Florida Senate - 2023                                    SB 1056
       By Senator Gruters
       22-00860-23                                           20231056__
    1                        A bill to be entitled                      
    2         An act relating to dosage form animal health products;
    3         creating s. 585.012, F.S.; defining terms; requiring a
    4         manufacturer or distributor of dosage form animal
    5         health products to register with the Department of
    6         Agriculture and Consumer Services; authorizing the
    7         department to waive the registration requirement under
    8         certain conditions and to require specified
    9         information for registration applications; providing
   10         requirements for product labels; providing conditions
   11         under which dosage form animal health products are
   12         considered misbranded or adulterated; providing
   13         construction; providing an effective date.
   15  Be It Enacted by the Legislature of the State of Florida:
   17         Section 1. Section 585.012, Florida Statutes, is created to
   18  read:
   19         585.012Dosage form animal health products.—
   20         (1)As used in this section, the term:
   21         (a)“Brand name” means any distinguishing word, name,
   22  symbol, or device, or combination thereof, identifying the
   23  dosage form animal health product of a manufacturer or
   24  distributor.
   25         (b)“Distribute” means to offer for sale, sell, barter, or
   26  exchange a dosage form animal health product or to supply,
   27  furnish, or otherwise provide such a product for use by any
   28  consumer or customer in the state.
   29         (c)“Distributor” means a person or entity that distributes
   30  dosage form animal health products.
   31         (d)“Dosage form animal health product” means any product,
   32  including oils, tinctures, capsules, tablets, liquids, soft
   33  chews, and chewable limited dose products, intended to affect
   34  the structure or function of an animal’s body other than by
   35  providing nutrition to the animal. The term does not include
   36  animal feed supplements, products represented as a primary meal
   37  for the intended animal species, products intended as a snack
   38  treat or behavioral reward treat, or dental products providing
   39  mechanical or abrasive action.
   40         (e)“Label” means a display of written, printed, or graphic
   41  matter upon or affixed to the container in which a dosage form
   42  animal health product is distributed, or on the invoice or
   43  delivery slip with which the product is distributed.
   44         (f)“Labeling” means all labels and other written, printed,
   45  or graphic matter upon a dosage form animal health product or
   46  any of its containers; all wrappers accompanying the product;
   47  and all advertisements, brochures, posters, or television or
   48  radio announcements used in promoting the sale of the product.
   49         (g)“Manufacture” means the grinding, mixing, blending, or
   50  further processing of a dosage form animal health product for
   51  distribution.
   52         (h)“Manufacturer” means a person or entity that
   53  manufactures dosage form animal health products.
   54         (i)“Product name” means the name of a dosage form animal
   55  health product which identifies the kind, class, or specific use
   56  of the product.
   57         (2)(a)A manufacturer or distributor that manufactures or
   58  distributes the finished form of a dosage form animal health
   59  product in the state must submit a registration application to
   60  the department every 2 years as prescribed by department rule.
   61  The department may waive the registration requirement if a
   62  manufacturer or distributor is registered under another federal
   63  or state law in compliance with department rule.
   64         (b)The department may require a registration application
   65  to include a copy of the label and labeling for each dosage form
   66  animal health product.
   67         (3)A dosage form animal health product label must contain,
   68  at a minimum, all of the following information:
   69         (a)The net weight or count of the product.
   70         (b)The product name and brand name, if any, under which
   71  the product is manufactured or distributed.
   72         (c)The established name of each active ingredient in the
   73  product and the amount of each active ingredient per serving in
   74  descending order by predominance of the ingredient in the
   75  product.
   76         (d)The established name of each inactive ingredient in the
   77  product and the amount of each inactive ingredient per serving
   78  in alphabetical order.
   79         (e)Adequate directions and precautionary statements and
   80  warnings necessary to ensure safe and effective use of the
   81  product.
   82         (f)The name and principal mailing address of the
   83  manufacturer or distributor. Only the name, city, state, and zip
   84  code are required for a manufacturer or distributor listed in a
   85  local telephone directory.
   86         (g)A structure-function claim stating the intended non
   87  nutritional benefit of the product.
   88         (h)The expiration date.
   89         (4)A dosage form animal health product is considered
   90  misbranded if the product label or labeling:
   91         (a)Does not provide the information required in subsection
   92  (3) in a prominent and conspicuous manner which can be easily
   93  identified and understood under customary conditions of purchase
   94  and use.
   95         (b)Includes the term “guaranteed analysis.”
   96         (c)Is false or misleading.
   97         (5)A dosage form animal health product is considered
   98  adulterated if:
   99         (a)The product contains any poisonous or deleterious
  100  substance that may be injurious to animal health.
  101         (b)Any valuable ingredient of the product has been in
  102  whole or in part omitted or removed.
  103         (c)Any valuable ingredient of the product has been in
  104  whole or in part substituted by any less valuable ingredient.
  105         (d)The composition or quality of the product falls below
  106  or differs from what the label or labeling purports or
  107  represents.
  108         (e)The methods or controls used to manufacture or package
  109  the product do not conform to current good manufacturing
  110  practice.
  111         (6)Dosage form animal health products may not be
  112  considered commercial feed, a drug, or feedstuff as those terms
  113  are defined in s. 580.031.
  114         Section 2. This act shall take effect July 1, 2023.