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Aspartame Fact Sheet P.1 of 8
THE FDA’S POSITION ON ASPARTAME
Provided by the Food and Drug Administration Via E-Mail January 27, 1999
The Food and Drug Administration's Center for Food Safety and Applied Nutrition has
recently received numerous requests for information and evaluation regarding an article
attributed to a Ms. Nancy Markle. In that article Ms. Markle claims that ingestion of the
artificial sweetener, aspartame, results in the occurrence of a number of toxicities. The
review of the safety of aspartame presented below is being circulated to provide a more
accurate and complete assessment of the data/findings, both from animal and clinical
studies, that are currently available on aspartame.
This review is compiled by the scientists that have worked on questions relating to the
safety of aspartame repeatedly since 1978. These scientists are familiar with the
scientific studies that have been conducted to support the safety of this food additive.
There were well over 100 separate toxicological and clinical studies conducted to
establish the safety of aspartame before it was approved for regulatory acceptance.
Since its approval in 1981 by the USFDA, there have been many additional studies
performed to follow up on some of the more credible reports of aspartame-mediated
adverse effects. Below agency scientists have tried to succintly respond to certain of the
allegations of toxicity proposed by Nancy Markle.
First, reports of the ingestion of aspartame in patients who later have suffered multiple
sclerosis or systemic lupus is obviously not scientifically sustainable evidence that
aspartame is responsible for the occurrence of either disease. Both of these disorders
are subject to spontaneous remissions and exacerbations so it is entirely possible that
when patients stopped using aspartame they might have also coincidentally have had
remission of their symptoms. Alternatively, the worsening of disease symptoms could be
temporally correlated with the start of aspartame use. The most important consideration,
however, is that there is no credible evidence that the FDA is aware of that suggests that
aspartame elicits multiple sclerosis or systemic lupus.
Second, the claim that aspartame ingestion results in the production of methanol,
formaldehyde and formate. These claims are factual. In the gastrointestinal tract
aspartame is hydrolyzed to one of its component materials, methanol, as well as the two
amino acids, phenylalanine and aspartic acid. This methanol is taken up by the cells of
the body and metabolized first to formaldhyde and then to formate. The key information
that is missing in the description by Ms. Markle is that the levels of ingestion are very
modest. In fact, there are other foodstuffs that we ingest that supply as much and
sometimes even more methanol; e.g., citrus fruits and juices, and tomatoes or tomato
juice. There are even higher quantities of methanol ingested when ethanol is consumed.
Thus, in the final analysis this methanol is the same as from other sources of food and in
the quantities consumed from aspartame, it is readily and naturally metabolized via the
one-carbon biochemical cycle to entirely innocuous and natural body components.
Third, the claim that the two amino acids, phenylalanine and aspartic acid have
neurotoxic effects. This is true in certain individuals and in high enough doses. The only
subpopulation of individuals potentially susceptible to adverse effects from phenylalanine
is homozygous phenylketonurics and in this case, food itself with much higher levels of
phenylalanine from the protein in the diet contributes much higher toxicity for these
unfortunate individuals. For those individual phenylketonurics who want to carefully
control their intake levels of phenylalanine, they can do that by simply taking into
consideration the amount of phenylalanine supplied by the aspartame product or, even
more likely, simply refraining from use of these products. The USFDA requires that the
aspartame product be labeled specially for phenylketonuric patients so that they will be
aware of its presence in these products. As for the other amino acid in aspartame, the
levels of aspartic acid ingested with aspartame use are many fold less than those levels
Aspartame Fact Sheet P.2 of 8
responsible for causing adverse effects on the brain of animals and/or man. In fact, it is
not clear that the experimentally derived data from animals is relevant to man. In any
case, the levels of aspartic acid intake from aspartame are many fold below those
needed to mediate neurotoxic effects.
Fourth, there have been numerous animal and human studies done to evaluate the
possibility that aspartame causes seizures or enhances the susceptibility to seizures. In
clinical studies done in adults and children with preexisting seizures, there was no
evidence of contributing to the frequency of occurrence or severity of seizures in seizureprone individuals. There were additional studies done on seizure-prone experimental
animal models to assess the possible influence of aspartame on their seizuring activity.
Again, the result was the same and no influence was demonstrated on the frequency or
severity of seizures.
