This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h1595.CRJ
DATE: 1/17/2024
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: HB 1595 Controlled Substances
SPONSOR(S): Plakon
TIED BILLS: IDEN./SIM. BILLS: SB 1512
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Criminal Justice Subcommittee Butcher Hall
2) Justice Appropriations Subcommittee
3) Judiciary Committee
SUMMARY ANALYSIS
Federal and state law both classify controlled substances into five schedules. The scheduling determination for a
controlled substance is based on a substance’s potential for abuse and whether the substance has a currently
accepted medical use. The classifications range from a Schedule I substance, which has a high potential for
abuse and no accepted medical use; to a Schedule V substance, which has a low potential for abuse and an
accepted medical use. These schedules regulate the manufacture, distribution, preparation, and dispensing of
the substances listed therein.
The Legislature delegated to the Florida Attorney General the authority to adopt rules to add a substance to a
schedule established under s. 893.03, F.S., or transfer a substance between schedules, if the substance has the
potential for abuse and meets other requirements, or to remove a scheduled substance if it no longer meets the
requirements for inclusion in that schedule. If the Attorney General finds that the scheduling of a substance in
Schedule I of s. 893.03, F.S., on a temporary basis is necessary to avoid an imminent hazard to the public
safety, he or she may bypass certain requirements and by rule schedule such substance in Schedule I.
Tianeptine, sometimes referred to as “gas station heroin,” was developed in the 1960s for use as an
antidepressant. Although it is approved in low doses for that purpose in some countries outside of the United
States, the United States Food and Drug Administration (FDA) has never approved tianeptine for any medical
use, and both its potency and dosage are unregulated. When used in high doses, tianeptine produces effects
similar to those produced by an opioid and delivers short-lived euphoria. Tianeptine comes in both powder and
pill forms but has also been found in counterfeit pills mimicking other pharmaceutical products and individual
stamp bags commonly used to distribute heroin.
On September 20, 2023, Florida’s Attorney General issued Emergency Rule 2ER23-1, temporarily scheduling
tianeptine as a Schedule I controlled substance and concluding that tianeptine was “an immediate danger to
the public” by producing side effects including respiratory depression, loss of consciousness, death, nausea,
vomiting, agitation, decreased blood pressure, rapid heartbeat, slowed or stopped breathing, drowsiness,
mental confusion, and dependence. The emergency rule and the temporary scheduling of tianeptine will expire
on June 30, 2024.
HB 1595 amends s. 893.03, F.S., to add tianeptine to the list of Schedule I controlled substances. As such,
under the bill, the manufacture, distribution, preparation, and dispensing of tianeptine will be regulated by
Florida law.
The bill may have a positive indeterminate impact on jail and prison beds by making the possession,
distribution, sale, or manufacture of more substances illegal which may result in more jail and prison
admissions.
The bill provides an effective date of July 1, 2024. STORAGE NAME: h1595.CRJ PAGE: 2
DATE: 1/17/2024
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Florida Law
Controlled Substance Schedules
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
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
Attorney General Emergency Scheduling Authority
The Legislature delegated to the Florida Attorney General the authority to adopt rules to add a
substance to a schedule established under s. 893.03, F.S., or transfer a substance between schedules,
if the substance has the potential for abuse and meets other classification requirements, or to remove a
substance previously added to a schedule if it no longer meets the requirements for inclusion in that
schedule.
9
Proof of potential for abuse can be based upon a showing that these activities are already
taking place, or upon a showing that the nature and properties of the substance make it reasonable to
assume that there is a substantial likelihood that such activities will take place, in other than isolated or
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.
7
S. 893.03(4), F.S.
8
S. 893.03(5), F.S.
9
S. 893.035(2), F.S.; “Potential for abuse” has the same meaning as provided in s. 893.02(22), F.S. STORAGE NAME: h1595.CRJ PAGE: 3
DATE: 1/17/2024
occasional instances.
10
Any findings and conclusions provided by the U.S. Attorney General with
respect to any substance is admissible as evidence in any rulemaking proceeding, including an
emergency rulemaking proceeding.
11
If the Attorney General finds that the scheduling of a substance in Schedule I of s. 893.03, F.S., on a
temporary basis is necessary to avoid an imminent hazard to public safety, he or she may by rule
12
schedule such substance in Schedule I if the substance is not listed in any other schedule of s. 893.03,
F.S. The Attorney General must consider, with respect to his or her finding of imminent hazard to public
safety, only:
The substance’s potential for abuse;
13
The substance’s history and current pattern of abuse;
The scope, duration, and significance of abuse;
What, if any, risk there is to the public health;
14
Diversion from legitimate channels, if any; and
Clandestine importation, manufacture, or distribution.
15
The Attorney General must provide specific facts and reasons for finding an immediate danger to the
public health, safety, or welfare.
16
The Attorney General shall report to the Legislature by March 1 of
each year concerning any rules adopted to schedule or reschedule any substance during the previous
year. Each such rule expires on the following June 30 unless the Legislature adopts the provisions in
statute.
