From: Mark Gold [[email protected]]
Sent: Sunday, January 12, 2003 11:12 PM
To: [email protected]
Subject: Docket # 02P-0317 Recall Aspartame as a Neurotoxic Drug: File
#4: Reported Aspartame Toxicity Reactions
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
Date: January 12, 2002
Please find below Evidence File #4: Reported Aspartame Toxicity Effects
Reported Aspartame Toxicity Effects
Q. What are the reported reactions to aspartame ingestion?
How often are such effects seen?
==> What are the reported reactions to aspartame ingestion?
We will limit our discussion in this FAQ to reported toxicity
reactions to aspartame ingestion. Controlled studies showing
problems with aspartame ingestion will be discussed in another
FAQ. Toxicity reactions to aspartame can be divided into three
1. Acute toxicity reactions occuring within 48 hours of ingestion of
an aspartame-containing product.
2. Chronic toxicity effects occuring anywhere from several days of
use to appearing a number of years (i.e., 1-20+ years) after the
beginning of aspartame use.
3. Potential toxicity effects that would be nearly impossible for
the user to recognize the link to aspartame.
In an epidemiological survey which appeared in the Journal of
Applied Nutrition (Roberts 1988), 551 persons who have
reported toxicity effects from aspartame ingestion were
surveyed. The adverse effects found cover a subset of reported
acute and chronic toxicity effects from aspartame.
What follows is a listing of the adverse health effects
which were found.
– Decreased vision and/or other eye problems 140 (25%)
(blurring, “bright flashes,” tunnel vision)
– Pain (or or both eyes) 51 (9%)
– Decreased tears, trouble with contact lens, 46 (8%)
– Blindness (one or both eyes) 14 (3%)
– Tinnitus (“ringing,” “buzzing”) 73 (13%)
– Severe intolerance for noise 47 (9%)
– Marked impairment of hearing 25 (5%)
– Headaches 249 (45%)
– Dizziness, unsteadiness, or both 217 (39%)
– Confusion, memory loss, or both 157 (29%)
– Severe drowsiness and sleepiness 93 (17%)
– Paresthesias (“pins and needles,” “tingling”) 82 (15%)
or numbness of the limbs
– Convulsions (grand mal epileptic attacks) 80 (15%)
– Petit mal attacks and “absences” 18 (3%)
– Severe slurring of speech 64 (12%)
– Severe tremors 51 (9%)
– Severe “hyperactivity” and “restless legs” 43 (8%)
– Atypical facial pain 38 (7%)
– Severe depression 139 (25%)
– “Extreme irritability” 125 (23%)
– “Severe anixiety attacks” 105 (19%)
– “Marked personality changes” 88 (16%)
– Recent “severe insomnia” 76 (14%)
– “Severe aggravation of phobias” 41 (7%)
– Palpitations, tachycardia (rapid heart action), 88 (16%)
– “Shortness of breath” 54 (10%)
– Atypical chest pain 44 (8%)
– Recent hypertension (high blood pressure) 34 (6%)
– Nausea 79 (14%)
– Diarrhea 70 (13%)
Associated gross blood in the stools (12)
– Abdominal pain 70 (13%)
– Pain on swallowing 28 (5%)
Skin and Allergies
– Severe itching without a rash 44 (8%)
– Severe lip and mouth reactions 29 (5%)
– Urticaria (hives) 25 (5%)
– Other eruptions 48 (9%)
– Aggravation of respiratory allergies 10 (2%)
Endocrine and Metabolic
– Problems with diabetes: loss of control; 60 (11%)
precipitation of clinical diabetes;
aggravation or simulation of diabetic
– Menstrual changes 45 (6%)
Severe reduction or cessation of periods (22)
– Paradoxic weight gain 34 (5%)
– Marked weight loss 26 (6%)
– Marked thinning or loss of the hair 32 (6%)
– Aggravated hypoglycemia (low blood sugar 25 (5%)
– Frequency of voiding (day and night), burning 69 (13%)
on urination (dysuria), or both
– Excessive thirst 65 (12%)
– Severe joint pains 58 (11%)
– “Bloat” 57 (10%)
– Fluid retention and leg swelling 20 (4%)
– Increased susceptibility to infection 7 (1%)
There are other clinical reports in the scientific literature of
aspartame-caused toxicity reactions including Blumenthal (1997),
Drake (1986), Johns (1986), Lipton (1989), McCauliffe (1991),
Novick (1985), Watts (1991), Walton (1986, 1988), and Wurtman
Many pilots appear to be particularly susceptible to the effects of
aspartame ingestion. They have reported numerous serious toxicity
effects including grand mal seizures in the cockpit (Stoddard 1995).
