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Subject:
From:
"Valerie W. McClain, IBCLC" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Tue, 23 Apr 2002 04:53:37 EDT
Content-Type:
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The Institute of Medicine (IOM) is conducting a 24-month study sponsored by
the USA FDA on the evidence base for the safety of ingredients new to oral
formulas for term infants.  I have to presume this is an evaluation of
components in infant formula that are genetically modified.  The government
likes to call gmo's "new," "novel."  I think it's less upsetting that way.
The following meeting will be held quite soon.  Wish I could go and listen to
the "sweet" talk.  I would say that alot of the presenters have a vested
interest in the biotechnology of infant formula.  The chair of the infant
formula committee is Richard Deckelbaum.  He has been an invited lecturer to
the Nestle Research Center, received grant funding from the National Dairy
Promotion and Research Board, Trustee for SlimFast, and received unrestricted
grant funding from Bristol Meyers/Mead Johnson.  Sanford Miller is from
Virginia Polytechnic Institute.  This Institute has connections to PPL of
Scotland.  This Institute has a small herd of transgenic cows.  Transgenic
cows produce human proteins in their milk such as human lactoferrin which
will be used (has been used?) in infant formula. We have Dr. Jose Saavedra of
Nestle (associate professor of John Hopkins) assessing the safety of
probiotics in infant formula.  Nestle has a patent on the use of  Probiotic
Bifidobacterium.  And someone from Martek, of course.  The various
universities such as Baylor and Buffalo have a vested interest in this new
technology--the human lactoferrin industry.  Thus we will get a thorough and
comprehensive review of the evidence base for the safety of gmo'd products
(oops..I should say new, novel products) in infant formula.  Let's hear it
for stacking the deck.  I think its just amazing how you can evaluate
something after-the-fact.  Don't ya just love evidence-based medicine brought
to you by the very industries that seek to benefit from that evidence!  The
web site has a viewer comment section for anyone interested.   Now let me
see, if there are any problems with infant formula we do have a quick and
timely recall system (yes, sarcasm) Note how they have someone speaking on
drug safety--maybe they view infant formula as a drug?   Valerie W. McClain,
IBCLC
http://www4.nas.edu/webcr.nsf/MeetingDisplay2/FNBX-H-01-03-A?OpenDocument

Project Title: Evaluation of the Addition of Ingredients New to Infant
Formula
Project Identification Number: FNBX-H-01-03-A

ADDITION OF INGREDIENTS NEW TO INFANT FORMULA
April 30, 2002 - May 2, 2002
National Academy of Sciences Building
2100 C St. NW
Washington, DC

If you would like to attend the sessions of this meeting that are open to the
public or need more information please contact:
Contact Name: Sandra Schlicker
Email: <A HREF="mailto:[log in to unmask]">[log in to unmask]</A>
Phone: 202-334-1735
Fax: 202-334-2316

Agenda:
ADDITION OF INGREDIENTS NEW TO INFANT FORMULA
WORKSHOP SPONSORED BY
Committee on the Evaluation of the Addition of Ingredients New to Infant
Formula
Food and Nutrition Board, Institute of Medicine
Washington, DC
May 1, 2002

AGENDA

8:30 am Welcome and Introduction
Sandra A. Schlicker, Study Director
Richard Deckelbaum, Chair, Infant Formula Committee

8:45 am Defining Safety
Sanford Miller, Virginia Polytechnic Institute and State University

9:15 am Determining the Safety of Drugs
Judith Racoosin, FDA Center for Drug Evaluation and Research

9:45 am Experiences in Determining that a Food Ingredient is GRAS for its
Intended Use
James Heimbach, ENVIRON

10:15 am Break

10:30 am Safety Concerns of Ingredients New to Infant Formula and
Extrapolating Animal Data to the Human Infant
William Heird, Baylor College of Medicine

11:15 am Methodologic Issues in Randomized Clinical Trials in Infancy
Lynn Singer, Case Western Reserve University

11:45 am Principles in Assessing Immunological Outcomes in Infants
Pearay Ogra, Children's Hospital of Buffalo

12:15 Lunch

1:00 pm Clinical Testing and Post-Market Surveillance of Ingredients New to
Infant Formula
William MacLean, Ross Products

1:30 pm Pre- and In-market Studies of Ingredients New to Infant Formula
Roberto Moran, Mead Johnson Nutritionals

2:00 pm Assessing the Safety of Probiotics as Ingredients New to Infant
Formula
Jose Saavedra, Nestle USA

2:30 pm A Case Study: GRAS Notice for Long Chain Polyunsaturated Fatty Acids
in Infant Formula
Linda Arterburn (Invited), Martek Biosciences Corporation

3:00 pm Open Forum

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