The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Commerce and Tourism
BILL: SB 1734
INTRODUCER: Senator Collins
SUBJECT: Florida Kratom Consumer Protection Act
DATE: March 24, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Dike McKay CM Pre-meeting
2. AEG
3. FP
I. Summary:
SB 1734 amends the Florida Kratom Consumer Protection Act to create requirements for kratom
products manufactured, delivered, offered for sale, distributed, or sold by processors in this state.
The bill sets out requirements for processors for state and federal registration, proof of testing
and analysis for kratom products, and reporting of adverse health events. The bill also creates
penalties for violations of s. 500.92, F.S.
The bill takes effect July 1, 2025.
II. Present Situation:
Florida Kratom Consumer Protection Act of 2023
In 2023, the Legislature enacted the Florida Kratom Consumer Protection Act,
1
which made it
unlawful to sell, deliver, barter, furnish, or give, directly or indirectly, any kratom product to a
person under 21 years of age. The Florida Department of Agriculture and Consumer Services
(FDACS) adopted rules to implement the act.
2
Kratom
Kratom is a tropical tree native to Southeast Asia that contains mitragynine and 7-
hydroxymytragynine in its leaves, which are two major psychoactive ingredients.
3
The leaves are
1
Section 500.92, F.S.
2
Fla. Admin. Code R. 5K-4.030.
3
Drug Enforcement Administration, Kratom (April 2020), available at https://www.dea.gov/sites/default/files/2020-
06/Kratom-2020_0.pdf (last visited Mar. 24, 2025).
REVISED: BILL: SB 1734 Page 2
crushed and then smoked, brewed with tea, or placed into gel capsules.
4
Consumption of kratom
leaves can produce stimulant and sedative effects, and may also lead to psychotic symptoms.
5
Some research finds that kratom can be used as a substitute for opiate users to combat
withdrawal symptoms, as well as to treat muscle ache, fatigue, and other conditions.
6
Low doses
of kratom are said to produce a stimulant effect, while higher doses may produce an opioid-like
effect.
7
Additionally, research points to the potential for further development of mitragynine and
the use of kratom as a harm reduction agent.
8
Even so, the toxicity of kratom remains a topic of
discussion, as well as its potential to cause herb-drug interactions and even be involved in
fatalities.
9
While research on kratom is in early stages, kratom itself has the potential to be
addictive and has not been shown to be safe or effective for any medical use.
10
Currently, kratom is not listed as a controlled substance under federal law or Florida law.
However, in 2014, Sarasota County banned kratom, labeling it as a designer drug.
11
With the
exception of Sarasota County, in Florida, all parts of the plant and its extracts are legal to
cultivate, buy, possess, and distribute without a license or prescription. Kratom is illegal in
Alabama,
12
Arkansas,
13
Indiana,
14
Rhode Island,
15
Vermont,
16
and Wisconsin.
17
In 12 other states
the possession, sale, manufacture, and distribution of kratom products is regulated.
18
Following an updated import alert that provides information to U.S. Food and Drug
Administration (FDA) field staff about detaining without physical examination imported dietary
supplements and bulk dietary ingredients that are or contain kratom,
19
in May of 2021, the FDA
4
Id.
5
Id.
6
See Dimy Fluyau and Neelambika Revedigar, Biochemical Benefits, Diagnosis, and Clinical Risks Evaluation of Kratom,
FRONTIERS IN PSYCH. J. VOL. 8 (April 24, 2017) available at
https://www.frontiersin.org/articles/10.3389/fpsyt.2017.00062/full (last visited Mar. 24, 2025).
7
Fluyau and Neelambika, supra note 6.
8
See Charles Veltri and Oliver Grundmann, Current Perspectives on the Impact of Kratom Use, SUBSTANCE ABUSE AND
REHAB. J. VOL. 10, 23-31 (July 1, 2019) available at https://pubmed.ncbi.nlm.nih.gov/31308789/ (last visited Mar. 24, 2025).
9
Id.; see also FLORIDA DEPT. LAW ENF’T, Drugs Identified in Deceased Persons by Florida Medical Examiners (May 2022),
available at https://www.fdle.state.fl.us/MEC/Publications-and-Forms/Documents/Drugs-in-Deceased-Persons/2021-Interim-
Drug-Report-FINAL.aspx (last visited Mar. 24, 2025). In May of 2022 the Florida Department of Law Enforcement
published its 2021 Interim Report, which found a 36% rise in kratom-involved deaths over the first half of 2021.
