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02P 0317 - Emc 000203
02P 0317 - Emc 000203
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Sent: Sunday, January 12, 2003 11:16 PM
To: fdadockets@oc.fda.gov
Subject: Docket # 02P-0317 Recall Aspartame as a Neurotoxic Drug: File
#8: Aspartame & Human Studies
Subject: Docket # 02P-0317
To: FDA Dockets Submittal
From: Mark D. Gold
Aspartame Toxicity Information Center
12 East Side Dr., Suite 2-18
Concord, NH 03301
603-225-2110
Date: January 12, 2002
Please find below Evidence File #8: Aspartame & Human Studies
Aspartame Testing on Humans
--------------------------Q. I have been told that there are no controlled human studies
showing that aspartame causes adverse effects. Is this true?
I ran a medical database MEDLINE search and found several
abstracts that demonstrated no problems when aspartame was
ingested in large amounts. Why is that?
Answer
-----==> I have been told that there are no controlled human studies
==> showing that aspartame causes adverse effects. Is this true?
I am afraid you have been given completely inaccurate information.
In many cases, persons who perpetuate these myths are simply
ignorant of the scientific literature. Unfortunately, some of these
persons are journalists who spread inaccurate information. In some
cases, however, blatantly false implications that aspartame has not
been shown to cause problems in controlled human studies come from
Monsanto, friends of Monsanto in certain government agencies (e.g.,
FDA), and public relations organizations that receive large sums of
money from the manufacturer (e.g., IFIC, ADA).
The following controlled human studies have shown that aspartame can
cause adverse changes or health problems: Camfield (1992), Elsas
(1988), Gulya (1992), Koehler (1988), Kulczycki (1995), Spiers
(1988), Van Den Eeden (1994), Walton (1993). Therefore, if you read
statements implying that there is no controlled research showing
problems with aspartame, you can rest assured that the writer is
completely ignorant of the scientific literature or simply relating
public relations nonsense.
==> I ran a medical database MEDLINE search and found several
==> abstracts that demonstrated no problems when aspartame was
==> ingested in large amounts. Why is that?