1 | 1 | | I |
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2 | 2 | | 119THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION H. R. 2203 |
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5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act with respect to the |
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6 | 6 | | regulation of zootechnical animal food substances. |
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7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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8 | 8 | | MARCH18, 2025 |
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9 | 9 | | Mr. L |
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10 | 10 | | ANGWORTHY(for himself, Ms. SCHRIER, Mr. BAIRD, Ms. PINGREE, Mrs. |
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11 | 11 | | H |
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12 | 12 | | OUCHIN, Mr. COSTA, Mr. MOOLENAAR, Ms. TENNEY, Mr. RILEYof |
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13 | 13 | | New York, Mr. J |
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14 | 14 | | OHNSONof South Dakota, Mr. PFLUGER, Mr. LATTA, |
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15 | 15 | | Mr. J |
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16 | 16 | | OYCEof Pennsylvania, Mr. MESSMER, Mr. BENTZ, Mr. |
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17 | 17 | | O |
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18 | 18 | | BERNOLTE, Mr. MILLERof Ohio, Mr. NUNNof Iowa, Mr. FEENSTRA, |
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19 | 19 | | Mr. N |
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20 | 20 | | EWHOUSE, Mr. BALDERSON, Mrs. MILLER-MEEKS, Mr. FINSTAD, |
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21 | 21 | | Mr. V |
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22 | 22 | | ALADAO, Mr. EVANSof Colorado, and Mr. FONG) introduced the |
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23 | 23 | | following bill; which was referred to the Committee on Energy and Com- |
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24 | 24 | | merce |
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25 | 25 | | A BILL |
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26 | 26 | | To amend the Federal Food, Drug, and Cosmetic Act with |
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27 | 27 | | respect to the regulation of zootechnical animal food |
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28 | 28 | | substances. |
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29 | 29 | | Be it enacted by the Senate and House of Representa-1 |
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30 | 30 | | tives of the United States of America in Congress assembled, 2 |
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31 | 31 | | SECTION 1. SHORT TITLE. 3 |
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32 | 32 | | This Act may be cited as the ‘‘Innovative Feed En-4 |
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33 | 33 | | hancement and Economic Development Act of 2025’’ or 5 |
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34 | 34 | | the ‘‘Innovative FEED Act of 2025’’. 6 |
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36 | 36 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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37 | 37 | | •HR 2203 IH |
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38 | 38 | | SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD 1 |
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39 | 39 | | SUBSTANCES. 2 |
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40 | 40 | | (a) D |
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41 | 41 | | EFINITION.—Section 201 of the Federal Food, 3 |
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42 | 42 | | Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 4 |
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43 | 43 | | adding at the end the following: 5 |
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44 | 44 | | ‘‘(tt)(1) The term ‘zootechnical animal food sub-6 |
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45 | 45 | | stance’ means a substance that— 7 |
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46 | 46 | | ‘‘(A) is added to the food or drinking water of 8 |
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47 | 47 | | animals; 9 |
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48 | 48 | | ‘‘(B) is intended to— 10 |
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49 | 49 | | ‘‘(i) affect the byproducts of the digestive 11 |
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50 | 50 | | process of an animal; 12 |
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51 | 51 | | ‘‘(ii) reduce the presence of foodborne 13 |
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52 | 52 | | pathogens of human health significance in an 14 |
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53 | 53 | | animal intended to be used for food; or 15 |
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54 | 54 | | ‘‘(iii) affect the structure or function of the 16 |
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55 | 55 | | body of the animal, other than by providing nu-17 |
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56 | 56 | | tritive value, by altering the animal’s gastro-18 |
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57 | 57 | | intestinal microbiome; and 19 |
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58 | 58 | | ‘‘(C) achieves its intended effect by acting solely 20 |
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59 | 59 | | within the gastrointestinal tract of the animal. 21 |
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60 | 60 | | ‘‘(2) Such term does not include a substance that— 22 |
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61 | 61 | | ‘‘(A) is intended for use in the diagnosis, cure, 23 |
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62 | 62 | | mitigation, treatment, or prevention of disease in an 24 |
