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From: TSS (216-119-129-86.ipset9.wt.net)
Subject: Re: Docket No. 2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting [TSS SUBMISSION]
Date: November 6, 2004 at 6:38 am PST

In Reply to: Docket No. 2004N-0454 Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting [TSS SUBMISSION] posted by TSS on November 5, 2004 at 10:03 am:

-------- Original Message --------
Subject: Capsules containing bovine brain phosphatidyl serine
Date: Sat, 06 Nov 2004 08:17:13 -0600
From: "Terry S. Singeltary Sr."
To: BSE-L
CC: CJDVOICE@YAHOOGROUPS.COM

CT4/1 0193

NATIONAL BIOLOGICAL
STANDARDS BOARD

NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL
Blanche Lane, South Mimms, Potters Bar
Hertfordshire. EN6 3QG

A W H.O. International

Laboratory for
Biological Standards

telegrams Nibsac Polters Bar
telex 21911 Nibsac G
fan no 0707 46730
telephone Potters Bar (0707) 54753 & 54763

SLJ/FF/87.360

Mr J Sloggem
D H S S
Market Towers
Nine Elms Lane
LONDON SW8 5NQ

17 December 1987

Dear Mr Sloggam

Capsules containing bovine brain phosphatidyl serine

CTC

I understand that Dr Calam has written separately to you on the chemical aspects of
this documentation. Our further responses are:

Virological. We consider that it would be advisable for the company to demonstrate
freedom from bovine viruses in general by attempts to isolate infectious agents on
suitable cell lines of bovine, human and other origin. It would be advisable to
measure nucleic acid content to demonstrate purity, and to show that the cattle are
in good health. The specific question of bovine slow viruses is almost impossible to
address, although it might be important. The difficulty is one of assay as, to our
knowledge, there is no assay. Scrapie, a comparable agent of sheep, has an incubation
period measured in years, which seems an insuperable obstacle. If the agent is
intended for use in people who have Alzheimer's this may not matter.

Haematology. ...

snip...

Yours sincerely,

S L Jeffcoate

87/12.17/3.2

http://www.bseinquiry.gov.uk/files/yb/1987/12/17003001.pdf

2004

Stability Prediction of Phosphatidylserine in
Gelatin Softgels: An Interaction Involving
Capsule Surface, Contaminants, and Product
by Dirk R. Cremer, Florian Glaser, Nicole Binder,
and Michaela Thalhammer

snip...

PS can either be produced via
extraction from bovine brain or it
can be derived from plant sources
such as the soybean lecithins.
With the advent of increased
consumer concern over bovine
spongiform encephalopathy
(BSE) (Mad Cow Disease), plantderived
PS has become the supplement
of choice.

http://www.iscpubs.com/articles/al/a0404cre.pdf

>The difficulty is one of assay as, to our
>knowledge, there is no assay. Scrapie, a comparable agent of sheep, has an incubation
>period measured in years, which seems an insuperable obstacle.

>If the agent is
>intended for use in people who have Alzheimer's this may not matter

unbelievable...

TSS

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