Senate Bill 1056 (2023) — Dosage form animal health products
SB 1056
Florida Bills
Florida Senate - 2023 SB 1056 By Senator Gruters 22-00860-23 20231056__ Page 1 of 4 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1
An act relating to dosage form animal health products; 2 creating s. 585.012, F.S.; defining terms; requiring a 3 manufacturer or distributor of dosage form animal 4 health products to register with the Department of 5 Agriculture and Consumer Services; authorizing the 6 department to waive the registration requirement under 7 certain conditions and to require specified 8 information for registration applications; providing 9 requirements for product labels; providing conditions 10 under which dosage form animal health products are 11 considered misbranded or adulterated; providing 12 construction; providing an effective date. 13 14 Be It Enacted by the Legislature of the State of Florida: 15 16
Section
Section 585.012, Florida Statutes, is created to 17 read: 18 585.012 Dosage form animal health products.— 19
(1) As used in this section, the term: 20 (a) “Brand name” means any distinguishing word, name, 21 symbol, or device, or combination thereof, identifying the 22 dosage form animal health product of a manufacturer or 23 distributor. 24 (b) “Distribute” means to offer for sale, sell, barter, or 25 exchange a dosage form animal health product or to supply, 26 furnish, or otherwise provide such a product for use by any 27 consumer or customer in the state. 28 (c) “Distributor” means a person or entity that distributes 29 Florida Senate - 2023 SB 1056 22-00860-23 20231056__ Page 2 of 4 CODING: Words stricken are deletions; words underlined are additions. dosage form animal health products. 30 (d) “Dosage form animal health product” means any product, 31 including oils, tinctures, capsules, tablets, liquids, soft 32 chews, and chewable limited dose products, intended to affect 33 the structure or function of an animal’s body other than by 34 providing nutrition to the animal.
The term does not include 35 animal feed supplements, products represented as a primary meal 36 for the intended animal species, products intended as a snack 37 treat or behavioral reward treat, or dental products providing 38 mechanical or abrasive action. 39 (e) “Label” means a display of written, printed, or graphic 40 matter upon or affixed to the container in which a dosage form 41 animal health product is distributed, or on the invoice or 42 delivery slip with which the product is distributed. 43 (f) “Labeling” means all labels and other written, printed, 44 or graphic matter upon a dosage form animal health product or 45 any of its containers; all wrappers accompanying the product; 46 and all advertisements, brochures, posters, or television or 47 radio announcements used in promoting the sale of the product. 48 (g) “Manufacture” means the grinding, mixing, blending, or 49 further processing of a dosage form animal health product for 50 distribution. 51 (h) “Manufacturer” means a person or entity that 52 manufactures dosage form animal health products. 53 (i) “Product name” means the name of a dosage form animal 54 health product which identifies the kind, class, or specific use 55 of the product. 56 (2)(
a) A manufacturer or distributor that manufactures or 57 distributes the finished form of a dosage form animal health 58 Florida Senate - 2023 SB 1056 22-00860-23 20231056__ Page 3 of 4 CODING: Words stricken are deletions; words underlined are additions. product in the state must submit a registration application to 59 the department every 2 years as prescribed by department rule. 60 The department may waive the registration requirement if a 61 manufacturer or distributor is registered under another federal 62 or state law in compliance with department rule. 63 (
b) The department may require a registration application 64 to include a copy of the label and labeling for each dosage form 65 animal health product. 66
(3) A dosage form animal health product label must contain, 67 at a minimum, all of the following information: 68 (
a) The net weight or count of the product. 69 (
b) The product name and brand name, if any, under which 70 the product is manufactured or distributed. 71 (
c) The established name of each active ingredient in the 72 product and the amount of each active ingredient per serving in 73 descending order by predominance of the ingredient in the 74 product. 75 (
d) The established name of each inactive ingredient in the 76 product and the amount of each inactive ingredient per serving 77 in alphabetical order. 78 (
e) Adequate directions and precautionary statements and 79 warnings necessary to ensure safe and effective use of the 80 product. 81 (
f) The name and principal mailing address of the 82 manufacturer or distributor. Only the name, city, state, and zip 83 code are required for a manufacturer or distributor listed in a 84 local telephone directory. 85 (
g) A structure-function claim stating the intended non-86 nutritional benefit of the product. 87 Florida Senate - 2023 SB 1056 22-00860-23 20231056__ Page 4 of 4 CODING: Words stricken are deletions; words underlined are additions. (
h) The expiration date. 88
(4) A dosage form animal health product is considered 89 misbranded if the product label or labeling: 90 (
a) Does not provide the information required in subsection 91 (3) in a prominent and conspicuous manner which can be easily 92 identified and understood under customary conditions of purchase 93 and use. 94 (
b) Includes the term “guaranteed analysis.” 95 (
c) Is false or misleading. 96
(5) A dosage form animal health product is considered 97 adulterated if: 98 (
a) The product contains any poisonous or deleterious 99 substance that may be injurious to animal health. 100 (
b) Any valuable ingredient of the product has been in 101 whole or in part omitted or removed. 102 (
c) Any valuable ingredient of the product has been in 103 whole or in part substituted by any less valuable ingredient. 104 (
d) The composition or quality of the product falls below 105 or differs from what the label or labeling purports or 106 represents. 107 (
e) The methods or controls used to manufacture or package 108 the product do not conform to current good manufacturing 109 practice. 110
(6) Dosage form animal health products may not be 111 considered commercial feed, a drug, or feedstuff as those terms 112 are defined in s. 580.031. 113