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As Introduced
136th
General Assembly
Regular
Session
H. B. No. 587
2025-2026
Representatives Odioso, Lorenz
Cosponsor: Representative Somani
To
amend sections 3715.01, 3715.99, 3717.01, and 3717.99 and to enact
sections 3715.026 and 3717.34 of the Revised Code
regarding
sales of kratom products.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section
1.
That
sections 3715.01, 3715.99, 3717.01, and 3717.99 be amended and
sections 3715.026 and 3717.34 of the Revised Code be enacted to read
as follows:
Sec.
3715.01.
(A)
As used in this chapter:
(1)
"Person" means an individual, partnership, corporation, or
association.
(2)
"Food" means:
(a)
Articles used for food or drink for humans or animals;
(b)
Chewing gum;
(c)
Articles used for components of any such articles.
(3)
"Drug" means:
(a)
Articles recognized in the United States pharmacopoeia and national
formulary, or any supplement to them;
(b)
Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or animals;
(c)
Articles, other than food, intended to affect the structure or any
function of the body of humans or other animals;
(d)
Articles intended for use as a component of any of the foregoing
articles, other than devices or their components, parts, or
accessories.
(4)
"Device," except when used in division (B)(1) of this
section and in division (A)(10) of section 3715.52, division (F) of
section 3715.60, division (A)(5) of section 3715.64, and division (C)
of section 3715.67 of the Revised Code, means any instrument,
apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including any
component, part, or accessory, that is any of the following:
(a)
Recognized in the United States pharmacopoeia and national formulary,
or any supplement to them;
(b)
Intended for use in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of disease in
humans or animals;
(c)
Intended to affect the structure or any function of the body of
humans or animals, and that does not achieve any of its principal
intended purposes through chemical action within or on the body of
humans or animals and is not dependent upon being metabolized for the
achievement of any of its principal intended purposes.
(5)
"Cosmetic" means:
(a)
Articles intended to be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human body or any part
thereof for cleansing, beautifying, promoting attractiveness, or
altering the appearance;
(b)
Articles intended for use as a component of any such article, except
that "cosmetic" does not include soap.
(6)
"Label" means a display of written, printed, or graphic
matter upon the immediate container, exclusive of package liners, of
any article.
Any
word, statement, or other information required by this chapter to
appear on the label must appear on the outside container or wrapper,
if any, of the retail package of the article, or the label must be
easily legible through the outside container or wrapper.
(7)
"Labeling" means all labels and other written, printed, or
graphic matter:
(a)
Upon an article or any of its containers or wrappers;
(b)
Accompanying such article.
(8)
"Advertisement" means all representations disseminated in
any manner or by any means, other than by labeling, for the purpose
of inducing, or that are likely to induce, directly or indirectly,
the purchase of food, drugs, devices, or cosmetics.
(9)
"New drug" means:
(a)
Any drug the composition of which is such that the drug is not
generally recognized among experts qualified by scientific training
and experience to evaluate the safety of drugs, as safe for use under
the conditions prescribed, recommended, or suggested in the labeling
thereof;
(b)
Any drug the composition of which is such that the drug, as a result
of investigation to determine its safety for use under such
conditions, has become so recognized, but that has not, other than in
an investigation, been used to a material extent or for a material
time under such conditions.
(10)
"Contaminated with filth" applies to any food, drug,
device, or cosmetic that has not been protected as far as may be
necessary by all reasonable means from dust, dirt, and all foreign or
injurious substances.
(11)
"Honey" means the nectar and saccharine exudation of plants
that has been gathered, modified, and stored in a honeycomb by
honeybees.
(12)
"Finished dosage form" means the form of a drug that is, or
is intended to be, dispensed or administered to humans or animals and
requires no further manufacturing or processing other than packaging,
reconstituting, or labeling.
(13)(a)
"Manufacture" means the planting, cultivating, harvesting,
processing, making, preparing, or otherwise engaging in any part of
the production of a drug by propagating, compounding, converting, or
processing, either directly or indirectly by extracting from
substances of natural origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical synthesis,
and includes the following:
(i)
Any packaging or repackaging of the drug or labeling or relabeling of
its container, the promotion and marketing of the drug, and other
activities incident to production;
(ii)
The preparation and promotion of commercially available products from
bulk compounds for resale by pharmacies, licensed health
professionals authorized to prescribe drugs, or other persons.
