SB 299: Regards sales of kratom products

As Introduced

136th General Assembly

Regular Session

S. B. No. 299

$2025-2026$

Senator Blessing

To amend sections 3715.01, 3715.99, 3717.01, and ..... 1 3717.99 and to enact sections 3715.026 and ..... 2 3717.34 of the Revised Code regarding sales of ..... 3 kratom products. ..... 4

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Section 1. That sections 3715.01, 3715.99, 3717.01, and ..... 5 3717.99 be amended and sections 3715.026 and 3717.34 of the ..... 6 Revised Code be enacted to read as follows: ..... 7

Sec. 3715.01. (A) As used in this chapter: ..... 8

(1) "Person" means an individual, partnership, ..... 9 corporation, or association. ..... 10

(2) "Food" means: ..... 11 (a) Articles used for food or drink for humans or animals; ..... 12 (b) Chewing gum; ..... 13 (c) Articles used for components of any such articles. ..... 14

(3) "Drug" means: ..... 15 (a) Articles recognized in the United States pharmacopoeia ..... 16 and national formulary, or any supplement to them; ..... 17 (b) Articles intended for use in the diagnosis, cure, ..... 18 mitigation, treatment, or prevention of disease in humans or ..... 19 animals; ..... 20 (c) Articles, other than food, intended to affect the ..... 21 structure or any function of the body of humans or other ..... 22 animals; ..... 23 (d) Articles intended for use as a component of any of the ..... 24 foregoing articles, other than devices or their components, ..... 25 parts, or accessories. ..... 26

(4) "Device," except when used in division (B) (1) of this ..... 27 section and in division (A) (10) of section 3715.52, division (F) ..... 28 of section 3715.60, division (A) (5) of section 3715.64, and ..... 29 division (C) of section 3715.67 of the Revised Code, means any ..... 30 instrument, apparatus, implement, machine, contrivance, implant, ..... 31 in vitro reagent, or other similar or related article, including ..... 32 any component, part, or accessory, that is any of the following: ..... 33 (a) Recognized in the United States pharmacopoeia and ..... 34 national formulary, or any supplement to them; ..... 35 (b) Intended for use in the diagnosis of disease or other ..... 36 conditions, or in the cure, mitigation, treatment, or prevention ..... 37 of disease in humans or animals; ..... 38 (c) Intended to affect the structure or any function of ..... 39 the body of humans or animals, and that does not achieve any of ..... 40 its principal intended purposes through chemical action within ..... 41 or on the body of humans or animals and is not dependent upon ..... 42 being metabolized for the achievement of any of its principal ..... 43 intended purposes. ..... 44

(5) "Cosmetic" means: ..... 45 (a) Articles intended to be rubbed, poured, sprinkled, or ..... 46 sprayed on, introduced into, or otherwise applied to the human ..... 47 body or any part thereof for cleansing, beautifying, promoting ..... 48 attractiveness, or altering the appearance; ..... 49 (b) Articles intended for use as a component of any such ..... 50 article, except that "cosmetic" does not include soap. ..... 51

(6) "Label" means a display of written, printed, or ..... 52 graphic matter upon the immediate container, exclusive of ..... 53 package liners, of any article. ..... 54 Any word, statement, or other information required by this ..... 55 chapter to appear on the label must appear on the outside ..... 56 container or wrapper, if any, of the retail package of the ..... 57 article, or the label must be easily legible through the outside ..... 58 container or wrapper. ..... 59

(7) "Labeling" means all labels and other written, ..... 60 printed, or graphic matter: ..... 61 (a) Upon an article or any of its containers or wrappers; ..... 62 (b) Accompanying such article. ..... 63

(8) "Advertisement" means all representations disseminated ..... 64 in any manner or by any means, other than by labeling, for the ..... 65 purpose of inducing, or that are likely to induce, directly or ..... 66 indirectly, the purchase of food, drugs, devices, or cosmetics. ..... 67

(9) "New drug" means: ..... 68 (a) Any drug the composition of which is such that the ..... 69 drug is not generally recognized among experts qualified by ..... 70 scientific training and experience to evaluate the safety of ..... 71 drugs, as safe for use under the conditions prescribed, ..... 72 recommended, or suggested in the labeling thereof; ..... 73 (b) Any drug the composition of which is such that the ..... 74 drug, as a result of investigation to determine its safety for ..... 75 use under such conditions, has become so recognized, but that ..... 76 has not, other than in an investigation, been used to a material ..... 77 extent or for a material time under such conditions. ..... 78

