Us Congress 2025-2026 Regular Session

Us Congress House Bill HB2300 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 2300
5	5	To ensure national uniformity with respect to certain requirements relating
6	6	to preterm infant formula, and for other purposes.
7	7	IN THE HOUSE OF REPRESENTATIVES
8	8	MARCH24, 2025
9	9	Mrs. H
10	10	ARSHBARGER(for herself and Mr. SCHNEIDER) introduced the
11	11	following bill; which was referred to the Committee on Energy and Commerce
12	12	A BILL
13	13	To ensure national uniformity with respect to certain require-
14	14	ments relating to preterm infant formula, and for other
15	15	purposes.
16	16	Be it enacted by the Senate and House of Representa-1
17	17	tives of the United States of America in Congress assembled, 2
18	18	SECTION 1. PRETERM INFANT FORMULA. 3
19	19	(a) S
20	20	TUDY.— 4
21	21	(1) I
22	22	N GENERAL.—The Secretary of Health and 5
23	23	Human Services, acting through the Commissioner 6
24	24	of Food and Drugs, shall study— 7
25	25	(A) the availability of preterm infant for-8
26	26	mula in the United States; 9
27	27	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2300.IH H2300
28	28	ssavage on LAPJG3WLY3PROD with BILLS 2
29	29	•HR 2300 IH
30	30	(B) Federal and State laws, regulations, 1
31	31	orders, and requirements, including under State 2
32	32	common law, that relate to preterm infant for-3
33	33	mula, including with respect to— 4
34	34	(i) the design, development, clinical 5
35	35	testing or investigation, formulation, man-6
36	36	ufacture, distribution, sale, donation, pur-7
37	37	chase, marketing, promotion, packaging, 8
38	38	labeling, licensing, and use of preterm in-9
39	39	fant formula; or 10
40	40	(ii) any aspect of the safety of 11
41	41	preterm infant formula; 12
42	42	(C) whether the Federal Food, Drug, and 13
43	43	Cosmetic Act (21 U.S.C. 301 et seq.) should be 14
44	44	amended to require a manufacturer of preterm 15
45	45	infant formula to obtain premarket approval for 16
46	46	such formula from the Food and Drug Admin-17
47	47	istration; and 18
48	48	(D) if the Secretary recommends such pre-19
49	49	market approval, a process and corresponding 20
50	50	requirements for such premarket approval. 21
51	51	(2) R
52	52	ECOMMENDATIONS .—Not later than two 22
53	53	years after the date of enactment of this Act, the 23
54	54	Secretary of Health and Human Services, acting 24
55	55	through the Commissioner of Food and Drugs, shall 25
56	56	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2300.IH H2300
57	57	ssavage on LAPJG3WLY3PROD with BILLS 3
58	58	•HR 2300 IH
59	59	submit to the Congress a report on the results of the 1
60	60	study under paragraph (1). 2
61	61	(b) T
62	62	EMPORARYPREEMPTION.— 3
63	63	(1) P
64	64	ERIOD OF APPLICABILITY .—This sub-4
65	65	section applies only during the period— 5
66	66	(A) beginning on the date of enactment of 6
67	67	this Act; and 7
68	68	(B) ending on the date that is two years 8
69	69	after the date of enactment of this Act. 9
70	70	(2) P
71	71	REEMPTION.—Except as provided in para-10
72	72	graph (3), no State or political subdivision of a 11
73	73	State may establish, implement, or enforce with re-12
74	74	spect to preterm infant formula any requirement, in-13
75	75	cluding under any State statute, regulation, order, 14
76	76	or common law— 15
77	77	(A) that is different from, or in addition 16
78	78	to, any requirement applicable to preterm in-17
79	79	fant formula under the Federal Food, Drug, 18
80	80	and Cosmetic Act (21 U.S.C. 301 et seq.), the 19
81	81	Poison Prevention Packaging Act of 1970 (15 20
82	82	U.S.C. 1471 et seq.), or the Fair Packaging 21
83	83	and Labeling Act (15 U.S.C. 1451 et seq.); and 22
84	84	(B) that relates to preterm infant formula, 23
85	85	including— 24
86	86	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2300.IH H2300
87	87	ssavage on LAPJG3WLY3PROD with BILLS 4
88	88	•HR 2300 IH
89	89	(i) the design, development, clinical 1
90	90	testing or investigation, formulation, man-2
91	91	ufacture, distribution, sale, donation, pur-3
92	92	chase, marketing, promotion, packaging, 4
93	93	labeling, licensing, and use of preterm in-5
94	94	fant formula; and 6
95	95	(ii) any aspect of the safety of 7