(b)
"Manufacture" does not include the preparation,
compounding, packaging, or labeling of a drug by a pharmacist as an
incident to either of the following:
(i)
Dispensing a drug in the usual course of professional practice;
(ii)
Providing a licensed health professional authorized to prescribe
drugs with a drug for the purpose of administering to patients or for
using the drug in treating patients in the professional's office.
(14)
"Dangerous drug" has the same meaning as in section 4729.01
of the Revised Code.
(15)
"Generically equivalent drug" means a drug that contains
identical amounts of the identical active ingredients, but not
necessarily containing the same inactive ingredients, that meets the
identical compendial or other applicable standard of identity,
strength, quality, and purity, including potency, and where
applicable, content uniformity, disintegration times, or dissolution
rates, as the prescribed brand name drug and the manufacturer or
distributor holds, if applicable, either an approved new drug
application or an approved abbreviated new drug application unless
other approval by law or from the federal food and drug
administration is required.
No
drug shall be considered a generically equivalent drug for the
purposes of this chapter if it has been listed by the federal food
and drug administration as having proven bioequivalence problems.
(16)
"Licensed health professional authorized to prescribe drugs"
and "prescriber" have the same meanings as in section
4729.01 of the Revised Code.
(17)
"Home" means the primary residence occupied by the
residence's owner, on the condition that the residence contains only
one stove or oven used for cooking, which may be a double oven,
designed for common residence usage and not for commercial usage, and
that the stove or oven be operated in an ordinary kitchen within the
residence.
(18)
"Potentially hazardous food" means a food that is natural
or synthetic, to which any of the following apply:
(a)
It has a pH level greater than 4.6 when measured at seventy-five
degrees fahrenheit or twenty-four degrees celsius.
(b)
It has a water activity value greater than 0.85.
(c)
It requires temperature control because it is in a form capable of
supporting the rapid and progressive growth of infectious or
toxigenic microorganisms, the growth and toxin production of
clostridium botulinium, or in the case of raw shell eggs, the growth
of salmonella enteritidis.
(19)
"Cottage food production operation" means a person who, in
the person's home, produces food items that are not potentially
hazardous foods, including bakery products, jams, jellies, candy,
fruit butter, and similar products specified in rules adopted
pursuant to section 3715.025 of the Revised Code.
(20)
"Biological product" means, except as provided in section
3715.011 of the Revised Code, a drug that is a biological product, as
defined on
the effective date of this amendment
March 21, 2017
,
in subsection (i) of section 351 of the "Public Health Service
Act," 42 U.S.C. 262(i).
(21)
"Interchangeable biological product" means, except as
provided in section 3715.011 of the Revised Code, both of the
following:
(a)
A biological product that, on
the effective date of this amendment
March 21, 2017
,
has been determined by the United States food and drug administration
to meet the standards for interchangeability set forth in subsection
(k) of section 351 of the "Public Health Service Act," 42
U.S.C. 262(k), as amended, and has been licensed under that
subsection;
(b)
A biological product that, prior to
the effective date of this amendment
March 21, 2017
,
was determined by the United States food and drug administration to
be therapeutically equivalent as set forth in its publication titled
"Approved Drug Products with Therapeutic Equivalence
Evaluations."
(22)
"Kratom" means the plant Mitragyna speciosa and any part of
that plant.
(23)
"Kratom product" means a finished article containing either
of the following:
(a)
Any part of a leaf of the plant Mitragyna speciosa in fresh,
dehydrated, or dried form;
(b)
A kratom extract that is manufactured using United States food and
drug administration approved food grade solvents.
(B)
For the purposes of sections 3715.52 to 3715.72 of the Revised Code:
(1)
If an article is alleged to be misbranded because the labeling is
misleading, or if an advertisement is alleged to be false because it
is misleading, then in determining whether the labeling or
advertisement is misleading, there shall be taken into account, among
other things, not only representations made or suggested by
statement, word, design, device, sound, or in any combination
thereof, but also the extent to which the labeling or advertisement
fails to reveal facts material in the light of such representations
or material with respect to consequence which may result from the use
of the article to which the labeling or advertisement relates under
the conditions of use prescribed in the labeling or advertisement
thereof or under such conditions of use as are customary or usual.
