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.
14
15 Be It Enacted by the Legislature of the State of Florida:
16
17 Section 1. Section 585.012, Florida Statutes, is created to
18 read:
19 585.012 Dosage 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.