Nearly 1,000 cases of pilot reactions have been reported to the
Aspartame Consumer Safety Network Pilot Hotline (Stoddard 1995).
This susceptibility may be related to ingesting methanol at altitude
as suggested in a letter from Dr. Phil Moskal, Professor of
Microbiology, Biochemistry, and Pathology, Chairman of the Department
of Pathology, Director of Public Health Laboratories (Moskal 1990),
or it may simply be that some pilots tend to ingest large quantities
of aspartame during a flight. Whatever the case, numerous warnings
about aspartame dangers have appeared in piloting journals including
The Aviation Consumer (1988), Aviation Medical Bulliten (1988),
Pacific Flyer (1988), CAA General Aviation (1989), Aviation Safety
Digest (1989), General Aviation News (1989), Plane & Pilot (1990),
Canadian General Aviation News (1990), National Business Aircraft
Association Digest (NBAA Digest 1993), International Council of
Air Shows (ICAS 1995), and the Pacific Flyer (1995). Both the U.S.
Air Force’s magazine “Flying Safety” and the U.S. Navy’s magazine,
“Navy Physiology” published articles warning about the many dangers
of aspartame including the cumlative deliterious effects of methanol
and the greater likelihood of birth defects. The articles note that
the ingestion of aspartame may make pilots more susceptible to
seizures and vertigo (US Air Force 1992).
Countless other toxicity effects have been reported to the FDA (DHHS
1995), other independent organizations (Mission Possible 1996,
Stoddard 1995), and independent scientists (e.g., 80 cases of
seizures were reported to Dr. Richard Wurtman, Food (1986)).
Samples of some aspartame toxicity reactions reported on the
Internet can be found on the Aspartame (NutraSweet) Toxicity Info
Center web page:
Frequently, aspartame toxicity is misdiagnosed as a specific disease.
This has yet to be reported in the scientific literature, yet it has
been reported countless times to independent organizations and
scientists (Mission Possible 1994, Stoddard 1995). In other cases,
it has been reported that chronic aspartame ingestion has triggered
or worsened certain chronic illnesses. Nearly 100% of the time, the
patient and physician assume that these worsening conditions are
simply a normal progression of the illness. Sometimes that may be
the case, but many times it is chronic aspartame poisoning.
According to researchers and physicians studying the adverse
effects of aspartame, the following list contains a selection
of chronic illnesses which may be caused or worsened by the chronic,
long-term ingestion of aspartame. (Mission Possible 1994, Stoddard
Brain tumors Multiple sclerosis
Epilepsy Chronic faigue syndrome
Parkinson’s Disease Alzheimer’s
Mental retardation Lymphoma
Birth defects Fibromyalgia
Diabetes Arthritis (including Rheumatoid)
Chemical Sensitivities Attention Deficit Disorder
*Note: In some cases such as MS, the severe symptoms
mimic the illness or exacerbate the illness,
but do not cause the disease.
Also, please note that this is an incomplete list. Clearly,
ingestion of a very slow poison (as discussed in other FAQs) is not
beneficial to anyone who has a chronic illness.
Finally, potential toxicity effects from aspartame including brain
cancer (as seen in pre-approval research) and effects on fetal brain
and nervous system development will be discussed in other FAQs.