96	96	preterm infant formula. 8
97	97	(3) E
98	98	XCEPTION FOR CIVIL AND CRIMINAL AC -9
99	99	TIONS FOR WILLFUL MISCONDUCT .— 10
100	100	(A) E
101	101	XCEPTION.—Paragraph (2) does not 11
102	102	preempt civil or criminal actions based on a re-12
103	103	quirement described in paragraph (2) to the ex-13
104	104	tent such actions are against a manufacturer 14
105	105	for willful misconduct in the manufacturing or 15
106	106	production of preterm infant formula that 16
107	107	caused death or serious physical injury. 17
108	108	(B) R
109	109	EMOVAL.—In the case of a civil ac-18
110	110	tion brought in a State court against a manu-19
111	111	facturer, if that manufacturer alleges that the 20
112	112	law under which the action is brought is pre-21
113	113	empted by paragraph (2), such action may be 22
114	114	removed by the manufacturer to the district 23
115	115	court of the United States for the district and 24
116	116	division embracing the place wherein the civil 25
117	117	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2300.IH H2300
118	118	ssavage on LAPJG3WLY3PROD with BILLS 5
119	119	•HR 2300 IH
120	120	action is pending. This subparagraph applies to 1
121	121	any action pending before, on, or after the date 2
122	122	of enactment of this Act, except to the extent 3
123	123	that there is a final judgment from which no 4
124	124	appeal may be taken and no further review may 5
125	125	be sought from a court of last resort, including 6
126	126	the Supreme Court of the United States. 7
127	127	(C) B
128	128	URDEN OF PROOF .—In determining 8
129	129	whether the exception in subparagraph (A) ap-9
130	130	plies, the plaintiff shall have the burden of 10
131	131	proving that the criteria described in subpara-11
132	132	graph (A) are met by clear and convincing evi-12
133	133	dence. 13
134	134	(4) D
135	135	ISMISSAL OF PENDING ACTIONS .—A civil 14
136	136	or criminal action that is pending as of the date of 15
137	137	enactment of this Act shall be dismissed to the ex-16
138	138	tent such action seeks to implement or enforce a re-17
139	139	quirement that is preempted by paragraph (2). 18
140	140	(c) D
141	141	EFINITIONS.—In this section: 19
142	142	(1) The term ‘‘infant formula’’ has the meaning 20
143	143	given to such term in section 201(z) of the Federal 21
144	144	Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)). 22
145	145	(2) The term ‘‘manufacturer’’— 23
146	146	(A) means a person who— 24
147	147	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2300.IH H2300
148	148	ssavage on LAPJG3WLY3PROD with BILLS 6
149	149	•HR 2300 IH
150	150	(i) prepares, reconstitutes, or other-1
151	151	wise changes the physical or chemical char-2
152	152	acteristics of a preterm infant formula; or 3
153	153	(ii) packages or labels a preterm in-4
154	154	fant formula in a container for distribu-5
155	155	tion; and 6
156	156	(B) does not include a person taking ac-7
157	157	tions described in subparagraph (A) exclusively 8
158	158	for an infant under such person’s direct care. 9
159	159	(3) The term ‘‘preterm infant formula’’ means 10
160	160	any infant formula that is exempt under section 11
161	161	412(h)(1) of the Federal Food Drug, and Cosmetic 12
162	162	Act (21 U.S.C. 350a(h)) and intended to be admin-13
163	163	istered to— 14
164	164	(A) an infant born before 37 weeks of ges-15
165	165	tation; or 16
166	166	(B) a low-birth-weight infant. 17
167	167	(4) The term ‘‘willful misconduct’’ means, ex-18
168	168	cept as such term is further restricted pursuant to 19
169	169	subparagraph (B), an act or omission that is 20
170	170	taken— 21
171	171	(A) intentionally to achieve a wrongful 22
172	172	purpose; 23
173	173	(B) knowingly without legal or factual jus-24
174	174	tification; and 25
175	175	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2300.IH H2300
176	176	ssavage on LAPJG3WLY3PROD with BILLS 7
177	177	•HR 2300 IH
178	178	(C) in disregard of a known or obvious risk 1
179	179	that is so great as to make it highly probable 2
180	180	that the harm will outweigh the benefit. 3
181	181	Æ
182	182	VerDate Sep 11 2014 18:58 Apr 07, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H2300.IH H2300
183	183	ssavage on LAPJG3WLY3PROD with BILLS