Infant Formula Regulations in Australia and the United States: A Brief Comparison

By Julie Cottle – Regulatory Matters Global Technical & Compliance Specialist | Food & Complementary Medicines

Infant formula is an important product for infants who cannot be breastfed, and ensuring its safety and nutritional adequacy is a global priority, guided by standards established in the Codex Alimentarius. The regulations governing infant formula have nuanced variations between countries reflecting differing public health priorities, cultural values, and scientific standards.

For manufacturers looking to produce and distribute infant formula in multiple markets, harmonization with Codex and relevant in-country regulations facilitates compliance with wider market access. This article looks at the regulatory frameworks of Australia and the United States, examining their differences and exploring compliance strategies to deliver safe, high-quality products in two key regions.

Staging

Staging presents a significant regulatory difference between Australia and the United States. Codex Alimentarius and Food Standards Australia New Zealand (FSANZ) divide infant formula into Stage 1 (0–6 months) and Stage 2 (6–12 months, or follow-on formula). Each stage has specific nutrient requirements designed to meet the developmental needs of infants at different ages.

The United States does not recognize separate stages for infant formula. The U.S. Food and Drug Administration (FDA) applies a single set of regulations to all formula intended for infants from birth to 12 months. This simplifies compliance for domestic manufacturers but can be challenging for cross-border manufacturers working with different international standards.

Iron Levels

Iron requirements vary across regions, reflecting differing public health priorities. Codex sets a minimum of 0.45 mg/100 kcal for infant formula and allows national authorities to determine upper limits. In follow-on formula, Codex requires 1.0–2.0 mg/100 kcal.

In the United States, the FDA mandates a minimum of 0.15 mg/100 kcal, though most formulas exceed 1.0 mg/100 kcal. Products with less than 1.0–3.0 mg/100 kcal must include a label advising that “additional iron may be necessary.” WIC-approved formulas require a minimum of 1.5 mg/100 kcal. FSANZ, on the other hand, sets an iron content range of 0.48–1.2 mg/100 kcal, aligning closely with Codex but falling below U.S. averages.

Premarket quality and safety assessment

Quality and safety assessment also differs between these regions. The U.S. FDA requires manufacturers to conduct protein quality assessments using the Protein Efficiency Ratio (PER) rat bioassay studies and document growth and tolerance studies. These studies must follow strict protocols, including 15-week trials comparing growth data from formula-fed and control groups.

FSANZ focuses on nutrient quality and comparability to breastfed infants but does not mandate specific bioassay studies. Instead, use the “chemical index” or amino acid score with human milk as the reference protein.

Labeling

In Australia, FSANZ is aligned with Codex requiring nutrient declarations per 100 mL and it prohibits marketing claims on labels and advertising materials, aligning with the International Code of Marketing of Breastmilk Substitutes. In contrast, the U.S. the FDA mandates nutrient declarations per 100 kcal and permits certain health claims, such as “supports brain development,” provided they are substantiated by scientific evidence.

Manufacturers face challenges in developing infant formulas that meet both FSANZ’s Codex-aligned composition standards and the FDA’s broader tolerances and comprehensive testing requirements. However, opportunities exist for dual compliance with the right strategy. Understanding these regulatory frameworks and adopting harmonized approaches not only ensures compliance but also facilitates market access, reduces duplication of effort, and supports the delivery of safe, high-quality nutrition to infants globally.