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| 1 | AN ACT concerning health. | |||||||||||||||||||
| 2 | Be it enacted by the People of the State of Illinois, | |||||||||||||||||||
| 3 | represented in the General Assembly: | |||||||||||||||||||
| 4 | Section 1. Short title. This Act may be cited as the | |||||||||||||||||||
| 5 | Illinois Kratom Consumer Protection Act. | |||||||||||||||||||
| 6 | Section 5. Definitions. In this Act: | |||||||||||||||||||
| 7 | "Attractive to children" means a product manufactured: | |||||||||||||||||||
| 8 | (1) in a shape that resembles a human, a cartoon | |||||||||||||||||||
| 9 | character, or an animal; or | |||||||||||||||||||
| 10 | (2) in a form that resembles an existing candy product | |||||||||||||||||||
| 11 | that is a widely distributed, branded food item. | |||||||||||||||||||
| 12 | "Department" means the Department of Public Health. | |||||||||||||||||||
| 13 | "Finished kratom product" means a kratom product that is | |||||||||||||||||||
| 14 | ready for sale to the end user. For purposes of registration, a | |||||||||||||||||||
| 15 | finished kratom product is differentiated by its ingredients, | |||||||||||||||||||
| 16 | not by its weight, volume, or size. | |||||||||||||||||||
| 17 | "Kratom" means the plant or any part of the plant | |||||||||||||||||||
| 18 | Mitragyna speciosa in any form. | |||||||||||||||||||
| 19 | "Kratom beverage" means a prepackaged liquid kratom | |||||||||||||||||||
| 20 | product in the form of tea, seltzer or tonic water, or | |||||||||||||||||||
| 21 | tincture. | |||||||||||||||||||
| 22 | "Kratom product" means a food product, food ingredient, | |||||||||||||||||||
| 23 | dietary ingredient, dietary supplement, or beverage intended | |||||||||||||||||||
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| 1 | for human consumption that contains any part of the leaf of the | ||||||
| 2 | plant Mitragyna speciosa or an extract, synthetic alkaloid, or | ||||||
| 3 | synthetically derived compound of such plant and is | ||||||
| 4 | manufactured as a powder, capsule, pill, beverage, or other | ||||||
| 5 | consumable edible form. | ||||||
| 6 | "Processor" means an entity that: | ||||||
| 7 | (1) refines kratom into input ingredients for the | ||||||
| 8 | purpose of manufacturing a finished kratom product; | ||||||
| 9 | (2) manufactures finished kratom products; or | ||||||
| 10 | (3) packages finished kratom products for resale. | ||||||
| 11 | Section 10. Finished kratom product retail sale | ||||||
| 12 | requirements. A finished kratom product sold to consumers at a | ||||||
| 13 | retail establishment, including a food service establishment, | ||||||
| 14 | convenience store, or kava or kratom bar, must: | ||||||
| 15 | (1) be in one of the following delivery forms: | ||||||
| 16 | (A) a dried leaf; | ||||||
| 17 | (B) a kratom beverage; | ||||||
| 18 | (C) a powder; | ||||||
| 19 | (D) a pill; | ||||||
| 20 | (E) a liquid dietary supplement; | ||||||
| 21 | (F) a gummy or food that is not attractive to | ||||||
| 22 | children; or | ||||||
| 23 | (G) a capsule; | ||||||
| 24 | (2) have a certificate of analysis submitted to the | ||||||
| 25 | Department as required by this Act; | ||||||
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| 1 | (3) be registered with the Department under this Act; | ||||||
| 2 | (4) include directions for consumption on the product | ||||||
| 3 | label, including: | ||||||
| 4 | (A) the maximum dosage of 100 milligrams of kratom | ||||||
| 5 | alkaloids per serving; | ||||||
| 6 | (B) the number of servings per package; | ||||||
| 7 | (C) a warning advising consumers of the number of | ||||||
| 8 | servings that may be safely consumed in a 24-hour period; | ||||||
| 9 | (D) a warning advising against use by individuals who | ||||||
| 10 | are pregnant or breastfeeding; | ||||||
| 11 | (E) a warning advising the consumer to consult a | ||||||
| 12 | health care professional before use, that the product may | ||||||
| 13 | be habit-forming, and that it may cause adverse health | ||||||
| 14 | effects; | ||||||
| 15 | (F) a warning stating: "These statements have not been | ||||||
| 16 | evaluated by the United States Food and Drug | ||||||
| 17 | Administration. This product is not intended to diagnose, | ||||||
| 18 | treat, cure, or prevent any disease."; | ||||||
| 19 | (G) the expiration date; and | ||||||
| 20 | (H) the name and place of business of the registrant; | ||||||
| 21 | (5) comply with packaging and labeling requirements set | ||||||
| 22 | forth in this Act and rules adopted under it; | ||||||
| 23 | (6) not be attractive to children; | ||||||
| 24 | (7) be in a container that: | ||||||
| 25 | (A) is suitable to contain products for human | ||||||
