As Introduced

136th General Assembly

Regular Session H. B. No. 587

2025-2026

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;

(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;

(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.

(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;

(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.

(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.