==> How often are such effects seen?
Until recently approximately 90% of aspartame sales were in the
United States (Monsanto 1994). Other countries are now being inundated
with aspartame, but it will be some time until they begin to feel the
full effects of aspartame toxicity on the general population. Since the
U.S. has some history of significant use, we will limit the discussion
to the frequency of effects in the U.S.
There have been well over 7,000 aspartame toxicity reactions officially
received by the U.S. Food and Drug Administration between 1982 (after
aspartame was first approved) until 1995 (DHHS 1993, DHHS 1995).
From this figure, we can estimate the number of actual toxicity
FDA officials believe that as little as 1% of the serious
adverse drug reactions are reported to the FDA (Kessler
1993). Using a reported rate of 1%, we would estimate that there
have been 700,000 recognized aspartame toxicity reactions in the U.S.
since 1982. However, there are a number of significant adjustments
that must be made before we can accept this estimate.
1. Most physicians are aware of the Adverse Reaction
Monitoring System (ARMS) and are encouraged by the FDA
to report serious adverse drug reactions (Kessler 1993).
Physicians are not encouraged by the FDA to report aspartame
toxicity reactions to the FDA (Food 1995). The lay
public is generally unaware of ARMS and much less likely to
report adverse reactions to the FDA. Therefore, this would
lower the estimated reporting rate below 1%. Let us make a
small adjustment and estimate a 0.88% reporting rate.
2. It was pointed out by James Turner, Esq. in a letter to the then
FDA Commissioner Frank Young that no program to monitor aspartame
toxicity reactions was created until February 1984, two years after
aspartame approval began (Turner 1984). This would probably add at
least 1,200 reported reactions (probably much more), so that we
should use 8,200 toxicity reaction reports. In addition, a
Freedom of Information act request determined that the regional
FDA offices had been told that only “serious” complaints should
be forwarded to the FDA headquarters (Turner 1984). “Serious”
complaints were complaints where the illness was severe enough
to require the attention of a physician. Since this happened
between 1984 (when the monitoring system began) and 1985, we can
estimate an additional 300 toxicity reactions would have been
reported for a total of 8,500.
3. In 1987, it was brought out at U.S. Congressional Hearings that
the FDA had been transferring aspartame toxicity reaction calls
to the AIDS Hotline (Turner 1987). In addition, it was reported
by James Turner, Esq. of Community Nutrition Institute (CNI) that
there were numerous cases of people calling the FDA to report
toxicity reaction and they were told that there was no connection
between aspartame and adverse reactions and no other information was
taken by the FDA. While this may not effect the reporting rate
after the start of 1988, it would significantly effect the reporting
rate before that time. Let us make another small adjustment and
estimate a 0.78% reporting rate.
4. Perhaps the biggest reduction in the reporting rate comes from
the fact that Commissioner Kessler’s estimated 1% reporting rate
for adverse drug reactions involves only “serious” adverse
reactions. The rate for reporting *all* drug reactions (if such
reporting were done) would almost certainly be no more than 0.5%.
Therefore, if we cut our current estimated reporting rate of
0.78% in half, the estimated reporting rate for *all* toxicity
reactions to aspartame (including serious or mild) would be no
more than 0.39%.
During the first couple of years that aspartame was on the market,
there was publicity that would likely have increased the reporting
rate. However, since the FDA did not have a monitoring system in
place until February 1984, the estimated increased number of reports
will not be that much. I will reduce the number of reports by 1,000
to 7,500 to take this into account.
We now have approximately 7,500 reports at an estimated reporting
rate of 0.39%. This totals approximately 1.9 million *recognized*
aspartame toxicity reactions in the U.S. between 1982 and 1995.
These reactions run anywhere from mild to very serious illnesses.
