•
NUTRITIONAL INFORMATION:
Children
need the most nutrition possible for proper growth and long-term
health. During the formative years it is so important to have the
proper nutrients present as the body is building, growing and setting
the stage for the rest of their lives. To us here at LifeSource
Nutrition, the most important time of life is during this building
stage of life. This sets the stage for their health for all the
years to come. All of our studies, as well as scientists all over
the world are finding that the nutrition, or lack there of during
the growth period pre-determines bone structure, and total health
patterns, whether they be good or bad. Our formula ensures that
no matter what their diet entails, they will be getting the nutrition
needed for optimum health for now and later life. Our vitamins are
sugar free, they taste great, but the most important thing is that
just like all of our products, you can trust what is on the label
is in the vitamin. When your children’s chewable cost less
per day than it costs to produce a gumball, which is almost all
sugar, then you might be skeptical of what the ingredient are in
the tablets.
Children
need a sound nutritional basis upon which to grow and develop, so
it’s important to ensure that they eat a balanced diet. Of
course, many children do not eat the right foods, opting instead
for fast foods and foods containing more sugar than nutritional
value. In order to ensure that your children get all the nutrients
needed, you may choose to give them a daily vitamin. However, the
last thing you want in that vitamin is a bunch of sugar. So what
is a parent to do? Try LifeSource Nutrition’s pride and joy
for your kids, which is a multivitamin formulated specifically to
ensure that children receive the nutrients they need to properly
support their bodies during their years of growth and development.
LifeSource
Chewables is a naturally flavored, good tasting, multiple vitamin
and mineral supplement with added ingredients that go well beyond
the sugar pills of today. LifeSource Children’s not only contains
the vitamins and minerals that are normally found in a children’s
vitamin, it also contains the full spectrum of all vitamins and
minerals classified as "essential." An essential vitamin
is one needed by the body but not produced by it. Therefore, they
must be obtained from our diet or supplements. LifeSource Children’s
also contains trace minerals and associated nutrients that are very
important to a child’s growth and development, but may not
be found in other children’s vitamins.
• As important as taking a quality Multivitamin is for adults
as stated by the American Medical Association, a majority of your
children’s future is decided by the decisions you as parents,
grandparents, or family and friends make for what goes in their
precious bodies. To give your child the foundation of good health
while growing up is so very important. Most kids are still going
to eat fast food, potato chips etc, but if they have the foundation
set, it will help their mental clarity at school, it will help them
sleep better, play longer, be sick much less if at all, imagine,
no more colds. Our Multi’s provide every nutrient that your
children’s growing body truly needs.
LifeSource Children’s Chewable’s were developed by our
team of pediatricians, biochemists and a pharmacist with years of
experience in this field. We saw a need for a totally comprehensive
multiple vitamin for children and LifeSource Nutrition the company
was formed for that very reason.
We have challenged everyone to look in any drug store or health
food store and try to find one that even comes close to LifeSource’s
Children’s Chewables. None can be found. All other children's
multiples contain Vitamins A, C, D and a small amount of B Complex.
For all practical purposes, most all other chewable products available
are made in a base of regular table sugar and flavored with synthetic
substances so they will taste like candy. They are all loaded with
different synthetic food coloring agents. (Studies have been done
in several public school systems proving that the various food additives,
including coloring agents, cause hyperkinetic children). These so
called "nutritional products" usually gain their appeal
by widespread intensive TV advertising, not because of their nutritional
value.
LifeSource Chewables is flavored with a blend of natural extracts
from citrus, pineapple, grape and cherry. It is sweetened with fructose,
a natural fruit sugar that does not stimulate the insulin response
by the pancreas like regular table sugar. LifeSource Chewables does
not contain any artificial coloring, flavoring agents or preservatives.
Natural Beta-Carotene, which is totally safe even in large amounts,
is used as the source of Vitamin A. As in all Life Plus products,
the Vitamin D found in our chewables is natural Vitamin D-3 from
fish liver oil. Also included is oil soluble Vitamins E and Vitamin
K.