(10) "Contaminated with filth" applies to any food, drug, ..... 79 device, or cosmetic that has not been protected as far as may be ..... 80 necessary by all reasonable means from dust, dirt, and all ..... 81 foreign or injurious substances. ..... 82

(11) "Honey" means the nectar and saccharine exudation of ..... 83 plants that has been gathered, modified, and stored in a ..... 84 honeycomb by honeybees. ..... 85

(12) "Finished dosage form" means the form of a drug that ..... 86 is, or is intended to be, dispensed or administered to humans or ..... 87 animals and requires no further manufacturing or processing ..... 88 other than packaging, reconstituting, or labeling. ..... 89

(13) (a) "Manufacture" means the planting, cultivating, ..... 90 harvesting, processing, making, preparing, or otherwise engaging ..... 91 in any part of the production of a drug by propagating, ..... 92 compounding, converting, or processing, either directly or ..... 93 indirectly by extracting from substances of natural origin, or ..... 94 independently by means of chemical synthesis, or by a ..... 95 combination of extraction and chemical synthesis, and includes ..... 96 the following: ..... 97 (i) Any packaging or repackaging of the drug or labeling ..... 98 or relabeling of its container, the promotion and marketing of ..... 99 the drug, and other activities incident to production; ..... 100 (ii) The preparation and promotion of commercially ..... 101 available products from bulk compounds for resale by pharmacies, ..... 102 licensed health professionals authorized to prescribe drugs, or ..... 103 other persons. ..... 104

(b) "Manufacture" does not include the preparation, ..... 105 compounding, packaging, or labeling of a drug by a pharmacist as ..... 106 an incident to either of the following: ..... 107 (i) Dispensing a drug in the usual course of professional ..... 108 practice; ..... 109 (ii) Providing a licensed health professional authorized ..... 110 to prescribe drugs with a drug for the purpose of administering ..... 111 to patients or for using the drug in treating patients in the ..... 112 professional's office. ..... 113

(14) "Dangerous drug" has the same meaning as in section ..... 114 4729.01 of the Revised Code. ..... 115

(15) "Generically equivalent drug" means a drug that ..... 116 contains identical amounts of the identical active ingredients, ..... 117 but not necessarily containing the same inactive ingredients, ..... 118 that meets the identical compendial or other applicable standard ..... 119 of identity, strength, quality, and purity, including potency, ..... 120 and where applicable, content uniformity, disintegration times, ..... 121 or dissolution rates, as the prescribed brand name drug and the ..... 122 manufacturer or distributor holds, if applicable, either an ..... 123 approved new drug application or an approved abbreviated new ..... 124 drug application unless other approval by law or from the ..... 125 federal food and drug administration is required. ..... 126 No drug shall be considered a generically equivalent drug ..... 127 for the purposes of this chapter if it has been listed by the ..... 128 federal food and drug administration as having proven ..... 129 bioequivalence problems. ..... 130

(16) "Licensed health professional authorized to prescribe ..... 131 drugs" and "prescriber" have the same meanings as in section ..... 132 4729.01 of the Revised Code. ..... 133

(17) "Home" means the primary residence occupied by the ..... 134 residence's owner, on the condition that the residence contains ..... 135 only one stove or oven used for cooking, which may be a double ..... 136 oven, designed for common residence usage and not for commercial ..... 137 usage, and that the stove or oven be operated in an ordinary ..... 138 kitchen within the residence. ..... 139

(18) "Potentially hazardous food" means a food that is ..... 140 natural or synthetic, to which any of the following apply: ..... 141 (a) It has a pH level greater than 4.6 when measured at ..... 142 seventy-five degrees fahrenheit or twenty-four degrees celsius. ..... 143 (b) It has a water activity value greater than 0.85. ..... 144 (c) It requires temperature control because it is in a ..... 145 form capable of supporting the rapid and progressive growth of ..... 146 infectious or toxigenic microorganisms, the growth and toxin ..... 147 production of clostridium botulinium, or in the case of raw ..... 148 shell eggs, the growth of salmonella enteritidis. ..... 149

