Since the Jane Brody article and Martek's announcement of the GRAS approval
of DHA and AA in formula for use in the US.  I thought I'd share the letter I
sent to the FDA and my response.  Seems like we have this semantics problem
(DHA or DHASCO, AA or ARASCO) but thought it worth posting.  Are they
implying that DHA and AA are approved but that the DHASCO and the ARASCO made
by Martek has not been approved .....of course that leads us to ask why is
Martek saying they have GRAS approval...but then again does GRAS approval
mean anything anyway....Valerie W. McClain, IBCLC

"Dear Ms. McClain:

FDA's letter dated May 17, 2001, that was in response to GRN 000041, states
that the subject of Martek's GRAS notice is the single cell oils ARASACO and
DHASCO rather than the fatty acids ARA and DHA.  FDA's response letter
states that "the agency has no questions at this time regarding Martek's
conclusion that ARASCO and DHASCO are GRAS sources of ARA and DHA under
their intended conditions of use".   The agency has not, however, made its
own determination regarding the GRAS status of the subject use of ARASCO and
DHASCO.


Sincerely,

Paulette Gaynor, Ph.D.
Office of Food Additive Safety
FDA/CFSAN
>
>     -----Original Message-----
>     From: [log in to unmask] [mailto:[log in to unmask]]
>     Sent: Wednesday, July 18, 2001 6:05 PM
>     To: [log in to unmask]
>     Subject: GRAS Approval
>
>
>     To Whom It May Concern,
>
>     Has Martek oils been given GRAS approval?  I noticed on the chart on
> the GRAS
>     list that it states that the FDA has no further questions.  Does
> that mean
>     then that DHA and AA are approved?  Thank you for your time.
>
>     Sincerely,
>     Valerie McClain
>     [log in to unmask]

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