It is very important to understand, however, that 1.9 million
represents only those toxicity reactions that have been discovered by
users and/or healthcare practitioners. Quite often, I encounter case
histories were people suffered for long time and did not make the
connection. For example:
“I have suffered from Migraines for years. As soon as I gave up
Nutrasweet my migraines disappeared. All those Cat Scans,
“Since I last wrote my brother has been off nutrisweet since
then. My brothers lupus type of symptoms completely went
away. My brother has been a physician for over 10 years
.. his doctor (a specialist) who has been treating him has
seen the significant difference and wants to write a research
paper on this .. my brothers physician has now started
prescribing getting off nutrisweet for his other patients.”
Therefore, I believe that in addition to the estimated 1.9 million
people in the U.S. who have recognized aspartame toxicity reactions
in themselves (from serious to mild), there are many times that
number who are suffering from some of the symptoms mentioned above
and that they do not recognize that chronic aspartame use is the
cause or at least a contribuatory factor. I would estimate that *at
least* 7.6 million others are suffering from some symptoms related to
aspartame use (many mild symptoms, but many serious ones as well) and
do not recognize the connection.
In addition to the estimated 1.9 million recognized reactions and 7.6
million unrecognized reactions in the U.S., it is very important to
note that aspartame has been used in significant amounts in the U.S.
for a relatively short time. A U.S. Department of Agriculture
report noted that it wasn’t until approximately 1987 that aspartame
was used in significant amounts in the U.S. (USDA 1988). Therefore,
aspartame had been used for only nine (9) years in signficant amounts
through 1995. When one considers that the damage from aspartame is
often silent and cumulative (much like chain-smoking cigarettes), one
can see that a couple of generations of aspartame use might be
The FDA and NutraSweet have claimed that the number of reported
adverse reactions have declined substantially since the mid-
1980s (Pauli 1995, Butchko 1994). In addition, the FDA recently
claimed that the number of reported toxicity reactions for 1995 was
only 11 (WSJ 1996)! It is important to realize that during the
mid-1970s the FDA was investigating wrong-doings of the aspartame
manufacturer and stated the facts exactly as they found them:
“[The manufacturer] lied and they didn’t submit the
real nature of their observations because had they
done that it is more than likely that a great number
of these studies would have been rejected simply
for adequacy. What Searle did, they took great
pains to camouflage these shortcomings of the
study. As I say filter and just present to the
FDA what they wished the FDA to know and they did
other terrible things for instance animals would
develop tumors while they were under study. Well
they would remove these tumors from the animals.”
[FDA Toxicologist and Task Force member, Dr. Andrian
Gross (Wilson 1985)]
During the late 1970s and early 1980s, a number of key government and
FDA officials left their jobs to work with companies related to the
aspartame industry (GAO 1986). This included key FDA officials such
as the head of the FDA Bureau of Foods becoming a Vice President of
the National Drink Association and the FDA Commissioner becoming a
high-paid consultant for the manufacturer’s PR firm, Burston
Marsteller (Gordon 1987). After this period of time, there was no
scientific evidence and no amount of serious toxicity reports that
could get the FDA to seriously consider funding independent,
properly-conducted (e.g., chronic exposure) research. That
appearance of the FDA being under the total control of the
manufacturer, Monsanto, continues to this day.
I include these comments about the FDA to demonstrate why no
independent scientist familiar with the aspartame issue takes
statements from the FDA such as “11 reported reactions in 1995”
seriously. There are many people, including myself who have received
that many toxicity reaction reports in a single day during 1995.
The reality is that independent organizations have noted that
aspartame toxicity reaction reports given to them have *increased*
every year since the late 1980s (Stoddard 1995). It is also
important to note that in mid-1995, the FDA admited that it had
stopped recording aspartame toxicity reactions (Food 1995). That
may have something to do with why the numbers that the FDA reported
to the Wall Street Journal (WSJ 1996) were so small!
Aviation Consumer 1988. “SafeGuard,” June 15, 1988.
