| 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. 2511 |
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| 5 | 5 | | To amend the Federal Food, Drug, and Cosmetic Act to establish certain |
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| 6 | 6 | | labeling requirements for caffeine, and for other purposes. |
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| 7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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| 8 | 8 | | MARCH31, 2025 |
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| 9 | 9 | | Mr. M |
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| 10 | 10 | | ENENDEZ(for himself, Mr. SMITHof New Jersey, Ms. SCHRIER, Mr. |
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| 11 | 11 | | V |
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| 12 | 12 | | EASEY, Mr. CARTERof Louisiana, Ms. NORTON, Mrs. MCIVER, Mrs. |
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| 13 | 13 | | W |
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| 14 | 14 | | ATSONCOLEMAN, Mr. SHERMAN, Mr. KENNEDYof New York, Ms. |
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| 15 | 15 | | T |
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| 16 | 16 | | LAIB, Mr. DELUZIO, Mr. GOLDMANof New York, and Ms. UNDER- |
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| 17 | 17 | | WOOD) introduced the following bill; which was referred to the Committee |
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| 18 | 18 | | on Energy and Commerce |
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| 19 | 19 | | A BILL |
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| 20 | 20 | | To amend the Federal Food, Drug, and Cosmetic Act to |
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| 21 | 21 | | establish certain labeling requirements for caffeine, and |
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| 22 | 22 | | for other purposes. |
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| 23 | 23 | | Be it enacted by the Senate and House of Representa-1 |
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| 24 | 24 | | tives of the United States of America in Congress assembled, 2 |
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| 25 | 25 | | SECTION 1. SHORT TITLE. 3 |
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| 26 | 26 | | This Act may be cited as the ‘‘Sarah Katz Caffeine 4 |
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| 27 | 27 | | Safety Act’’. 5 |
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| 28 | 28 | | SEC. 2. CAFFEINE LABELING REQUIREMENTS. 6 |
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| 29 | 29 | | (a) I |
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| 30 | 30 | | NFORMATIONREQUIREDTOBEDISCLOSED BY 7 |
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| 31 | 31 | | R |
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| 32 | 32 | | ESTAURANTS AND RETAILFOODESTABLISHMENTS.— 8 |
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| 34 | 34 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 2 |
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| 35 | 35 | | •HR 2511 IH |
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| 36 | 36 | | (1) IN GENERAL.—Section 403(q)(5)(H) of the 1 |
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| 37 | 37 | | Federal Food, Drug, and Cosmetic Act (21 U.S.C. 2 |
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| 38 | 38 | | 343(q)(5)(H)) is amended— 3 |
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| 39 | 39 | | (A) by amending subclause (i) to read as 4 |
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| 40 | 40 | | follows: 5 |
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| 41 | 41 | | ‘‘(i) G |
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| 42 | 42 | | ENERAL REQUIREMENTS FOR RES -6 |
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| 43 | 43 | | TAURANTS AND SIMILAR RETAIL FOOD ESTABLISH -7 |
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| 44 | 44 | | MENTS.— 8 |
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| 45 | 45 | | ‘‘(I) S |
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| 46 | 46 | | TANDARD MENU ITEMS .—Except for 9 |
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| 47 | 47 | | food described in subclause (vii), in the case of 10 |
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| 48 | 48 | | food that is a standard menu item that is of-11 |
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| 49 | 49 | | fered for sale in a restaurant or similar retail 12 |
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| 50 | 50 | | food establishment that is part of a chain with 13 |
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| 51 | 51 | | 20 or more locations doing business under the 14 |
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| 52 | 52 | | same name (regardless of the type of ownership 15 |
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| 53 | 53 | | of the locations) and offering for sale substan-16 |
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| 54 | 54 | | tially the same menu items, the restaurant or 17 |
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| 55 | 55 | | similar retail food establishment shall disclose 18 |
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| 56 | 56 | | the information described in subclauses (ii) and 19 |
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| 57 | 57 | | (iii). 20 |
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| 58 | 58 | | ‘‘(II) T |
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| 59 | 59 | | EMPORARY MENU ITEMS .— 21 |
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| 60 | 60 | | ‘‘(aa) I |
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| 61 | 61 | | N GENERAL.—In the case of 22 |
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| 62 | 62 | | food that is a temporary menu item that is 23 |
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| 63 | 63 | | offered for sale in a restaurant or similar 24 |
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| 64 | 64 | | retail food establishment that is part of a 25 |
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| 67 | 67 | | •HR 2511 IH |
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| 68 | 68 | | chain with 20 or more locations doing busi-1 |
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| 69 | 69 | | ness under the same name (regardless of 2 |
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| 70 | 70 | | the type of ownership of the locations) and 3 |
