FDA Uses Rats to Prove Your Baby Formula Works
Published Date: 5/22/2026
Notice
Summary
The FDA just released new guidance to help baby formula makers prove their products have good-quality protein using special rat studies. This update affects formula manufacturers and labs, making it easier and clearer to show their formulas meet nutrition standards. The guidance is effective now, helping companies avoid costly mistakes and speed up getting new formulas to market.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
FDA guidance helps formula makers pass PER studies
The FDA published guidance on May 22, 2026 that explains how infant formula manufacturers and contract laboratories should design, conduct, evaluate, and report Protein Efficiency Ratio (PER) rat bioassay studies under AOAC Official Method 960.48 to show a new infant formula meets the quality factor of sufficient biological quality of protein.
Technical rules: diet matching and method changes
The guidance finalizes ‘‘appropriate modifications’’ to AOAC Method 960.48, including recommendations to match compositions of test and reference PER study diets to within 20 percent above or below and to delete a prior recommendation for an optional casein reference group with matched sulfur amino acid concentrations.
Guidance aims to support formula supply resilience
FDA states the guidance will help ensure infant formula products meet regulatory requirements and 'will contribute to ensuring a more resilient infant formula supply.' The guidance was announced on May 22, 2026.
FDA signals future validation and alternatives talk
The guidance notes FDA anticipates future discussions about validation data for PER modifications and 'considering alternative methods besides the PER method,' including non-animal methods.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-10268 — Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
The FDA decided not to add Hepatitis Delta Virus (HDV) to the list of tropical diseases because it doesn’t fully meet the rules about market size and who it affects. This means drug makers won’t get special priority review vouchers for HDV treatments right now. People working on HDV drugs should keep an eye out for future updates but won’t see changes or new incentives immediately.
2026-10295 — M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
The FDA just released a new, easy-to-use digital guide called M11 CeSHarP to help everyone involved in clinical trials share and review study plans faster and clearer. This affects drug companies, researchers, and regulators worldwide by setting a global standard for how trial info is written and shared electronically. The new rules kick in now, aiming to save time and reduce confusion, with no direct cost but big efficiency gains.
2026-10321 — Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
The FDA is holding a public meeting on June 18, 2026, to talk about the safety and effectiveness of MFLUSIVA, a new flu vaccine made by Moderna. Anyone can watch online and share their thoughts before June 17. This is a big deal for people who get flu shots and could affect how this vaccine is used and approved.
2026-10277 — Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The FDA just released new draft guides to help drug makers design studies proving their generic drugs work like the originals. If you’re in the drug business, now’s your chance to share feedback by July 21, 2026, before these guides become final. These updates aim to speed up drug approvals, potentially saving time and money for companies and patients alike!
2026-10190 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
The FDA is updating how companies ask for extra patent time when their new drugs or devices take a while to get approved. This affects drug and medical device makers who want to protect their inventions longer. Comments on these changes are open until June 22, 2026, and the update aims to keep the process clear without adding extra costs or delays.
2026-10188 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program
The FDA is updating how it collects info about drug making to keep medicines safe and high-quality. This affects drug makers who must follow good manufacturing rules and may see some changes in paperwork. Comments on these updates are open until June 22, 2026, so industry folks have time to weigh in before any new rules kick in.
Previous / Next Documents
Previous: 2026-10283 — Order Granting Additional Directors and Officers of Certain Foreign Private Issuers an Exemption From the Filing Requirements of Section 16(a) of the Exchange Act
Next: 2026-10285 — New Postal Products
The Postal Regulatory Commission is reviewing new deals the Postal Service wants to add or change for competitive mail products. If you use or rely on these postal services, now’s your chance to share your thoughts before the Commission makes a decision. Keep an eye out for deadlines to comment and possible changes that might affect prices or services soon!