LifeSource
is the only children's product that we have seen that contains all
of the trace minerals, Manganese, Copper, Zinc, Iodine, Selenium,
Molybdenum, Chromium and Vanadium, in addition to the two standard
important minerals, Calcium and Magnesium.
•
DOSE:
Children 4 years and above take ONE tablet daily (a 6 month
supply) and children under 4 years of age take ½ tablet daily
(1 full year supply).
* Because heat destroys the activity of many vitamins, enzymes and
phytonutrients, LifeSource Nutrition employs only cold processing
manufacturing techniques. Even though cold processing is costly
and time consuming, it is the standard procedure at LifeSource Nutrition.
**
Contains no preservatives, sugar, starch, salt, wheat, yeast, corn,
milk, soy derivatives, artificial flavoring or coloring agents.
***
No sucrose, no yeast, no artificial flavor, no artificial color.
Just vitamins and minerals from A to Z.
Supplement
Facts |
| |
UNDER
4 YEARS OLD |
4
YEARS & OLDER |
| Vitamin
A
|
2500
IU |
100
% |
5000
IU |
100
% |
| Vitamin
C
|
50
mg. |
125% |
100
mg. |
100
% |
| Vitamin
D
|
200
IU |
50% |
400
IU |
100
% |
| Vitamin
E
|
15
IU |
150% |
30
IU |
100
% |
| Vitamin
B1 (Thiamin)
|
0.75
mg. |
107% |
1.5
mg. |
100
% |
| Vitamin
B2 (Riboflavin)
|
0.85
mg. |
106% |
1.7
mg. |
100
% |
| Vitamin
B6
|
1
mg. |
143% |
2
mg. |
100
% |
| Vitamin
B12
|
3
mcg. |
100% |
6
mcg. |
100
% |
Copper |
1
mg. |
100% |
2
mg. |
100
% |
Iodine |
75
mcg. |
107% |
150
mcg. |
100
% |
Iron |
9
mg. |
90% |
18
mg. |
100
% |
Niacin |
10
mg. |
111% |
20
mg. |
100
% |
Pantonthenic
Acid |
5
mg. |
100% |
10
mg. |
100
% |
Zinc |
7.5
mg. |
94% |
15
mg. |
100
% |
Calcium |
100
mg. |
13% |
200
mg. |
26% |
Biotin |
20
mcg. |
13% |
40
mcg. |
40% |
Phosphorus |
50
mg. |
6% |
100
mg. |
100% |
Magnesium |
10
mg. |
5% |
20
mg |
10% |
L-Lysine |
15
mg. |
* |
30
mg. |
* |
DHA |
7.5
mg. |
* |
15mg. |
* |
Choline
(Bitartrate) |
2.5
mg. |
* |
5
mg. |
* |
Inositol |
2.5
mg. |
* |
5
mg. |
* |
Pyridoxal-5-Phosphate |
0.75
mg. |
* |
1.5
mg. |
* |
*No USDA has been established
• NO ARTIFICIAL COLORS, SWEETNERS, PRESERVATIVES,
NON-ALLERGENIC, NO YEAST, GLUTEN OR WHEAT, CORN,
SOY OR MILK & NO ASPARTAME.
|
|
VERY IMPORTANT, WHEN YOUR CHILDREN’S
CHEWABLES OR ANYTHING THEY TAKE SAYS: * CONTAINS ASPARTAME. ** PHENYLKETONURICS:
CONTAINS PHENYLALANINE. DO NOT LET THEM EAT IT!
BELOW YOU CAN READ WHY!
DEAR DR.PAUL:
Everything seems to contain aspartame today. I have an eight-month-old
son. Is aspartame safe for use in children? .
PEDIATRICIAN
DR.PAUL Answers: A very good question which makes me think of a
few other "inactive" ingredients found in food and drug
products.
In
fact, there are over 700 chemical agents including aspartame, coloring
dyes, preservatives in food and asthma medications which have been
FDA approved for use as "inactive ingredients". They are
labeled as inactive, as they presumably do not have any effect on
the people consuming them.
For
example, the active ingredient in a chewable fever tablet, would
be acetaminophen. The aspartame, an inactive component, acts as
an artificial sweetener but presumably has no other effects.
