FDA Asks for Comments on Infant Formula Reporting Rules
Published Date: 7/17/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about infant formula rules, like labeling, quality checks, and recordkeeping. This affects infant formula makers who must follow these rules and use a new electronic form to report info. You’ve got until September 15, 2026, to share your comments—no cost changes yet, just a chance to improve how info is gathered!
Analyzed Economic Effects
6 provisions identified: 3 benefits, 3 costs, 0 mixed.
Specific Infant Formula Recall Timelines
Under 21 CFR 107.230 and 107.240, firms conducting an infant formula recall must evaluate the hazard, write a recall strategy, promptly notify each affected direct-account customer, and give FDA copies of these documents. If a recalled formula presents a risk, firms must notify the FDA district office by telephone within 24 hours, submit a written report within 14 days, provide written status reports at least every 14 days until termination, and maintain distribution records for at least 1 year after the product's shelf-life expiration.
Estimated Annual Paperwork Burden Change
FDA estimates the infant formula information collection generates 14,938 annual reporting hours, 126,482 annual recordkeeping hours, and 645 annual third‑party disclosure hours. FDA states revisions (adding draft guidance activities and correcting omissions, and removing prior enforcement-discretion guidance) result in a net reduction of 3,129 hours and 96 responses.
Risk Management Plan Requirement
Section 424(b) of the FD&C Act requires manufacturers of a critical food to develop, maintain, and implement a redundancy risk management plan that identifies and evaluates risks to supply and mitigation mechanisms. Records of the risk management plan are subject to FDA inspection and copying. FDA's draft guidance estimates 60 hours per plan and estimates 11 manufacturers will create such plans (660 hours total annually).
New Electronic Form FDA 3978 Option
The FDA developed electronic Form FDA 3978 (Infant Formula Tracking System) so infant formula manufacturers may submit reports and notifications in a standard electronic format. The form is optional (manufacturers may still submit paper submissions), and screenshots and instructions are available on FDA's website.
5-Day Notice for Supply Disruptions
Section 424(a)(1) of the FD&C Act requires a manufacturer of a 'critical food' (including infant formula) to notify FDA of a permanent discontinuance or an interruption in manufacture that is likely to meaningfully disrupt supply. The notification must be made as soon as practicable, but not later than 5 business days after the discontinuance or interruption; FDA accepts notifications via email.
Voluntary Microbiological Sample Notifications
FDA requests voluntary notifications when product samples test positive for Cronobacter spp. or Salmonella, even if the affected lots have not been distributed; related recordkeeping is found in 21 CFR 106.55(e). FDA says these notifications help prevent future illnesses associated with powdered infant formula.
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Key Dates
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