Florida Senate - 2023                          SENATOR AMENDMENT
       Bill No. CS/HB 179, 1st Eng.
       
       
       
       
       
       
                                Ì7336544Î733654                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 2/RE/2R         .                                
             04/27/2023 06:10 PM       .                                
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       Senator Gruters moved the following:
       
    1         Senate Substitute for Amendment (330544) (with title
    2  amendment)
    3  
    4         Delete everything after the enacting clause
    5  and insert:
    6         Section 1. Section 501.9745, Florida Statutes, is created
    7  to read:
    8         501.9745 Kratom products; prohibition; penalties.
    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 product” means a food product, food ingredient,
   13  dietary ingredient, dietary supplement, or beverage intended for
   14  human consumption which contains any part of the leaf of the
   15  plant Mitragyna speciosa or an extract of such plant and is
   16  manufactured as a powder, capsule, pill, or beverage or any
   17  other edible form.
   18         (b)“Processor” means a person who sells, prepares,
   19  manufactures, distributes, or maintains kratom products.
   20         (3)PROHIBITIONS.—A processor may not sell, distribute, or
   21  expose for sale any kratom product to an individual under 21
   22  years of age.
   23         (4)VIOLATIONS.—A person who violates this section commits
   24  a misdemeanor of the second degree, punishable as provided in s.
   25  775.082 or s. 775.083.
   26         (5)RULES.—The department shall adopt rules to administer
   27  this section.
   28         Section 2. Effective July 1, 2024, section 501.9745,
   29  Florida Statutes, as created by this act, is amended to read:
   30         (Substantial rewording of section. See
   31         s. 501.9745, F.S., as created by this act,
   32         for present text.)
   33         501.9745 Kratom products; prohibitions; registration;
   34  penalties.
   35         (1)SHORT TITLE.—This section may be cited as the “Florida
   36  Kratom Consumer Protection Act.”
   37         (2)DEFINITIONS.—As used in this section, the term:
   38         (a)“Kratom extract” means a food product or dietary
   39  ingredient that contains any part of the leaf of the plant
   40  Mitragyna speciosa which has been extracted and concentrated to
   41  provide more standardized dosing.
   42         (b)“Kratom product” means a food product, food ingredient,
   43  dietary ingredient, dietary supplement, or beverage intended for
   44  human consumption which contains any part of the leaf of the
   45  plant Mitragyna speciosa or an extract of such plant and is
   46  manufactured as a powder, capsule, pill, or beverage or any
   47  other edible form.
   48         (c)“Processor” means a person who sells, prepares,
   49  manufactures, distributes, or maintains kratom products.
   50         (3)PROHIBITIONS.—
   51         (a)A processor may not sell, prepare, distribute, or
   52  expose for sale:
   53         1.A kratom product that:
   54         a.Is adulterated with a dangerous non-kratom substance
   55  that affects the quality or strength of the kratom product to
   56  such a degree that it may injure a consumer.
   57         b.Contains a poisonous or otherwise harmful non-kratom
   58  ingredient, including, but not limited to, any substance listed
   59  in s. 893.03.
   60         c.Contains a level of 7-hydroxymitragynine in the alkaloid
   61  fraction which is greater than 1 percent of the alkaloid
   62  composition of the product.
   63         d.Contains a synthetic alkaloid, including, but not
   64  limited to, synthetic mitragynine, synthetic 7
   65  hydroxymitragynine, or any other synthetically derived compound
   66  of the plant Mitragyna speciosa.
   67         e.Does not include directions for the safe and effective
   68  use of the product, including, but not limited to, a suggested
   69  serving size, on the product’s packaging or label.
   70         f.Has a label that contains any claim that the product is
   71  intended to diagnose, treat, cure, or prevent any medical
   72  condition or disease.
   73         2.Kratom extract that contains levels of residual solvents
   74  higher than the standards set forth in USP-NF chapter 467.
   75         (b)A processor may not sell, distribute, or expose for
   76  sale any kratom product to an individual under 21 years of age.
   77         (4)REGISTRATION.—A person who manufactures kratom products
   78  shall annually register with the department any kratom product
   79  intended for sale to an end consumer in this state which is in
   80  an approved kratom delivery form. The registration must include
   81  a certificate of analysis from an independent, certified third
   82  party laboratory which shows that the kratom product is in
   83  compliance with the requirements of this section for safe kratom
   84  products.
   85         (5)REPORTING REQUIREMENTS.—
   86         (a)If the department receives a report that any kratom
   87  product offered for sale in this state is not in compliance with
   88  the requirements of this section for safe kratom products, the
   89  department must require the manufacturer to produce an updated
   90  certificate of analysis in a reasonable timeframe from an
   91  independent, certified third-party laboratory which shows that
   92  the kratom product is in compliance with the requirements of
   93  this section for safe kratom products.
   94         (b)If a manufacturer receives notice of an adverse event
   95  related to the manufacturer’s kratom product, the manufacturer
   96  must submit by certified mail to the department a copy of the
   97  adverse event report required to be submitted to the United
   98  States Food and Drug Administration under the Federal Food,
   99  Drug, and Cosmetic Act, 21 U.S.C. s. 379aa-1(b)(1).
  100         (c)If a manufacturer fails to provide the department with
  101  an updated certificate of analysis within the specified
  102  timeframe or fails to report an adverse event to the department
  103  as required by this subsection, the department may revoke the
  104  manufacturer’s kratom product registration.
  105         (6)VIOLATIONS.—
  106         (a)A person who violates this section commits a
  107  misdemeanor of the second degree, punishable as provided in s.
  108  775.082 or s. 775.083.
  109         (b)A processor that sells kratom products at retail does
  110  not violate this section if it is shown by a preponderance of
  111  the evidence that the processor relied in good faith upon the
  112  representations of a manufacturer, processor, packer, or
  113  distributor of food represented to be a kratom product.
  114         (7)RULES.—The department shall adopt rules to administer
  115  this section.
  116         Section 3. Except as otherwise expressly provided in this
  117  act, this act shall take upon becoming a law.
  118  
  119  ================= T I T L E  A M E N D M E N T ================
  120  And the title is amended as follows:
  121         Delete everything before the enacting clause
  122  and insert:
  123                        A bill to be entitled                      
  124         An act relating to the Florida Kratom Consumer
  125         Protection Act; creating s. 501.9745, F.S.; providing
  126         a short title; defining the terms “kratom product” and
  127         “processor”; prohibiting processors from distributing,
  128         selling, or exposing for sale any kratom product to an
  129         individual under 21 years of age; providing criminal
  130         penalties; requiring the Department of Agriculture and
  131         Consumer Services to adopt rules; defining the term
  132         “kratom extract”; prohibiting processors, beginning on
  133         a specified date, from selling, preparing,
  134         distributing, or exposing for sale certain kratom
  135         products; requiring manufacturers to annually register
  136         kratom products with the department; providing
  137         requirements for such registration; requiring
  138         manufacturers to report certain violations and adverse
  139         events to the department; providing for the revocation
  140         of a manufacturer’s kratom product registration under
  141         certain circumstances; providing criminal penalties;
  142         providing an exception; requiring the department to
  143         adopt rules; providing effective dates.