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| 71 | 71 | | offering for sale substantially the same 4 |
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| 72 | 72 | | menu items, the restaurant or similar re-5 |
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| 73 | 73 | | tail food establishment shall disclose the 6 |
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| 74 | 74 | | information described in subclause (ii)(III). 7 |
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| 75 | 75 | | ‘‘(bb) T |
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| 76 | 76 | | EMPORARY MENU ITEM DE -8 |
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| 77 | 77 | | FINED.—In this item, the term ‘temporary 9 |
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| 78 | 78 | | menu item’ means a food that appears on 10 |
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| 79 | 79 | | a menu or menu board for less than a total 11 |
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| 80 | 80 | | of 60 days per calendar year. The 60 days 12 |
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| 81 | 81 | | includes the total of consecutive and non- 13 |
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| 82 | 82 | | consecutive days the item appears on the 14 |
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| 83 | 83 | | menu.’’; 15 |
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| 84 | 84 | | (B) in subclause (ii)— 16 |
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| 85 | 85 | | (i) by redesignating items (III) and 17 |
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| 86 | 86 | | (IV) as items (IV) and (V), respectively, 18 |
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| 87 | 87 | | and moving the margins of such items 2 19 |
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| 88 | 88 | | ems to the right; 20 |
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| 89 | 89 | | (ii) by inserting after item (II) the fol-21 |
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| 90 | 90 | | lowing: 22 |
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| 91 | 91 | | ‘‘(III) in the case of a standard menu item 23 |
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| 92 | 92 | | or temporary menu item that contains any 24 |
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| 93 | 93 | | added caffeine (as the Secretary shall by regu-25 |
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| 95 | 95 | | kjohnson on DSK7ZCZBW3PROD with $$_JOB 4 |
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| 96 | 96 | | •HR 2511 IH |
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| 97 | 97 | | lation define) and at least 150 milligrams of 1 |
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| 98 | 98 | | total caffeine per serving, the statement ‘High 2 |
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| 99 | 99 | | caffeine’, or such other similar statement or 3 |
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| 100 | 100 | | symbol as the Secretary determines appropriate, 4 |
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| 101 | 101 | | adjacent to the name of the standard menu 5 |
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| 102 | 102 | | item or temporary menu item, so as to be clear-6 |
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| 103 | 103 | | ly associated with such menu item, on the menu 7 |
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| 104 | 104 | | listing the item for sale and on the menu board, 8 |
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| 105 | 105 | | including a drive through menu board;’’; and 9 |
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| 106 | 106 | | (iii) in item (IV) (as so redesignated), 10 |
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| 107 | 107 | | by inserting before the semicolon the fol-11 |
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| 108 | 108 | | lowing: ‘‘and the number of milligrams of 12 |
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| 109 | 109 | | caffeine in the item’’; and 13 |
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| 110 | 110 | | (C) in subclause (vii)(I), by striking ‘‘Sub-14 |
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| 111 | 111 | | clauses (i) through (vi)’’ and inserting ‘‘Subject 15 |
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| 112 | 112 | | to subclause (i)(II), subclauses (i) through 16 |
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| 113 | 113 | | (vi)’’. 17 |
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| 114 | 114 | | (2) C |
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| 115 | 115 | | ONFORMING AMENDMENTS .—Section 18 |
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| 116 | 116 | | 403(q)(5) of the Federal Food, Drug, and Cosmetic 19 |
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| 117 | 117 | | Act (21 U.S.C. 343(q)(5)) is amended— 20 |
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| 118 | 118 | | (A) in clause (A)— 21 |
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| 119 | 119 | | (i) in subclause (i), by striking 22 |
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| 120 | 120 | | ‘‘clause (H)(ii)(III)’’ and inserting ‘‘clause 23 |
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| 121 | 121 | | (H)(ii)(IV)’’; and 24 |
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| 124 | 124 | | •HR 2511 IH |
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| 125 | 125 | | (ii) in subclause (ii), by striking 1 |
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| 126 | 126 | | ‘‘clause (H)(ii)(III)’’ and inserting ‘‘clause 2 |
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| 127 | 127 | | (H)(ii)(IV)’’; and 3 |
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| 128 | 128 | | (B) in clause (H)— 4 |
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| 129 | 129 | | (i) in subclause (ii)(V) (as redesig-5 |
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| 130 | 130 | | nated by subsection (a)(1)(B)(i) of this 6 |
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| 131 | 131 | | section), by striking ‘‘item (III)’’ and in-7 |
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| 132 | 132 | | serting ‘‘item (IV)’’; 8 |
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| 133 | 133 | | (ii) in subclause (vi), by striking ‘‘sub-9 |
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| 134 | 134 | | clause (ii)(III)’’ each place it appears and 10 |
