http://groups.yahoo.com/group/aspartameNM/message/988
aspartame classified as a "food additive", no GRAS status: Stoddard:
Wurtman: Gold: Murray 4.10.3 rmforall

April 10 2003 Hello Mary Nash Stoddard, Good question!

Here is the key information: "food additives" are not required to be
tested or monitored for safety.
GRAS means "Generally Regarded as Safe."

"Compounds that do
affect physiological systems are classified as drugs by the Food and
Drug Administration (FDA), and are subject to considerably more
demanding regulatory procedures than food constituents. Moreover,
because food additives must be shown to be physiologically inert in
order to win initial FDA approval, once they have obtained this approval
they are exempted from the requirement, imposed on all drugs, that their
safety be continuously monitored: Companies that manufacture and use
approved food additives are not obligated to monitor adverse reactions
associated with consumption of their product, nor to submit to the FDA
reports of such adverse reactions; they also are not required to carry
out further government-mandated research programs to affirm their
product's safety."

http://www.dorway.com/wurtman1.html
http://www.dorway.com/wurtman1.txt

Possible Neurologic Effects of Aspartame, a Widely Used Food Additive
-- by Timothy J. Maher (Department of Pharmacology, Massachusetts
College of Pharmacy, 179 Longwood Avenue, Boston, MA 02115) and Richard
J. Wurtman (Department of Brain and Cognitive Sciences, Massachusetts
Institute of Technology, Cambridge, MA 02139). <dick@...>

Introduction: Food Additives as Neuroactive Environmental Constituents

For the very great majority of Americans, i.e., those who elect to
eat processed foods, food additives are a ubiquitous constituent of the
environment, and one with potentially important health effects. The laws
governing the sale of these compounds require that their addition to
foods fulfill a specific purpose, such as improving flavor, retarding
spoilage, or enhancing nutritional quality, and that such use be risk-
free. Implicit in this latter requirement is the expectation that the
food additive not be found to affect physiological processes other than
the nutritional or sensory ones underlying its use: Compounds that do
affect physiological systems are classified as drugs by the Food and
Drug Administration (FDA), and are subject to considerably more
demanding regulatory procedures than food constituents. Moreover,
because food additives must be shown to be physiologically inert in
order to win initial FDA approval, once they have obtained this approval
they are exempted from the requirement, imposed on all drugs, that their
safety be continuously monitored: Companies that manufacture and use
approved food additives are not obligated to monitor adverse reactions
associated with consumption of their product, nor to submit to the FDA
reports of such adverse reactions; they also are not required to carry
out further government-mandated research programs to affirm their
product's safety.

However, the consumption of a number of food additives can cause
physiological effects which include, for some, modification of the
chemical composition and functional activities of the nervous system (1
,2). These effects may generate health risks for some people. Moreover,
in the case of one such compound, the artificial sweetener aspartame
(L-aspartyl-L-phenylalanyl-methyl ester), these neural effects were
largely unexplored prior to the compound's addition to the food supply,
and were not a factor in calculating the quantities that individuals can
safely consume (the ADI, or acceptable daily intake, currently set for
aspartame at 50 mg/kg) (3). The effects of aspartame, and of certain
other food additives, like caffeine, on the nervous system are sometimes
not of such a nature as to allow their detection by the standard
neurotoxicological tests used to assess the safety of food additives,
inasmuch as these effects need not be associated with cell death, nor
with other visible manifestations of neuronal damage. Rather, they
involve more subtle biochemical changes, as well as functional
consequences that are demonstrable only in specially treated animals (4)
(and possibly, by extrapolation, only in especially vulnerable people).

Although these physiological effects are unrelated to the reason that
the additive was placed in the food, they may have important health
implications just the same, given the very large number of Americans who
are routinely exposed to environmental constituents added to the food
supply. If only 1% of the 100,000,000 Americans thought to consume
aspartame ever exceed the sweetener's ADI, and if only 1% of this group
happen coincidentally to have an underlying disease that makes their
brains vulnerable to the effects of an aspartame-induced rise in brain
phenylalanine levels, then the number of people who might manifest
adverse brain reactions attributable to aspartame would still be about
10,000, a number on the same order as the number of neurally related
consumer complaints already registered with the FDA and other federal
agencies (5,6).

A Google search on "aspartame, GRAS" gives 3,100 links.

http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk3/1977/7702/770207.PD\
F
Cancer Testing Technology and Saccharin (Part 7 of 13)
FDA approved aspartame as a food additive for a number of foods in July
1974,...

http://www.doh.state.fl.us/chdpasco/DI_Web/2000abstracts%5Caspartame.htm
What is Aspartame? What is It Used For? by Rebecca Granda
The FDA is the primary regulatory body that oversees the safety and
truthfulness in labeling of food and drug products in the United States.
Aspartame was approved for use in tabletop sweeteners, various foods,
and dry beverage mixes in 1981. It was approved for use in carbonated
beverages in 1983. Aspartame was awarded Generally Regarded As Safe
(GRAS) Affirmation. The FDA evaluates, affirms, and regularly
monitors intakes of GRAS status products.

http://www.parkinson.org/aspartame.htm
Food and Drug Administration, FDA Consumer November - December 1999
by John Henkel
While questions about saccharin may persist, the safety of another
artificial sweetener, aspartame, is clear cut, say FDA officials. FDA
calls aspartame, sold under trade names such as NutraSweet and Equal,
one of the most thoroughly tested and studied food additives the agency
has ever approved. The agency says the more than 100 toxicological and
clinical studies it has reviewed confirm that aspartame is safe for the
general population.

http://www.nzhealth.net.nz/poisons/aspartame.html
H.J. Roberts
DOES ASPARTAME CAUSE HUMAN BRAIN CANCER?
Journal of Advancement in Medicine
Volume 4, Number 4, Winter 1991

Aspartame (NutraSweet) was licensed for use as an additive in the
Generally Regarded as Safe (GRAS) category by the Federal Drug
Administration (FDA), first as a tabletop sweetener in July 1981, and
then for “wet” use in beverages in July 1983.

