FDA Updates Infant Formula Reporting Rules for Safety
Published Date: 10/14/2026
Notice
Summary
The FDA is updating how infant formula makers report and keep records to keep babies safe and healthy. They’re asking for public comments by November 13, 2026, before finalizing these changes. This affects formula manufacturers and aims to improve quality control without adding big costs or delays.
Analyzed Economic Effects
8 provisions identified: 2 benefits, 6 costs, 0 mixed.
Estimated annual reporting and record burden
FDA estimates the total annual burden for this collection at 14,938 reporting hours, 126,482 recordkeeping hours, and 645 third-party disclosure hours. FDA also reports a net reduction of 3,129 hours and 96 responses after adding draft guidance activities and removing a prior enforcement-discretion guidance.
Quality control and record requirements
If you make infant formula, you must establish and follow quality control procedures, notify FDA when formula that has left your control may be adulterated or misbranded, and keep records of infant formula distribution. These requirements implement section 412 of the Federal Food, Drug, and Cosmetic Act and are enforced through 21 CFR parts 106 and 107.
Recall duties and timelines
If you conduct an infant formula recall, you must evaluate the hazard, write a recall strategy, promptly notify affected direct accounts, furnish FDA copies of recall documents, and keep distribution records for at least 1 year after the product's shelf-life expiration. You must also notify the appropriate FDA district office by telephone within 24 hours, submit a written report within 14 days, and provide status reports at least every 14 days until the recall is ended.
Redundancy risk management plans required
Section 424(b) requires manufacturers of critical foods to develop, maintain, and implement a redundancy risk management plan that identifies risks to supply and how the firm would mitigate them (for example, alternative suppliers or stockpiling). FDA may inspect and copy these risk management plan records. FDA estimates 11 manufacturers will create such plans, each taking about 60 hours (660 hours total) per year.
Labeling must show nutrients and use
Infant formula labels must include nutrient information and directions for use. If labels do not meet part 107 requirements, the formula is misbranded under section 403 of the FD&C Act, and consumers rely on these label disclosures when preparing and using formula.
Electronic IFTRACK reporting option
The FDA offers electronic Form FDA 3978 (IFTRACK) so manufacturers may submit standardized reports and notifications electronically, though firms may still submit paper submissions if they prefer. Screenshots and instructions for Form FDA 3978 are available on FDA's website.
Voluntary reporting of positive test results
FDA has requested voluntary notifications when product samples test positive for Cronobacter spp. or Salmonella, even if the affected lot has not been distributed; associated recordkeeping is in 21 CFR 106.55(e). This is intended to help prevent future illnesses linked to powdered infant formula.
Notify FDA of supply interruptions (5 days)
If you manufacture infant formula (a 'critical food'), you must notify FDA of a permanent discontinuance or an interruption in manufacture that is likely to cause a meaningful disruption in U.S. supply as soon as practicable, but no later than 5 business days after the discontinuance or interruption. FDA accepts notifications via email to the address provided.
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