Florida Senate - 2023                       CS for CS for SB 136
       By the Appropriations Committee on Agriculture, Environment, and
       General Government; the Committee on Commerce and Tourism; and
       Senators Gruters, Stewart, and Perry
       601-03765-23                                           2023136c2
    1                        A bill to be entitled                      
    2         An act relating to the Florida Kratom Consumer
    3         Protection Act; creating s. 501.9745, F.S.; providing
    4         a short title; defining terms; prohibiting processors
    5         from selling, preparing, distributing, or exposing for
    6         sale certain kratom products; prohibiting processors
    7         from distributing, selling, or exposing for sale a
    8         kratom product to an individual under 21 years of age;
    9         requiring processors to annually register kratom
   10         products with the Department of Agriculture and
   11         Consumer Services; providing requirements for such
   12         registration; requiring processors to report certain
   13         violations and adverse events to the department;
   14         providing for the revocation of a processor’s kratom
   15         product registration under certain circumstances;
   16         providing criminal penalties; providing an exception;
   17         requiring the department to adopt rules; providing an
   18         effective date.
   20  Be It Enacted by the Legislature of the State of Florida:
   22         Section 1. Section 501.9745, Florida Statutes, is created
   23  to read:
   24         501.9745 Kratom products; processor prohibitions;
   25  registration; fines.
   26         (1)SHORT TITLE.—This section may be cited as the “Florida
   27  Kratom Consumer Protection Act.”
   28         (2)DEFINITIONS.—As used in this section, the term:
   29         (a)“Kratom extract” means a food product or dietary
   30  ingredient that contains any part of the leaf of the plant
   31  Mitragyna speciosa which has been extracted and concentrated to
   32  provide more standardized dosing.
   33         (b)“Kratom product” means a food product, food ingredient,
   34  dietary ingredient, dietary supplement, or beverage intended for
   35  human consumption which contains any part of the leaf of the
   36  plant Mitragyna speciosa or an extract of such plant and is
   37  manufactured as a powder, capsule, pill, or beverage or any
   38  other edible form.
   39         (c)“Processor” means a person who sells, prepares,
   40  manufactures, distributes, or maintains kratom products.
   41         (3)PROHIBITIONS.—
   42         (a)A processor may not sell, prepare, distribute, or
   43  expose for sale:
   44         1.A kratom product that:
   45         a.Is adulterated with a dangerous non-kratom substance
   46  that affects the quality or strength of the kratom product to
   47  such a degree that it may injure a consumer.
   48         b.Contains a poisonous or otherwise harmful non-kratom
   49  ingredient, including, but not limited to, any substance listed
   50  in s. 893.03.
   51         c.Contains a level of 7-hydroxymitragynine in the alkaloid
   52  fraction which is greater than 1 percent of the alkaloid
   53  composition of the product.
   54         d.Contains a synthetic alkaloid, including, but not
   55  limited to, synthetic mitragynine, synthetic 7
   56  hydroxymitragynine, or any other synthetically derived compound
   57  of the plant Mitragyna speciosa.
   58         e.Does not include directions for the safe and effective
   59  use of the product, including, but not limited to, a suggested
   60  serving size, on the product’s packaging or label.
   61         f.Has a label that contains any claim that the product is
   62  intended to diagnose, treat, cure, or prevent any medical
   63  condition or disease.
   64         2.Kratom extract that contains levels of residual solvents
   65  higher than the standards set forth in USP-NF chapter 467.
   66         (b)A processor may not sell, distribute, or expose for
   67  sale a kratom product to an individual under 21 years of age.
   68         (4)REGISTRATION.—A processor shall annually register with
   69  the department any kratom product it intendeds to offer for sale
   70  to an end consumer in this state which is in an approved kratom
   71  delivery form. The registration must include a certificate of
   72  analysis from an independent certified third-party laboratory
   73  which shows that the kratom product is in compliance with the
   74  requirements of this section for safe kratom products.
   76         (a)If the department receives a report that any kratom
   77  product offered for sale in this state is not in compliance with
   78  the requirements of this section for safe kratom products, the
   79  department must require the processor to produce an updated
   80  certificate of analysis in a reasonable timeframe from an
   81  independent certified third-party laboratory which shows that
   82  the kratom product is in compliance with the requirements of
   83  this section for safe kratom products.
   84         (b)If a processor receives notice of an adverse event
   85  related to its kratom product, the processor must submit via
   86  certified mail to the department a copy of the adverse event
   87  report required to be submitted to the United States Food and
   88  Drug Administration under the Federal Food, Drug, and Cosmetic
   89  Act, 21 U.S.C. s. 379aa-1(b)(1).
   90         (c)If a processor fails to provide the department with an
   91  updated certificate of analysis within the specified timeframe
   92  or fails to report an adverse event to the department as
   93  required by this subsection, the department may revoke the
   94  processor’s kratom product registration.
   95         (6)VIOLATIONS.—
   96         (a)A person who violates this section commits a
   97  misdemeanor of the second degree, punishable as provided in s.
   98  775.082 or s. 775.083.
   99         (b)A processor that sells kratom products at retail does
  100  not violate this section if it is shown by a preponderance of
  101  the evidence that the processor relied in good faith upon the
  102  representations of a manufacturer, processor, packer, or
  103  distributor of food represented to be a kratom product.
  104         (7)RULES.—The department shall adopt rules to administer
  105  this section.
  106         Section 2. This act shall take effect July 1, 2023.