HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 179 Florida Kratom Consumer Protection Act
SPONSOR(S): Regulatory Reform & Economic Development Subcommittee, Andrade
TIED BILLS: IDEN./SIM. BILLS: CS/SB 136
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY
CHIEF
1) Regulatory Reform & Economic Development 11 Y, 0 N, As CS Wright Anstead
Subcommittee
2) Commerce Committee 19 Y, 0 N Wright Hamon
SUMMARY ANALYSIS
Kratom, Mitragyna speciosa, is a tropical tree native to Southeast Asia that contains psychoactive ingredients
in its leaves, which may be crushed and then smoked, brewed with tea, or placed into gel capsules.
Consumption of kratom leaves can produce stimulant and sedative effects, and addiction may lead to
psychotic symptoms. Currently, kratom is not listed as a controlled substance under federal law or Florida law,
and is generally regulated as a food. There are no specific state laws related to the regulation of kratom.
The bill places the regulation of kratom products within ch. 500, F.S., which is under the Department of
Agriculture and Consumer Services (DACS).
The bill defines "kratom product" to mean a food product, food ingredient, dietary ingredient, dietary
supplement, or beverage intended for human consumption which contains any part of the leaf of the plant
Mitragyna speciosa or an extract, synthetic alkaloid, or synthetically derived compound of such plant and is
manufactured as a powder, capsule, pill, beverage, or other edible form.
As a food product, kratom products are subject to regulation and inspection by DACS.
The bill provides that it is unlawful to sell, deliver, barter, furnish, or give, directly or indirectly, any kratom
product to any person who is under 21 years of age.
If any retail food store, food establishment, or cottage food operation sells kratom products to someone under
21, they are subject to an administrative fine of not more than $100 for the first offense, not more than $500 for
the second offense, and not more than $1,000 for the third or subsequent offense.
The bill does not appear to have a fiscal impact on local governments and may have a negative fisc al impact
on state government. See Fiscal Analysis and Economic Impact Statement.
The bill provides an effective date of July 1, 2023.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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DATE: 3/8/2023
 FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Kratom
Kratom, or Mitragyna speciosa, is a tropical tree native to Southeast Asia that contains the alkaloids
mitragynine and 7-hydroxymytragynine in its leaves, which are two major psychoactive ingredients. 1
The leaves are crushed and then smoked, brewed with tea, or placed into gel capsules.2
Some people consumer kratom to treat muscle ache, fatigue, and other conditions. 3 Low doses of
kratom are said to produce a stimulant effect, while higher doses may produce an opioid-like effect.4
Research finds that kratom can be used as a substitute for opiate users to combat withdrawal
symptoms,5 though kratom addiction may lead to psychotic symptoms.6
The U.S. Food and Drug Administration (FDA) has found that:7
Kratom is abused for its ability to produce opioid-like effects… Evidence suggests
that kratom is abused individually and with other psychoactive substances. Kratom
does not have an approved medical use in the United States and has not been
studied as a treatment agent in the United States. Kratom has a history of being
used as an opium substitute in Southeast Asia. In the United States, kratom is
misused to self-treat chronic pain and opioid withdrawal symptoms. Consumption
of kratom can lead to a number of health impacts, including, among others,
respiratory depression, vomiting, nervousness, weight loss, and constipation.
Kratom has been reported to have both narcotic and stimulant-like effects, and
withdrawal symptoms may include hostility, aggression, excessive tearing, aching
of muscles and bones, and jerky limb movements.
A Centers for Disease Control and Prevention study of approximately 27,000 overdoses that occurred
between 2016 and 2017 found that kratom was implicated in less than one percent of deaths.8 The
exact incidence of kratom dependency is not known and there is no U.S. reporting system.9 It is
estimated that there are between 10-16 million kratom users in the U.S.10 Users indicate self-
treatment of anxiety, depression, pain, fatigue, and substance use disorder symptoms.11
1 Drug Enforcement Administration, Kratom (April 2020), available at https://www.dea.gov/sites/default/files/2020-06/Kratom-
2020_0.pdf (last visited Feb. 15, 2023).
2 Id.
3 Id.
4 See Dimy Fluyau and Neelambika Revedigar, Biochemical Benefits, Diagnosis, and Clinical Risks Evaluation of Kratom, Frontiers
in Psychiatry Journal Volume 8 (April 24, 2017).
5 Id.
6 Id.
7 86 FR 39038.
8 Emily O’Malley Olsen, PhD; Julie O’Donnell, PhD; Christine L. Mattson, PhD; Joshua G. Schier, MD; Nana Wilson, PhD; Notes
from the Field: Unintentional Drug Overdose Deaths with Kratom Detected — 27 States, July 2016–December 2017; CDC Morbidity
and Mortality Weekly Report, Apr. 12, 2019; Notes from the Field: Unintentional Drug Overdose Deaths with Kratom Detected — 27
States, July 2016–December 2017 | MMWR (cdc.gov) (last visited Feb. 15, 2023); Maia Szalavitz, The FDA Shouldn’t Support a Ban
on Kratom, Scientific American, Aug. 12, 2021, The FDA Shouldn't Support a Ban on Kratom - Scientific American (last visited Jan.