(19) "Cottage food production operation" means a person ..... 150 who, in the person's home, produces food items that are not ..... 151 potentially hazardous foods, including bakery products, jams, ..... 152 jellies, candy, fruit butter, and similar products specified in ..... 153 rules adopted pursuant to section 3715.025 of the Revised Code. ..... 154

(20) "Biological product" means, except as provided in ..... 155 section 3715.011 of the Revised Code, a drug that is a ..... 156 biological product, as defined on-the-effective date of this- ..... 157 amendment March 21, 2017, in subsection (i) of section 351 of ..... 158 the "Public Health Service Act," 42 U.S.C. 262(i). ..... 159

(21) "Interchangeable biological product" means, except as ..... 160 provided in section 3715.011 of the Revised Code, both of the following: ..... 161 (a) A biological product that, on-the-effective-date-of- ..... 162 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; ..... 163 (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." ..... 164

(22) "Kratom" means the plant Mitragyna speciosa and any part of that plant. ..... 165

(23) "Kratom product" means a finished article containing either of the following: ..... 166 (a) Any part of a leaf of the plant Mitragyna speciosa in fresh, dehydrated, or dried form; ..... 167 (b) A kratom extract that is manufactured using United States food and drug administration approved food grade solvents. ..... 168

(B) For the purposes of sections 3715.52 to 3715.72 of the Revised Code: ..... 169 (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 ..... 170 labeling or advertisement is misleading, there shall be taken ..... 171 into account, among other things, not only representations made ..... 172 or suggested by statement, word, design, device, sound, or in ..... 173 any combination thereof, but also the extent to which the ..... 174 labeling or advertisement fails to reveal facts material in the ..... 175 light of such representations or material with respect to ..... 176 consequence which may result from the use of the article to ..... 177 which the labeling or advertisement relates under the conditions ..... 178 of use prescribed in the labeling or advertisement thereof or ..... 179 under such conditions of use as are customary or usual. ..... 180 (2) The provisions regarding the selling of food, drugs, ..... 181 devices, or cosmetics include the manufacture, production, ..... 182 processing, packing, exposure, offer, possession, and holding of ..... 183 any such article for sale; and the sale, dispensing, and giving ..... 184 of any such article, and the supplying or applying of any such ..... 185 articles in the conduct of any food, drug, or cosmetic ..... 186 establishment. The provisions do not prohibit a licensed health ..... 187 professional authorized to prescribe drugs from administering or ..... 188 personally furnishing a drug or device to a patient. ..... 189 (3) The representation of a drug, in its labeling or ..... 190 advertisement, as an antiseptic is a representation that it is a ..... 191 germicide, except in the case of a drug purporting to be, or ..... 192 represented as, an antiseptic for inhibitory use as a wet ..... 193 dressing, ointment, dusting powder, or other use that involves ..... 194 prolonged contact with the body. ..... 195 (4) Whenever jurisdiction is vested in the director of ..... 196 agriculture or the state board of pharmacy, the jurisdiction of ..... 197 the board shall be limited to the sale, offering for sale, ..... 198 giving away, delivery, or dispensing in any manner of drugs at ..... 199 the wholesale and retail levels or to the consumer and shall be ..... 200 exclusive in the case of such sale, offering for sale, giving ..... 201 away, delivery, or dispensing in any manner of drugs at the ..... 202 wholesale and retail levels or to the consumer in any place ..... 203 where prescriptions are dispensed or compounded. ..... 204 (5) To assist in effectuating the provisions of those ..... 205 sections, the director of agriculture or state board of pharmacy ..... 206 may request assistance or data from any government or private ..... 207 agency or individual. ..... 208

Sec. 3715.026. (A) As used in this section: ..... 209

(1) "Food processing establishment" has the same meaning ..... 210 as in section 3715.021 of the Revised Code and includes any ..... 211 premises or part of a premises where kratom is processed, ..... 212 packaged, manufactured, or otherwise held or handled for ..... 213 distribution to another location or for sale at wholesale. ..... 214

(2) "Synthesized material" means an alkaloid, metabolite ..... 215 of an alkaloid, or alkaloid derivative that has been created by ..... 216 chemical synthesis or biosynthetic means, including ..... 217 fermentation, recombinant techniques, yeast derived, enzymatic ..... 218 techniques, and oxidation. "Synthesized material" does not ..... 219 include an alkaloid, metabolite of an alkaloid, or alkaloid ..... 220 derivative created by traditional food preparation techniques. ..... 221