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63 | 63 | | animal; 25 |
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64 | 64 | | ‘‘(B) is a hormone; 26 |
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67 | 67 | | •HR 2203 IH |
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68 | 68 | | ‘‘(C) is an active moiety in an animal drug, 1 |
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69 | 69 | | which, prior to the filing of a petition under section 2 |
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70 | 70 | | 409 was approved under section 512, conditionally 3 |
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71 | 71 | | approved under section 571, indexed under section 4 |
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72 | 72 | | 572, or for which substantial clinical investigations 5 |
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73 | 73 | | have been instituted and for which the existence of 6 |
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74 | 74 | | such investigations has been made public; 7 |
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75 | 75 | | ‘‘(D) is an ionophore; or 8 |
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76 | 76 | | ‘‘(E) is otherwise excluded from the definition 9 |
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77 | 77 | | based on criteria established by the Secretary 10 |
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78 | 78 | | through notice and comment rulemaking. 11 |
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79 | 79 | | ‘‘(3) A zootechnical animal food substance shall be 12 |
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80 | 80 | | deemed to be a food additive within the meaning of para-13 |
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81 | 81 | | graph (s) and its introduction into interstate commerce 14 |
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82 | 82 | | shall be in accordance with a regulation issued under sec-15 |
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83 | 83 | | tion 409. A zootechnical animal food substance shall not 16 |
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84 | 84 | | be considered a drug under paragraph (g)(1)(C) solely be-17 |
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85 | 85 | | cause the substance has an intended effect described in 18 |
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86 | 86 | | subparagraph (1).’’. 19 |
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87 | 87 | | (b) F |
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88 | 88 | | OODADDITIVES.—Section 409 of the Federal 20 |
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89 | 89 | | Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amend-21 |
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90 | 90 | | ed— 22 |
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91 | 91 | | (1) in subsection (b)— 23 |
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94 | 94 | | •HR 2203 IH |
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95 | 95 | | (A) by redesignating paragraphs (3) 1 |
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96 | 96 | | through (5) as paragraphs (4) through (6), re-2 |
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97 | 97 | | spectively; and 3 |
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98 | 98 | | (B) by inserting after paragraph (2) the 4 |
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99 | 99 | | following: 5 |
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100 | 100 | | ‘‘(3) In the case of a zootechnical animal food 6 |
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101 | 101 | | substance, such petition shall, in addition to any ex-7 |
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102 | 102 | | planatory or supporting data, contain— 8 |
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103 | 103 | | ‘‘(A) all relevant data bearing on the effect 9 |
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104 | 104 | | the zootechnical animal food substance is in-10 |
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105 | 105 | | tended to have and the quantity of such sub-11 |
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106 | 106 | | stance required to produce the intended effect; 12 |
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107 | 107 | | and 13 |
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108 | 108 | | ‘‘(B) full reports of investigations made 14 |
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109 | 109 | | with respect to the intended use of such sub-15 |
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110 | 110 | | stance, including full information as to the 16 |
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111 | 111 | | methods and controls used in conducting such 17 |
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112 | 112 | | investigations.’’; 18 |
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113 | 113 | | (2) in subsection (c)— 19 |
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114 | 114 | | (A) by amending subparagraph (A) of 20 |
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115 | 115 | | paragraph (1) to read as follows: 21 |
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116 | 116 | | ‘‘(A)(i) by order establish a regulation (whether 22 |
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117 | 117 | | or not in accord with that proposed by the peti-23 |
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118 | 118 | | tioner) prescribing— 24 |
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121 | 121 | | •HR 2203 IH |
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122 | 122 | | ‘‘(I) with respect to one or more proposed 1 |
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123 | 123 | | uses of the food additive involved, the condi-2 |
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124 | 124 | | tions under which such additive may be safely 3 |
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125 | 125 | | used (including specifications as to the par-4 |
