STORAGE NAME: h0057a.JUB DATE: 3/17/2025 1 FLORIDA HOUSE OF REPRESENTATIVES BILL ANALYSIS This bill analysis was prepared by nonpartisan committee staff and does not constitute an official statement of legislative intent. BILL #: CS/HB 57 TITLE: Regulation of Xylazine SPONSOR(S): Plakon, Bankson COMPANION BILL: SB 1360 (Leek) LINKED BILLS: None RELATED BILLS: None Committee References Criminal Justice 17 Y, 0 N, As CS Justice Budget Judiciary SUMMARY Effect of the Bill: The bill creates new criminal offenses relating to xylazine and exempts specified xylazine animal drug products from being classified as a Schedule I controlled substance, as long as such products are not for human use. Specifically, the bill prohibits a person from selling, manufacturing, delivering, or possessing with the intent to sell, manufacture, or deliver, specified forms of xylazine that resemble a food product or contain other specified markings as a first degree felony and requires an offender convicted of such an offense to be sentenced to a three- year mandatory minimum term of imprisonment. Additionally, the bill creates a new offense for trafficking in xylazine and prohibits a person from knowingly selling, purchasing, manufacturing, delivering, or bringing into this state, or knowingly being in actual or constructive possession of, 4 grams or more of xylazine. Under the bill, trafficking in xylazine is a first degree felony and an offender convicted of such an offense must be sentenced to a mandatory minimum term of imprisonment and fine, the length and amount of which varies depending upon the amount of xylazine involved in the offense. Fiscal or Economic Impact: The bill may have an indeterminate positive impact on the prison bed population by creating new first degree felony offenses related to xylazine and requiring offenders convicted of such offenses to be sentenced to mandatory minimum terms of imprisonment. JUMP TO SUMMARY ANALYSIS RELEVANT INFORMATION BILL HISTORY ANALYSIS EFFECT OF THE BILL: The bill creates a first degree felony for selling, manufacturing, delivering, or possessing with the intent to sell, manufacture, or deliver, xylazine, a xylazine analog, or a mixture containing xylazine, when such substance or mixture is in a form that resembles, or is mixed, granulated, absorbed, spray-dried, or aerosolized as or onto, coated on, in whole or in part, or solubilized with or into, a product, when such product or its packaging further has at least one of the following attributes: Resembles the trade dress of a branded food product, consumer food product, or logo food product; Incorporates an actual or fake registered copyright, service mark, or trademark; Resembles candy, cereal, a gummy, a vitamin, or a chewable product, such as a gum or gelatin-based product; or Contains a cartoon character imprint. The bill requires an offender convicted of such an offense to be sentenced to a three-year mandatory minimum term of imprisonment. (Section 2) The bill also creates a first degree felony for trafficking in xylazine if a person knowingly sells, purchases, manufactures, delivers, or brings into this state, or is knowingly in actual or constructive possession of, 4 grams or more of xylazine or any mixture containing xylazine. The bill requires an offender convicted of trafficking in JUMP TO SUMMARY ANALYSIS RELEVANT INFORMATION BILL HISTORY 2 xylazine to be sentenced to a mandatory minimum term of imprisonment and fine, the length and amount of which varies depending on the amount of xylazine involved in the offense, as follows: 7 year mandatory minimum sentence , and a $50,000 fine, if the amount is 4 grams or more, but less than 14 grams. 20 year mandatory minimum sentence, and a $100,000 fine, if the amount is 14 grams or more, but less than 28 grams. 25 year mandatory minimum sentence, and a $500,000 fine, if the amount is 28 grams or more. (Section 3) The effective date of Sections 2 and 3 of the bill is October 1, 2025. (Section 4) The bill excepts from the list of Schedule I controlled substances xylazine animal drug products that are approved by the United States Food and Drug Administration and the use of which conforms to the approved application or is authorized under 21 U.S.C. s. 360b(a)(4), a federal law relating to animal drug products. The bill specifies that the manufacture, importation, distribution, prescribing, or sale of xylazine for human use is not subject to this exception. (Section 1) The effective date of Section 1 of the bill is July 1, 2025. (Section 1) FISCAL OR ECONOMIC IMPACT: STATE GOVERNMENT: The bill may have an indeterminate positive impact on the prison bed population by creating new first degree felony offenses related to xylazine and requiring offenders convicted of such offenses to be sentenced to mandatory minimum terms of imprisonment. RELEVANT INFORMATION SUBJECT OVERVIEW: Controlled Substances Chapter 893, F.S., the Florida Comprehensive Drug Abuse Prevention and Control Act, classifies controlled substances 1 into five categories, called schedules. These schedules regulate the manufacture, distribution, preparation, and dispensing of the substances listed therein. The distinguishing factors between the different controlled substance schedules are the “potential for abuse” 2 of the substance and whether there is a currently accepted medical use for the substance. 