(2)
The provisions regarding the selling of food, drugs, devices, or
cosmetics include the manufacture, production, processing, packing,
exposure, offer, possession, and holding of any such article for
sale; and the sale, dispensing, and giving of any such article, and
the supplying or applying of any such articles in the conduct of any
food, drug, or cosmetic establishment. The provisions do not prohibit
a licensed health professional authorized to prescribe drugs from
administering or personally furnishing a drug or device to a patient.
(3)
The representation of a drug, in its labeling or advertisement, as an
antiseptic is a representation that it is a germicide, except in the
case of a drug purporting to be, or represented as, an antiseptic for
inhibitory use as a wet dressing, ointment, dusting powder, or other
use that involves prolonged contact with the body.
(4)
Whenever jurisdiction is vested in the director of agriculture or the
state board of pharmacy, the jurisdiction of the board shall be
limited to the sale, offering for sale, giving away, delivery, or
dispensing in any manner of drugs at the wholesale and retail levels
or to the consumer and shall be exclusive in the case of such sale,
offering for sale, giving away, delivery, or dispensing in any manner
of drugs at the wholesale and retail levels or to the consumer in any
place where prescriptions are dispensed or compounded.
(5)
To assist in effectuating the provisions of those sections, the
director of agriculture or state board of pharmacy may request
assistance or data from any government or private agency or
individual.
Sec.
3715.026.
(A)
As used in this section:
(1)
"Food processing establishment" has the same meaning as in
section 3715.021 of the Revised Code and includes any premises or
part of a premises where kratom is processed, packaged, manufactured,
or otherwise held or handled for distribution to another location or
for sale at wholesale.
(2)
"Synthesized material" means an alkaloid, metabolite of an
alkaloid, or alkaloid derivative that has been created by chemical
synthesis or biosynthetic means, including fermentation, recombinant
techniques, yeast derived, enzymatic techniques, and oxidation.
"Synthesized material" does not include an alkaloid,
metabolite of an alkaloid, or alkaloid derivative created by
traditional food preparation techniques.
(3)
"Semi-synthetic alkaloid" means a substance derived from an
alkaloid naturally occurring in kratom that has been chemically
altered through chemical reactions, including oxidation, reduction,
acetylation, or other processes to change the structure or
pharmacological activity of the naturally occurring kratom alkaloid.
"Semi-synthetic alkaloid" includes the synthesis of
7-hydroxymitragynine when produced by chemical alteration of
mitragynine.
(4)
"Synthetic kratom-like compound" means a synthesized
material that is not found naturally in the Mitragyna speciosa plant
and is created entirely through laboratory synthesis to mimic the
pharmacological effects of kratom alkaloids or constituent.
(B)
No food processing establishment registered under section 3715.041 of
the Revised Code shall process, package, manufacture, hold or handle
for distribution, distribute, or sell a kratom product unless the
establishment has registered the kratom product with the director of
agriculture. To register a kratom product, a food processing
establishment shall apply to the director of agriculture in a manner
prescribed by the director.
(C)(1)
No food processing establishment registered under section 3715.041 of
the Revised Code shall process, package, manufacture, hold or handle
for distribution, distribute, or sell a kratom product that meets any
of the following:
(a)
Contains a controlled substance or a residual solvent higher than is
allowed in the United States Pharmacopeia (U.S.P.) general chapter
467;
(b)
Contains a level of naturally occurring 7-hydroxymitragynine in the
alkaloid fraction that is greater than two per cent of the alkaloid
composition of the kratom product and contains a level of
7-hydroxymitragynine that is greater than one milligram per serving
in its final product form, as documented by a certificate of analysis
on the finished product prior to distribution;
(c)
Contains a synthetic kratom-like compound or semi-synthetic alkaloid
where mitragynine is not the majority of the alkaloid in the product;
(d)
Does not include a product label on the kratom product that states
the amount of mitragynine and 7-hydroxymitragynine contained in the
product.
