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CURRENT MARKETING AND USE OF POWDERED INFANT FORMULA IN THE UNITED STATES Sue Ann Anderson, Ph.D. Infant Formula and Medical Foods Staff Center for Food Safety and Applied Nutrition Food and Drug Administration

Today’s Presentation Uses and types of formulas currently marketed in U.S. Preparation of powdered formulas for feeding Feeding in health care settings

Infant Formula Product intended for use by infants  that simulates  human milk or is suitable as a complete or partial substitute for human milk

Infants Persons not more than 12 months of age

Introduction to Market Powder—late 1800s Liquid Concentrate—early 1950s Liquid Ready-to-Feed—about 1960

Marketshare Powdered Infant Formulas Half of U.S. marketshare (dollar sales) (Source:  Information Resources, Inc., 1999)

Populations Fed Infant Formulas Infants with generally good health status Term and preterm infants, Born ≥ 37 or < 37 weeks gestational age, respectively

Populations Fed Infant Formulas (continued) Infants with special medical conditions Unique genetic disorders e.g., phenylketonuria (PKU) Other system disorders    e.g., gastrointestinal diseases

Federal Regulations for Infant Formula Labels Preparation and use instructions include Product storage “Sterilization” of water, bottle, and nipples, when necessary Dilution for powder and liquid concentrates, including pictogram showing major steps for preparation (Source:  Title 21 Code of Federal Regulations 107.20)

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Federal Regulations for Infant Formula Labels Other required information “The health of your infant depends on carefully following the directions for preparation and use.” “Use as directed by a physician.” “Use by” date (Source:  Title 21 Code of Federal Regulations 107.20)

Examples of Manufacturers’ Label Instructions for Powdered Formulas Water Preparation Bring water to a boil then cool to 100° F (40°C). Boil additional water for formula to a rolling boil (approximately 1 minute), then let cool to lukewarm temperature. Boil water for 5 minutes.  Cool to a warm temperature (120° - 130° F)

Sample Pictogram from Product Label

Examples of Manufacturers’ Label Instructions for Powdered Formulas Water preparation Ask your baby’s doctor about infant formula use, including the need to boil water for formula, bottle, and nipple assembly.  Pour desired amount of warm water into bottle. Ask your baby’s doctor if you need to boil (sterilize) water for formula and bottle preparations.  Pour desired amount of warm water into bottle.

Sample Pictogram from Product Label

Examples of Manufacturers’ Label Instructions for Powdered Formulas Feeding and storage Feed immediately or cover and refrigerate prepared formula.  Use within 48 hours. Cover prepared formula not used immediately.  Store in refrigerator and use within 48 hours.

Examples of Manufacturers’ Label Instructions for Powdered Formulas Feeding and storage Feed immediately or cover and refrigerate bottled formula to be used within 24 hours. Feed immediately, or cover and refrigerate bottled formula until needed.  Use within 24 hours. Store in refrigerator until used.  Use within 24 hours after mixing.

Examples of Manufacturers’ Label Instructions for Powdered Formulas Disposal of unused formula after feeding Discard unused formula in bottle after feeding. Throw away prepared formula left in feeding bottle or cup within one hour after feeding begins.

Preparation of Formulas for Infants Guidelines for Health Care Facilities Recommendations developed by The American Dietetic Association (ADA)  2002 revised and abbreviated version: http://www.eatright.org/formulaguide.html

Guidelines for Infant Formula Use for Nipple-fed Infants Feed within 4 hours of preparation Cover and refrigerate for up to 24 hours If warmed, warming should take less than 15 minutes Discard any product remaining in bottle one hour after feeding begins (Source:  The American Dietetic Association, 2002)

Guidelines for Infant Formula Use for Tube-fed Infants Feed within 4 hours of preparation Cover and refrigerate for up to 24 hours Intermittent (bolus)—Package in amounts for one feeding or for a 4-hour period Continuous—Hang time should not exceed 4 hours Source:  (The American Dietetic Association, 2002)

Summary Half of marketshare (dollar sales) for powdered products Powders are not sterile products Small percentage of infant formulas are not available in liquid forms Methods given for reconstitution and delivery are variable