Aviation Medical Bulletin 1988. “Pilots and Aspartame,”
Aviation Safety Digest 1989. “Aspartame — not for the
dieting pilot?” Aviation Safety Digest, ASD 142, Spring
1989 (Australia – 062/5841111).
Blumenthal, H.J., D.A. Vance, 1997, “Chewing Gum Headaches,”
Headache, Volume 37, Number 10, pages 665-666.
Butchko, Harriett H., Frank N. Kotsonis 1994. “Postmarketing
Surveillance in the Food Industry: The Aspartame Case
Study,” in Nutritional Toxicology, edited by Frank N.
Kotsonis, Maureen Macky and Jerry Hjelle, Raven Press,
Ltd., New York, c1994.
CAA General Aviation (1989). Safety Information Leaflet,
April 1989, Great Britain.
Canadian General Aviation News 1990. “Fit to fly” Canadian
General Aviation News, March 1990, page 28.
DHHS 1993. “Adverse Reactions Associated With Aspartame
Consumption,” Department of Health & Human Services
Memorandum, April 1, 1993, Reprinted in preface of
“Bittersweet Aspartame: A Diet Delusion” by Barbara
Alexander Mullarkey, NutriVoice, P.O. Box 946, Oak
Park, Illinois 60303, (708) 848-0116.
DHHS 1995. Department of Health and Human Services. “Report
on All Adverse Reactions in the Adverse Reaction
Monitoring System.” (April 20, 1995).
Drake, M.E., 1986. “Panic Attacks and Excessive Aspartame Ingestion”
(Letter), Lancet, September 13, 1986, page 631.
Food 1986. Food Chemical News, July 28, 1986, page 44.
Food 1995. “Aspartame Adverse Reaction Reports Down in 1994
From 1985 Peak: FDA,” Food Chemical News, June 12, 1995,
GAO 1986. “Six Former HHS Employees’ Involvement in
Aspartame’s Approval,” United States General Accounting
Office, GAO/HRD-86-109BR, July 1986.
General Aviation News 1989. “NutraSweet…too good to be
true?” by Megan Hicks, General Aviation News, July 31,
Gordon, Gregory, 1987. “NutraSweet: Questions Swirl,” UPI
Investigative Report, 10/12/87. Reprinted in US Senate
U.S. Senate Committee on Labor and Human Resources,
November 3, 1987 regarding “NutraSweet Health and Safety
Concerns.” Document # Y 4.L 11/4:S.HR6.100, page 499.
ICAS 1995. “Aspartame Side Effects: Fact or Fiction?”
International Council of Air Shows, February 1995.
Johns, Donald R., 1986. “Migraine Provoked By Aspartame,” (Letter),
New England Journal of Medicine, Volume 314, August 14, 1986,
Kessler, David A. 1993, “Introducing MEDWatch: A New
Approach to Reporting Medication and Device Adverse
Effects and Product Problems” Journal of the American
Medical Association 269:2765-68.
Lipton, Richard B., et al., 1989. “Aspartame as a Dietary Trigger of
Headache,” Headache, Volume 29, pages 90-92.
McCauliffe, D.P., K. Poitras, 1991. “Aspartame-Induced Lobular
Panniculitis,” Journal of the American Academy of Dermitology, Volume
24, page 298-300.
Mission Possible 1994. Compiled by researchers, physicians,
and artificial sweetner experts for Mission Possible, a
group dedicated to warning consumers about aspartame.
Available from Mission Possible, 9270 River Club Pkwy,
Duluth, Georgia 30155, 770-242-2599, [email protected].
Mission Possible 1996. Conversations between Betty Martini of
Mission Possible and Mark D. Gold.
Monsanto 1994. “Monsanto Annual Report,” 1994.
Moskal, Phil, 1990. Letter from Dr. Phil Moskal to George
Leighton, June 19, 1990, Reprinted in “The Deadly Deception”
Compiled by the Aspartame Consumer Safety Network for volumes
of available published information, ACSN, P.O. Box 780634,
Dallas, Texas 75378, (800) 969-6050.
