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Subject:
From:
"Valerie W. McClain" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Fri, 26 Sep 2003 04:01:17 EDT
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text/plain
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Judy,
One has to get the hang of government bureacractic mumbo-jumbo in order to 
understand GRAS. GRAS is now just a notification system.  And no it is not a 
preliminary status.  GRAS does not mean that they are FDA approved.  Have you 
ever read "Catch-22?" by Joseph Heller?  This is the catch-22 at its finest. GRAS 
is no longer about approval.  

I had written to the FDA on the GRAS status of DHA when Martek announced that 
DHA had GRAS approval.  I was floored because independent studies have shown 
problems with these microbial oils.  The FDA stated quite clearly to me that 
DHA is GRAS.  But that the FDA had yet to make its own determination on this 
matter. (catch-22)

You ask, "can we say that these substances are 'approved but unproven,' or 
that they are not approved?"  I would not use the word approved.  I would 
suggest that we just say that GRAS is a notification system and we are being 
notified though the FDA that the manufacturer thinks their product is safe.   

In a January 18, 2002 article written by Steven Milloy called, "Formula for a 
Scam,"
Milloy writes the following:

http://www.foxnews.com/story/0,2933,43317,00.html
The FDA approval letter stated it had "no questions at this time regarding 
Martek's conclusion" that DHA and AA are GRAS. The FDA added, "The agency has 
not, however, made its own determination regarding the GRAS status …"Did you get 
that? The FDA didn't pass its own judgment on safety; it relied on Martek's 
decision-making. Covering its bureaucratic rear end, the FDA added, "it is the 
continuing responsibility of Martek to ensure that food ingredients that the 
firm markets are safe." The FDA will also place a similar burden on formula 
manufacturers. This mandatory post-market surveillance of infant formula is 
unprecedented and means that infants will be guinea pigs."

Yes, infants around the world, are the guinea pigs for this industry. 
Valerie W. McClain, IBCLC























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