Description
Book SynopsisInfant formulas are unique because they are the only source of nutrition for many infants during the first 4 to 6 months of life. This book, prepared at the request of the Food and Drug Administration and Health Canada, addresses the regulatory and research issues that are critical in assessing the safety of the addition of ingredients to infants.
Table of Contents1 Front Matter; 2 Executive Summary; 3 1 Introduction and Background; 4 2 Defining Safety for Infants; 5 3 Comparing Infant Formulas with Human Milk; 6 4 Strengthening the Current Processes to Evaluate New Ingredients for Infant Formulas; 7 5 Testing Ingredients with Preclinical Studies; 8 6 Going Beyond Current Clinical Studies; 9 7 Selecting an In-Market Surveillance Plan; 10 A Acronyms and Glossary; 11 B Composition of Infant Formulas and Human Milk for Feeding Term Infants in the United States; 12 C Redbook Table of Contents; 13 D Applying the Recommended Approaches; 14 E Biographical Sketches of Committee Members