(3) "Semi-synthetic alkaloid" means a substance derived ..... 222 from an alkaloid naturally occurring in kratom that has been ..... 223 chemically altered through chemical reactions, including ..... 224 oxidation, reduction, acetylation, or other processes to change ..... 225 the structure or pharmacological activity of the naturally ..... 226 occurring kratom alkaloid. "Semi-synthetic alkaloid" includes ..... 227 the synthesis of 7-hydroxymitragynine when produced by chemical ..... 228 alteration of mitragynine. ..... 229

(4) "Synthetic kratom-like compound" means a synthesized ..... 230 material that is not found naturally in the Mitragyna speciosa ..... 231 plant and is created entirely through laboratory synthesis to ..... 232 mimic the pharmacological effects of kratom alkaloids or ..... 233 constituent. ..... 234

(B) No food processing establishment registered under ..... 235 section 3715.041 of the Revised Code shall process, package, ..... 236 manufacture, hold or handle for distribution, distribute, or ..... 237 sell a kratom product unless the establishment has registered ..... 238 the kratom product with the director of agriculture. To register ..... 239 a kratom product, a food processing establishment shall apply to ..... 240 the director of agriculture in a manner prescribed by the ..... 241 director. ..... 242

(C) (1) No food processing establishment registered under ..... 243 section 3715.041 of the Revised Code shall process, package, ..... 244 manufacture, hold or handle for distribution, distribute, or ..... 245 sell a kratom product that meets any of the following: ..... 246 (a) Contains a controlled substance or a residual solvent ..... 247 higher than is allowed in the United States Pharmacopeia ..... 248 (U.S.P.) general chapter 467; ..... 249 (b) Contains a level of naturally occurring 7- ..... 250 hydroxymitragynine in the alkaloid fraction that is greater than ..... 251 two per cent of the alkaloid composition of the kratom product ..... 252 and contains a level of 7-hydroxymitragynine that is greater ..... 253 than one milligram per serving in its final product form, as ..... 254 documented by a certificate of analysis on the finished product ..... 255 prior to distribution; ..... 256 (c) Contains a synthetic kratom-like compound or semi- ..... 257 synthetic alkaloid where mitragynine is not the majority of the ..... 258 alkaloid in the product; ..... 259 (d) Does not include a product label on the kratom product ..... 260 that states the amount of mitragynine and 7-hydroxymitragynine ..... 261 contained in the product. ..... 262 (2) A food processing establishment does not violate ..... 263 division (C) (1) of this section if the establishment ..... 264 demonstrates by a preponderance of the evidence that it relied ..... 265 in good faith on the representation of another registered food ..... 266 processing establishment that the kratom product meets the ..... 267 requirements of division (C) (1) of this section. ..... 268

(D) No food processing establishment registered under ..... 269 section 3715.041 of the Revised Code shall distribute or sell a ..... 270 kratom product without disclosing to the director of agriculture ..... 271 at the time the product is registered the factual basis on which ..... 272 the establishment represents the food as a kratom product. ..... 273

(E) No food processing establishment registered under ..... 274 section 3715.041 of the Revised Code shall distribute or sell a ..... 275 kratom product to an individual who is under eighteen years of ..... 276 age. ..... 277

(F) The director of agriculture shall adopt rules in ..... 278 accordance with Chapter 119. of the Revised Code to implement ..... 279 this section, including rules establishing all of the following: ..... 280 (1) Application procedures and a fee for registering a ..... 281 kratom product. The registration fee established under this ..... 282 section shall be based on the square footage of the food ..... 283 processing establishment and shall not exceed the registration ..... 284 fee for the establishment specified in rule 901:3-21-01 of the ..... 285 Administrative Code. ..... 286 (2) Civil penalties for any of the following: ..... 287 (a) Failing to register a kratom product; ..... 288 (b) Processing, packaging, manufacturing, or holding or ..... 289 handling for distribution an unregistered kratom product; ..... 290 (c) Failing to disclose on the kratom product's label the ..... 291 factual basis on which the establishment represents the food as ..... 292 a kratom product. ..... 293 (3) Standards and procedures for appealing civil ..... 294 penalties; ..... 295 (4) Procedures for seizing and destroying a kratom product ..... 296 that does not meet the requirements of this section; ..... 297 (5) Standards and procedures for kratom product testing; ..... 298 (6) Standards for labeling of kratom products; ..... 299 (7) Any other standards or procedures the director ..... 300 determines necessary to implement this section. ..... 301

