THE BILL ITSELF
SB 994
Florida Kratom Consumer Protection Act
Florida Senate - 2026 SB 994 By Senator Gruters 22-00574B-26 2026994__
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A bill to be entitled
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An act relating to the Florida Kratom Consumer
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Protection Act; amending s. 500.92, F.S.; defining
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terms; revising the definition of the term “kratom
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product”; requiring that finished kratom products sold
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to consumers at certain establishments meet certain
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requirements; requiring that kratom products be
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manufactured only by a processor who holds a certain
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permit issued by the Department of Agriculture and
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Consumer Services; prohibiting specified operations;
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prohibiting exemptions from certain requirements;
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requiring certain processors to be properly registered
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with the United States Food and Drug Administration;
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requiring processors to comply with certain
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regulations; requiring processors to maintain product
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liability insurance with a specified occurrence limit;
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requiring processors of a finished kratom product to
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retain and submit a certificate of analysis from an
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accredited laboratory to the Department of Agriculture
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and Consumer Services for each batch of finished
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kratom product; specifying requirements for such
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laboratory; prohibiting processors from having any
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financial or economic interest in such laboratory or
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the body accrediting such laboratory; requiring
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processors to maintain their certificates of analysis
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for a specified amount of time after the finished
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kratom product’s expiration date; requiring that the
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certificate of analysis demonstrate that the finished
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kratom product is in compliance with statutory and
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rule concentration limits for specified substances;
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requiring that certain finished kratom products comply
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with product registration and testing requirements;
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providing an exception; providing nonapplicability;
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providing requirements for finished kratom products
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produced in this state and subsequently shipped or
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transported out of this state for sale outside of this
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state; requiring a processor or the department to
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submit a certain report to the United States Food and
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Drug Administration if a processor or the department
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receives a certain notice; authorizing the department
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to conduct an independent third-party test of a kratom
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product if probable cause exists that the product is
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adulterated; requiring the processor to pay the
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testing cost; authorizing the department to revoke the
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processor’s product registration if the processor
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fails to pay for such test within a specified
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timeframe; providing prohibitions; providing criminal
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penalties; providing that certain kratom products are
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subject to a stop-sale order; authorizing the
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department to revoke a processor’s finished kratom
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product registration under certain circumstances;
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providing that a processor whose kratom product
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contains a controlled substance or other prohibited
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substances is in violation of the act; authorizing the
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levying of administrative fines for laboratories that
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fail to comply with certain requirements; providing an
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appropriation; providing an effective date.
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Be It Enacted by the Legislature of the State of Florida:
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Section 1. Section 500.92, Florida Statutes, is amended to
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read:
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500.92 Florida Kratom Consumer Protection Act.—
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(1) SHORT TITLE.— This section may be cited as the “Florida
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Kratom Consumer Protection Act.”
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(2) DEFINITIONS.— As used in this section, the term :
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(a) “Attractive to children” means a product manufactured:
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1. In a shape that resembles a human, a cartoon character,
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or an animal; or
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2. In a form that resembles an existing candy product that
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is widely distributed or branded.
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(b) “Finished kratom product” means a kratom product that
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is ready for sale to the end user. For purposes of registration,
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a finished kratom product is differentiated by its ingredients,
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not by its weight, volume, or size.
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(c) “Kratom” means the plant or any part of the plant
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Mitragyna speciosa in any form.
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(d) “Kratom beverage” means a prepackaged liquid kratom
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product in the form of a tea, a seltzer or tonic water, or a
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tincture.
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(e) “Kratom food service establishment” means any public
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food service establishment licensed as provided in chapter 509
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which sells finished kratom products.
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(f) “Kratom product” means a food product, food ingredient,
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dietary ingredient, dietary supplement, or beverage intended for
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human consumption which contains any part of the leaf of the
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plant Mitragyna speciosa or an extract , synthetic alkaloid, or
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synthetically derived compound of such plant and is manufactured
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as a powder, capsule, pill, beverage, or other consumable edible
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form.
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(g) “Processor” means an entity that:
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1. Refines kratom into input ingredients for the purpose of
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manufacturing a finished kratom product;
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2. Manufactures finished kratom products; or
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3. Packages finished kratom products for resale.