Fifth, aspartame was comprehensively evaluated for its potential to mediate adverse
reactions on the ability of pilots to fly planes. There were a number of individual
complaints registered with the FDA claiming that ingestion of aspartame resulted in an
interference with individuals' ability to fly planes. For example, dizziness, impairment of
vision and mental acuity were reported. The FDA took these reports seriously and
instituted a contract to perform a study to see if these effects could, in deed, be
reproduced. FDA contracted with the Federal Aviation Agency who subcontracted
studies with psychophysiological testing laboratories to determine whether aspartame
could affect mental functioning, and manual dexterity. The overall outcome of the studies
was that there was no difference between placebo (control) treatment and exposure to
aspartame although a positive control group receiving ethanol did show impairment of
manual dexterity and ability to deal with complex information.
Sixth, recently Dr. John Olney of Washington University in St. Louis, Missouri claimed
that data collected by the National Cancer Institute demonstrated an increase in the
incidence of brain tumors in human patients since aspartame was approved for use in
the US food supply. A number of scientists both in government and in academic settings
have carefully evaluated Dr. Olney's claim and have refuted it. There has been an
increase in the number of brain tumors reported during recent years, but the explanation
for this increase is most likely to be the technological enhancements of tumor diagnosis
(e.g., computerized tomography and magnetic resonance imaging) introduced during
this same time that has enabled greater sensitivity and certainty in the diagnosis of
tumors. In the more recent data on tumor occurrence in the US, there is a plateauing or
even a slight diminution of brain tumor incidence and this in the face of the continued
presence and use of aspartame in many food products.
Seventh, aspartame was subjected to several specially designed animal tests to assess
its potential to adversely influence reproduction and to mediate birth defects. All of the
well-designed and conducted tests demonstrated that aspartame was safe and did not
produce birth defects or adverse responses on reproductive function.
In conclusion, as mentioned earlier, aspartame is one of the most thoroughly tested food
additives ever submitted to the FDA. All of the early testing in animals and human
subjects conducted to support the safety of aspartame as well as the well-designed and
conducted studies subsequently performed to assess whether aspartame might mediate
a number of anecdotally reported symptoms have reinforced the appropriateness of
FDA's approval and regulation of aspartame as a safe food additive.
http://www.caloriecontrol.org/response.html
Aspartame Fact Sheet P.3 of 8
ANOTHER VIEWPOINT ON ASPARTAME
Reprinted from “Aspartame... the BAD news!”
Article courtesy of: Mark Gold, Aspartame Toxicity Information Center
via www.dorway.com
Aspartame was not approved until 1981, in dry foods. For over eight years the FDA
refused to approve it because of the seizures and brain tumors this drug produced in lab
animals. The FDA continued to refuse to approve it until President Reagan took office (a
friend of Searle) and fired the FDA Commissioner who wouldn't approve it. Dr. Arthur
Hull Hayes was appointed as commissioner. Even then there was so much opposition to
approval that a Board of Inquiry was set up. The Board said: "Do not approve
aspartame". Dr. Hayes OVERRULED his own Board of Inquiry.
Shortly after Commissioner Arthur Hull Hayes, Jr., approved the use of aspartame in
carbonated beverages, he left for a position with G.D. Searle's Public Relations firm.
Long-Term Damage. It appears to cause slow, silent damage in those unfortunate
enough to not have immediate reactions and a reason to avoid it. It may take one year,
five years, 10 years, or 40 years, but it seems to cause some reversible and some
irreversible changes in health over long-term use.
How it happens:
Methanol, from aspartame, is released in the small intestine when the methyl group of
aspartame encounters the enzyme chymotrypsin (Stegink 1984, page 143). Free
methanol begins to form in liquid aspartame-containing products at temperatures above
86 degrees F.. also within the human body.
The methanol is then converted to formaldehyde. The formaldehyde converts to formic
acid, ant sting poison. Toxic formic acid is used as an activator to strip epoxy and
urethane coatings. Imagine what it does to your tissues!
Phenylalanine and aspartic acid, 90% of aspartame, are amino acids normally used in
synthesis of protoplasm when supplied by the foods we eat. But when unaccompanied
by other amino acids we use [there are 20], they are neurotoxic.
That is why a warning for Phenylketonurics is found on EQUAL and other aspartame
products. Phenylketenurics are 2% of the population with extreme sensitivity to this
chemical unless it's present in food. It gets you too, causing brain disorders and birth
defects! Finally, the phenyalanine breaks down into DKP, a brain tumor agent.