(G) Notwithstanding any provision of section 121.95 of the ..... 302 Revised Code to the contrary, a regulatory restriction contained ..... 303 in a rule adopted under this section is not subject to sections ..... 304 121.95 to 121.953 of the Revised Code. ..... 305

(H) An individual may bring a civil action for damages ..... 306 resulting from a violation of divisions (B) to (E) of this ..... 307 section. ..... 308

Sec. 3715.99. (A) Whoever violates section 3715.13 or ..... 309 3715.38 of the Revised Code is guilty of a minor misdemeanor. ..... 310

(B) Whoever violates section 3715.22, 3715.25, or 3715.27 ..... 311 of the Revised Code is guilty of a misdemeanor of the fourth ..... 312 degree. ..... 313

(C) Whoever violates section 3715.23 or 3715.34 of the ..... 314 Revised Code is guilty of a misdemeanor of the second degree. ..... 315

(D) Whoever violates section 3715.52 or 3715.65 of the ..... 316 Revised Code is guilty of a misdemeanor of the fourth degree on ..... 317 a first offense; on each subsequent offense, the person is ..... 318 guilty of a misdemeanor of the second degree. ..... 319

(E) Whoever violates section 3715.521 of the Revised Code ..... 320 is guilty of a minor misdemeanor. A violation of that section ..... 321 occurs on a daily basis, not according to the number of times ..... 322 per day that an expired drug, baby food, or infant formula is ..... 323 sold, offered for sale, or delivered at retail or to the ..... 324 consumer. Each day of violation is a separate offense. ..... 325

(F) Whoever recklessly violates division (C) or (E) of ..... 326 section 3715.026 of the Revised Code is guilty of a misdemeanor ..... 327 of the second degree. ..... 328

Sec. 3717.01. As used in this chapter: ..... 329

(A) "Ohio uniform food safety code" means the food safety ..... 330 and related standards adopted under section 3717.05 of the ..... 331 Revised Code. ..... 332

(B) "Food" means any raw, cooked, or processed edible ..... 333 substance used or intended for use in whole or in part for human ..... 334 consumption. "Food" includes ice, water or any other beverage, ..... 335 food ingredients, and chewing gum. ..... 336

(C) "Retail food establishment" means a premises or part ..... 337 of a premises where food is stored, processed, prepared, ..... 338 manufactured, or otherwise held or handled for retail sale. ..... 339 Except when expressly provided otherwise, "retail food ..... 340 establishment" includes a mobile retail food establishment, ..... 341 seasonal retail food establishment, and temporary retail food ..... 342 establishment. ..... 343

As used in this division: ..... 344 (1) "Retail" means the sale of food to a person who is the ..... 345 ultimate consumer. ..... 346 (2) "Prepared" means any action that affects a food, ..... 347 including receiving and maintaining it at the temperature at ..... 348 which it was received. ..... 349

(D) "Seasonal retail food establishment" means a retail ..... 350 food establishment, other than a mobile retail food ..... 351 establishment, that is operated for not more than six months in ..... 352 a licensing period. ..... 353

(E) "Temporary retail food establishment" means a retail ..... 354 food establishment that is operated at an event for not more ..... 355 than five consecutive days, except when operated for more than ..... 356 five consecutive days pursuant to division (E) (2) of section ..... 357 3717.23 of the Revised Code. ..... 358

(F) "Food service operation" means a place, location, ..... 359 site, or separate area where food intended to be served in ..... 360 individual portions is prepared or served for a charge or ..... 361 required donation. As used in this division, "served" means a ..... 362 response made to an order for one or more individual portions of ..... 363 food in a form that is edible without washing, cooking, or ..... 364 additional preparation and "prepared" means any action that ..... 365 affects a food other than receiving or maintaining it at the ..... 366 temperature at which it was received. ..... 367 Except when expressly provided otherwise, "food service ..... 368 operation" includes a catering food service operation, food ..... 369 delivery sales operation, mobile food service operation, ..... 370 seasonal food service operation, temporary food service ..... 371 operation, and vending machine location. ..... 372