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126 | 126 | | ticular food or classes of food in or on which 5 |
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127 | 127 | | such additive may be used, the maximum quan-6 |
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128 | 128 | | tity which may be used or permitted to remain 7 |
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129 | 129 | | in or on such food, the manner in which such 8 |
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130 | 130 | | additive may be added to or used in or on such 9 |
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131 | 131 | | food, and any directions or other labeling or 10 |
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132 | 132 | | packaging requirements for such additive as the 11 |
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133 | 133 | | Secretary determines necessary to assure the 12 |
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134 | 134 | | safety of such use); and 13 |
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135 | 135 | | ‘‘(II) in the case of a zootechnical animal 14 |
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136 | 136 | | food substance, the conditions under which such 15 |
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137 | 137 | | substance may be used to achieve the intended 16 |
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138 | 138 | | effect; and 17 |
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139 | 139 | | ‘‘(ii) notify the petitioner of such order and the 18 |
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140 | 140 | | reasons for such action; or’’; and 19 |
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141 | 141 | | (B) in paragraph (3)— 20 |
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142 | 142 | | (i) in subparagraph (A), by striking ‘‘; 21 |
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143 | 143 | | or’’ and inserting a semicolon; 22 |
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144 | 144 | | (ii) in subparagraph (B), by striking 23 |
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145 | 145 | | the period and inserting ‘‘; or’’; and 24 |
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148 | 148 | | •HR 2203 IH |
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149 | 149 | | (iii) by adding at the end the fol-1 |
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150 | 150 | | lowing: 2 |
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151 | 151 | | ‘‘(C) in the case of a zootechnical animal food 3 |
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152 | 152 | | substance, fails to establish that the proposed use of 4 |
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153 | 153 | | the substance, under the conditions of use to be 5 |
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154 | 154 | | specified in the regulation, will achieve the intended 6 |
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155 | 155 | | effect.’’; and 7 |
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156 | 156 | | (3) by adding at the end the following: 8 |
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157 | 157 | | ‘‘(l) Z |
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158 | 158 | | OOTECHNICALANIMALFOODSUBSTANCES.— 9 |
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159 | 159 | | The labeling of a zootechnical animal food substance— 10 |
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160 | 160 | | ‘‘(1) shall include the statement: ‘Not for use in 11 |
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161 | 161 | | the diagnosis, cure, mitigation, treatment, or preven-12 |
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162 | 162 | | tion of disease in animals.’; and 13 |
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163 | 163 | | ‘‘(2) may include statements regarding the in-14 |
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164 | 164 | | tended effect of the substance on the structure or 15 |
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165 | 165 | | function of the body of animals, as set forth in sec-16 |
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166 | 166 | | tion 201(tt)(1).’’. 17 |
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167 | 167 | | (c) M |
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168 | 168 | | ISBRANDEDFOOD.—Section 403 of the Federal 18 |
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169 | 169 | | Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend-19 |
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170 | 170 | | ed by adding at the end the following: 20 |
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171 | 171 | | ‘‘(z) If it is a zootechnical animal food substance and 21 |
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172 | 172 | | the labeling of the food does not include the statement 22 |
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173 | 173 | | required by section 409(l)(1).’’. 23 |
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174 | 174 | | (d) R |
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175 | 175 | | ULE OFCONSTRUCTION.—Nothing in this sec-24 |
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176 | 176 | | tion, or the amendments made by this section, shall be 25 |
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179 | 179 | | •HR 2203 IH |
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180 | 180 | | construed to authorize the Secretary of Health and 1 |
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181 | 181 | | Human Services to require the use of any zootechnical 2 |
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182 | 182 | | food substance or food additive (as those terms are defined 3 |
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183 | 183 | | in section 201 of the Federal Food, Drug, and Cosmetic 4 |
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184 | 184 | | Act, as amended by subsection (a)). 5 |
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185 | 185 | | Æ |
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