30, 2022).
9 Charles Veltri and Oliver Grundmann, Current Perspectives on the Impact of Kratom Use. Substance Abuse and Rehabilitation
Journal Volume 10 23-31 (July 1, 2019).
10 Maia Szalavitz, supra note 8.
11 Jeffrey Rogers, Kirsten Smith, Justin Strickland, and David Epstein, Kratom Use in the US: Both a Regional Phenomenon and a
White Middle-Class Phenomenon? Evidence From NSDUH 2019 and an Online Convenience Sample , Frontiers on Pharmacology,
https://www.frontiersin.org/articles/10.3389/fphar.2021.789075/ full (last visited Feb. 19, 2023).
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 Kratom is a $1.3 billion industry in the U.S. with sales generally occurring online and in smoke
shops.12 Hundreds of businesses around Florida sell the product.13
Public opinions in the U.S. range on the topic of kratom bans, either citing concerns of addiction or
praising perceived health benefits. Some point to kratom’s uses for opioid addicts to cease use and
aid in withdrawal symptoms.14 Other reports indicate that the use of kratom may lead to addiction. 15
State and Federal Prohibitions
Currently, kratom is not listed as a controlled substance under federal law or Florida law. In 2016, the
U.S. Drug Enforcement Administration (DEA) submitted a notice of intent to place kratom into Schedule
I of the Controlled Substances Act (CSA) based on abuse potential and risk to public health.16
However, the DEA withdrew the notice a few months later based on public comments. 17 In a letter
obtained by an industry group, U.S. Health and Human Services appeared to rescind their
recommendation to the DEA to place kratom on Schedule I of the CSA in 2018, stating that such action
should wait until it is supported by further research on kratom uses, abuse, and risks. 18 The DEA
continues to label kratom as a drug of concern.19
The FDA has 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.20 The
FDA is actively evaluating all available scientific information on the safety and effects of kratom and
continues to warn consumers not to use any kratom products, but has made no official findings.21
In 2015, the FDA issued an import alert22 that labels kratom as an adulterating ingredient.23 As a result,
the FDA seized imports of kratom-containing dietary supplements and bulk dietary ingredients. In May
of 2021, the FDA announced the seizure of around 37,500 tons of adulterated kratom in Fort Myers,
Florida, worth an estimated $1.3 million.24 On October 26, 2021, a consent decree of condemnation
and destruction against the seized articles by the FDA was entered, which required the claimants to
pay a penal bond and destroy all seized articles. 25
Generally, the official federal legal and regulatory status of kratom or kratom included in food products
is still being decided.
12 Brody Ford, Opiate Alternative Kratom Spurs Investor Interest, Bloomberg News, Dec. 20, 2021,
https://www.bloomberg.com/news/newsletters/2021-12-20/ krato m-attracts-investor-attention-after-regulatory-win (last visited Jan. 30,
2022).
13 Kirby Wilson, Florida Kratom for customers under 21 to be banned if this bill passes, Tampa Bay Times, Jan. 18, 2022, Florida
Kratom for customers under 21 to be banned if this bill passes (tampabay.com) (last visited Jan. 30, 2022).
14 Jennifer Clopton, Regulations Are On Hold as Kratom Debate Rages, WebMD, Feb. 11, 2019, https://www.webmd.com/mental-
health/addiction/news/20190211/regulations -are-on-hold-as-kratom-debate-rages (last visited Feb. 15, 2023).
15 Mayo Clinic, Kratom for opioid withdrawal: Does it work?, https://www.mayoclinic.org/diseases -conditions/prescription-drug-
abuse/in-depth/kratom-opioid-withdrawal/art-20402170 (last visited Feb. 15, 2023).
16 81 FR 59929.
17 81 FR 70652
18 Josh Long, HHS in 2018 rescinded recommendation to schedule kratom as a drug, Jan. 28, 2021,
https://www.naturalproductsinsider.com/regulatory/hhs -2018-rescinded-recommendation-schedule-kratom-drug (last visited Feb. 15,
2023).
19 U.S. Drug Enforcement Administration, Kratom, https://www.dea.gov/factsheets/kratom (last visited Feb. 15, 2023).
20 U.S. Food and Drug Administration, FDA and Kratom, https://www.fda.gov/news -events/public-health-focus/fda-and-kratom (last
visited Feb. 15, 2023).
