15 | 15 | | An act relating to dosage form animal health products; 2 |
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16 | 16 | | amending s. 580.031, F.S.; providing a definition; 3 |
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17 | 17 | | amending s. 580.051, F.S.; providing an exception from 4 |
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18 | 18 | | guaranteed analysis requirements for products sold 5 |
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19 | 19 | | solely as dosage form animal products; providing 6 |
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20 | 20 | | labeling requirements for dosage form animal products; 7 |
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21 | 21 | | providing an effective date. 8 |
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22 | 22 | | 9 |
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23 | 23 | | Be It Enacted by the Legislature of the State of Florida: 10 |
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24 | 24 | | 11 |
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25 | 25 | | Section 1. Subsections (9) through (24) of section 12 |
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26 | 26 | | 580.031, Florida Statutes, are renumbered as subsections (10) 13 |
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27 | 27 | | through (25), respectively, and a new subsection (9) is added to 14 |
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28 | 28 | | that section to read: 15 |
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29 | 29 | | 580.031 Definitions of words and terms. —As used in this 16 |
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30 | 30 | | chapter, the term: 17 |
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31 | 31 | | (9) "Dosage form animal product" means a feedstuff that 18 |
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32 | 32 | | includes any product intended to affect the structure or 19 |
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33 | 33 | | function of the animal's body other than by providing nutrition 20 |
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34 | 34 | | to the animal. 21 |
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35 | 35 | | (a) The term includes oils, tinctures, caps ules, tablets, 22 |
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36 | 36 | | liquids, and chewables. 23 |
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37 | 37 | | (b) The term does not include: 24 |
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38 | 38 | | 1. Minerals or vitamins; 25 |
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46 | 46 | | Page 2 of 6 |
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47 | 47 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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50 | 50 | | |
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51 | 51 | | 2. Products represented as a primary meal for the intended 26 |
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52 | 52 | | animal species; 27 |
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53 | 53 | | 3. Products intended as a treat; 28 |
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54 | 54 | | 4. Dental products providing mechanical or abrasive action 29 |
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55 | 55 | | or both; or 30 |
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56 | 56 | | 5. Drugs, biologics, parasiticides, medical devices, or 31 |
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57 | 57 | | diagnostics used to treat, or administered to, animals pursuant 32 |
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58 | 58 | | to: 33 |
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59 | 59 | | a. The United States Food and Drug Administration Federal 34 |
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60 | 60 | | Food, Drug, and Cosmetic Act, 21 U.S.C. ss . 301 et seq., as 35 |
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61 | 61 | | amended; 36 |
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62 | 62 | | b. The United States Department of Agriculture federal 37 |
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63 | 63 | | Virus-Serum-Toxin Act, 21 U.S.C. ss. 151 et seq., as amended; or 38 |
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64 | 64 | | c. The United States Environmental Protection Agency 39 |
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65 | 65 | | Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 40 |
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66 | 66 | | ss. 136 et seq., as amended. 41 |
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67 | 67 | | 42 |
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68 | 68 | | Except as provided by law or rule, all terms used in connection 43 |
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69 | 69 | | with commercial feed or feedstuff have the meanings ascribed to 44 |
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70 | 70 | | them by the Association of American Feed Control Officials. 45 |
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71 | 71 | | Section 2. Subsection (1 ) of section 580.051, Florida 46 |
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72 | 72 | | Statutes, is amended to read: 47 |
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73 | 73 | | 580.051 Labels; requirements; penalty. — 48 |
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74 | 74 | | (1) Any commercial feed or feedstuff distributed in this 49 |
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75 | 75 | | state, except a customer -formula feed and feed distributed 50 |
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84 | 84 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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87 | 87 | | |
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88 | 88 | | through an integrated poultry operat ion or by a cooperative to 51 |
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89 | 89 | | its members, shall be accompanied by a legible label bearing all 52 |
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90 | 90 | | information required by the federal Food and Drug Administration 53 |
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91 | 91 | | and the following information: 54 |
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92 | 92 | | (a) An accurate statement of the net weight. 55 |
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93 | 93 | | (b) The name and pr incipal address of the registrant. 56 |
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94 | 94 | | (c) The brand name and product name, if any, under which 57 |
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95 | 95 | | the commercial feed is distributed. The word "medicated" shall 58 |
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96 | 96 | | be incorporated as part of the brand or product name if the 59 |
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97 | 97 | | commercial feed contains a drug. 60 |
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98 | 98 | | 1. The department may require feeding directions and 61 |
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99 | 99 | | precautionary statements to be placed on the label for the safe 62 |
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100 | 100 | | and effective use of medicated and other feed as deemed 63 |
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101 | 101 | | necessary. 64 |
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102 | 102 | | 2. Labels on medicated feed shall include all of the 65 |
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103 | 103 | | following: 66 |
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104 | 104 | | a. Any feeding directions prescribed by the department to 67 |
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105 | 105 | | ensure safe usage. 68 |
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106 | 106 | | b. The stated purpose of the medication contained in the 69 |
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107 | 107 | | feed as stated in the claim statement. 70 |
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108 | 108 | | c. The established name of each active drug ingredient. 71 |
