Food and Drug Administration

Food Advisory Committee

November 18-19, 2002

Briefing Information

White Papers - Prepared for the Food Advisory Committee on Infant Formula

Use of Physical Growth Measurements to Assess Infant Growth: Birth to 6 Months of Age, Dr. W. Chumlea, PhD and Dr. Shumei Sun, PhD (PDF)

Body Composition (PDF)

The Use of NCHS and CDC Growth Charts in Nutritional Assessment of Young Infants, Dr. Laurence Grummer-Strawn, PhD (PDF)

Reference Data for Evaluating Infant Formulas Gains in Weight and Length of Term Infants Iowa and Iowa/Fels Growth Data, Dr. Samuel Fomon, MD and Steven Nelson, BA (PDF)

Growth Data for Preterm Infants (PDF)

Analytic Issues Related to the Evaluation of Normal Physical Growth As an Indicator of Nutritional Adequacy of New Infant Formulas, Dr. Edward Frongillo, PhD (PDF)

Criteria for Determining When a Clinical Study is Needed to Establish Quality of an Infant Formula Product Composition Perspective, Dr. Duane Benton, PhD (PDF)

Principles and Criteria for Determining When a Clinical Study is Needed to Assure that Normal Physical Growth of Infants Will Not be Adversely Affected Clinical Perspective, Dr. Dennis Brier, MD (PDF)

World Health Organization Growth Reference (PDF)


Notice of Meeting published in the Federal Register, Vol., No. 200, October 16, 2002 (PDF)

Federal  Food, Drug, and Cosmetic Act, Section 412 Requirements for Infant Formulas (PDF)

21 CFR Ch. 1 Subpart D, Part 106 Infant Formula Quality Control Procedures (PDF)

21 CFR Ch.1 Part 107 Infant Formula (PDF)

Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants (PDF)

Federal Register April 24, 2001, 21 CFR Parts 50 & 56, Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products (PDF)