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| 135 | 135 | | inserting ‘‘subclause (ii)(IV)’’; and 11 |
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| 136 | 136 | | (iii) in subclause (vii)(II), by striking 12 |
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| 137 | 137 | | ‘‘subclauses (ii)(III) and (vi)’’ and insert-13 |
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| 138 | 138 | | ing ‘‘subclauses (ii)(IV) and (vi)’’. 14 |
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| 139 | 139 | | (b) C |
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| 140 | 140 | | AFFEINELABELINGREQUIREMENTS FOR FOOD 15 |
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| 141 | 141 | | ANDDIETARYSUPPLEMENTS.—Section 403 of the Fed-16 |
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| 142 | 142 | | eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) is 17 |
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| 143 | 143 | | amended by adding at the end the following: 18 |
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| 144 | 144 | | ‘‘(z) If it is a food (including a dietary supplement) 19 |
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| 145 | 145 | | that contains more than 10 milligrams of caffeine, unless 20 |
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| 146 | 146 | | the label of such food includes— 21 |
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| 147 | 147 | | ‘‘(1) the number of milligrams of caffeine in the 22 |
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| 148 | 148 | | food; 23 |
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| 149 | 149 | | ‘‘(2) a statement of whether the caffeine in the 24 |
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| 150 | 150 | | food is naturally occurring or an additive; and 25 |
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| 153 | 153 | | •HR 2511 IH |
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| 154 | 154 | | ‘‘(3) an advisory statement indicating that the 1 |
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| 155 | 155 | | daily recommended limit of caffeine for healthy 2 |
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| 156 | 156 | | adults is 400 milligrams (or such other limit as the 3 |
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| 157 | 157 | | Secretary determines appropriate).’’. 4 |
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| 158 | 158 | | SEC. 3. FDA AND NIH REVIEWS OF SAFETY OF CAFFEINE. 5 |
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| 159 | 159 | | (a) FDA R |
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| 160 | 160 | | EVIEW OFCAFFEINE ASGRAS.— 6 |
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| 161 | 161 | | (1) I |
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| 162 | 162 | | N GENERAL.—The Secretary of Health and 7 |
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| 163 | 163 | | Human Services, acting through the Commissioner 8 |
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| 164 | 164 | | of Food and Drugs, (in this subsection referred to 9 |
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| 165 | 165 | | as the ‘‘Commissioner’’) shall conduct a review of 10 |
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| 166 | 166 | | the safety of caffeine and other stimulants, as the 11 |
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| 167 | 167 | | Commissioner determines appropriate, in food (in-12 |
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| 168 | 168 | | cluding beverages) and dietary supplements. 13 |
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| 169 | 169 | | (2) E |
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| 170 | 170 | | LEMENTS.—In conducting the review 14 |
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| 171 | 171 | | under paragraph (1), the Commissioner shall con-15 |
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| 172 | 172 | | sider the following: 16 |
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| 173 | 173 | | (A) Whether caffeine should be considered 17 |
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| 174 | 174 | | to be generally recognized to be safe, with re-18 |
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| 175 | 175 | | spect to consumption by healthy populations, 19 |
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| 176 | 176 | | under section 201(s) of the Federal Food, 20 |
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| 177 | 177 | | Drug, and Cosmetic Act (21 U.S.C. 321(s)). 21 |
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| 178 | 178 | | (B) The safety of added caffeine or other 22 |
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| 179 | 179 | | stimulants, or a complex blend containing a 23 |
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| 180 | 180 | | combination of caffeine and other stimulants, in 24 |
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| 181 | 181 | | food and dietary supplements. 25 |
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| 184 | 184 | | •HR 2511 IH |
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| 185 | 185 | | (C) The safety of guarana, taurine, and 1 |
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| 186 | 186 | | similar substances in food and dietary supple-2 |
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| 187 | 187 | | ments with added caffeine. 3 |
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| 188 | 188 | | (D) Thresholds for the amount of caffeine, 4 |
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| 189 | 189 | | or the amount of a complex blend containing a 5 |
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| 190 | 190 | | combination of caffeine and other stimulants, 6 |
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| 191 | 191 | | that should be generally recognized as safe 7 |
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| 192 | 192 | | when included in food or dietary supplements. 8 |
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| 193 | 193 | | (E) Whether any regulations relating to 9 |
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| 194 | 194 | | caffeine in food and dietary supplements should 10 |
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| 195 | 195 | | be issued or updated. 11 |
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| 196 | 196 | | (3) R |
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| 197 | 197 | | EPORT.—Not later than 6 months after 12 |