Looking
specifically at your concern, aspartame is being increasingly used
in chewable tablets and other sugar-free medications, as well as
in diet sodas, gum and sweetened foods such as pudding and cereal.
While considered safe in children, there have been some concerns
about aspartame in children with in-born metabolic problems such
as PKU (or phenylketonuria).
In
normal children, it can be taken safely in small amounts. However,
when a small child drinks a 12-ounce can of diet soda he consumes
almost twice the daily amount considered safe.
What
are the effects of aspartame? Although there are not that many studies,
some reports suggest symptoms that may include headache (especially
in patients prone to migraines), mood changes, dizziness and panic
attacks. There is no link between aspartame use and aggressive or
hyperactive behaviors in children. The bottom line is: taken in
small amounts, such as in medications I think aspartame is safe.
But we should not take the fact that it is labeled as inactive at
face value.
How Safe IS Aspartame?
WARNING:
Side effects may include: Seizures. Depression. Brain damage. Memory
loss. Migraine headaches. Numbness. Blindness. (57-66) Serious sounding
repercussions. Surely the FDA would warn you if it knew a common
product might trigger reactions like these.
NOT
SO. This substance, sweetly packaged, rests quietly on tabletops,
in soft drinks, chewing gum, vitamins and in medicines. (37-55)
The illusion it portrays is as free of warning as a Sunday stroll
in the park. Consumers recognize it by its attractive red and white
swirled logo, and are drawn by its promise of an all-natural, low-calorie,
sweet flavor. In a country obsessed by dieting and abhorrent of
the perceived sins of sugar, this product has gained unprecedented
popularity since it was discovered accidentally thirty years ago
by a chemist mixing chemicals in search of a medicine to relieve
ulcers. NutraSweet. Equal. Equal Measure. Spoonful. Its brand names
are ubiquitous in food and food products as it corners the market
on low calorie sweeteners. Aspartame, as it is known generically,
skyrocketed to its position as the most popular sugar substitute
in the world shortly after it gained approval for public consumption.
Worldwide, the aspartame industry's sales of the product amount
to over $1 billion yearly. (58) In the United States, NutraSweet
enjoys a $700 million sales share, and shows no signs of retreat.
(58,68)
The
NutraSweet group became a part of G.D. Searle Company, a pharmaceutical
business, after one of its chemists discovered the sweetener, and
realized the sales potential of a sugar substitute. Searle and NutraSweet
are now owned by Monsanto Company. Producers of NutraSweet maintain
their platform that the safety of aspartame has been confirmed.
They cite affirmation of aspartame by a number of agencies and organizations
nation-wide, including the American Medical Association, the World
Health Organization, the American Academy of Pediatrics, the American
Diabetes Association, the American Dietetic Association, and the
American Epilepsy Association. Yet aspartame came amazingly close
to not being approved by the Food and Drug Administration (FDA)
in the first place. What aspartame actually is, and how it affects
certain individuals, is at the heart of a continuing controversy
over its increasing distribution in food (including food served
in hospitals), medicine, candy, confections, cereal, soft drinks,
and scores of other products.
Known
chemically as aspartame (C14H18O5), NutraSweet is a compound composed
of the following chemicals by weight: methanol (10%), aspartic acid
(40%), and phenylalanine (50%). In dry form, the composition is
stable, however, when placed in liquid it can break down into its
component parts (methanol, aspartate, and phenylalanine). Heat will
speed its breakdown. Another breakdown product is diketopiperazine
(DKP). In certain combinations these elements can results in adverse
reactions in some people. Methanol further breaks down into formaldehyde
and formic acid, both known to cause serious side effects in sensitive
individuals. (58,64,67,69)
The RANDOM HOUSE DICTIONARY defines methanol (also known as methyl
alcohol) "as a colorless, poisonous liquid used chiefly as
a solvent, fuel, etc." (70) Methanol is on the Environmental
Protection Agency's (EPA) Community Right to Know List, and is reported
in EPA's Toxic Substances Control Act Inventory. Sax's Dangerous
Properties of Industrial Materials states methanol is "a human
poison by ingestion." (71)
The
levels of methanol are quite low in a single serving of a product
containing aspartame, provided that it has not been exposed to heat
or left for a long time on the shelf. Because these factors promote
the breakdown of aspartame into its component parts, researchers
are concerned that high consumption levels combined with aspartame's
unstable shelf life may allow methanol to reach toxic levels in
some cases. (21,72) Human systemic effects from methanol include
changes in circulation, cough, headache, nausea and vomiting, optic
nerve neuropathy, respiratory effects, and visual field changes.