10
NAT’L CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH, Kratom, available at
https://www.nccih.nih.gov/health/kratom (last visited Mar. 24, 2025).
11
See SARASOTA, FL, Code of Ordinances, Sec. 62-351 (2014).
12
See ALABAMA PUBLIC HEALTH, Controlled Substance List (Jan. 20, 2021), available at
https://www.alabamapublichealth.gov/blog/assets/controlledsubstanceslist.pdf (last visited Mar. 24, 2025).
13
See ARKANSAS DEPT. OF HEALTH, List of Controlled Substances, available at
http://secureservercdn.net/166.62.109.105/e17.085.myftpupload.com/wp-content/uploads/2016/02/arkansas-
controlled_substances_list.pdf (last visited Mar. 4, 2025).
14
See IC 35-31.5-2-321.
15
See RHODE ISLAND DEPT. OF HEALTH, Notice of Designation of Controlled Substance (May 31, 2017), available at
https://docs.wixstatic.com/ugd/9ba5da_9836aee2b9f04a30b55fe480fe3c6ff4.pdf. (last visited Mar. 24, 2025).
16
See Vt. Admin. Code 12-5-23:4.0.
17
See W.S.A. 961.14.
18
See LEGIS. ANALYSIS AND PUB. POL’Y ASS’N, Regulation of Kratom in America: Update (September 2022), available at
https://legislativeanalysis.org/wp-content/uploads/2022/10/Kratom-Fact-Sheet-FINAL.pdf (last visited Mar. 24, 2025).
19
The import alert labels kratom as an adulterating ingredient. See U.S. FDA, Import Alert 54-15, available at
https://www.accessdata.fda.gov/CMS_IA/importalert_1137.html (last visited Mar. 24, 2025) The FDA labeled kratom as BILL: SB 1734 Page 3
announced the seizure of around 37,500 tons of adulterated kratom in Florida, worth an
estimated $1.3 million.
20
The FDA’s Associate Commissioner for Regulatory Affairs stated that
there is substantial concern regarding the safety of kratom and the risk it may pose to public
health and indicated that there are currently no FDA-approved uses for kratom.
21
The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District
Court for the Middle District of Florida alleging that kratom is a new dietary ingredient for
which there is inadequate information to provide reasonable assurance that it does not present a
significant or unreasonable risk of illness or injury.
22
Additionally, the FDA stated that dietary
supplements and bulk dietary ingredients that are or contain kratom are adulterated under the
Federal Food, Drug, and Cosmetic Act.
23
On October 26, 2021, a consent decree of
condemnation and destruction against the articles seized by the FDA in May of 2021 was
entered, which requires the claimants to pay a penal bond and destroy all seized articles.
24
III. Effect of Proposed Changes:
Kratom Consumer Protection
Section 1 amends s. 500.92, F.S., to establish product, reporting, and registration requirements,
in addition to punishments for violations of the bill for kratom products sold in this state.
Definitions
The bill provides the following definitions:
• “Attractive to children” means a product manufactured: (1) In a shape that resembles a
human, a cartoon character, or an animal; (2) In a form that resembles an existing candy
product that is a widely distributed, branded food item; or (3) Using any color additives.
• “Finished kratom product” means a kratom product that is ready for sale to the end user. For
purposes of registration, a finished kratom product is differentiated by its ingredients, not by
its weight, volume, or size.
• “Kratom” means the plant or any part of the plant Mitragyna speciosa.
• “Kratom beverage” means a prepackaged liquid kratom product in the form of a tea, seltzer
or tonic water, or tincture.
• “Kratom food service establishment” means any public food service establishment licensed
as provided in ch. 509, F.S. which sells finished kratom products.
adulterating based on the absence of a history of use or other evidence of safety establishing that kratom will reasonably be
expected to be safe as a dietary ingredient, kratom and kratom-containing dietary supplements and bulk dietary ingredients
are adulterated because they contain a new dietary ingredient for which there is inadequate information to provide reasonable
assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
20
U.S. FDA, FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom (May 21, 2021), available at
https://www.fda.gov/news-events/press-announcements/fda-announces-seizure-adulterated-dietary-supplements-containing-
kratom (last visited Mar. 24, 2025).
21
Id.
22
Id.
23
Id.; see also FDA, FDA Roundup: April 28, 2023, available at https://www.fda.gov/news-events/press-announcements/fda-
roundup-april-28-2023 (last visited Mar. 24, 2025) (describing a 2023 seizure of kratom-adulterated products).
24
Id. BILL: SB 1734 Page 4
• “Processor” means a person who manufactures, delivers, or offers for sale, distributes, or
sells kratom products.
