Florida Senate - 2023                          SENATOR AMENDMENT
       Bill No. CS/HB 179, 1st Eng.
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       Senator Gruters moved the following:
    1         Senate Amendment (with title amendment)
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 501.9745, Florida Statutes, is created
    6  to read:
    7         501.9745 Kratom products; processor prohibitions;
    8  registration; fines.
    9         (1)SHORT TITLE.—This section may be cited as the “Florida
   10  Kratom Consumer Protection Act.”
   11         (2)DEFINITIONS.—As used in this section, the term:
   12         (a)“Kratom extract” means a food product or dietary
   13  ingredient that contains any part of the leaf of the plant
   14  Mitragyna speciosa which has been extracted and concentrated to
   15  provide more standardized dosing.
   16         (b)“Kratom product” means a food product, food ingredient,
   17  dietary ingredient, dietary supplement, or beverage intended for
   18  human consumption which contains any part of the leaf of the
   19  plant Mitragyna speciosa or an extract of such plant and is
   20  manufactured as a powder, capsule, pill, or beverage or any
   21  other edible form.
   22         (c)“Processor” means a person who sells, prepares,
   23  manufactures, distributes, or maintains kratom products.
   24         (3)PROHIBITIONS.—
   25         (a)A processor may not sell, prepare, distribute, or
   26  expose for sale:
   27         1.A kratom product that:
   28         a.Is adulterated with a dangerous non-kratom substance
   29  that affects the quality or strength of the kratom product to
   30  such a degree that it may injure a consumer.
   31         b.Contains a poisonous or otherwise harmful non-kratom
   32  ingredient, including, but not limited to, any substance listed
   33  in s. 893.03.
   34         c.Contains a level of 7-hydroxymitragynine in the alkaloid
   35  fraction which is greater than 1 percent of the alkaloid
   36  composition of the product.
   37         d.Contains a synthetic alkaloid, including, but not
   38  limited to, synthetic mitragynine, synthetic 7
   39  hydroxymitragynine, or any other synthetically derived compound
   40  of the plant Mitragyna speciosa.
   41         e.Does not include directions for the safe and effective
   42  use of the product, including, but not limited to, a suggested
   43  serving size, on the product’s packaging or label.
   44         f.Has a label that contains any claim that the product is
   45  intended to diagnose, treat, cure, or prevent any medical
   46  condition or disease.
   47         2.Kratom extract that contains levels of residual solvents
   48  higher than the standards set forth in USP-NF chapter 467.
   49         (b)A processor may not sell, distribute, or expose for
   50  sale a kratom product to an individual under 21 years of age.
   51         (4)REGISTRATION.—A processor shall annually register with
   52  the department any kratom product it intendeds to offer for sale
   53  to an end consumer in this state which is in an approved kratom
   54  delivery form. The registration must include a certificate of
   55  analysis from an independent certified third-party laboratory
   56  which shows that the kratom product is in compliance with the
   57  requirements of this section for safe kratom products. The
   58  Department of Agriculture and Consumer Services is not required
   59  to test or inspect kratom products pursuant to chapter 500;
   60  however, nothing prohibits the department from performing tests
   61  and conducting inspections based on consumer complaints, based
   62  on agency referrals, or as the department deems necessary.
   64         (a)If the department receives a report that any kratom
   65  product offered for sale in this state is not in compliance with
   66  the requirements of this section for safe kratom products, the
   67  department must require the processor to produce an updated
   68  certificate of analysis in a reasonable timeframe from an
   69  independent certified third-party laboratory which shows that
   70  the kratom product is in compliance with the requirements of
   71  this section for safe kratom products.
   72         (b)If a processor receives notice of an adverse event
   73  related to its kratom product, the processor must submit via
   74  certified mail to the department a copy of the adverse event
   75  report required to be submitted to the United States Food and
   76  Drug Administration under the Federal Food, Drug, and Cosmetic
   77  Act, 21 U.S.C. s. 379aa-1(b)(1).
   78         (c)If a processor fails to provide the department with an
   79  updated certificate of analysis within the specified timeframe
   80  or fails to report an adverse event to the department as
   81  required by this subsection, the department may revoke the
   82  processor’s kratom product registration.
   83         (6)VIOLATIONS.—
   84         (a)A person who violates this section commits a
   85  misdemeanor of the second degree, punishable as provided in s.
   86  775.082 or s. 775.083.
   87         (b)A processor that sells kratom products at retail does
   88  not violate this section if it is shown by a preponderance of
   89  the evidence that the processor relied in good faith upon the
   90  representations of a manufacturer, processor, packer, or
   91  distributor of food represented to be a kratom product.
   92         (7)RULES.—The department shall adopt rules to administer
   93  this section.
   94         Section 2. This act shall take effect July 1, 2024.
   96  ================= T I T L E  A M E N D M E N T ================
   97  And the title is amended as follows:
   98         Delete everything before the enacting clause
   99  and insert:
  100                        A bill to be entitled                      
  101         An act relating to the Florida Kratom Consumer
  102         Protection Act; creating s. 501.9745, F.S.; providing
  103         a short title; defining terms; prohibiting processors
  104         from selling, preparing, distributing, or exposing for
  105         sale certain kratom products; prohibiting processors
  106         from distributing, selling, or exposing for sale a
  107         kratom product to an individual under 21 years of age;
  108         requiring processors to annually register kratom
  109         products with the Department of Agriculture and
  110         Consumer Services; providing requirements for such
  111         registration; providing construction; requiring
  112         processors to report certain violations and adverse
  113         events to the department; providing for the revocation
  114         of a processor’s kratom product registration under
  115         certain circumstances; providing criminal penalties;
  116         providing an exception; requiring the department to
  117         adopt rules; providing an effective date.