| 26 | consumption; | ||||||
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| 1 | (B) complies with the United States Poison Prevention | ||||||
| 2 | Packaging Act of 1970; or | ||||||
| 3 | (C) contains a graduated measuring device, if | ||||||
| 4 | applicable; | ||||||
| 5 | (8) not be adulterated, including containing metals, | ||||||
| 6 | pesticides, or pathogens in excess of limits set by this Act or | ||||||
| 7 | Department rule; | ||||||
| 8 | (9) only be sold in establishments that restrict entry to | ||||||
| 9 | persons 21 years of age or older and require age verification; | ||||||
| 10 | and | ||||||
| 11 | (10) not be served in a form that combines or mixes | ||||||
| 12 | finished kratom products with psychoactive substances that | ||||||
| 13 | impact the central nervous system, including alcohol, | ||||||
| 14 | caffeine, kava, cannabinoids, or nicotine. | ||||||
| 15 | Section 15. Permit and registration requirements for | ||||||
| 16 | processors. | ||||||
| 17 | (a) Kratom products may be manufactured or distributed in | ||||||
| 18 | Illinois only by a processor that holds a permit to operate as | ||||||
| 19 | a food service establishment. | ||||||
| 20 | (b) A processor must be registered with the United States | ||||||
| 21 | Food and Drug Administration and comply with Current Good | ||||||
| 22 | Manufacturing Practices under 21 CFR Part 210. | ||||||
| 23 | (c) A processor must maintain product liability insurance | ||||||
| 24 | with an occurrence limit of $3,000,000. | ||||||
| 25 | (d) For each batch of a registered finished kratom | ||||||
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| 1 | product, the processor shall retain and submit, upon request, | ||||||
| 2 | a certificate of analysis from an accredited laboratory. The | ||||||
| 3 | certificate must demonstrate compliance with statutory and | ||||||
| 4 | rule limits for alkaloids, residual solvents, heavy metals, | ||||||
| 5 | and pesticides. | ||||||
| 6 | (e) A finished kratom product served by a kratom food | ||||||
| 7 | service establishment must comply with this Act; however, a | ||||||
| 8 | separate registration is not required when a kratom beverage | ||||||
| 9 | is combined with another food or beverage for on-premises | ||||||
| 10 | consumption. Serving kratom beverages combined with alcohol, | ||||||
| 11 | drugs, or other kratom products is prohibited. | ||||||
| 12 | Section 20. Reporting and testing. | ||||||
| 13 | (a) If a processor or the Department receives notice of an | ||||||
| 14 | adverse health event suspected to be related to a kratom | ||||||
| 15 | product, the processor or the Department must submit an | ||||||
| 16 | adverse event report under 21 U.S.C. 379aa-1(b)(1) to the | ||||||
| 17 | United States Food and Drug Administration. | ||||||
| 18 | (b) If probable cause exists that a kratom product may be | ||||||
| 19 | adulterated, the Department may require an independent | ||||||
| 20 | third-party test by a laboratory of the Department's choice, | ||||||
| 21 | and the processor must pay the cost of the test. | ||||||
| 22 | Section 25. Violations; enforcement. | ||||||
| 23 | (a) A violation of Section 15 is a Class C misdemeanor. | ||||||
| 24 | (b) A processor that manufactures, delivers, offers for | ||||||
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| 1 | sale, distributes, or sells a finished kratom product that | ||||||
| 2 | violates paragraph (2) or (3) of Section 10 commits a Class C | ||||||
| 3 | misdemeanor. | ||||||
| 4 | (c) A kratom product possessed, manufactured, delivered, | ||||||
| 5 | offered for sale, distributed, or sold in violation of this | ||||||
| 6 | Act by an entity regulated under this Act is subject to | ||||||
| 7 | detention and destruction of the product or related processing | ||||||
| 8 | equipment and to an immediate stop-sale order. The entity is | ||||||
| 9 | subject to a civil penalty of $1,000 or an administrative fine | ||||||
| 10 | as provided by Department rule. The Department may not | ||||||
| 11 | authorize removal or use of finished kratom products subject | ||||||
| 12 | to a stop-sale order, except for disposal, if the products are | ||||||
| 13 | attractive to children, until the products comply with this | ||||||
| 14 | Act. | ||||||
| 15 | (d) The State's Attorney of the county where the violation | ||||||
| 16 | occurred or the Attorney General may bring an action to | ||||||
| 17 | recover civil penalties and obtain relief under this Act. This | ||||||
| 18 | Section does not limit any damages or relief available under | ||||||
| 19 | common law or statute. | ||||||
| 20 | Section 30. Rules. The Department shall adopt rules to | ||||||
| 21 | implement and administer this Act. | ||||||