Fla. Admin. Code Ann. R. 5K-4.030 - Kratom Products
(1) Definitions.
The definitions provided in Section
500.03, F.S., and the following
shall apply to this rule:
(a) "Approved
Source" means an establishment manufacturing Kratom Products for human
consumption that meets local, state, or federal regulatory food safety or
health standards from the jurisdiction of origin.
(b) "Human Consumption" means human ingestion
and/or human inhalation. Products intended for Human Consumption include,
snuff, chewing gum, and other smokeless products. This term does not include
topical applications.
(c)
"Ingestion" means the process of consuming Kratom Products through the mouth,
whether by swallowing into the gastrointestinal system or through tissue
absorption.
(d) "Inhalation" means
the process of consuming Kratom Products through the mouth or nasal passages
into the respiratory system.
(e)
"Kratom Product" means 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.
(f) "Self-Service Merchandising" means an
open display of Kratom Products to which the public has access without the
intervention of the vendor or a store employee.
(g) "Vending machines" for the purposes of
this rule are defined as any self-service device, which upon completion of
payment, dispense Kratom Products without the necessity of replenishing the
device between each operation.
(2) Permits.
(a) Each establishment distributing products
consisting of or containing Kratom Products must be permitted as a Food
Establishment pursuant to Section
500.12, F.S., and Rule
5K-4.020, F.A.C.
(b) The annual permit fee for a Food
Establishment distributing Kratom Products is $650.00.
(3) Packaging and Labeling.
(a) Kratom Products must be packaged and
labeled as required by Chapter 500, F.S.
(b) The label and advertisement shall not
contain claims indicating the product is intended for diagnosis, cure,
mitigation, treatment, or prevention of disease, rendering it a drug as defined
in 21 U.S.C. ยง
321(g)(1), revised as of
January 3, 2022, incorporated by reference and available online at
http://www.flrules.org/Gateway/reference.asp?No=Ref-16176,
or by requesting a copy by emailing FoodSafety@FDACS.gov. Pursuant to Section
500.03(1)(m) 4., F.S., such articles shall be considered misbranded.
(4) Age Limit for
Kratom.
(a) Any retailer that sells Kratom
shall post a clear and conspicuous sign directly adjacent to the display of the
product which states the following: THE SALE OF KRATOM TO PERSONS UNDER THE AGE
OF 21 IS PROHIBITED. PROOF OF AGE IS REQUIRED FOR PURCHASE.
(b) Kratom may not be mailed, shipped, or
otherwise delivered to a purchaser unless, before the delivery to the
purchaser, the Food Establishment obtains confirmation that the purchaser is 21
years of age or older.
(c) Food
Establishments shall require proof of age from a purchaser of any Kratom
product before selling the product to that person. Food Establishments shall
exercise diligence in the management and supervision of their premises and in
the supervision and training of their employees to prevent the underage sale of
these products.
(d) Kratom shall
not be offered for sale by means of self-service merchandising unless proof of
age has been verified before allowing access to the self-service
merchandising.
(e) The giving or
sampling of Kratom products by a Food Establishment to any person under the age
of 21 is prohibited.
(f) Kratom
products shall not be offered for sale by means of vending
machines.
(5) Penalties.
(a) Violations of this rule will be evaluated
and penalties imposed in accordance with Rule
5K-4.035, F.A.C.
(b) Kratom Products distributed or sold in
violation of this rule shall be considered adulterated or misbranded pursuant
to Chapter 500, F.S.
(c) Kratom
Products must meet the requirements of this rule. Such products not meeting the
requirements of this rule may not be sold in this state.
(d) Violations of this rule shall result in
the imposition of stop-sale/stop-use orders, an administrative fine of up to
$5, 000 per violation, permit suspension, permit revocation, or any combination
thereof.
(e) The sale of Kratom
Products to persons under the age of 21 is punishable as provided in chapter
500, F.S.
(f) Kratom Products
distributed or sold in violation of this subsection is subject to Section
500.172, F.S. and penalties as
provided in Section 500.121,
F.S.
Notes
Rulemaking Authority 500.09, 500.12, 500.92, 570.07(23), FS. Law Implemented 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.92, 500.172, FS.
New 1-10-24.
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