysis in the specified time frame, the
registration for that product shall be revoked and a stop sale order shall be
issued for products covered by the registration.

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(g)
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If the department has a reasonable basis to
require an independent third-party test of a registered kratom product by an independent
testing laboratory of the department's choice, the person shall be required to
submit payment for the test within a reasonable time frame.
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If the person does not tender payment to the
department within thirty days of receipt of the invoice for the testing, the
department shall revoke the registration for that product and a stop sale order
shall be issued for products covered by the registration.

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(h)
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No person shall be in violation of this part
for any kratom product that has been reviewed and approved by the department
for safe consumption in combination with psychoactive compounds under clearly
defined conditions of use.

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(i)
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No person shall be in violation of this part
if it is shown by a preponderance of the evidence that the person relied in
good faith upon the representations of a manufacturer, producer, or distributor
of food represented to be a kratom product.

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328-G
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Rules.
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The department shall adopt rules pursuant to chapter 91 to effectuate
this part.
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The rules shall provide:

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(1)
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The process for a registration of a kratom
product by a person;

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(2)
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The requirements for enforcing the restriction
on the sale of any kratom product to a person under the age of eighteen; and

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(3)
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Proof of appropriate quality testing from an
independent testing laboratory in the form of a certificate of analysis
representing the product does not contain levels of residual solvents,
biological contaminants or heavy metal contaminants that violates the standard
for dietary supplement products.

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328-H
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Federal preemption.
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If at any time on or after the effective date
of this part, the federal government or any department or agency thereof,
including but not limited to the federal Drug Enforcement Administration or
United States Food and Drug Administration, regulates 7-hydroxymitragynine,
7-hydroxymitragynine extracts, 7-hydroxymitragynine products, any other
derivative of the plant Mitragyna speciosa, 7-hydroxymitragynine processors, or
7-hydroxymitragynine retailers, including the acceptance by the United States
Food and Drug Administration of a new dietary ingredient notification, those
federal regulations shall supersede and take precedence over any provision of
this part and any administrative regulation promulgated thereunder to the
contrary that is addressed by the federal action."

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SECTION 2.
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In codifying the new sections added by
section 1 of this Act, the revisor of statutes shall substitute appropriate
section numbers for the letters used in designating the new sections in this
Act.

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SECTION 3.
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This Act does not affect rights and duties
that matured, penalties that were incurred, and proceedings that were begun
before its effective date.

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SECTION 4.
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This Act shall take effect on January 1,
2026.

INTRODUCED BY:

_____________________________

Report Title:

Hawaii
Kratom Consumer Protection Act; Kratom Products; Registration

Description:

Beginning
1/1/2026, requires kratom products to be registered with the Department of
Health and imposes labeling requirements.

The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.