In experiments, it has shown teratogenic (birth defects) and adverse
reproductive effects.
Genetic
mutations from methanol have been reported in human tissue. Methanol
is classified as a narcotic. (71) According to Sax, methanol's "main
toxic effect is exerted upon the nervous system, particularly the
optic nerve, and possibly the retinae which can progress to permanent
blindness. Once absorbed, methanol is only very slowly eliminated.
Coma resulting from massive exposures may last as long as 2-4 days.
In the body, the products formed by its oxidation are formaldehyde
and formic acid, both of which are toxic. Because of the slow elimination,
methanol should be regarded as a cumulative poison. Though single
exposures to fumes may cause no harmful effect, daily exposure may
result in the accumulation of sufficient methanol in the body to
cause illness. Death from ingestion of less than 30 ml (milliliters)
has been reported." (71) Phenylalanine is an amino acid. However,
in high levels it can cause brain damage. People with phenylketonuria
are at risk for brain damage if they consume even just one liter
of aspartame sweetened soda pop in a day, because the disease inhibits
the body's ability to metabolize it. (67,72)
The FDA and the Centers for Disease Control have received nearly
7,000 complaints, including five deaths, attributed to the use of
aspartame in food products since the FDA first permitted limited
use in 1981. (39,47,56) A number of researchers and doctors around
the country object not only to the product itself, but to the questionable
preliminary research that led FDA to approve it for use in dry products
in 1981. Aspartame was the accidental discovery of chemist Jim Schlatter,
who was working or Searle on an anti-ulcer drug. It was December
1965; Schlatter licked his finger and tasted the substance that
had spilled on his flask. It's sweetness stunned him, and he realized
that tiny amounts of the chemicals he'd been mixing were powerfully
sweet. Searle began testing the chemical mixture - aspartame - and
it eventually gained FDA approval, but not without concerns about
its safety. A consumer hot line was organized in 1987 to answer
questions about the sweetener and its potential deleterious effects.
(74) Doctors and researchers have protested both its us and the
research that led to its approval. A number of books have been published
denouncing and challenging its self-portrayed description as an
innocuous food additive. And victims of its side effects are listed
in doctors' case studies. (1.57-66,75,76,79)
After
reviewing scientific and medical literature on aspartame published
since 1970, Cherry Gaffney, the Armed Forces Institute of Pathology
concluded aspartame 's ingestion may lead to blood pressure instability
and perceptual disorders in some persons. She said that additional
studies were necessary to evaluate the impact of aspartame on aviation.
(65) Her warning was directed to pilots whose performance could
be affected by using the substance. The organization of the Aspartame
Consumer Safety Network in 1987 was the direct result of the founder's
nightmarish encounter with aspartame.
In
1989 Mary Stoddard related her physical and emotional decline in
1984 during an attempt to lose weight. She said she experienced
dozens of symptoms that she'd never had before. She described ringing
in her ears, tremors, weakness in her limbs, muscle cramping, twitching,
blocked ears, skin lesions, depression, sinus congestion, blurred
vision, joint pains, and hearing loss. Stoddard did not have symptoms
until she started using diet products, like soft drinks, which contained
aspartame. As she continued to use more and more diet products containing
aspartame, she observed her symptoms worsened. Stoddard did not
initially link aspartame to her symptoms. She believed that a healthy
diet and regular exercise would make her feel physically better,
but she continued to have health problems that had no apparent source.