3 The controlled substance schedules are as follows: Schedule I substances have a high potential for abuse and currently have no accepted medical use in the United States and their use under medical supervision does not meet accepted safety standards. 4 Schedule II substances have a high potential for abuse and have a currently accepted but severely restricted medical use in the United States, and abuse of the substance may lead to severe psychological or physical dependence. 5 Schedule III substances have a potential for abuse less than the substances contained in Schedules I and II and have a currently accepted medical use in the United States, and the abuse of the substance may lead to moderate or low physical dependence or high psychological dependence, or in the case of anabolic steroids, may lead to physical damage. 6 1 “Controlled substance” means any substance named or described in Schedules I-V of s. 893.03, F.S. S. 893.02(4), F.S. 2 “Potential for abuse” means that a substance has properties of a central nervous system stimulant or depressant or a hallucinogen that create a substantial likelihood of its being: 1) used in amounts that create a hazard to the user’s health or safety of the community; 2) diverted from legal channels and distributed through illegal channels; or 3) taken on the user’s own initiative rather than on the basis of professional medical advice. S. 893.02(22), F.S. 3 See s. 893.03, F.S. 4 S. 893.03(1), F.S. 5 S. 893.03(2), F.S. 6 S. 893.03(3), F.S. JUMP TO SUMMARY ANALYSIS RELEVANT INFORMATION BILL HISTORY 3 Schedule IV substances have a low potential for abuse relative to substances in Schedule III and have a currently accepted medical use in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule III. 7 Schedule V substances, compounds, mixtures, or preparation of substances have a low potential for abuse relative to the substances in Schedule IV and have a currently accepted medical use in the United States, and abuse of such compound, mixture, or preparation may lead to limited physical or psychological dependence relative to the substances in Schedule IV. 8 Xylazine The United States Food and Drug Administration (FDA) approved xylazine for use with animals in 1972. 9 Under 21 U.S.C. s. 360b(a)(4), the Secretary of Health and Human Services (Secretary) can exempt an animal drug from specified requirements if its use is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship and in compliance with regulations promulgated by the Secretary. Current regulations include the special consideration that federal law restricts xylazine to use by or on the order of a licensed veterinarian. 10 When administered to horses and cattle, xylazine sedates the animal so that a veterinarian can safely provide treatment. 11 When used by humans, however, xylazine, or “tranq,” causes sedation, difficulty breathing, low blood pressure, slowed heart rate, infected wounds, and even death. 12 It is especially dangerous when combined with opioids like fentanyl but is not an opioid itself, so medications that counteract opioids do not reverse xylazine’s effects. 13 In 2016, the Florida Legislature classified xylazine as a Schedule I controlled substance under s. 893.03(1)(c)37., F.S. 14 However, although xylazine is still only FDA-approved for use with animals, it is not a federal controlled substance. 15 Thus, while the FDA has repeatedly warned against xylazine use in humans and restricted its unlawful import, xylazine possession is not subject to federal criminal penalties. 16,17 As recently as 2022, the United States Drug Enforcement Administration (DEA) reported that “[a] kilogram of xylazine powder can be purchased online from Chinese suppliers with common prices ranging from six to 20 dollars per kilogram.” 18 Offenses Related to Xylazine and Fentanyl Possession of a Controlled Substance Under s. 893.13(6)(a), F.S., a person may not be in actual or constructive possession of a controlled substance unless such controlled substance was: Lawfully obtained from a practitioner or pursuant to a valid prescription or order of a practitioner while acting in the course of his or her professional practice, or Otherwise authorized under chapter 893, F.S. A person who unlawfully possesses specified controlled substances, including xylazine and fentanyl, commits a third degree felony. 19 Possession of a Controlled Substance with Specified Intent 7 S. 893.03(4), F.S. 8 S. 893.03(5), F.S. 9 FDA, What We’re Doing to Stop Illicit Xylazine from Getting into the U.S., 2023 (last visited Mar. 7, 2025). 10 21 CFR 522.2662. 11 Supra note 9. 12 Center for Disease Control, What You Should Know About Xylazine, 2024 (last visited Mar. 7, 2025). 13 Id. 14 Ch. 2016-105, Laws of Fla. 15 21 U.S. Code § 812. 16 FDA, FDA Takes Action to Restrict Unlawful Import of Xylazine, 2023 (last visited Mar. 7, 2025). 17 FDA, FDA Warns About the Risk of Xylazine Exposure in Humans, 2022 (last visited Mar. 7, 2025). 18 DEA, The Growing Threat of Xylazine and its Mixture with Illicit Drugs, 2022 (last visited Mar. 7, 2025). 