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(3) KRATOM PRODUCT RETAIL SALE REQUIREMENTS.—Finished
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kratom products sold to consumers at retail establishments,
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including a food establishment as defined in s. 500.03(1), a
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convenience store, or a kava or kratom bar:
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(a) Must be in one of the following delivery forms:
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1. Dried leaf;
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2. Kratom beverage;
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3. Powder;
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4. Pill;
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5. Liquid dietary supplement;
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6. Gummy or food; or
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7. Capsule.
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(b) Must possess a certificate of analysis, which must be
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submitted to the department pursuant to paragraph (4)(e).
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(c) Must be registered with the department pursuant to this
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section.
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(d) Must include directions for consumption of the kratom
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product on the product’s label, including, but not limited to:
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1. Maximum dosage of 100 milligrams of kratom alkaloids per
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serving;
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2. Number of servings per package;
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3. Milligrams of mitragynine and 7-hydroxymitragynine per
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serving;
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4. A warning advising consumers of the number of servings
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that may be safely consumed in a 24-hour period;
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5. A warning prohibiting use by individuals who are under
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21 years of age;
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6. A warning advising against use by individuals who are
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pregnant or breastfeeding;
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7. A warning advising the consumer to consult a health care
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professional before use, that the product may be habit-forming,
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and that it may cause adverse health effects;
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8. A warning stating the following: “These statements have
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not been evaluated by the United States Food and Drug
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Administration. This product is not intended to diagnose, treat,
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cure, or prevent any disease.”;
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9. The expiration date; and
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10. The name and place of business of the registrant.
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(e) Must comply with the packaging and labeling
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requirements set forth in this chapter and with the rules
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adopted pursuant thereto.
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(f) May not be attractive to children.
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(g) Must be packaged in a container that:
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1. Is suitable to contain products for human consumption.
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2. Is compliant with the United States Poison Prevention
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Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
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3. Contains a graduated measuring device, if applicable.
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(h) May not be adulterated, including containing metals,
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pesticides, or pathogens in excess of the limits set by this
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section or department rule.
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(i) May be sold only in establishments that restrict entry
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to persons who are 21 years of age or older and require age
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verification.
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(j) May not be served in a form that combines or mixes
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finished kratom products with psychoactive substances that
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impact the central nervous system, including, but not limited
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to, alcohol, caffeine, kava, cannabinoids, and nicotine.
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(4) PERMIT FOR PROCESSING FINISHED KRATOM PRODUCTS AND
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FEDERAL AND STATE REGISTRATION REQUIREMENTS FOR PROCESSORS.—
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(a) Kratom products may be manufactured or distributed in
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this state only by a processor who holds a permit issued by the
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department to operate as a food establishment as defined in s.
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500.03(1). A processor may not operate as a cottage food
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operation pursuant to s. 500.80 and is not exempt from food
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permit requirements pursuant to s. 500.12(1)(a)1.
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(b) A processor that manufactures, processes, packs, or
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offers for sale kratom, kratom products, or finished kratom
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products must be properly registered with the United States Food
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and Drug Administration.
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(c) A processor shall comply with 21 C.F.R. part 210.
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(d) A processor shall maintain product liability insurance
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with an occurrence limit of $3 million.
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(e) For each batch of a registered, finished kratom
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product, the processor shall retain and, upon request, submit a
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certificate of analysis to the department from an accredited
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laboratory. The laboratory must be accredited under the
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International Organization for Standardization
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(ISO)/International Electrotechnical Commission (IEC) 17025:2017
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general requirements for competence of testing and calibration
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laboratories standard by an accreditation body that is a
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signatory to the International Laboratory Accreditation
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Cooperation Mutual Recognition Arrangement or a subsequent
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arrangement. The processor may not have any direct or indirect
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financial or economic interest in the laboratory or accrediting
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body. The processor shall maintain the certificates of analysis
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for a minimum of 1 year after the finished kratom product’s
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expiration date. The certificate of analysis must demonstrate
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that the finished kratom product is in compliance with the
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statutory and rule concentration limits for:
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1. Alkaloid and alkaloid metabolites;
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2. Residual solvents;
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3. Heavy metals, including cadmium, arsenic, mercury, and
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lead; and
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4. Pesticides and any substance limited by department rule.