She said that she sought medical help, but received conflicting
advice. She said she eventually began to suspect the products containing
aspartame in her diet were creating her problems after she traced
the onset of the symptoms to aspartame use, and on that hunch she
decided to eliminate NutraSweet from her diet. She began to feel
better immediately after removing the products containing aspartame
from her diet, but Stoddard said it took six months for the symptoms
to completely recede. At one point during her recovery she inadvertently
ingested a food product containing aspartame, and had a recurrence
of the symptoms. She then had no doubt that aspartame was the root
cause of her unusual reactions. In 1987, three years after her own
adverse reactions to NutraSweet, Stoddard formed the Aspartame Consumer
Safety Network to help others afflicted with aspartame sensitivity
problems. Some specialist in food and nutrition have spoken out
against aspartame use.
Woodrow
Monte, R.D., Ph.D., director of the Arizona State University Food
Sciences and Nutrition Laboratory, is uncomfortable with the methanol
content of aspartame. In an 1986 interview, Monte called aspartame
"a crime against humanity." "Humans are 100 times
more sensitive to methanol than animals. When you ingest aspartame,
it breaks down into methanol within one hour of ingestion. Methanol
forms as soon as aspartame goes into solution and increases the
longer it is in solution." according to Monte. Because heat
speeds the breakdown of aspartame into methanol, if aspartame is
added to coffee or tea at 80 degrees C (145 degrees F), one half
of the amount breaks down into methanol in 10 minutes, according
to Monte. This raises serious concern about ASPARTAME 'S 1993 approval
for use in baked goods and other heated products, like hot cocoa
and tea. Although aspartame came about as the result of a search
for a drug, and its compounds were the basis for a potential prescription
medication, the petition for approval of NutraSweet was based on
the premise that it was a food additive. The FDA followed its precedent
of permitting manufacturers to conduct their own product safety
research.
Monte feels that aspartame was mislabeled from the beginning. "Aspartame
is a drug, not a food additive," he said. "One hundred
million people, from little babies to the elderly, are consuming
this stuff in megadoses, more than they ever would if it were labelled
a drug."
Dr. Jacqueline Verrett, a former FDA toxicologist, and member of
an FDA task force that investigated the authenticity of research
done by Searle to establish the safety of aspartame, says she believes
the original aspartame studies were "built on a foundation
of sand." (20) She testified in front of a U.S. Senate hearing
in 1987 that flawed tests conducted by Searle - used as the basis
of FDA approval - were a "disaster" and should have been
"thrown out." She said she believed the studies left many
unanswered questions about possible birth defects and the safety
of aspartame. (20)
Verrett
said the team was instructed not to be concerned with, or comment
upon, the overall validity of the study. She said a subsequent review
discarded or ignored the problems and deficiencies outlined by her
team's original report. She said, "serious departures from
acceptable toxicological protocols" that her investigative
team noted in the revaluation of these studies were also discounted.
(20)
She
warned that any of the improper practices would compromise and negate
a safety study of a food additive. Verrett concluded the data in
the study was worthless, and the safety of aspartame and its breakdown
products have therefore not been determined. (20) She emphasized
that aspartame exists in the marketplace without basic toxicity
information. She said there are not data to assess the interactions
with DKP, excess phenylalanine, other aspartame metabolites, additives,
drugs, or other chemicals. In her testimony, Verrett elaborated
on DKP problems, including significant increases of uterine polyps
and changes in blood cholesterol. DKP is formed when liquids in
particular are pre-sweetened with aspartame. The production of DKP
is vulnerable to increase in temperature and higher temperatures
produce increasing amounts of DKP. She reminded members of the Congressional
Committee "that is why initially, aspartame was not intended
or not planned to be used in liquids because of this decomposition...it
was decided it was too unstable to be used in hot preparations,
hot liquids, and also in diet drinks." (20)
Senator
Howard Metzenbaum (D-OH), chairman of the hearing when Verrett testified,
asked her if she disagreed with the FDA's position that tests for
aspartame safety were credible. Verrett succinctly said she disagreed.