S. B. No. 299

As Introduced

(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. ..... 373

(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. ..... 374

(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. ..... 375

(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. ..... 376

(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. ..... 377

S. B. No. 299

As Introduced

(L) "Vending machine location" means an area or room where ..... 378 one or more vending machines are installed and operated, except ..... 379 that if the machines within an area are separated by more than ..... 380 one hundred fifty feet, each area separated by that distance ..... 381 constitutes a separate vending machine location. As used in this ..... 382 division, "vending machine" means a self-service device that ..... 383 automatically dispenses on the insertion of currency, tokens, or ..... 384 similar means a predetermined unit serving of food, either in ..... 385 bulk or in package, without having to be replenished after each ..... 386 use. ..... 387

(M) "Board of health" means a board of health of a city or ..... 388 general health district or the authority having the duties of a ..... 389 board of health under section 3709.05 of the Revised Code. ..... 390

(N) "Government entity" means this state, a political ..... 391 subdivision of this state, another state, or a political ..... 392 subdivision or other local government body of another state. ..... 393

(O) "Licensor" means one of the following: ..... 394 (1) A board of health approved under section 3717.11 of ..... 395 the Revised Code; ..... 396 (2) The director of agriculture acting pursuant to section ..... 397 3717.11 of the Revised Code with respect to the licensing of ..... 398 retail food establishments; ..... 399 (3) The director of health acting pursuant to section ..... 400 3717.11 of the Revised Code with respect to the licensing of ..... 401 food service operations. ..... 402

(P) "Licensing period" means the first day of March to the ..... 403 last day of February of the next succeeding year. ..... 404

(Q) "Mobile retail food establishment" means a retail food ..... 405 establishment that is operated from a movable vehicle or other ..... 406 portable structure, and that routinely changes location, except ..... 407 that if the establishment operates from any one location for ..... 408 more than forty consecutive days, the establishment is no longer ..... 409 a mobile retail food establishment. ..... 410

(R) "Unprocessed," when used with respect to fruits and ..... 411 vegetables, means that the fruits and vegetables are not ..... 412 processed beyond merely rough trimming and rinsing. ..... 413

(S) "Cottage food production operation" has the same ..... 414 meaning as in division (A) (19) of section 3715.01 of the Revised ..... 415 Code. ..... 416

(T) "Kratom" and "kratom product" have the same meanings ..... 417 as in section 3715.01 of the Revised Code. ..... 418

Sec. 3717.34. (A) As used in this section: ..... 419

(1) "Synthesized material" means an alkaloid, metabolite ..... 420 of an alkaloid, or alkaloid derivative that has been created by ..... 421 chemical synthesis or biosynthetic means, including ..... 422 fermentation, recombinant techniques, yeast derived, enzymatic ..... 423 techniques, and oxidation. "Synthesized material" does not ..... 424 include an alkaloid, metabolite of an alkaloid, or alkaloid ..... 425 derivative created by traditional food preparation techniques. ..... 426

(2) "Semi-synthetic alkaloid" means a substance derived ..... 427 from an alkaloid naturally occurring in kratom that has been ..... 428 chemically altered through chemical reactions, including ..... 429 oxidation, reduction, acetylation, or other processes to change ..... 430 the structure or pharmacological activity of the naturally ..... 431 occurring kratom alkaloid. "Semi-synthetic alkaloid" includes ..... 432 the synthesis of 7-hydroxymitragynine when produced by chemical ..... 433 alteration of mitragynine. ..... 434

(3) "Synthetic kratom-like compound" means a synthesized ..... 435 material that is not found naturally in the Mitragyna speciosa ..... 436 plant and is created entirely through laboratory synthesis to ..... 437 mimic the pharmacological effects of kratom alkaloids. ..... 438

(B) No retail food establishment license holder shall ..... 439 store, process, prepare, manufacture, hold or handle for retail ..... 440 sale, or sell a kratom product unless the establishment has ..... 441 registered the kratom product with the director of agriculture. ..... 442 To register a kratom product, a retail food establishment ..... 443 license holder shall apply to the director of agriculture or ..... 444 director of health in a manner prescribed by the director. ..... 445