19 A third degree felony is punishable by up to five years in prison and a $5,000 fine. Ss. 775.082, F.S., 775.083, F.S., or 775.084, F.S. JUMP TO SUMMARY ANALYSIS RELEVANT INFORMATION BILL HISTORY 4 Under s. 893.13(1)(a), F.S., a person may not sell, manufacture, or deliver, or possess with the intent to sell, manufacture, or deliver, a controlled substance, except as authorized by and chapters 499 or 893, F.S. A person who sells or unlawfully possesses xylazine with the intent to sell commits a third degree felony, 20 while a person who sells or unlawfully possesses fentanyl with the intent to sell commits a second degree felony. 21, 22 Possession of a Controlled Substance with Specified Attributes Under s. 893.13(1)(i), F.S., a person commits a first degree felony 23 and must be sentenced to a mandatory minimum term of imprisonment of three years if he or she sells, manufactures, or delivers, or possesses with the intent to sell, manufacture, or deliver: Alfentanil, carfentanil, fentanyl, sufentanil, a fentanyl derivative, a specified fentanyl analog, 24 or a mixture containing any such substance; and The substance or mixture is in a form that resembles, or is mixed, granulated, absorbed, spray-dried, or aerosolized as or onto, coated on, in whole or in part, or solubilized with or into, a product, when such product or its packaging further has at least one of the following attributes: o Resembles the trade dress of a branded food product, consumer food product, or logo food product; o Incorporates an actual or fake registered copyright, service mark, or trademark; o Resembles candy, cereal, a gummy, a vitamin, or a chewable product, such as a gum or gelatin- based product; or o Contains a cartoon character imprint. There is currently no offense for selling, or possessing with the intent to sell, xylazine with specified attributes. Trafficking in a Controlled Substance Under s. 893.135(1)(c)4., F.S., a person commits a first degree felony of “trafficking in dangerous fentanyl or fentanyl analogues,” if he or she knowingly sells, purchases, manufactures, delivers, or brings into this state, or is knowingly in actual or constructive possession of, 4 grams or more of: Alfentanil; Carfentanil; Fentanyl; Sufentanil; A fentanyl derivative; A controlled substance analog of any substance described above; or A mixture containing any substance described above. A person convicted of trafficking in dangerous fentanyl or fentanyl analogues must be sentenced to a mandatory minimum term of imprisonment and fine, the length and amount of which varies depending on the amount of fentanyl or fentanyl analogues involved in the offense, as follows: 7 year mandatory minimum sentence , and a $50,000 fine, if the amount is 4 grams or more, but less than 14 grams. 20 year mandatory minimum sentence, and a $100,000 fine, if the amount is 14 grams or more, but less than 28 grams. 25 year mandatory minimum sentence, and a $500,000 fine, if the amount is 28 grams or more. 20 The unlawful possession of a controlled substance under s. 893.03(1)(c), F.S., with specified intent, is a third degree felony. S. 893.13(1)(a)2., F.S. 21 The unlawful possession of a controlled substance under s. 893.03(2)(b), F.S., with specified intent, is a second degree felony. S. 893.13(1)(a)1., F.S. 22 A second degree felony is punishable by up to 15 years in prison and a $10,000 fine. Ss. 775.082, F.S., 775.083, F.S., or 775.084, F.S. 23 A first degree felony is punishable by up to 30 years in prison and a $10,000 fine. Ss. 775.082, 775.083, or 775.084, F.S. 24 Under s. 893.0356(2)(a), F.S., a “controlled substance analog” means a substance which, due to its chemical structure and potential for abuse, meets the following criteria: 1. Is substantially similar to that of a controlled substance listed in Schedule I or Schedule II of s. 893.03, F.S.; and 2. Has a stimulant, depressant, or hallucinogenic effect on the central nervous system or is represented or intended to have a stimulant, depressant, or hallucinogenic effect on the central nervous system substantially similar to or greater than that of a controlled substance listed in Schedule I or Schedule II of s. 893.03, F.S. JUMP TO SUMMARY ANALYSIS RELEVANT INFORMATION BILL HISTORY 5 There is currently no offense for trafficking in xylazine. OTHER RESOURCES: Fentanyl Adulterated or Associated with Xylazine Response Plan | The White House Drug Scheduling Information | FDA Xylazine: Considerations for Federal Control | Congressional Research Service Letter to the Federal Government Recommending Scheduling Xylazine | Florida Attorney General BILL HISTORY COMMITTEE REFERENCE ACTION DATE STAFF DIRECTOR/ POLICY CHIEF ANALYSIS PREPARED BY Criminal Justice Subcommittee 17 Y, 0 N, As CS 3/6/2025 Hall Butcher THE CHANGES ADOPTED BY THE COMMITTEE: Created an exception from the list of Schedule I controlled substances for specified xylazine animal drug products. Specified that the above exception does not apply to the manufacture, importation, distribution, prescribing, or sale of xylazine for human use. Justice Budget Subcommittee DiCola Keith Judiciary Committee ------------------------------------------------------------------------------------------------------------------------------------- THIS BILL ANALYSIS HAS BEEN UPDATED TO INCORPORATE ALL OF THE CHANGES DESCRIBED ABOVE. -------------------------------------------------------------------------------------------------------------------------------------