In other words: Aspartame converts to dangerous byproducts that have no natural
countermeasures. A dieter's empty stomach accelerates these conversions and
amplifies the damage. Components of aspartame go straight to the brain, damage that
causes headaches, mental confusion, seizures and faulty balance. Lab rats and other
test animals died of brain tumors.
Given the following points, it is definitely premature for researchers to discount the role
of methanol in aspartame side effects:
1. The amount of methanol ingested from aspartame is unprecedented in human history.
Methanol from fruit juice ingestion does not even approach the quantity of methanol
ingested from aspartame, especially in persons who ingest one to three liters (or more)
of diet beverages every day. Unlike methanol from aspartame, methanol from natural
products is probably not absorbed or converted to its toxic metabolites in significant
amounts as discussed earlier.
Aspartame Fact Sheet P.4 of 8
2. Lack of laboratory-detectable changes in plasma formic acid and formaldehyde levels
do not preclude damage being caused by these toxic metabolites. Laboratory-detectable
changes in formate levels are often not found in short exposures to methanol.
3. Aspartame-containing products often provide little or no nutrients which may protect
against chronic methanol poisoning and are often consumed in between meals. Persons
who ingest aspartame-containing products are often dieting and more likely to have
nutritional deficiencies than persons who take the time to make fresh juices.
4. Persons with certain health conditions or on certain drugs may be much more
susceptible to chronic methanol poisoning.
5. Chronic diseases and side effects from slow poisons often build silently over a long
period of time. Many chronic diseases which seem to appear suddenly have actually
been building in the body over many years.
6. An increasing body of research is showing that many people are highly sensitive to
low doses of formaldehyde in the environment. Environmental exposure to formaldehyde
and ingestion of methanol (which converts to formaldehyde) from aspartame likely has a
cumulative deleterious effect.
7. Formic acid has been shown to slowly accumulate in various parts of the body. Formic
acid has been shown to inhibit oxygen metabolism.
8. The are a very large and growing number of persons are experiencing chronic health
problems similar to the side effects of chronic methanol poisoning when ingesting
aspartame-containing products for a significant length of time. This includes many cases
of eye damage similar to the type of eye damage seen in methanol poisoning cases.
Aspartame Fact Sheet P.5 of 8
THE LATEST NEWS ON ASPARTAME
10/5/05 SANTA FE (AP) - The New Mexico Environmental Improvement Board plans to
hold five days of hearings next July on the artificial sweetener aspartame.
The hearings are aimed at determining whether the state should ban the sugar
substitute.
The board voted in favor of the hearings yesterday in Santa Fe.
Santa Fe gallery owner Stephen Fox has been pushing for a statewide ban on
aspartame. An Albuquerque attorney representing Fox, Stevan Looney, says state laws
give the board responsibility to protect consumers and make rules regarding food
protection.
An attorney for the Calorie Control Council, T.J. Trujillo, says state laws cannot trump
federal laws. The council is an association of diet food and beverage manufacturers.
http://www.kobtv.com/index.cfm?viewer=storyviewer&id=22021&cat=4H
EALTH
9/7/05 Group Seeks to Ban Sugar Substitute from State
By Diana Heil – from The New Mexican
Santa Fe gallery owner Stephen Fox is pushing for New Mexico to close its borders to
aspartame, a sugar substitute sold under the brand names NutraSweet and Equal. He’s
not a doctor or a lawyer — and he’s not sick. But in the fight against what he believes is
a poison, he has pulled together people who are.
Aspartame is approved for use in all foods and beverages in the United States and the
European Union. But a host of doctors, state legislators, activists and patients who say
their health was damaged by the sweetener are siding with Fox. They have petitioned
New Mexico leaders to outlaw this so-called neurotoxic substance. Citing case studies in
the United States and recent research in Italy, they say aspartame is linked to brain
tumors, lymphoma, leukemia, seizures, allergic reactions, headaches and dizziness.
As a result, the state’s Environmental Improvement Board faces tough questions about
this popular, though controversial, ingredient, which Americans have consumed since
1981. Does the state have the legal power to dictate a ban on products that have federal
approval? Does the evidence against aspartame hold up under scientific scrutiny?
The EIB has the authority to adopt rules that govern food protection. But at a meeting
Tuesday, board members spent more than an hour debating whether they have the
power to challenge NutraSweet. They scheduled a public hearing in October to sort out
the legal issues.