NBAA Digest 1993. “Operationally Speaking” by G. Dennis
Wright, Vice President of Operations. NBAA Digest, Volume
6, Number 6, June 1993. Available from National Business
Aircraft Association, Inc., 1200 Eighteenth St., NW,
Suite 200, Washington, DC 20036-2506, (202) 783-9000.
Novick, Nelson Lee, 1995. “Aspartame-Induced Granulomatous
Panniculitis,” Annals of Internal Medicine, Volume 102, Number 2,
Pacific Flyer 1988. “This Could Save Your Life” Pacific
Flyer Aviation News, November 1988, 3355 Mission Ave.,
Oceanside, CA 92054.
Pacific Flyer 1995. “ICAS Issues Warning To Its Members About Diet
Drinks,” March 1995.
Pauli, George, 1995. FDA Center for Food Safety and Applied
Nutrition (CFSAN). Radio broadcast: “Aspartame,” The
Derek McGinty Show, WAMU Radio (88.5 FM), Brandywine
Building, The American University, Washington, DC 20016-
8082, (202) 885-1200, August 29, 1995.
Plane & Pilot 1990. “Getting High” Plane & Pilot, January
1990, page 36-37.
Roberts, H.J., 1988. “Reactions Attributed to Aspartame-
Containing Products: 551 Cases,” Journal of Applied
Nutrition, Volume 40, page 85-94.
Stoddard, Mary Nash, 1995. Conversations between Mary Nash
Stoddard of the Aspartame Consumer Safety Network and
Mark D. Gold.
Turner, James, Leonard, Rodney, 1984. Letter from Rodney E. Leonard
and James S. Turner of Community Nutrition Institute to Dr. Fank E.
Young, FDA Commissioner, September 13, 1984. Reprinted in
“Aspartame Safety Act,” Congressional Record, Volume 131, No. 106,
August 1, 1985, page S10841.
Turner, James, 1987. Testimony of James Turner, Esq.,
Community Nutrition Institute before the U.S. Senate
Committee on Labor and Human Resources, November 3, 1987
regarding “NutraSweet Health and Safety Concerns.”
Document # Y 4.L 11/4:S.HR6.100, page 316.
US Air Force 1992. “Aspartame Alert.” Flying Safety 48(5):
20-21 (May 1992).
USDA 1988. “1988 United States Department of Agriculture
Situation and Outlook Report; Sugar and Sweeteners.”
Washington, DC: U.S. Government Printing Office, pp. 51.
WSJ 1996. “Aspartame Critic Seeks More Research On Possibility of
Links to Brain Tumors,” The Wall Street Journal, November 8, 1996.
Walton, Ralph G., 1986. “Seizure and Mania After High Intake
of Aspartame,” Psychosomatics, Volume 27, page 218-220.
Walton, Ralph G., 1988. “The Possible Role of Aspartame in
Seizure Induction,” Presented at “Dietary Phenylalanine
and Brain Function.” Proceedings of the First
International Meeting on Dietary Phenylalanine and Brain
Function, Washington, D.C., May 8-10, 1987. Center for
Brain Sciences and Metabolism Charitable Trust, P.O. Box
64, Kendall Square, Cambridge, MA 02142. Reprinted in
“Dietary Phenyalalnine and Brain Function,” c1988,
Birkhauser, Boston, MA USA, page 159-162.
Watts, Richard S., 1991. “Aspartame, Headaches and Beta Blockers”
(Letter to the Editor), Headache, March, 1991, Page 181-182.
Wilson, Steve, 1985. “Sweet Suspicions,” Television
broadcast and interviews regarding aspartame. Transcript
in Congressional Record, Volume 131, No. 106, August 1,
1985, page S10826-S10827.
Wurtman, Richard J., 1985. “Aspartame: Possible Effect on
Seizure Susceptibility” (Letter), The Lancet, Volume 2, page 1060.