But this link
http://www.eatright.org/adap0598.html
Use of nutritive and nonnutritive sweeteners-- Position of ADA
J Am Diet Assoc. 1998;98:580-587.

lists the GRAS status of most sweeteners, but lists aspartame as:

"Approved as a general-purpose sweetener"

So, I and others seem to have been mistaken in believing that aspartame
had specific GRAS status, but it clearly was classified as a food
additive, not a drug, and is therefore rather exempt from rigorous
safety testing and monitoring.

http://groups.yahoo.com/group/aspartameNM/message/262
Gordon: UPI: aspartame toxicity Part 1/3 Oct 1987:
Murray 7.10.0 rmforall [Gregory Gordon, UPI investigative reporter]

Dr. Gary Flamm, the FDA’s top toxicologist overseeing food additives,
said that beyond labeling, once a food additive such as NutraSweet has
won approval, it is far more difficult to restrict its marketing.

"If...our approval of it was a mistake, we couldn't rectify that without
data showing that aspartame was unsafe," said Flamm, an aspartame
defender.

Even then, he said, the agency would face a new regulatory thicket
unless it could be shown NutraSweet posed "an imminent hazard." Consumer
lawyer James Turner, who has campaigned for more than a decade for a
NutraSweet ban, assailed the FDA’s treatment of such safety issues.
"Once a product is on the market, whether there by nefarious or honest
means," he said, "it is impossible to get it off the market until it
has caused severe, undeniable damage that has probably lasted over many
years."

http://groups.yahoo.com/group/aspartameNM/message/56
Gold: aspartame history 1979-1999: Murray 11.6.99 rmforall

Community Nutrition Institute (CNI) filed suit against the FDA in
District Court claiming that the FDA did not follow proper procedure
in approving aspartame for beverages and that they should have held a
public hearing before giving final approval (Farber 1989, page 39).
After the District Court dismissed their suit and the D.C. Circuit
Court of Appeals denied their request for a hearing stating that they
failed to "raise any material issues of fact that require the FDA to
grant a hearing," CNI stated:

...where the holding of a public hearing is no longer a
responsible part of the food additive process, the F.D.A. and the
appeals court have increased the likelihood that unsafe food
additives will reach the market.

http://www.HolisticMed.com/aspartame 603-225-2100
Aspartame Toxicity Information Center Mark D. Gold
mgold@... 12 East Side Drive #2-18 Concord, NH 03301
http://www.holisticmed.com/aspartame/abuse/methanol.html
"Scientific Abuse in Aspartame Research"
************************************************************************

Rich Murray, MA Room For All rmforall@...
1943 Otowi Road, Santa Fe, New Mexico 87505 USA 505-986-9103

http://groups.yahoo.com/group/aspartameNM/message/984
aspartame review: methanol, formaldehyde, formic acid toxicity:
Murray 4.10.3 rmforall

http://groups.yahoo.com/group/aspartameNM/message/983
aspartame & formaldehyde toxicity: Murray 4.10.3 rmforall

http://groups.yahoo.com/group/aspartameNM/messages
for 988 posts in a public searchable archive

http://groups.yahoo.com/group/aspartame/ 633 member group

http://groups.yahoo.com/group/aspartameNM/message/985
details on EU Environment Committee vote 2.19.3 to reevaluate aspartame
and stevia and limit cyclamate-- EU vote April 9: Murray 4.8.3 rmforall

http://groups.yahoo.com/group/aspartameNM/message/968
EU MEPs vote to re-evaluate aspartame and stevia:
Martini: Murray 2.21.3 rmforall

http://www.holisticmed.com/aspartame/scf2002-response.htm
Mark Gold exhaustively critiques European Commission Scientific
Committee on Food re aspartame (12.4.2): 59 pages, 230 references
************************************************************************

Aspartame Consumer Safety Network and Pilot Hotline [1987-2001]
Mary Nash Stoddard, Founder & President
P.O. Box 780634 Dallas, TX 75378 .
214-352-4268 marystod@...
http://web2.airmail.net/marystod/index.html
http://web2.airmail.net/marystod/espanol.htm
Toxicology Sourcebook: "Deadly Deception: Story of Aspartame"

Subject: GRAS substance?
Date: Wed, 9 Apr 2003 17:34:16 -0500
From: Mary Stoddard <marystod@...>
To: rmforall@...

Dear Rich:

Thank you for keeping us on your mailing list for updates.

In a recent mailing, you wrote:
Also, the potent effects of aspartame clearly vitiates the industry's
claim that it is a "food additive", Generally Regarded As Safe (GRAS),
not a "drug", which should be vetted for safety by stringent and
thorough studies.

It is our understanding that aspartame has not yet been officially
classified by FDA as a GRAS [generally recognized as safe] substance.
I asked that specific question, on my last meeting with them in their
Washington D.C. headquarters, and their top officials assured
A.C.S.N. co-founder, James Turner, Esq. and me that it was not
officially GRAS. Do you have information from them that says
something different?

Best regards, Mary

Hon. Mary Nash Stoddard, Founder and President
Aspartame Consumer Safety Network & Pilot Hotline [1987-2003]
P.O. Box 780634 - Dallas TX 75378-0634 U.S.
************************************************************************