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	National Alliance for Breastfeeding Advocacy 254 Conant Rd, Weston, MA 02493 Phone/ Fax: 781 893-8608 Email: Marshalact@aol.com

Docket No. 1998N-0359
Program Priorities in the Center for Food Safety and Applied Nutrition

The National Alliance for Breastfeeding Advocacy (NABA) hereby submits the following comments on CFSAN Program Priorities for FY 2008

NABA is a nonprofit organization whose mission involves the protection, promotion, and support of breastfeeding in the United States. One of its programs involves the monitoring of the International Code of Marketing of Breast Milk Substitutes, a voluntary infant formula industry marketing guide. Within this guide
are recommendations to assure that parents using infant formula are educated on how to prepare and
use the product correctly and safely. NABA recognizes that FDA/CFSAN has worked to improve both health
care provider and consumer access to information on the safe use of infant formula.

FDA/CFSAN must continue efforts aimed at educating both health care providers and consumers about the
safe and proper use of infant formula, in particular powdered infant formula. Powdered formula is not sterile and can pose a health risk to young or compromised infants (Forsythe 2005). While the FDA warned clinicians that powdered infant formula should not be used in neonatal intensive care units (FDA/CFSAN 2002), more recent investigation from the CDC recommends that ALL infants under 4 weeks of age as well as premature infants be placed in a high risk category and not receive powdered infant formula (Bowen 2006).

Enterobacter sakazakii is an emerging pathogen that has been identified in 3-28% or more of powdered infant formula samples (Drudy 2006; Torres-Chavolla 2007; Zink 2003). While powdered infant formula may be intrinsicly contaminated at low levels, the method of reconstitution, handling, and storage can significantly increase bacterial levels and danger to the recipient infant. It takes approximately 14 hours for E sakazakii to double at 50F (slightly above normal refrigeration) and only 45 minutes at room temperature. To minimize the risk of an infant receiving contaminated infant formula, the World Health Organization and the Food and Agriculture Organization of the United Nations has issued guidelines for the safe preparation, storage and handling of powdered infant formula (WHO/FAO 2007).Among other recommendations these guidelines
include:

Preparing one feeding at a time and avoiding mixing powdered infant formula in 24 hour batches
Reconstituting powdered formula with water that has been boiled and cooled to 158F-194F; using
water at a lower temperature will not inactivate E sakazakii; the formula is cooled rapidly to body temperature and fed immediately to the baby
Reconstituted bottles should not be placed in bottle warmers or thermoses

Currently, few labels on infant formula cans warn parents that powdered infant formula is not sterile. Some parents may not understand what this really means. Any language regarding non-sterility that does exist
is not offset in any way to draw parents’ attention to a potential problem. Caregivers are sent to their physicians to ask if water should be boiled. Many health care providers are unaware of research based reconstitution instructions and are unable to properly advise their patients. In order to improve the safety profile of powdered formulas, CFSAN should require that labels on infant formula cans state that:

Powdered infant formula is not sterile and can contain disease causing germs. This warning should be either boxed or called out in a manner that draws attention to the warning
Powdered infant formula should not be fed to any baby under 4 weeks of age, including term infants, preterm infants, or infants who are ill or hospitalized
Bottles should be prepared immediately before each feeding, not in 24 hour batches
Water should be boiled, cooled to 158F-194F and used at that temperature to reconstitute the formula; then further rapidly cooled to about body temperature for feeding
Bottles should not be placed in warmers or left out at room temperature

CFSAN should include this information on its website and in any written materials on infant formula. It should inform other relevant government agencies of this information to assure that it reaches consumers affected
by all pertinent government programs. CFSAN should also provide this information in the form of a press
release to the general public to assure as many parents, professionals, and child care providers as possible receive the message

Infant formula manufacturers should be required to place this information on the labels of all powdered
infant formula products, on their websites, and on all printed materials distributed to health care
professionals and parents.

References

Bowen AB, Braden CR. Invasive Enterobacter sakazakii disease in infants. Emerg Infect Dis 2006;
12:1185-1189

Drudy D, Mullane NR, Quinn T, et al. Enterobacter sakazakii: an emerging pathogen on powdered
infant formula. Clinical Infectious Dis 2006; 42:996-1002

FDA/CFSAN. Health professionals letter on Enterobacter sakazakii infections associated with use of
powdered (dry) infant formulas in neonatal intensive care units. April 11, 2002; revised October 10, 2002. www.cfsan.fda.gov/~dms/inf-ltr3.html

Forsythe SJ. Enterobacter sakazakii and other bacteria in powdered infant milk formula. Maternal Child Nutr 2005; 1:44-50

Torres-Chavolla E, Ramirez-Cerda E, Gutierrez-Rojo R. Isolation and identification of Enterobacter sakazakii in infant milk formulas. Foodborne Pathogens and Disease 2007; 4:164-168

World Health Organization/Food and Agriculture Organization. Safe preparation, storage and handling of powdered infant formula: guidelines. 2007.

http://www.who.int/foodsafety/publications/micro/pif_guidelines.pdf