(20) Dr. H. J. Roberts, a Florida internist and author, cites cause
studies of individuals adversely affected by aspartame use. (75)
In one case described by Roberts, the destruction left in the wake
of aspartame use was so debilitating that a college honor student
deteriorated from the brain damage and finally had to be institutionalized
because her mental retardation was so severe. Roberts said he treated
the 18-year-old student in 1986 because of "profound intellectual
deterioration" that followed her use of aspartame products
for weight control The young woman suffered mental incapacitation
that destroyed her academic goal when she had a drop of 20 IQ points,
according to Roberts, who said prior to use of the aspartame she
had been an outstanding student at a major university, as well as
a skilled typist and pianist. Her skills had rapidly declined according
to Roberts, by the time of her first visit to his office. Her physical
complaints included headaches, decreasing vision in one eye, dizziness,
intense drowsiness, tremors, insomnia, suicidal depression, itching,
burning on urination, personality change, abdominal pain, recurrent
nausea, loss of menstrual cycle, and an ironic 15-pound weight gain.
Roberts said extensive neuro-physical tests were conducted on the
woman, and no consistent patterns were found for a primary disorder
or schizophrenia. When he noted the woman experienced drowsiness
after ingesting aspartame drinks and dozed while driving, he advised
her to avoid aspartame, and to follow an anti-hypoglycemic diet
with medication. Avoidance of aspartame relieved her symptoms, but
the apparent brain damage remained, requiring her placement in a
facility for the mentally retarded. (75)
In
a recent study investigating the consequences of aspartame on people
with mood disorders, Ralph Walton, M.D., Robert Hudak, Ph.D., and
Ruth J. Green-Waite concluded "individuals with mood disorders
are particularly sensitive to this artificial sweetener (aspartame)
and its use in this population should be discouraged." (60)
Walton said their study was terminated after only 20 days by the
Institutional Review Board of Western Reserve Care System, Youngstown,
Ohio because the reactions (including a detached retina and conjunctival
hemorrhage) among the patients with a history of depression were
so severe they could not "ethically continue the study."
(60) The study included a total of 13 subjects. Eight of the subjects
were patients, ranging in age from 24 to 60 years. All suffered
from recurrent major depression. Five healthy hospital employees,
including the hospital administrator, volunteered as a control group
for the study. Each participant was asked to monitor his or her
own symptoms for a checklist of headache, nervousness, dizziness,
memory problems, binge eating, lower back pain, nausea, upset stomach,
depression, insomnia, uncontrollable temper outburst, or other symptoms.
The hospital's pharmacy prepared 300-mg capsules of aspartame for
some participants, and sugar placebos for others. (NutraSweet Company
denied the request from the researchers to purchase the aspartame
for the study, so capsules were provided by Schwiezerhall, Inc.,
of New Jersey.) A 154-pound person ingested seven of the prepared
capsules daily - the approximate aspartame equivalent would be 10
to 12 cans of diet soda.
Although
the study was abbreviated because of the severity of the subjects'
symptoms, the researchers did find the incidence of headaches in
participants taking aspartame increased and that persons with a
history of depression demonstrated significant adverse reactions
while taking aspartame. They also reported adverse symptoms for
the group taking aspartame increased significantly. (60) Walton,
then chief of psychiatry at New York's Jamestown Hospital and Chautauque
County mental health commissioner, reported a case study of a patient
who reacted adversely to aspartame. His 54-year-old female patient
"suddenly experienced a grand mal seizure followed by profound
behavior changes." Some of the personality changes included
euphoria, flight of ideas, increased motor activity and insomnia.
A history of the woman's eating habits revealed she had been accustomed
to drinking about a gallon of sugar-sweetened iced tea daily. In
the weeks before her seizure, she had switched from sugar-sweetened
tea to an iced tea product containing aspartame. After reviewing
her case, Walton advised her to eliminate the aspartame product,
upon which she returned to normal and the symptoms subsided. (66)
Walton questions the reliability and validity of studies for the
safety of aspartame funded by the NutraSweet Company. "I'm
absolutely convinced," he says. "I know it causes seizures.
I'm convinced also that it definitely causes behavioral changes.
I'm very angry that this substance is on the market. I personally
question the reliability and validity of any studies funded by the
NutraSweet Company." In the 1987 proceedings of the First International
Meeting on Dietary Phenylalanine and Brain Function, he also presented
either other seizures cases, along with case studies of mania, panic
attacks and weight gain induced by aspartame use.