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(f) A finished kratom product served by a kratom food
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service establishment must comply with the requirements of this
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section; however, a separate registration under this subsection
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is not required when a kratom beverage is combined with another
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food or beverage by the kratom food service establishment for
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consumption on premises.
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(g) Subsection (3) does not apply to finished kratom
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products processed or manufactured in this state and
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subsequently shipped or transported out of this state for sale
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or use outside of this state.
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(h) Finished kratom products produced in this state and
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subsequently shipped or transported out of this state for sale
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outside of this state:
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1. May not be sold, shipped, or transported to a consumer
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in this state, a retail establishment in this state, or to a
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person who intends to sell such products to a consumer in this
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state;
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2. Must be in a package marked “NOT FOR USE OR RETAIL SALE
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IN FLORIDA” in a bold font size of at least 36 points; and
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3. Must be physically separated from finished kratom
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products that are, or are intended to be, sold or used in this
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state.
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(5) REPORTING AND TESTING.—
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(a) If a processor or the department receives notice of any
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adverse health event suspected to be related to the processor’s
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kratom product, the processor or the department must submit an
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adverse event report as set out in chapter 9 of the Federal
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Food, Drug, and Cosmetic Act, 21 U.S.C. s. 379aa-1(b)(1) to the
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United States Food and Drug Administration.
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(b) If probable cause exists that a kratom product may be
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adulterated, the department may require an independent third
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party test of the kratom product by a laboratory of the
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department’s choice, and the processor must pay the cost of the
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test. If the processor does not make such payment to the
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department within 30 days after receiving the invoice for the
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testing fee, the department must revoke the registration for
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that product.
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(6) PROHIBITIONS.—
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(a) It is unlawful to serve kratom beverages combined with
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alcohol, drugs, or other kratom products.
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(b) It is unlawful to sell, deliver, barter, furnish, or
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give, directly or indirectly, any kratom product to a person who
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is under 21 years of age.
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(7) (4) VIOLATIONS.—
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(a) A violation of subsection (4) (3) is a misdemeanor of
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the second degree, punishable as provided in s. 775.082 or s.
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775.083.
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(b) A processor that manufactures, delivers, offers for
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sale, distributes, or sells a finished kratom product that
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violates paragraph (3)(b) or paragraph (3)(c) commits a
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misdemeanor of the second degree, punishable as provided in s.
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775.082 or s. 775.083.
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(c) Kratom products possessed, manufactured, delivered,
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offered for sale, distributed, or sold in violation of this
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section by an entity regulated under this chapter are subject to
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s. 500.172 and an immediate stop-sale order, and the entity is
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subject to penalties as provided in s. 500.121. The department
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may not grant permission to remove or use, except for disposal,
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finished kratom products subject to a stop-sale order which are
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attractive to children until the finished kratom products comply
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with this section.
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(d) If a processor fails to provide the department with a
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certificate of analysis within 7 days after receiving a request
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from the department or fails to immediately report an adverse
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health event to the department as required by this section, the
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department may revoke the processor’s finished kratom product
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registration.
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(e) A processor that manufactures, delivers, offers for
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sale, distributes, or sells a kratom product that contains any
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controlled substance or adulterants is in violation of this
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section.
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(f) A laboratory that fails to ensure the accuracy of its
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certificates of analysis issued pursuant to this section is
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subject to an administrative fine as provided by department
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rule.
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(8) (5) RULES.— The department shall adopt rules to
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administer this section.
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Section 2. For the 2026-2027 fiscal year, the sums of
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$1,920,141.22 in recurring funds and $1,791,608 in nonrecurring
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funds from the General Inspection Trust Fund are appropriated to
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the Department of Agriculture and Consumer Services, and 24
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full-time equivalent positions with associated salary rate of
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$1,508,152.18 are authorized, for the purpose of implementing
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this act.
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Section 3. This act shall take effect October 1, 2026.