(C) (1) No retail food establishment license holder shall ..... 446 store, process, prepare, manufacture, hold or handle for retail ..... 447 sale, or sell a kratom product that meets any of the following: ..... 448 (a) Contains a controlled substance or a residual solvent ..... 449 higher than is allowed in the United States Pharmacopeia ..... 450 (U.S.P.) general chapter 467; ..... 451 (b) Contains a level of naturally occurring 7- ..... 452 hydroxymitragynine in the alkaloid fraction that is greater than ..... 453 two per cent of the alkaloid composition of the kratom product ..... 454 and contains a level of 7-hydroxymitragynine that is greater ..... 455 than one milligram per serving in its final product form, as ..... 456 documented by a certificate of analysis on the finished product ..... 457 prior to distribution; ..... 458 (c) Contains a synthetic kratom-like compound or semi- ..... 459 synthetic alkaloid where mitragynine is not the majority of the ..... 460 alkaloid in the product; ..... 461 (d) Does not include a product label on the kratom product ..... 462 that states the amount of mitragynine and 7-hydroxymitragynine ..... 463 contained in the product. ..... 464 (2) A retail food establishment license holder does not ..... 465 violate division (C) (1) of this section if the holder ..... 466 demonstrates by a preponderance of the evidence that the holder ..... 467 relied in good faith on the representation of another license ..... 468 holder or a food processing establishment registered under ..... 469 section 3715.041 of the Revised Code that the kratom product ..... 470 meets the requirements of division (C) (1) of this section. ..... 471

(D) No retail food establishment license holder shall sell ..... 472 a kratom product without disclosing to the director of ..... 473 agriculture at the time the product is registered the factual ..... 474 basis on which the holder represents the food as a kratom ..... 475 product. ..... 476

(E) No retail food establishment license holder shall sell ..... 477 a kratom product to an individual who is under eighteen years of ..... 478 age. ..... 479

(F) The director of agriculture and director of health ..... 480 shall adopt rules in accordance with Chapter 119. of the Revised ..... 481 Code to implement this section, including rules establishing all ..... 482 of the following: ..... 483 (1) Application procedures and a fee for registering a ..... 484 kratom product. The registration fee for a retail food ..... 485 establishment established under this section shall be based on ..... 486 the square footage of the retail food establishment and shall ..... 487 not exceed the registration fee for a food processing ..... 488 establishment with equivalent square footage specified in rule ..... 489 901:3-21-01 of the Administrative Code. ..... 490 (2) Civil penalties for any of the following: ..... 491 (a) Failing to register a kratom product; ..... 492 (b) Selling an unregistered kratom product; ..... 493 (c) Failing to disclose on the kratom product's label the ..... 494 factual basis on which the holder represents the food as a ..... 495 kratom product. ..... 496 (3) Standards and procedures for appealing civil ..... 497 penalties; ..... 498 (4) Procedures for seizing and destroying a kratom product ..... 499 that does not meet the requirements of this section; ..... 500 (5) Standards and procedures for kratom product testing; ..... 501 (6) Standards for labeling of kratom products; ..... 502 (7) Any other standards or procedures the director ..... 503 determines necessary to implement this section. ..... 504

(G) Notwithstanding any provision of section 121.95 of the ..... 505 Revised Code to the contrary, a regulatory restriction contained ..... 506 in a rule adopted under this section is not subject to sections ..... 507 121.95 to 121.953 of the Revised Code. ..... 508

(H) An individual may bring a civil action for damages ..... 509 resulting from a violation of divisions (A) to (D) of this ..... 510 section. ..... 511

Sec. 3717.99. Whoever violates section 3717.21 or 3717.41 ..... 512 of the Revised Code is guilty of a misdemeanor of the third ..... 513 degree on a first offense; for a second offense or subsequent ..... 514 offense, such person is guilty of a misdemeanor of the second ..... 515 degree. Each day the violation continues is a separate offense. ..... 516 Whoever recklessly violates division (C) or (E) of section ..... 517 3717.34 of the Revised Code is guilty of a misdemeanor of the ..... 518 second degree. ..... 519

Section 2. That existing sections $3715.01,3715.99$, ..... 520 3717.01, and 3717.99 of the Revised Code are hereby repealed. ..... 521