17
Federal Law
The federal Controlled Substances Act
18
(CSA) also classifies controlled substances into schedules
based on the potential for abuse and whether there is a currently accepted medical use for the
substance. The U.S. Attorney General is required to consider the following when determining where to
schedule a substance:
19
The substance’s actual or relative potential for abuse;
Scientific evidence of the substance’s pharmacological effect, if known;
The state of current scientific knowledge regarding the substance;
The substance’s history and current pattern of abuse;
The scope, duration, and significance of abuse;
What, if any, risk there is to public health;
The substance’s psychic or physiological dependence liability; and
Whether the substance is an immediate precursor of a substance already controlled.
Tianeptine
General Information
10
S. 893.035(3)(a), F.S.
11
Id.
12
In an emergency rulemaking proceeding, the Attorney General may proceed without regard to the requirements to request a medical
and scientific evaluation of the substance from and consider recommendations regarding scheduling from the Department of Health and
the Department of Law Enforcement. S. 893.035(5) and (7), F.S.
13
S. 893.035(3)(a), F.S.
14
S. 893.035(4)(d-f), F.S.
15
S. 893.035(7), F.S.
16
S. 120.54(4)(a)3., F.S.
17
These expiration provisions are notwithstanding the 90-day expiration described in s. 120.54(4)(c), F.S.
18
21 U.S.C. § 812.
19
21 U.S.C. § 811(c). STORAGE NAME: h1595.CRJ PAGE: 4
DATE: 1/17/2024
Tianeptine, sometimes referred to as “gas station heroin,” was developed in the 1960s for use as an
antidepressant.
20,21
Although it is approved in low doses for that purpose in some countries outside of
the United States, the United States Food and Drug Administration (FDA) has never approved
tianeptine for any medical use, and both its potency and dosage are unregulated.
22
When used in high
doses, tianeptine produces effects similar to those produced by an opioid and delivers short-lived
euphoria.
23
Tianeptine comes in both powder and pill forms but has also been found in counterfeit pills
mimicking other pharmaceutical products and individual stamp bags commonly used to distribute
heroin.
24
Reports have indicated that people may be taking tianeptine under the widespread, mistaken belief that
it is a safe alternative to street opioids like fentanyl or heroin, or even as a way to taper off using those
other drugs.
25
Tianeptine is also relatively cheap and accessible to consumers, with capsules costing
slightly more than $30 for a package of 15 and liquid solutions costing around $15 for a single 10mL
bottle.
26
Tianeptine is similar to opioids in terms of side effects, withdrawal symptoms, and overall addiction
potential.
27
At low dosages, common side effects include headaches, dizziness, constipation, dry
mouth, drowsiness, insomnia, and nightmares.
28
At higher doses, side effects, some of which may
cause death, may include increased blood pressure and other cardiovascular effects; liver and kidney
damage; addiction and dependence; and irregular heartbeat, difficulty breathing, seizures,
hallucinations, and loss of consciousness.
29
Withdrawal symptoms related to tianeptine initially last five
to seven days and are similar to those seen with opioids, including nausea or vomiting, flu-like illness,
muscle aches, and tremors; depression and anxiety; strong cravings for tianeptine; and seizures.
30
Florida’s poison control center had 15 exposure calls for tianeptine in the first half of 2023, 24 calls in
2022, and 54 calls over the last 4 years combined.
31
Five deaths in the United States have been
attributed to tianeptine intoxication.
32
Federal Tianeptine Regulation
The United States Food and Drug Administration (FDA) has never approved tianeptine to treat
depression or for any other medical use, and both its potency and dosage are unregulated.
33
Additionally, the FDA considers tianeptine to be an unsafe food additive that does not meet the
statutory definition of a dietary ingredient.
34
20
Cleveland Clinic, Know the Dangers of ‘Gas Station Heroin’ (May 25, 2023), https://health.clevelandclinic.org/gas-station-heroin-
tianeptine (last visited Jan. 17, 2024).
21
See also United States Drug Enforcement Agency (DEA), Tianeptine (May 2023),
https://www.deadiversion.usdoj.gov/drug_chem_info/tianeptine.pdf (last visited Jan. 17, 2024).
22
Supra note 20.
23
Jan Hoffman, ‘Gas-Station Heroin’ Sold as Dietary Supplement Alarms Health Officials (Jan. 10, 2024), The New York Times,
https://www.nytimes.com/2024/01/10/health/gas-station-heroin-tianeptine-addiction.html (last visited Jan. 17, 2024).
24
Florida Department of State, Emergency Rule 2ER23-1 (Sep. 20, 2023), https://www.myfloridalegal.com/sites/default/files/2023-
09/2er23-1.pdf (last visited Jan. 17, 2024).
25
Supra note 23.
26
Id.
27
Carmen Pope, BPharm, Tianeptine (Jan. 12, 2024), Drugs.com, https://www.drugs.com/illicit/tianeptine.html (last visited Jan. 17,
2024).
28
Id.
29
Id.
30
Id.
