<http://www4.nas.edu/news.nsf/6a3520dc2dbfc2ad85256ca8005c1381/d995805ea80876dc85256e4a006dadd5?OpenDocument>

and

<http://www.iom.edu/includes/DBFile.asp?id=19049>

Date: March 1, 2004
Contacts: Christine Stencel, Media Relations Officer
Chris Dobbins, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail <[log in to unmask]>

FOR IMMEDIATE RELEASE

Report Recommends More Explicit Guidelines
For Assessing Safety of New Ingredients Added to Infant Formula

WASHINGTON -- Although the federal regulatory processes for evaluating the
safety of food ingredients have worked well for conventional substances,
they were not designed to address the unique needs and vulnerabilities of
infants and are insufficient to ensure the safety of new types of
ingredients proposed for infant formula, says a new report from the
Institute of Medicine of the National Academies. The committee that wrote
the report laid out guidelines that clarify the types and extent of safety
testing necessary for new formula ingredients, particularly unconventional
substances derived from novel sources or technologies. It also called for
outside experts to take a more proactive role in determining how and when
such tests should be done.

"The current regulatory processes do not fully address the unique role of
formula as a food source," explained committee chair Richard J. Deckelbaum,
professor of nutrition and pediatrics and director, Institute of Human
Nutrition, Columbia University, New York City. "Formula is infants' only
food if they are not being breast-fed. The processes used to regulate the
safety of any new additions to formula should be tailored to these products'
distinct role and the special needs and susceptibilities of infants. Our
report offers a set of guidelines and steps to accomplish this goal."

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