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109 | 109 | | d. The level of each drug use d in the final mixture 72 |
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110 | 110 | | expressed in metric units as well as the required avoirdupois. 73 |
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118 | 118 | | Page 4 of 6 |
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119 | 119 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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123 | 123 | | (d) The date of manufacture or expiration date of 74 |
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124 | 124 | | commercial feed sold at retail as the department may by rule 75 |
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125 | 125 | | require. 76 |
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126 | 126 | | (e) The guaranteed analysis stated in terms th at advise 77 |
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127 | 127 | | the consumer of the composition of the feed or feedstuff or 78 |
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128 | 128 | | support claims made in the labeling. In all cases, the elements 79 |
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129 | 129 | | or compounds listed in the analysis must be determinable by 80 |
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130 | 130 | | laboratory methods approved by the department. However, products 81 |
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131 | 131 | | sold solely as dosage form animal products and guaranteed as 82 |
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132 | 132 | | specified in this section need not show a guaranteed analysis. 83 |
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133 | 133 | | 1. The guaranteed analysis, listing the minimum percentage 84 |
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134 | 134 | | of crude protein, minimum percentage of crude fat, and maximum 85 |
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135 | 135 | | percentage of crude fiber and, when more than 10 percent mineral 86 |
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136 | 136 | | ingredients are present, the minimum or maximum percentages of 87 |
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137 | 137 | | mineral elements or compounds as provided by rule. 88 |
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138 | 138 | | 2. Vitamin ingredients, when guaranteed, shall be shown in 89 |
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139 | 139 | | amounts and terms pro vided by rule. For mineral feed, the list 90 |
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140 | 140 | | shall include the following: maximum or minimum percentages of 91 |
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141 | 141 | | calcium (Ca), phosphorus (P), salt (NaCl), iron (Fe), copper 92 |
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142 | 142 | | (Cu), cobalt (Co), magnesium (Mg), manganese (Mn), potassium 93 |
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143 | 143 | | (K), selenium (Se), zinc (Zn) , and fluorine (F) if ingredients 94 |
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144 | 144 | | used as sources of any of these constituents are declared. All 95 |
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145 | 145 | | mixtures that contain mineral or vitamin ingredients generally 96 |
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146 | 146 | | regarded as dietary factors essential for the normal nutrition 97 |
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147 | 147 | | of animals and that are sold or r epresented for the primary 98 |
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155 | 155 | | Page 5 of 6 |
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156 | 156 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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160 | 160 | | purpose of supplying these minerals or vitamins as additions to 99 |
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161 | 161 | | rations in which these same mineral or vitamin factors may be 100 |
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162 | 162 | | deficient shall be classified as mineral or vitamin supplements. 101 |
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163 | 163 | | Products sold solely as mineral or vit amin supplements and 102 |
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164 | 164 | | guaranteed as specified in this section need not show guarantees 103 |
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165 | 165 | | for protein, fat, and fiber. 104 |
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166 | 166 | | 3. Other nutritional substances or elements determinable 105 |
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167 | 167 | | by laboratory methods may be guaranteed by permission of, or 106 |
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168 | 168 | | shall be guaranteed a t the request of, the department as may be 107 |
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169 | 169 | | provided by rule. 108 |
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170 | 170 | | (f) The common or usual name of each ingredient used in 109 |
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171 | 171 | | the manufacture of the commercial feed; however, for all 110 |
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172 | 172 | | commercial feed except horse feed, the department by rule may 111 |
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173 | 173 | | permit the use of collective terms for a group of ingredients 112 |
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174 | 174 | | which perform a similar nutritional function. 113 |
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175 | 175 | | (g) A label on a dosage form animal product must contain 114 |
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176 | 176 | | all of the following: 115 |
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177 | 177 | | 1. An accurate statement of the net weight. 116 |
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178 | 178 | | 2. The name and principal address of the registrant. 117 |
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179 | 179 | | 3. The brand name and product name, if any, under which 118 |
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180 | 180 | | the dosage form animal product is distributed. 119 |
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181 | 181 | | 4. The date of manufacture or expiration date of the 120 |
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182 | 182 | | dosage form animal product sold at retail as the department may 121 |
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183 | 183 | | by rule require. 122 |
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184 | 184 | | 5. The amount of each active ingredient per serving. 123 |
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192 | 192 | | Page 6 of 6 |
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193 | 193 | | F L O R I D A H O U S E O F R E P R E S E N T A T I V E S |
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197 | 197 | | 6. The common or usual name of each inactive ingredient 124 |
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198 | 198 | | contained in the dosage form animal product. 125 |
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199 | 199 | | 7. A statement that identifies how the dosage form animal 126 |
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200 | 200 | | product supports the structure or function of the animal. 127 |
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201 | 201 | | 8. Precautionary statements and warnings required to 128 |
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202 | 202 | | ensure the safe and effective use of the dosage form animal 129 |
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203 | 203 | | product. 130 |
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204 | 204 | | 9. Recommended dosage by animal weight. 131 |
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205 | 205 | | 10. The statement "Not for human consumption." 132 |
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206 | 206 | | Section 3. This act shall take effect October 1, 2023. 133 |
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