Realizing a statewide ban might take a long time, Dr. Grant La Farge, a Santa Fe
cardiologist, said in an interview after the meeting, “I’d like to see it removed from
schools.”
Meanwhile, overwhelmed by the campaign against NutraSweet, state assistant Attorney
General Mary H. Smith set her computer to automatically delete any e-mails containing
the word “aspartame,” according to a memo she sent Friday to the EIB. Smith said she
worried viruses might accompany the “flood” of unsolicited e-mails .
Smith, in her memo, also gave a narrow reading on the power of the EIB to ban
aspartame. She would not provide legal advice on whether the board should adopt Fox’s
proposed rules, nor did she research federal interstate-commerce laws.
New Mexico law, however, does grant the board the authority to limit unsafe foods in
which poisonous substances are added.
Aspartame Fact Sheet P.6 of 8
According to nutritionist Janis Roszler’s column in Diabetes Health magazine:
“Aspartame has been the target of many Internet rumors and urban legends linking it to
such diseases as multiple sclerosis, Parkinson’s , Alzheimer’s and lupus. These
allegations have been examined and are absolutely false. Over 200 scientific studies
have confirmed its safety, and regulatory agencies in more than 100 countries have
endorsed its use.”
The U.S. Food and Drug Administration says most people can ingest aspartame safely,
except for those who experience allergic reactions and people who have the rare
disease phenylketonuria . The FDA admits NutraSweet and Equal turn into
formaldehyde and methanol in your stomach, but the agency emphasizes that other
foods, such as citrus fruits and tomatoes, produce as much or more methanol as these
sweeteners do.
Various health groups also have stuck up for these sugar substitutes: the Multiple
Sclerosis Foundation, the American Diabetes Association, the Mayo Clinic, the Calorie
Control Council.
Aspartame is found in about 6,000 products, including Diet Coke and Pepsi, chewing
gum, desserts, jellies, yogurt, vitamins, cough drops and coffee sweeteners. Marsha
Gilford, a spokeswoman for Smith’s grocery stores in the Utah office, said the company
will keep tabs on Fox’s proposal.
“It would be a significant reduction of products in our stores,” she said of the proposed
ban. “Like many other sugar replacements, it’s popular.”
ON THE WEB David O. Rietz’s DORway to Discovery : http://www.dorway.com FDA
rebuttal: www.caloriecontrol.org/response.html
7/14/05 Excerpts from Press Release: Results of study on the carcinogenicity of
the artificial sweetener aspartame CRC/ERF (Cancer Research Center of the
European Foundation of Oncology and Environmental Sciences)
Summary. A long-term study to evaluate the potential carcinogenic effects of aspartame,
an artificial sweetener used in more than 6,000 food and pharmaceutical products has
recently been completed in the experimental laboratories of its Cancer Research Center
of the European Foundation of Oncology and Environmental Sciences Ramazzini in
Bologna, Italy
…First results demonstrate that aspartame, when administered to rats for the entire life
span, induces an increase of lymphomas and leukemias in female rats.
… The above results demonstrate for the first time that aspartame is a carcinogenic
agent, capable of inducing lymphomas and leukemias in female rats, including when
administered at dose levels very close to the acceptable daily intake for humans. In
addition, the data demonstrate that the integration of aspartame into the diet did not
affect the body weight of treated animals compared with untreated animals.
Aspartame Fact Sheet P.7 of 8
Connection between MS and aspartame
by neurosurgeon Russell L. Blaylock,M.D.
Recently, much controversy has surrounded a claim that aspartame may produce an
MS-like syndrome. A current review of recent peer-reviewed scientific studies have
disclosed a pathophysiological mechanism to explain this connection. As far back as
1996 it was shown that the lesions produced in the myelin sheath of axons in cases
of multiple sclerosis were related to excitatory receptors on the primary cells involved
called oligodendroglia. Recent studies have now confirmed what was suspected
back then. The loss of myelin sheath on the nerve fibers characteristic of the disease
are due to the death of these oligodendroglial cells at the site of the lesions (called
plaques). Further, these studies have shown that the death of these important cells
is as a result of excessive exposure to excitotoxins at the site of the lesions.
