Scientists Raise Health Standards for Infant Formula, Impacting Global Policy

The FDA estimates over 1 million infants in the United States (from one month to two years of age) rely on infant formula for nutrition. Because of food safety and integrity concerns, infant formula is one of the most heavily regulated consumer food products in the world. Internationally, health risks resulting from poorly regulated infant formula have caused illness and deaths in infants. The infant formula industry recently determined many of the methods of analysis for nutrients and contaminants for infant formula within the U.S. were outdated and therefore required new scientific research to set revised standards.

AOAC INTERNATIONAL is the leading third-party organization trusted by the FDA when setting standards and establishing methods of analysis that ensure the safety and integrity of foods and other products that impact public health. Over a seven-year period, AOAC INTERNATIONAL developed nearly 50 standards as AOAC Official Methods of Analysis (OMA) and over 30 different Standard Method Performance Requirements (SMPRs). OMAs not only inform policy in the U.S. regarding standards and regulations, but also impact international policy as well as the compliance requirements for manufacturers of powder, liquid, and ready-to-feed infant formula.

Improved, modern infant formula analysis methods support the safety and wholesomeness of infant formula throughout the world. OMA methods adopted in the U.S. are a collaborative model for the development of standards that are used to ensure safety and compliance.

Infant formula is one of the most highly regulated foods in the world and AOAC collaborates with global standards organizations, government agencies and the industry to develop harmonized, validated test methods to verify that infant formula will deliver all of the essential nutrients .

— Deborah McKenzie, Senior Director of Standards at AOAC INTERNATIONAL