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FDA Updates Infant Formula Nutrient Standards for First Time in Nearly 30 Years — What Parents Should Know

Guides · November 6, 2026 · 3 min read · By AnbuBaby

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Deep Dive: FDA’s First Major Infant Formula Nutrient Update in Nearly 30 Years



Parenting · 6 November 2026 · Deep dive



The FDA has released the first proposed rule under Operation Stork Speed that would update required nutrient levels in infant formula — the first comprehensive review since 1998. The proposal narrows ranges for iodine, manganese, vitamin A and vitamin D while leaving most other requirements unchanged for now. At the same time, the agency continues post-outbreak work on the 2025–2026 infant botulism cases linked to powdered formula and shared milk suppliers.



Background



Infant formula nutrient standards have not been comprehensively updated since 1998. Operation Stork Speed, launched in March 2025, aims to modernize those standards, expand options, increase contaminant testing, and strengthen supply-chain oversight after the 2022 shortage and later safety events.



In 2025–2026, two outbreaks of infant botulism were linked to powdered formula (ByHeart and later Nara Organics). Investigations pointed to a shared organic milk powder supplier chain (Organic West Milk / Dairy Farmers of America). ByHeart discontinued its formula; its founders later formed MeridianMade and announced plans to acquire Perrigo’s infant formula business. FDA has called on the industry for stronger supplier oversight and released chemical contaminant testing data showing most samples had low or non-detectable levels.



What changed this week / phase 1



On 29 October 2026 the FDA issued the first of three planned proposed rules. If finalized it would:



  1. Raise the iodine minimum from 5 μg to 15 μg per 100 kcal and lower the maximum from 75 μg to 50 μg.


  1. Adjust manganese (lower minimum, new upper limit).


  1. Slightly lower the vitamin A minimum and switch units to retinol activity equivalents.


  1. Update vitamin D requirements and labeling.



Chloride, potassium, selenium and sodium requirements stay the same. The comment period runs until 26 February 2027. Two more proposed rules covering the remaining nutrients are planned before a single final rule. FDA also published additional contaminant testing results under the same initiative.



Critics note the nutrient proposal does not directly address bacterial contamination risks highlighted by the recent botulism outbreaks.



Competing viewpoints



  1. FDA / HHS: First science-based update in nearly 30 years; part of making formula safer and more nutritious; contaminant testing is “reassuring.”


  1. Industry / consolidation concerns: ByHeart founders’ move into Perrigo’s formula business raises questions about market concentration after a major safety event. Lawmakers have flagged that families still lack full root-cause transparency.


  1. Public-health advocates: Nutrient updates are welcome but incomplete without stronger pathogen controls, better ingredient-supplier tracing, and faster response capacity. Some want botulism-related testing added to routine requirements.


  1. Parents: Want clear, stable products they can trust; many still check pantry stocks for any remaining recalled lots from earlier outbreaks.



What parents should do now



  1. Continue using current formula as directed; no immediate reformulation is required.


  1. Check any leftover product against official recall lists (Nara Organics lots with Best By ending 2027 were recalled; ByHeart was discontinued).


  1. Watch FDA’s Operation Stork Speed page and the infant-formula contaminants dashboard for updates.


  1. If your baby shows signs of botulism (constipation, weak cry, poor feeding, floppy muscles) seek care immediately — it is rare but treatable with BabyBIG.


  1. Comment on the proposed rule at regulations.gov (docket FDA-2026-N-10832) if you want to weigh in.



What to watch next



  1. Public comments and the two remaining nutrient proposed rules.


  1. Final rule timeline and any reformulation timelines for manufacturers.


  1. Progress on root-cause investigations of the shared milk-powder supply chain.


  1. Whether additional pathogen testing or supplier-verification rules are proposed.


  1. Market effects of the MeridianMade / Perrigo deal.



Sources: FDA Operation Stork Speed and proposed rule notices; C&EN coverage of the nutrient proposal and botulism context; HHS/FDA announcements on contaminant testing; industry reporting on ByHeart/MeridianMade/Perrigo.



Not medical advice. Follow your pediatrician and official FDA/CDC guidance.

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