21 Id.
22 U.S. Food and Drug Administration, Import Alert 54-15, Import Alert 54-15 (fda.gov) (last visited Feb. 15, 2023).
23 Id. The FDA labeled kratom as adulterating based on the absence of a history of use or other evidence of safe ty 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 inade quate information to provide
reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
24 U.S. Food and Drug Administration, FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom, May 21,
2021, https://www.fda.gov/news -events/press-announcements/fda-announces-seizure-adulterated-dietary-supplements-containing-
kratom (last visited Feb. 15, 2023).
25 Id.
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 In 2014, Sarasota County banned kratom, labeling it as a designer drug. 26 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, 27 Arkansas,28 Indiana,29
Vermont,30 and Wisconsin.31 Other states such as Arizona,32 Georgia,33 and Utah34 regulate kratom
under their state’s version of the Kratom Consumer Protection Act.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FDCA) is a federal law which establishes the legal
framework within which the FDA operates.35 The FDA develops regulations under the FDCA for the
safety of foods, drugs, and cosmetics based on the laws set forth in the FDCA, including when a food is
adulterated.36 Instances where a food must be determined to be adulterated include when it:37
 Bears or contains any poisonous or deleterious substance which may render it injurious to
health; such as consisting in whole or in part of any filthy, putrid, or decomposed substance;
 Is a dietary supplement or contains a dietary ingredient that presents a significant or
unreasonable risk of illness or injury under use pursuant to the label;
 Is 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.
When a food is determined to be adulterated, the FDA may take the following compliance measures: 38
 Warning and untitled letters,
 Import alerts,
 Recalls,
 Debarment,
 Civil money penalties,
 Seizure of products,
 Injunctions, and
 Criminal prosecution.
Florida Department of Agriculture and Consumer Services, Division of Food Safety
The Department of Agriculture and Consumer Services (DACS) is the department in charge of
regulating agriculture in Florida.39 As such, DACS promotes Florida agriculture, protects the
environment, safeguards consumers, and ensures the safety and wholesomeness of food. 40
26 See Sarasota, FL., Code of Ordinances, Sec. 62-351 (2014).
27 See Alabama Public Health, Controlled Substance List (Jan. 20, 2021), available at
https://www.alabamapublichealth.gov/blog/assets/controlledsubstanceslist.pdf (last visited Jan. 22, 2022).
28 See Arkansas Department 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 Jan. 22, 2022).
29 See IC 35-31.5-2-321.
30 See Vt. Admin. Code 12-5-23:4.0.
31 See W.S.A. 961.14.
32 See AZ Rev Stat § 36-795.02.
33 See GA Code § 16-13-121.
34 See UT Code § 4-45-101.
35 21 U.S.C. 301.
36 See 21 C.F.R. §§ 1-1299.
37 21 U.S.C. 342.
38 CRS Report R43609, Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues, February 9, 2018,
https://www.everycrsreport.com/reports/R43609.html#fn 96 (last visited Feb. 15, 2023).
39 S. 20.14, F.S. DACS also regulates certain professions, unfair and deceptive business practices and provides consumer information.
40 Florida Department of Agriculture and Consumer Services, About Us, h https://www.fdacs.gov/About-Us (last visited Feb. 15,
2023).
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 The Division of Food Safety (division), under DACS, is responsible for assuring a safe, wholesome, and
properly represented food supply in Florida. This is accomplished through the permitting and inspection
of food establishments, inspection of food products, and through specialized laboratory analyses on a
variety of food products sold or produced in the state. The division monitors food from the farm gate
through processing and distribution to the retail point of purchase. 41
The division is charged with administration and enforcement of food, poultry, and egg laws, and also
provides support in the enforcement of other food safety laws. In addition to regulatory surveillance and
enforcement, the division evaluates consumer complaints related to food. 42
“Food” includes:43
 Articles used for food or drink for human consumption;
 Chewing gum;
 Articles used for components of any such article;
 Articles for which health claims are made, which claims are approved by the Secretary of the
United States Department of Health and Human Services and which claims are made in
accordance with s. 343(r) of the federal act, and which are not considered drugs solely because
their labels or labeling contain health claims; and
 Certain dietary supplements.
“Food establishment” means a factory, food outlet, or other facility manufacturing, processing, packing,
holding, or preparing food or selling food at wholesale or retail. A food permit is required of any person
who operates a food establishment.44
“Retail food store” means any establishment or section of an establishment where food and food
products are offered to the consumer and intended for off-premises consumption.45
A food permit from the department is required of any person who operates a food establishment or
retail food store, except:46
 Persons operating minor food outlets that sell food that is commercially prepackaged, not
potentially hazardous, and not time or temperature controlled for safety, if the shelf space for
those items does not exceed 12 total linear feet and no other food is sold by the minor food
outlet.
 Persons subject to continuous, onsite federal or state inspection.
 Persons selling only legumes in the shell, either parched, roasted, or boiled.
 Persons selling sugar cane or sorghum syrup that has been boiled and bottled on a premise