Product Requirements
Under the bill, a processor may not manufacture, deliver, offer for sale, distribute, or sell a
finished kratom product that:
• Is not in the delivery form of dried leaves, kratom beverages, powders, pills, or capsules.
• Contains a level of synthetic 7-hydroxymitragynine in the alkaloid fraction which is greater
than 2% of the alkaloid composition of the kratom product.
• Is not registered with FDACS pursuant to s. 500.92, F.S.
• Does not have a certificate of analysis submitted to FDACS as required by this section.
• Does not comply with the packaging and labeling requirements set forth in ch. 500, F.S., and
the rules adopted pursuant thereto. Such kratom products are considered misbranded.
• Is extracted using solvents other than water or Class 3 solvents set forth in USP-NF chapter
467.
• Contains levels of Class 3 solvents greater than the limits set forth in USP-NF chapter 467.
• Is attractive to children.
• Is in a container that:
o Is not suitable to contain products for human consumption;
o Is not compliant with the U.S. Poison Prevention Packaging Act of 1970, 15 U.S.C. ss.
1471 et seq.; or
o Does not contain graduated measuring devices, if applicable.
• Is adulterated, including containing metals, pesticides, or pathogens in excess of the limits set
by this section or FDACS’s rules.
Additionally, a processor may not manufacture, deliver, offer for sale, distribute, or sell a
finished kratom product that does not include directions for consumption of the kratom product
on the product’s label, including, but not limited to:
• Maximum dosage of 40 milligrams of mitragynine per serving.
• Number of servings per package.
• Milligrams of 7-hydroxmitragynine and mitragynine per serving.
• A warning which advises consumers of the number of servings that may be safely consumed
in a 24-hour period.
• A warning prohibiting use by individuals who are under 21 years of age.
• A warning which advises against use by individuals who are pregnant or breastfeeding.
• A warning which advises the consumer to consult a health care professional before use, that
the product may be habit-forming, and that it may cause adverse health effects.
• A warning stating the following: “These statements have not been evaluated by the United
States Food and Drug Administration. This product is not intended to diagnose, treat, cure, or
prevent any disease.”
• The expiration date.
• The name and place of business of the registrant.
BILL: SB 1734 Page 5
Permit and Federal Registration Requirements
The bill provides that kratom products may only be manufactured by, delivered to, offered for
sale by, distributed by, or sold by a processor who holds a permit to operate as a food
establishment as defined in s. 500.03, F.S. A processor may not operate as a cottage food
operation pursuant to s. 500.80, F.S. and is not exempt from food permit requirements pursuant
to s. 500.12(1)(a)1, F.S. The bill also requires that a processor that manufactures, processes,
packs, or offers for sale kratom, kratom products, or finished kratom products must be properly
registered with the FDA, except for processors exclusively selling finished kratom products at
retail.
State Registration Requirements
A processor must register its finished kratom product with FDACS annually. A processor must
also certify by sworn statement that any finished kratom product that any finished kratom
product the processor manufactures, delivers, offers for sale, distributes, or sells in this state:
• Is registered with the state; and
• Does not contain dangerous or harmful substances, including, but not limited to, red-OH,
synthetic 7-OH, synthetic 7-hydroxymitragynine, synthetic mitragynine, pseudoindoxyl,
super alkaloid, or any other synthetically derived compounds, synthetic alkaloids, or
controlled substances.
For each batch of a registered finished kratom product, the processor must submit a certificate of
analysis to FDACS from an independent, third-party, accredited laboratory. The laboratory must
be accredited under the International Organization for Standardization (ISO)/International
Electrotechnical Commission (IEC) 17025:2017 General Requirements for Competence of
Testing and Calibration Laboratories standard by an accreditation body that is a signatory to the
International Laboratory Accreditation Cooperation Mutual Recognition Arrangement. The bill
also requires that:
• The processor may not have any direct or indirect financial or economic interest in the
laboratory or accrediting body.
• The processor must maintain the certificates of analysis for at least one year after the finished
kratom product’s expiration date.
• The certificate of analysis must demonstrate that the finished kratom product complies with
the statutory and rule concentration limits for:
o Alkaloid and alkaloid metabolites;
o Residual solvents;
o Heavy metals, including cadmium, arsenic, mercury, and lead; and
o Pesticides and any other substance limited by FDACS regulations.
Further, kratom food service establishments:
• Must comply with s. 500.92, F.S., for finished kratom products that they serve.
• Are not required to have a separate registration for kratom beverages combined with another
food or beverage by the kratom food service establishment for consumption on the premises.
• Shall not serve kratom beverages combined with alcohol, drugs, or other kratom products.
The bill also sets out that a processor assumes all responsibility and liability for its kratom and
kratom products. BILL: SB 1734 Page 6
Reporting and Testing
If a processor or FDACS receives notice of any adverse health event suspected of being related
to the processor’s kratom product, the processor or FDACS must submit an adverse event report
to the FDA per 21 U.S.C. s. 379aa-1(b)(1).
If probable cause exists that a kratom product may be adulterated, FDACS may require an
independent third-party test of the kratom product, and the processor must pay the cost of the
test. If the processor does not make such payment to FDACS within 30 days after receiving the
invoice for the testing fee, FDACS must revoke the registration for that product.
Violations
The bill mandates that a processor that manufactures, delivers, offers for sale, distributes, or sells
a finished kratom product that (1) contains a level of synthetic 7-hydroxymitragynine in the
alkaloid fraction which is greater than 2% of the alkaloid composition of the kratom product or
(2) is not registered with FDACs, commits a felony of the third degree, punishable as provided in
s. 775.082, F.S., or s. 232 775.083, F.S.
Kratom products possessed, manufactured, delivered, offered for sale, distributed, or sold in
violation of this bill by an entity regulated under ch. 500, F.S., are subject to s. 500.172, F.S., and
an immediate stop-sale order, and the entity is subject to penalties as provided in s. 500.121, F.S.
FDACS may not grant permission to remove or use, except for disposal, finished kratom
products subject to a stop-sale order which are attractive to children until the finished kratom
products comply with s. 500.92, F.S.
If a processor fails to provide a certificate of analysis within two days of receiving a request from
FDACS, or fails to immediately report an adverse health event, FDACS may revoke the
processor’s finished kratom product registration.
Under the bill, a processor that manufactures, delivers, offers for sale, distributes, or sells a
kratom product that contains:
• any controlled substance listed in s. 893.03, F.S.;
• an alkaloid not naturally present in kratom;
• a synthetic alkaloid or a synthetic alkaloid metabolite, including, but not limited to, red-
OH, synthetic 7-OH, synthetic 7-hydroxymitragynine, synthetic mitragynine,
pseudoindoxyl, super alkaloid; or
• any other synthetically derived compounds of the plant Mitragyna speciosa, or a level of
7-hydroxymitragynine in the alkaloid fraction which is greater than 2%
is in violation s. 500.92, F.S.
Further, if a laboratory fails to ensure the accuracy of its certificates of analysis, the laboratory is
subject to administrative fines as provided by FDACS rule pursuant to this bill. BILL: SB 1734 Page 7
Funding for Implementation
Section 2 appropriates $1,920,141.22 in recurring funds, $1,791,608 in nonrecurring funds, and
$1,508,152.18 for salary for 24 full-time employees from the General Inspection Trust Fund to
FDACS for the 2025-2026 fiscal year to implement this bill.
Effective Date
Section 3 provides an effective date of July 1, 2025.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None identified.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
Indeterminate. There will be an increased cost to processors to manufacture, produce, and
sell kratom products in the state due to the registration, reporting, and testing
requirements in the bill.
C. Government Sector Impact:
There is an increased workload on FDACS to govern registration and reporting
requirements for kratom products. The bill appropriates $1,920,141.22 in recurring funds, BILL: SB 1734 Page 8
$1,791,608 in nonrecurring funds, and $1,508,152.18 for salary for 24 full-time
employees from the General Inspection Trust Fund to FDACS for implementation.
VI. Technical Deficiencies:
None.
VII. Related Issues:
In their agency bill analysis, the Florida Department of Law Enforcement (FDLE) noted that:
• A laboratory cannot determine whether an alkaloid is synthetic or natural.
• Red-OH and super alkaloid appear to be names of tablets containing 7-hydroxymitragynine.
• Synthetic 7-OH is synthetic 7-hydroxymitragynine.
• If FDACS requests that FDLE be the third-party laboratory for testing, FDLE does not have
the instrumentation or training needed to perform full quantification to determine whether the
level of active ingredient is greater than 2% of the product’s alkaloid composition.
As such, the processor may not be able to guarantee that their kratom product does not contain
synthetic alkaloids in the sworn statement required by subsection (6)(a). Moreover, some of the
listed substances may be duplicative of other listed substances in subsection (8)(e).
VIII. Statutes Affected:
This bill substantially amends section 500.92 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.