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| 198 | 198 | | the date of enactment of this Act, the Commissioner 13 |
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| 199 | 199 | | shall submit to Congress and make publicly available 14 |
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| 200 | 200 | | a report detailing the results of the review under 15 |
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| 201 | 201 | | paragraph (1). 16 |
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| 202 | 202 | | (4) C |
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| 203 | 203 | | ONSIDERATION OF RESULTS .—Following 17 |
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| 204 | 204 | | the completion of the review under paragraph (1), 18 |
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| 205 | 205 | | the Secretary of Health and Human Services— 19 |
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| 206 | 206 | | (A) shall, in considering the results of such 20 |
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| 207 | 207 | | review, make a determination regarding wheth-21 |
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| 208 | 208 | | er caffeine is generally recognized to be safe, 22 |
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| 209 | 209 | | with respect to consumption by healthy popu-23 |
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| 210 | 210 | | lations, under section 201(s) of the Federal 24 |
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| 213 | 213 | | •HR 2511 IH |
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| 214 | 214 | | Food, Drug, and Cosmetic Act (21 U.S.C. 1 |
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| 215 | 215 | | 321(s)); and 2 |
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| 216 | 216 | | (B) may consider the results of such re-3 |
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| 217 | 217 | | view in making a determination pursuant to 4 |
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| 218 | 218 | | paragraph (q)(5)(H)(ii)(III) or (z)(3) of section 5 |
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| 219 | 219 | | 403 of the Federal Food, Drug, and Cosmetic 6 |
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| 220 | 220 | | Act (21 U.S.C. 343) (as inserted by subsection 7 |
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| 221 | 221 | | (a)(1)(B)(ii), and added by subsection (b), of 8 |
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| 222 | 222 | | section 2 of this Act). 9 |
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| 223 | 223 | | (b) NIH R |
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| 224 | 224 | | EVIEW OFCAFFEINE INVULNERABLE 10 |
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| 225 | 225 | | P |
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| 226 | 226 | | OPULATIONS.— 11 |
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| 227 | 227 | | (1) I |
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| 228 | 228 | | N GENERAL.—The Secretary of Health and 12 |
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| 229 | 229 | | Human Services, acting through the Director of the 13 |
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| 230 | 230 | | National Institutes of Health, (in this subsection re-14 |
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| 231 | 231 | | ferred to as the ‘‘Director’’) shall conduct or support 15 |
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| 232 | 232 | | a review of the effect of the consumption of caffeine 16 |
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| 233 | 233 | | and other stimulants, as the Director determines ap-17 |
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| 234 | 234 | | propriate, on the vulnerable populations described in 18 |
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| 235 | 235 | | paragraph (2). The Director may enter into a con-19 |
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| 236 | 236 | | tract with an appropriate entity under which such 20 |
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| 237 | 237 | | entity will conduct such review. 21 |
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| 238 | 238 | | (2) V |
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| 239 | 239 | | ULNERABLE POPULATIONS .—The ‘‘vulner-22 |
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| 240 | 240 | | able populations’’ described in this paragraph are 23 |
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| 241 | 241 | | the following: 24 |
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| 242 | 242 | | (A) Children and adolescents. 25 |
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| 245 | 245 | | •HR 2511 IH |
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| 246 | 246 | | (B) Individuals with underlying heart con-1 |
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| 247 | 247 | | ditions. 2 |
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| 248 | 248 | | (C) Pregnant and breast-feeding women. 3 |
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| 249 | 249 | | (D) Individuals with seizure disorders. 4 |
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| 250 | 250 | | (E) Individuals with mental health condi-5 |
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| 251 | 251 | | tions that may be worsened by stimulants. 6 |
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| 252 | 252 | | (F) Caffeine-sensitive individuals. 7 |
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| 253 | 253 | | (G) Such other individuals as the Director 8 |
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| 254 | 254 | | determines appropriate. 9 |
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| 255 | 255 | | (3) R |
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| 256 | 256 | | EPORT.—Not later than 6 months after 10 |
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| 257 | 257 | | the date of enactment of this Act, the Director shall 11 |
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| 258 | 258 | | submit to Congress and make publicly available a re-12 |
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| 259 | 259 | | port detailing the results of the review under para-13 |
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| 260 | 260 | | graph (1). 14 |
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| 261 | 261 | | (c) A |
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| 262 | 262 | | UTHORIZATION OF APPROPRIATIONS.—There is 15 |