31
Supra note 24.
32
Id.
33
Supra note 20.
34
DEA, Tianeptine in Dietary Supplements (Feb. 22, 2023) https://www.fda.gov/food/dietary-supplement-ingredient-directory/tianeptine-
dietary-supplements (last visited Jan. 17, 2024). A “dietary ingredient” is a vitamin; mineral; herb or other botanical; amino acid; dietary
substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract,
or combination of any dietary ingredient from the preceding categories. Non-dietary ingredients intended for use in dietary supplements
must be used in accordance with a food additive regulation or be generally recognized as safe, unless they meet one of the other listed
exceptions to the food additive definition. STORAGE NAME: h1595.CRJ PAGE: 5
DATE: 1/17/2024
On November 21, 2023, after receiving severe adverse event reports from the public, the FDA issued a
warning to consumers not to purchase or use any products containing tianeptine—which it
characterized as a potentially dangerous substance that is not FDA-approved for any medical use but
is nonetheless sold with unauthorized and unsubstantiated claims that it improves brain function and
treats anxiety, depression, pain, opioid use disorder and other conditions.
35
The FDA’s warning noted
that products containing tianeptine “may contain other harmful ingredients not listed on the label,”
36
in
line with prior consumer warnings about the overall risks of using tianeptine.
37
Despite the FDA’s warnings, as of January 2024, tianeptine is still not a controlled substance under
federal law.
Florida Tianeptine Regulation
On September 20, 2023, Florida’s Attorney General issued Emergency Rule 2ER23-1, temporarily
scheduling tianeptine as a Schedule I controlled substance and concluding that tianeptine was “an
immediate danger to the public” by producing side effects including respiratory depression, loss of
consciousness, death, nausea, vomiting, agitation, decreased blood pressure, rapid heartbeat, slowed
or stopped breathing, drowsiness, mental confusion, and dependence.
38,39
Emergency Rule 2ER23-1 and the temporary scheduling of tianeptine will expire on June 30, 2024.
40
Effect of Proposed Changes
HB 1595 amends s. 893.03, F.S., to add tianeptine to the list of Schedule I controlled substances.
As such, under the bill, the manufacture, distribution, preparation, and dispensing of tianeptine will be
regulated by Florida law.
The bill provides an effective date of July 1, 2024.
B. SECTION DIRECTORY:
Section 1: Amends s. 893.03, F.S., relating to standards and schedules.
Section 2: Amends s. 893.13, F.S., relating to prohibited acts; penalties.
Section 3: Amends s. 893.131, F.S., relating to distribution of controlled substances resulting in
overdose or serious bodily injury.
Section 4: Amends s. 893.135, F.S., relating to trafficking; mandatory sentences; suspension or
reduction of sentences; conspiracy to engage in trafficking.
Section 5: Provides an effective date of July 1, 2024.
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
35
FDA, FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks (Nov. 21, 2023),
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-neptunes-fix-or-any-tianeptine-
product-due-serious-risks (last visited Jan. 17, 2024).
36
Id.
37
FDA, Tianeptine Products Linked to Serious Harm, Overdoses, Death (Feb. 10, 2022), https://www.fda.gov/consumers/consumer-
updates/tianeptine-products-linked-serious-harm-overdoses-death (last visited Jan. 17, 2024).
38
Office of the Attorney General, Video: Attorney General Moody Outlaws Gas Station Heroin in Florida (Sep. 21, 2023)
https://www.myfloridalegal.com/newsrelease/video-attorney-general-moody-outlaws-gas-station-heroin-florida (last visited Jan. 17,
2024).
39
Tianeptine is a controlled substance in Alabama, Georgia, Indiana, Kentucky, Michigan, Minnesota, Mississippi, Ohio, and
Tennessee.
40
Supra note 24. STORAGE NAME: h1595.CRJ PAGE: 6
DATE: 1/17/2024
None.
2. Expenditures:
See Fiscal Comments.
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
See Fiscal Comments.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
Prior to the issuance of Emergency Rule 2ER23-1, tianeptine was sold by some private businesses,
including gas stations and other convenience stores. The Emergency Rule currently classifies
tianeptine as a Schedule I controlled substance, prohibiting its sale or distribution by such private
businesses. The bill codifies the scheduling of tianeptine, consistent with the Emergency Rule and as
such, to the extent that a private business was selling the substance prior to the issuance of the
Emergency Rule, such businesses may continue to experience reduced profits as they will continue to
be prohibited from selling tianeptine or tianeptine products under the bill.
D. FISCAL COMMENTS:
The bill may have a positive indeterminate impact on jail and prison beds by making the possession,
distribution, sale, or manufacture of more substances illegal which may result in more jail and prison
admissions.
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
1. Applicability of Municipality/County Mandates Provision:
Not Applicable. This bill does not appear to require counties or municipalities to spend funds or take
action requiring the expenditures of funds; reduce the authority that counties or municipalities have
to raise revenues in the aggregate; or reduce the percentage of state tax shared with counties or
municipalities.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
None.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES