Baby Food Safety Act of 2026

Summary of HR 8429 — Baby Food Safety Act of 2026

Date introduced: April 22, 2026

Sponsor: Raja Krishnamoorthi (with multiple co-sponsors)

Purpose
- To amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) to enhance the safety of infant and toddler foods by establishing enforceable contaminant limits, strengthening testing and recordkeeping, expanding enforcement tools, and improving traceability and oversight to better protect young children from toxic elements and other contaminants.

Key Provisions

1) Definition expansion
- Adds a specific definition for “infant or toddler food” to cover foods represented as for infants or children up to 24 months. Note: infant formula is explicitly excluded from this definition.

2) Contaminant limits for infant and toddler foods
- Establishes new regulatory authority (Section 425) to set limits on toxic elements—lead, cadmium, mercury, and arsenic (or their chemical forms) in:
- Infant or toddler foods, and
- Foods predominantly composed of fruit or vegetable purees or juices.
- Mechanism:
- The Secretary would issue administrative orders to set initial limits, with potential for additional limits as data warrant.
- Limits must reflect health-based thresholds and account for the feasibility of avoiding certain contaminants in production, along with available alternatives and best practices.
- Process and transparency:
- Proposed orders must follow a public notice-and-comment process with a 45-day docket.
- Final orders must include a substantive summary of the scientific evidence.

3) Timeline for initial limits
- Draft timelines specify proposed orders for:
- Lead and arsenic by end of 2026
- Cadmium by end of 2027
- Mercury by end of 2029
- Final orders to follow within 18 months after the respective proposed orders.

4) Mandatory testing, sampling, and recordkeeping for manufacturers
- Within 180 days of enactment, facilities that produce infant/toddler foods or fruit/vegetable puree/juice products must:
- Implement a control program for specified contaminants
- Collect representative final-product samples
- Test samples for lead, cadmium, mercury, arsenic, and any additional contaminants the Secretary designates
- Sampling plan requirements:
- Written sampling/testing plan detailing sample unit size, number, testing methods, and testing frequency (at least quarterly, plus additional testing if production changes)
- Guidance to be issued within 18 months to help facilities develop plans
- Records:
- Maintain testing and sampling records for at least 2 years (or shelf life, whichever is longer)
- Records must be accessible to the Secretary and include detailed information about testing and methods
- Lab accreditation:
- Testing must be performed by labs accredited under FD&C Act section 422 or by labs meeting international accreditation standards

5) Importer requirements and traceability
- Amends import-related provisions to monitor and verify the accuracy of records related to 425(b) requirements, enhancing oversight of imported infant/toddler foods.

6) Enforcement and adulteration provisions
- Adds new adulteration trigger: if infant/toddler foods or specified other foods contain contaminants above established limits, or if facilities fail to comply with 425(b) or 425(c), they may be considered adulterated under FD&C Act section 402(j).
- Prohibits act or omission by facility operators that fails to meet these requirements under the new 425 provisions.

7) Implementation planning and oversight
- Requires the Secretary to finalize an implementation plan by January 20, 2027 to align with FDA traceability regulations (existing 2022 rule on "Requirements for Additional Traceability Records for Certain Foods") and to describe resources, compliance strategies, and outreach plans.
- Requires a study on inspections:
- Determine adequate annual facility inspections to ensure imported foods meet safety standards
- Compare inspection targets to prior FDA inspection targets
- Report findings to Congress within 1 year of enactment, including any steps needed to reach inspection goals within two years

8) Reporting and transparency enhancements
- Amends FDA’s annual reporting related to inspections to include details on domestic vs. foreign facility inspections, aggregate results, and foreign importer compliance rates.

9) Expanded use of remote records inspections
- Allows remote access to certain records in lieu of on-site inspections when appropriate, with conditions ensuring security, timeliness, and proper documentation (and clarifies that this does not override other on-site inspection authorities).

10) Mandatory recall authority
- Expands FDA recall authority to permit recalls when an article of food is adulterated or when facilities fail to comply with 425 provisions.

Who is affected
- Manufacturers and processors of infant or toddler foods and foods predominantly composed of fruit/vegetable purées or juices.
- Importers and importers’ facilities handling such foods.
- Labs conducting testing and accredited to perform contaminant analyses.
- FDA and HHS agencies responsible for implementing traceability, testing, and enforcement.

Procedural and timeline notes
- Enactment triggers initial compliance deadlines, with phased rulemakings (proposed limits by deadlines in 2026–2029; final limits within 18 months of each proposed limit).
- 180-day deadline for initial facility testing programs, with 18-month guidance development period.
- Plan for implementing recordkeeping, testing, and traceability measures due by Jan 20, 2027.
- Periodic review: limits reviewed at least every 4 years with potential revisions under the same rulemaking process.

Overall impact
- Aims to reduce exposure of infants and toddlers to lead, cadmium, mercury, arsenic, and other contaminants in early-age foods.
- Increases regulatory oversight, testing rigor, traceability, and enforcement to deter unsafe production and distribution of vulnerable foods.
- Introduces mandatory recall authority tied to contamination and noncompliance with 425 requirements.