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| 263 | 263 | | authorized to be appropriated— 16 |
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| 264 | 264 | | (1) $1,000,000 for the purpose of carrying out 17 |
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| 265 | 265 | | subsection (a); and 18 |
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| 266 | 266 | | (2) $1,000,000 for the purpose of carrying out 19 |
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| 267 | 267 | | subsection (b). 20 |
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| 268 | 268 | | SEC. 4. PUBLIC EDUCATION CAMPAIGN ON CAFFEINE SAFE-21 |
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| 269 | 269 | | TY. 22 |
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| 270 | 270 | | The Secretary of Health and Human Services, acting 23 |
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| 271 | 271 | | through the Commissioner of Food and Drugs, in con-24 |
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| 272 | 272 | | sultation with the Director of the Centers for Disease Con-25 |
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| 275 | 275 | | •HR 2511 IH |
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| 276 | 276 | | trol and Prevention, and working with consumer advocacy 1 |
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| 277 | 277 | | and patient groups, shall conduct a public education cam-2 |
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| 278 | 278 | | paign on the safe consumption of caffeine and caffeinated 3 |
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| 279 | 279 | | food (including beverages) and dietary supplements. Such 4 |
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| 280 | 280 | | campaign shall pay special attention to the following: 5 |
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| 281 | 281 | | (1) The dangers of the overconsumption of caf-6 |
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| 282 | 282 | | feine. 7 |
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| 283 | 283 | | (2) The health impacts caffeine can have on 8 |
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| 284 | 284 | | certain vulnerable populations, including— 9 |
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| 285 | 285 | | (A) children and adolescents; 10 |
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| 286 | 286 | | (B) individuals with underlying heart con-11 |
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| 287 | 287 | | ditions; 12 |
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| 288 | 288 | | (C) pregnant and breast-feeding women; 13 |
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| 289 | 289 | | (D) individuals with seizure disorders; 14 |
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| 290 | 290 | | (E) individuals with mental health condi-15 |
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| 291 | 291 | | tions that may be worsened by stimulants; and 16 |
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| 292 | 292 | | (F) caffeine-sensitive individuals. 17 |
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| 293 | 293 | | (3) How caffeine is marketed to children and 18 |
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| 294 | 294 | | adolescents. 19 |
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| 295 | 295 | | (4) How guarana, taurine, and similar sub-20 |
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| 296 | 296 | | stances impact safety. 21 |
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| 297 | 297 | | (5) How to safely consume caffeine. 22 |
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| 300 | 300 | | •HR 2511 IH |
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| 301 | 301 | | SEC. 5. GAO STUDY AND REPORT ON MARKETING OF 1 |
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| 302 | 302 | | CAFFEINATED BEVERAGES. 2 |
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| 303 | 303 | | (a) I |
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| 304 | 304 | | NGENERAL.—The Comptroller General of the 3 |
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| 305 | 305 | | United States shall conduct a study on the marketing of 4 |
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| 306 | 306 | | caffeinated beverages in restaurants, in stores, and online 5 |
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| 307 | 307 | | (including on social media and by social media 6 |
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| 308 | 308 | | influencers). In conducting such study, the Comptroller 7 |
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| 309 | 309 | | General shall focus on— 8 |
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| 310 | 310 | | (1) ways in which the marketing of caffeinated 9 |
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| 311 | 311 | | beverages (including to children and adults) may be 10 |
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| 312 | 312 | | misleading; and 11 |
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| 313 | 313 | | (2) how the marketing of such caffeinated bev-12 |
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| 314 | 314 | | erages is targeted at children and teens. 13 |
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| 315 | 315 | | (b) R |
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| 316 | 316 | | EPORT.—Not later than 180 days after the date 14 |
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| 317 | 317 | | of enactment of this Act, the Comptroller General of the 15 |
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| 318 | 318 | | United States shall submit to Congress a report describing 16 |
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| 319 | 319 | | the results of the study conducted under subsection (a), 17 |
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| 320 | 320 | | including any recommendations for legislative or adminis-18 |
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| 321 | 321 | | trative action to address the misleading marketing of 19 |
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| 322 | 322 | | caffeinated beverages or the targeted marketing of such 20 |
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| 323 | 323 | | beverages to children and teens. 21 |
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| 324 | 324 | | Æ |
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