H.R. 2472
INFANTS Act of 2025
Official summary
Written by the Congressional Research Service.
Improving Newborns’ Food and Nutrition Testing Safety Act of 2025 or the INFANTS Act of 2025
This bill requires infant and toddler food to be tested periodically for contaminants and imposes other safety requirements on food and formula manufacturers.
Specifically, the bill requires facilities that manufacture or process infant and toddler food in final form to conduct quarterly tests for contaminants, including lead and arsenic. The Food and Drug Administration (FDA) may subject other foods to this requirement as appropriate. If a facility that is subject to these requirements fails to comply, food manufactured or processed there is deemed adulterated and may not be introduced into interstate commerce.
The bill also specifies that if the FDA determines an infant and toddler food, other than infant formula, contains a contaminant that renders the food adulterated, the FDA must provide the responsible party with an opportunity to initiate a voluntary recall. (Under current law, if a responsible party does not voluntarily recall an adulterated product, the FDA may impose a mandatory recall.)
Further, if testing of an infant formula reveals the presence of certain pathogens, including Listeria monocytogenes or Salmonella, the manufacturer must (1) notify the FDA within 24 hours, (2) properly dispose of the product, and (3) provide the FDA with test results and isolates from the formula.
Finally, the bill requires manufacturers of powdered infant formula to monitor the effectiveness of sanitation and hygiene controls where the formula has the potential to be exposed to Cronobacter spp. or Salmonella.
Text of the bill
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following:
425. Sampling and testing for contaminants in food
(a) Sampling and testing
(1) In general. The owner, operator, or agent in charge of a food facility that manufactures or processes food, including infant and toddler food, in final product form intended for sale to consumers shall—
(A) collect representative samples of each such food; and
(B) conduct testing of the samples for contaminants, including toxic elements.
(2) Requirement for sampling plan
(A) In general. The owner, operator, or agent in charge of a facility described in paragraph (1) shall—
(i) prepare a written sampling plan for all sampling and testing required under this section; and
(ii) ensure that all sampling and testing conducted under this section is conducted in accordance with the sampling plan.
(B) Requirements. A sampling plan under subparagraph (A) shall identify—
(i) the number of sampling units and sample unit size based upon appropriate criteria for identifying, in a representative fashion, the levels of contaminants in each food; and
(ii) one or more appropriate test methods and procedures to be used to analyze the samples.
(C) Guidance. Not later than 18 months after the date of enactment of this section, the Secretary shall issue guidance to assist food facilities in developing sampling plans. Such guidance may, as determined appropriate by the Secretary, address when samples should be tested for specific species of contaminants.
(3) Contaminants to be tested. Each sample taken pursuant to a sampling plan under this section shall be tested for levels of lead, cadmium, mercury, arsenic, and any other contaminant, including other toxic elements, that the Secretary may specify by regulation.
(4) Frequency of testing. The sampling and testing conducted under this section shall be conducted at least once per quarter of each calendar year.
(5) Foods to be tested. The sampling and testing conducted under this section shall be conducted for—
(A) infant and toddler foods, in final package form; and
(B) such other foods as the Secretary may specify, by regulation, as appropriate to protect public health.
(b) Recordkeeping
(1) In general. The owner, operator, or agent in charge of a facility described in subsection (a)(1) shall maintain, for not less than 2 years or the shelf-life of each infant and toddler food manufactured or processed at the facility, whichever is longer, records documenting the sampling and testing conducted under this section with respect to the food.
(2) Requirements. Records required by paragraph (1) to be maintained shall include a detailed description of the foods sampled and tested, the number of samples and tests performed, the size and number of items in each sample unit, a copy of the facility’s sampling plan, identification of the entity conducting the sampling, identification of the entity conducting the testing, and the analytical methods used to perform the sampling and testing.
(3) Applicability. This subsection applies to all records of sampling and testing conducted under this section, regardless of the findings.
(c) Laboratory accreditation. The owner, operator, or agent in charge of a food facility described in subsection (a)(1) shall ensure that testing conducted pursuant to this section is performed in accordance with international standards by a laboratory that is accredited by an accreditation body that conforms to international accreditation standards. Testing conducted under this section is not subject to the requirements regarding laboratory accreditation described in section 422.
(d) Records availability
(1) In general. The owner, operator, or agent in charge of a food facility described in subsection (a)(1) shall make all records required under this section available promptly to the Secretary, upon request, for inspection and copying. Upon request of the Secretary, such an owner, operator, or agent in charge shall provide within a reasonable time an English translation of records maintained in a language other than English.
(2) Records availability in lieu of an inspection. Any records that the Secretary may inspect under this section shall, upon the request of the Secretary, be provided to the Secretary by the owner, operator, or agent in charge of a food facility described in subsection (a)(1), in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such owner, operator, or agent. The Secretary’s request shall include a sufficient description of the records requested.
(3) Confirmation. Upon receipt of records requested under paragraph (2), the Secretary shall provide to the person confirmation of receipt.
(4) Authority of the Secretary. Nothing in this subsection supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.
(e) Delayed applicability. The requirements for sampling and testing under this section apply beginning on the date that is 180 days after the date on which the Secretary publishes the guidance required by subsection (a)(2)(C).