(2)
A food processing establishment does not violate division (C)(1) of
this section if the establishment demonstrates by a preponderance of
the evidence that it relied in good faith on the representation of
another registered food processing establishment that the kratom
product meets the requirements of division (C)(1) of this section.
(D)
No food processing establishment registered under section 3715.041 of
the Revised Code shall distribute or sell a kratom product without
disclosing to the director of agriculture at the time the product is
registered the factual basis on which the establishment represents
the food as a kratom product.
(E)
No food processing establishment registered under section 3715.041 of
the Revised Code shall distribute or sell a kratom product to an
individual who is under eighteen years of age.
(F)
The director of agriculture shall adopt rules in accordance with
Chapter 119. of the Revised Code to implement this section, including
rules establishing all of the following:
(1)
Application procedures and a fee for registering a kratom product.
The registration fee established under this section shall be based on
the square footage of the food processing establishment and shall not
exceed the registration fee for the establishment specified in rule
901:3-21-01 of the Administrative Code.
(2)
Civil penalties for any of the following:
(a)
Failing to register a kratom product;
(b)
Processing, packaging, manufacturing, or holding or handling for
distribution an unregistered kratom product;
(c)
Failing to disclose on the kratom product's label the factual basis
on which the establishment represents the food as a kratom product.
(3)
Standards and procedures for appealing civil penalties;
(4)
Procedures for seizing and destroying a kratom product that does not
meet the requirements of this section;
(5)
Standards and procedures for kratom product testing;
(6)
Standards for labeling of kratom products;
(7)
Any other standards or procedures the director determines necessary
to implement this section.
(G)
Notwithstanding any provision of section 121.95 of the Revised Code
to the contrary, a regulatory restriction contained in a rule adopted
under this section is not subject to sections 121.95 to 121.953 of
the Revised Code.
(H)
An individual may bring a civil action for damages resulting from a
violation of divisions (B) to (E) of this section.
Sec.
3715.99.
(A)
Whoever violates section 3715.13 or 3715.38 of the Revised Code is
guilty of a minor misdemeanor.
(B)
Whoever violates section 3715.22, 3715.25, or 3715.27 of the Revised
Code is guilty of a misdemeanor of the fourth degree.
(C)
Whoever violates section 3715.23 or 3715.34 of the Revised Code is
guilty of a misdemeanor of the second degree.
(D)
Whoever violates section 3715.52 or 3715.65 of the Revised Code is
guilty of a misdemeanor of the fourth degree on a first offense; on
each subsequent offense, the person is guilty of a misdemeanor of the
second degree.
(E)
Whoever violates section 3715.521 of the Revised Code is guilty of a
minor misdemeanor. A violation of that section occurs on a daily
basis, not according to the number of times per day that an expired
drug, baby food, or infant formula is sold, offered for sale, or
delivered at retail or to the consumer. Each day of violation is a
separate offense.
(F)
Whoever recklessly violates division (C) or (E) of section 3715.026
of the Revised Code is guilty of a misdemeanor of the second degree.
Sec.
3717.01.
As
used in this chapter:
(A)
"Ohio uniform food safety code" means the food safety and
related standards adopted under section 3717.05 of the Revised Code.
(B)
"Food" means any raw, cooked, or processed edible substance
used or intended for use in whole or in part for human consumption.
"Food" includes ice, water or any other beverage, food
ingredients, and chewing gum.
(C)
"Retail food establishment" means a premises or part of a
premises where food is stored, processed, prepared, manufactured, or
otherwise held or handled for retail sale. Except when expressly
provided otherwise, "retail food establishment" includes a
mobile retail food establishment, seasonal retail food establishment,
and temporary retail food establishment.
As
used in this division:
(1)
"Retail" means the sale of food to a person who is the
ultimate consumer.
(2)
"Prepared" means any action that affects a food, including
receiving and maintaining it at the temperature at which it was
received.
(D)
"Seasonal retail food establishment" means a retail food
establishment, other than a mobile retail food establishment, that is
operated for not more than six months in a licensing period.
(E)
"Temporary retail food establishment" means a retail food
establishment that is operated at an event for not more than five
consecutive days, except when operated for more than five consecutive
days pursuant to division (E)(2) of section 3717.23 of the Revised
Code.