Normally, most of these excitotoxins are secreted from microglial immune cells in the
central nervous system. This not only destroys these myelin-producing cells it also
breaks down the blood-brain barrier (BBB), allowing excitotoxins in the blood stream
to enter the site of damage. Aspartame contains the excitotoxin aspartate as 40% of
its molecular structure. Numerous studies have shown that consuming aspartame
can significantly elevate the excitotoxin level in the blood. There is a common
situation during which the excitotoxin exposure is even greater. When aspartate (as
aspartame) is combined in the diet with monosodium glutamate (MSG) blood levels
are several fold higher than normal. With the BBB damaged, as in MS, these
excitotoxins can freely enter the site of injury,greatly magnifying the damage. So, we
see that dietary excitotoxins, such
as aspartame and MSG, can greatly magnify the damage produced in multiple
sclerosis. Likewise, excitotoxins have been shown to breakdown the BBB as well.
Of equal concern is observation that we know that about 10% of the
population (based on autopsy studies of elderly) have MS lesions without ever
developing the full blown disease, a condition called benign MS. A diet high in
excitotoxins, such as aspartame, can convert this benign, subclinical condition into
full-blown clinical MS. The amount of excitotoxins consumed in the average
American diet is considerable, as shown by several studies. In addition, the toxin
methanol is also in the aspartame molecule. Methanol is a axon poison. Combined
toxicity of the aspartate and the methanol adds up to considerable brain toxicity and
can convert benign, subclinical MS into full-blown MS. Once the MS becomes fullblown, further consumption of excitotoxins magnifies the toxicity, increasing disability
and death.
Recent studies have also shown that even single exposures to these
food-based excitotoxins can produce prolonged worsening of neurological lesions. In
addition, it has been demonstrated that autoimmune reactions (as occurs with MS)
greatly magnifies the toxicity of aspartate and glutamate (the excitotoxins). We also
know liquid forms of excitotoxins are significantly more toxic because of rapid
absorption and higher blood levels. In the face of this connection between
excitotoxicity and the pathophysiology of MS, it would be ludicrous to allow further
use of this excitotoxin containing sweetener.
References:
Aspartame Fact Sheet P.8 of 8
1. Sannchez-Gomez MV, Malute C. AMPA and kainate receptors each mediate
excitotoxicity in oligodendroglial cultures. Neurobiology of Disease 6:475-485, 1999
2. Yoshika A, et al. Pathophysiology of oligodendroglial excitotoxicity, J
Neuroscience Research 46: 427-437, 1996.
3. Singh P, et al. Prolonged glutamate excitotoxicity: effects on
mitochondrial antioxidants and antioxidant enzymes. Molecular Cell
Biochemistry 243: 139-145, 2003.
4. Leuchtmann EA, et al. AMPA receptors are the major mediators of
excitotoxin death in mature oligodendrocytes. Neurobiology of Disease 14:336-348,
2003.
5. Takahashi JL, et al. Interleukin1 beta promotes oligodendrocyte death through
glutamate excitotoxicity. Annal Neurology 53: 588-595, 2003.
6. Pitt D, et al Glutamate uptake by oligodendrocytes: implications for
excitotoxicity in multiple sclerosis. neurology 61: 1113-1120, 2003.
7. Soto A, et al. Excitotoxic insults to the optic nerve alter visual evoked potentials.
Neuroscience 123: 441-449, 2004.
8. Blaylock RL. Interactions of cytokines, excitotoxins and reactive
nitrogen and oxygen species in autism spectrum disorders. Journal of American
Nutraceutical Association 6: 21-35, 2003.
9. Blaylock RL. Chronic microglial activation and excitotoxicity secondary to
excessive immune stimulation: possible factors in Gulf War Syndrome and autism.
Journal American Physicians and Surgeons, Summer, 2004.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Dr. Blaylock is a recently retired board-certified neurosurgeon with more than twenty
six years experience. He is a recently retired Clinical Assistant Professor of
Neurosurgery at the Medical University of Mississippi. Author of thirty scientific
papers on various medical subjects, chapters in three medical textbooks and a
booklet on multiple sclerosis, he recently completed a booklet on bioterrorism and is
the author of "Excitotoxins: The Taste That Kills", "Health & Nutrition Secrets to Save
Your Life", and "Natural Strategies for Cancer Patients".www.russellblaylockmd.com
He serves on the editorial staff of The Journal of American Physicians and
Surgeons, the Journal of the American Nutraceutical Association, and acts as a
medical advisor to the American Nutraceutical Association. His excellent newsletter
is available at www.blaylockreport.com He lives in Ridgeland, Mississippi.