In 'NO-NONSENSE NUTRITION FOR KIDS' Annette Natow and Jo Ann Heslin
write "animal and human studies have shown that aspartame cause
chemical changes in the brain. More research is needed to determine
if aspartame is a health hazard." (76) The questions about
the validity of the Searle research and tests of aspartame date
back to 1976 when FDA was uncertain about the animal test data provided
by Searle. The FDA administrators asked Sam Skinner, former U.S.
attorney in the Northern District of Illinois, to convene a grand
jury to investigate discrepancies in the animal test data provided
by Searle. (15) On January 10, 1977, RDA chief counsel, Richard
Merril, sent a 33-page letter to Skinner repeating the request for
the grand jury investigation "into apparent violations of the
Federal Food, Drug, and Cosmetic Act...and False Reports to the
Government Act...by G. D. Searle Company". (12) The letter
also charged that Searle concealed material facts and made false
statements in reports of animal studies conducted to establish the
safety of the food additive aspartame. The studies cities for investigation
had been conducted in 1972, and five-year statutes of limitation
for criminal prosecution were due to expire on October 10, and December
8, 1977. (7) The statutes of limitation ran out before any criminal
charges were ever filed. In 1977 Skinner was offered and accepted
a job with Sidley and Austin, the law firm that represented Searle.
While still U.S. district attorney, Skinner did eventually excuse
himself from the Searle investigation.
The
next U.S. attorney, Tom Sullivan, then dropped NutraSweet from the
grand jury investigation. (7) In 1988 Senator Metzenbaum challenged
Skinner's nomination for appointment as U.S. Secretary of Transportation.
Metzenbaum issued a press release that said Skinner "failed
to launch a grand jury probe of G.D. Searle, the manufacturer of
NutraSweet, which was requested by the Food and Drug Administration.
A year after the FDA brought Skinner allegations of fraudulent safety
tests by Searle, Skinner took a job with the law firm that defended
Searle in the case." (7) Although Metzenbaum did later say
he would not object to the nomination to the position of Secretary
of Transportation, he said that Skinner told him that "he may
have made mistakes in his handling the NutraSweet investigation."
The studies under scrutiny were the purview of Dr. Harry Waisman,
a researcher at the University of Wisconsin's Regional Primate Center.
He was asked to compare toxicity effects from aspartame (particularly
seizures and learning defects from brain damage) with those from
phenylalanine, a primary ingredient in aspartame. Waisman's 52-week
toxicity study on seven infant Rhesus monkeys fed a diet containing
aspartame did not include a control group for comparison. The results
of the study, submitted to Searle in 1972, showed the death of one
monkey after 300 days, the administration of aspartame halted on
two monkeys after 200 days, and four monkeys that received aspartame
for 365 days. The FDA, in a report on the tests, said that no behavioral
or learning tests were undertaken on the monkeys. Former FDA Commissioner
Alexander Schmidt, now deceased, said the tests were "shoddy"
and "far less than perfect "(79)
A second study initiated by Searle was to have been a 104-week toxicity
study on the effects of aspartame on hamsters. The study was halted
prematurely after 46 weeks because of the unexpectedly high mortality
rate in both control and treated animals following an outbreak of
diarrhea among the test animals. The FDA, including submission of
false information noted other inconsistencies in the tests upon
review, and reports that were written to convey impressions more
favorable than underlying data would support. (7,16) The FDA researchers
also said that their agency needed more adequate and better controlled
studies. They said the FDA must base its recommendations on sound
data because the substance could be part of the daily diet of every
American. (25) Schmidt commented that "if you're approving
a food additive that will be taken by children around the world,
you will accept absolutely no risk, particularly if it's a non-nutritive
sweetener." (7)
The FDA task force observed laboratory methods at Searle from April
25 to August 4, 1977. The Bressler Report (named for team leader
Jerome Bressler) identified major discrepancies, including "substantial
differences between gross observation on pathology sheets when compared
with those submitted to the FDA" in a rat toxicology test of
aspartame. (16) According to the Bressler Report, one rat even appeared
resurrected. It stated, "Observed records indicated that animal
A23LM was alive at week 88, dead from week 92 to week 104, alive
at week 108, and dead at week 112." (16) The actual meal fed
to the rats was also in question. Raymond Schroeder, a former Searle
employee, said in an FDA interview on July 13, 1977 that "the
particles of DKP were large enough to allow the rats to discriminate
between the DKP and the basal diet." In 1982, representatives
of the carbonated beverage industry asked Monte to evaluate the
scientific data for aspartame. Monte said "I was stunned by
the poor quality research and recommended against aspartame's use
in carbonated beverages. I understood that the industry was going
to abide by my evaluation but something turned them around."