(F)
"Food service operation" means a place, location, site, or
separate area where food intended to be served in individual portions
is prepared or served for a charge or required donation. As used in
this division, "served" means a response made to an order
for one or more individual portions of food in a form that is edible
without washing, cooking, or additional preparation and "prepared"
means any action that affects a food other than receiving or
maintaining it at the temperature at which it was received.
Except
when expressly provided otherwise, "food service operation"
includes a catering food service operation, food delivery sales
operation, mobile food service operation, seasonal food service
operation, temporary food service operation, and vending machine
location.
(G)
"Catering food service operation" means a food service
operation where food is prepared for serving at a function or event
held at an off-premises site, for a charge determined on a
per-function or per-event basis.
(H)
"Food delivery sales operation" means a food service
operation from which individual portions of food are ordered by a
customer, prepared at another food service operation or a retail food
establishment, and delivered to the customer by a person other than
an employee of the food service operation or retail food
establishment that prepared the food.
(I)
"Mobile food service operation" means a food service
operation that is operated from a movable vehicle, portable
structure, or watercraft and that routinely changes location, except
that if the operation remains at any one location for more than forty
consecutive days, the operation is no longer a mobile food service
operation. "Mobile food service operation" includes a food
service operation that does not remain at any one location for more
than forty consecutive days and serves, in a manner consistent with
division (F) of this section, only frozen desserts; beverages, nuts,
popcorn, candy, or similar confections; bakery products identified in
section 911.01 of the Revised Code; or any combination of those
items.
(J)
"Seasonal food service operation" means a food service
operation, other than a mobile food service operation, that is
operated for not more than six months in a licensing period.
(K)
"Temporary food service operation" means a food service
operation that is operated at an event for not more than five
consecutive days, except when operated for more than five consecutive
days pursuant to division (E)(2) of section 3717.43 of the Revised
Code.
(L)
"Vending machine location" means an area or room where one
or more vending machines are installed and operated, except that if
the machines within an area are separated by more than one hundred
fifty feet, each area separated by that distance constitutes a
separate vending machine location. As used in this division, "vending
machine" means a self-service device that automatically
dispenses on the insertion of currency, tokens, or similar means a
predetermined unit serving of food, either in bulk or in package,
without having to be replenished after each use.
(M)
"Board of health" means a board of health of a city or
general health district or the authority having the duties of a board
of health under section 3709.05 of the Revised Code.
(N)
"Government entity" means this state, a political
subdivision of this state, another state, or a political subdivision
or other local government body of another state.
(O)
"Licensor" means one of the following:
(1)
A board of health approved under section 3717.11 of the Revised Code;
(2)
The director of agriculture acting pursuant to section 3717.11 of the
Revised Code with respect to the licensing of retail food
establishments;
(3)
The director of health acting pursuant to section 3717.11 of the
Revised Code with respect to the licensing of food service
operations.
(P)
"Licensing period" means the first day of March to the last
day of February of the next succeeding year.
(Q)
"Mobile retail food establishment" means a retail food
establishment that is operated from a movable vehicle or other
portable structure, and that routinely changes location, except that
if the establishment operates from any one location for more than
forty consecutive days, the establishment is no longer a mobile
retail food establishment.
(R)
"Unprocessed," when used with respect to fruits and
vegetables, means that the fruits and vegetables are not processed
beyond merely rough trimming and rinsing.
(S)
"Cottage food production operation" has the same meaning as
in division (A)(19) of section 3715.01 of the Revised Code.
(T)
"Kratom" and "kratom product" have the same
meanings as in section 3715.01 of the Revised Code.
Sec.
3717.34.
(A)
As used in this section:
(1)
"Synthesized material" means an alkaloid, metabolite of an
alkaloid, or alkaloid derivative that has been created by chemical
synthesis or biosynthetic means, including fermentation, recombinant
techniques, yeast derived, enzymatic techniques, and oxidation.
"Synthesized material" does not include an alkaloid,
metabolite of an alkaloid, or alkaloid derivative created by
traditional food preparation techniques.
