Judy has asked about the status of the fatty acids added to infant formula.
The best place to find the information you are seeking is from the
source--the FDA. The FDA has NOT approved these ingredients, it simply had no
questions to the GRAS application from Mead Johnson. "...the agency has no
questions at this time regarding Mead Johnson's conclusion that ARASCO is
GRAS under the intended conditions of use. The agency has NOT, however, made
its own determination regarding the GRAS status of the subject use of
ARASCO."

I have posted before that the website, www.cfsan.fda.gov has a whole section
on explaining what the FDA can and cannot do regarding approval of formulas.
The history of these GRAS notices as well as the ones that state these
ingredients have NOT been approved, just allowed onto the market can be found
at:
www.cfsan.fda.gov/~rbd/opa-g007.html (this one from 1999 rejects Wyeth's
application for GRAS in 1999 because of potential side effects that could
occur in humans)

http://www.cfsan.fda.gov/~rdb/opa-g041.html (this one to Martek mentions side
effects such as diarrhea, flatulence, jaundice, and apnea in infants fed
LCPUFA, raises no questions to this, and stipulates "rigorous post-market
surveillance," "regular reports on such studies and post-market
surveillance."

http://www.cfsan.fda.gov/~rdb/opa-g080.html (this one to Mead Johnson raised
no questions about using a 50% increased amount of these oils but has NOT
made its own determination regarding the use of a 50% increase)

The formula salesmen are trained to manipulate words. Print out all of the
GRAS notices, print the information from the cfsan website on formula, and
attend these meetings with evidence on hand. NABA continuously receives
reports of diarrhea, diaper rash and other side effects from these formulas.
These side effects were known and mentioned in the GRAS letters. Too bad
parents are not informed about the status of the sole source of food being
given to their babies.

Marsha Walker, RN, IBCLC
Weston, MA

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