In
1984, Florence Graves, vice president of COMMON CAUSE wrote "NutraSweet
has been touted as the most tested food additive in history, but
our investigation reveals such serious flaws in the government's
approval of NutraSweet that Congress should begin its own investigation
immediately." (38) A 1987 report released by the General Accounting
Office, "FDA Food Additive Approval Process Followed for Aspartame,"
included information that waved red flags of potential calamity.
Some of the findings in the report: (11)
• The rat DKP Study showed a significant incidence of uterine
polyps in rats fed at the two highest dose levels as compared to
rats not fed DKP. Review teams later said the polyps were not cancerous,
precancerous, or potentially cancerous.
• The Center for Safety and Nutrition advised Searle that
because it had not submitted studies for evaluating long-term effects
of DKP, aspartame was not approved for products that could have
an appreciable breakdown to DKP.
• An investigative team report showed that examination of
rat fetuses and the reporting of the results in two teratology studies
were inadequate.
• Dr. John Olney, psychiatrist, neuro-pathologist, and professor
at Washington University in St. Louis found 12 brain tumors in 320
dosed rats and none in 120 control rats when he examined FDA files
on aspartame animal studies in 1978.
• Olney advised that the high number of brain tumors was unusual.
Olney voiced another concern based on his research. He showed that
when glutamate and aspartic acid are ingested together each agent
augments the neurotoxic effects of the other.
In
a 1981 interview at Washington University, Olney said, "Chemicals
marketed as food additives are consumed without supervision by hundreds
of millions, most of whom do not know they are ingesting the additive,
do not derive health benefits from it and have no understanding
of its adverse effects." Olney, along with consumer activist
attorney James Turner, initiated court action over aspartame. In
a 1986 interview Turner said he had spent 15 years battling approval
of aspartame because "it's hurting people." Monte also
called the scientific data supplied on aspartame as "poor quality
research" and said he recommended against aspartame's use in
carbonated beverages. Dr. Jeffrey Bada, a chemistry professor at
the University of California at San Diego, warned against heating
aspartame and the resultant internal rearrangement of its chemical
structure.
The
late Dr. M. Adrian Gross, an FDA toxicologist, spoke out against
aspartame in the August 1, 1985 Congressional Record. Gross, who
took part in on-site investigations at Searle laboratories, said
the study carried out by Searle to show the safety of aspartame
were "to a large extent unreliable." He said "at
least one of those studies has established beyond any reasonable
doubt that aspartame is capable of inducing brain tumors in experimental
animals and that this...is of extremely high significance."(
42) Gross also testified that because aspartame was capable of producing
brain tumors and brain cancer, FDA should not have been able to
set an allowable daily intake of the substance at any level. He
said at least one of Searle's studies "has established beyond
any responsible doubt that aspartame is capable of inducing brain
tumors in experiments animals and that this predisposition of it
is of extremely high significance..."
In
view of these indications that the cancer causing potential of aspartame
is a matter that had been established way beyond any reasonable
doubt, one can ask: "What is the reason for the apparent refusal
by the FDA to invoke for this food additive the so-called Delaney
Amendment to the Food, Drug and Cosmetic Act?" The Delaney
Amendment makes it illegal to allow any residues of cancer causing
chemicals in foods. In his concluding testimony Gross asked, "Given
the [cancer causing potential of aspartame] how would the FDA justify
its position that it views a certain amount of aspartame as constituting
an allowable daily intake or 'safe' level of it? Is that position
in effect not equivalent to setting a 'tolerance' for this food
additive and thus a violation of that law? And it the FDA itself
elects to violate the law, who is left to protect the health of
the public?" |