(2)
"Semi-synthetic alkaloid" means a substance derived from an
alkaloid naturally occurring in kratom that has been chemically
altered through chemical reactions, including oxidation, reduction,
acetylation, or other processes to change the structure or
pharmacological activity of the naturally occurring kratom alkaloid.
"Semi-synthetic alkaloid" includes the synthesis of
7-hydroxymitragynine when produced by chemical alteration of
mitragynine.
(3)
"Synthetic kratom-like compound" means a synthesized
material that is not found naturally in the Mitragyna speciosa plant
and is created entirely through laboratory synthesis to mimic the
pharmacological effects of kratom alkaloids.
(B)
No retail food establishment license holder shall store, process,
prepare, manufacture, hold or handle for retail sale, or sell a
kratom product unless the establishment has registered the kratom
product with the director of agriculture. To register a kratom
product, a retail food establishment license holder shall apply to
the director of agriculture or director of health in a manner
prescribed by the director.
(C)(1)
No retail food establishment license holder shall store, process,
prepare, manufacture, hold or handle for retail sale, or sell a
kratom product that meets any of the following:
(a)
Contains a controlled substance or a residual solvent higher than is
allowed in the United States Pharmacopeia (U.S.P.) general chapter
467;
(b)
Contains a level of naturally occurring 7-hydroxymitragynine in the
alkaloid fraction that is greater than two per cent of the alkaloid
composition of the kratom product and contains a level of
7-hydroxymitragynine that is greater than one milligram per serving
in its final product form, as documented by a certificate of analysis
on the finished product prior to distribution;
(c)
Contains a synthetic kratom-like compound or semi-synthetic alkaloid
where mitragynine is not the majority of the alkaloid in the product;
(d)
Does not include a product label on the kratom product that states
the amount of mitragynine and 7-hydroxymitragynine contained in the
product.
(2)
A retail food establishment license holder does not violate division
(C)(1) of this section if the holder demonstrates by a preponderance
of the evidence that the holder relied in good faith on the
representation of another license holder or a food processing
establishment registered under section 3715.041 of the Revised Code
that the kratom product meets the requirements of division (C)(1) of
this section.
(D)
No retail food establishment license holder shall sell a kratom
product without disclosing to the director of agriculture at the time
the product is registered the factual basis on which the holder
represents the food as a kratom product.
(E)
No retail food establishment license holder shall sell a kratom
product to an individual who is under eighteen years of age.
(F)
The director of agriculture and director of health shall adopt rules
in accordance with Chapter 119. of the Revised Code to implement this
section, including rules establishing all of the following:
(1)
Application procedures and a fee for registering a kratom product.
The registration fee for a retail food establishment established
under this section shall be based on the square footage of the retail
food establishment and shall not exceed the registration fee for a
food processing establishment with equivalent square footage
specified in rule 901:3-21-01 of the Administrative Code.
(2)
Civil penalties for any of the following:
(a)
Failing to register a kratom product;
(b)
Selling an unregistered kratom product;
(c)
Failing to disclose on the kratom product's label the factual basis
on which the holder represents the food as a kratom product.
(3)
Standards and procedures for appealing civil penalties;
(4)
Procedures for seizing and destroying a kratom product that does not
meet the requirements of this section;
(5)
Standards and procedures for kratom product testing;
(6)
Standards for labeling of kratom products;
(7)
Any other standards or procedures the director determines necessary
to implement this section.
(G)
Notwithstanding any provision of section 121.95 of the Revised Code
to the contrary, a regulatory restriction contained in a rule adopted
under this section is not subject to sections 121.95 to 121.953 of
the Revised Code.
(H)
An individual may bring a civil action for damages resulting from a
violation of divisions (A) to (D) of this section.
Sec.
3717.99.
Whoever
violates section 3717.21 or 3717.41 of the Revised Code is guilty of
a misdemeanor of the third degree on a first offense; for a second
offense or subsequent offense, such person is guilty of a misdemeanor
of the second degree. Each day the violation continues is a separate
offense.
Whoever
recklessly violates division (C) or (E) of section 3717.34 of the
Revised Code is guilty of a misdemeanor of the second degree.
Section
2.
That
existing sections 3715.01, 3715.99, 3717.01, and 3717.99 of the
Revised Code are hereby repealed.