ASPARTAME...THE SHOCKING STORY!

October 3, 2005

Aspartame -- the shocking story, Pat Thomas, The Ecologist, 2005

Sept.,

p. 35-51, full text: Murray 2005.09.30

[ Comments by Rich Murray are in square brackets. ]

http://www.ecologist.cognita.info/archive_detail.asp?content_id=451

http://www.theecologist.org/current.asp [ photo of cover, re

aspartame ]

In this month's issue

September 2005. On sale tomorrow - August 19, 2005

Aspartame - COVER STORY

Once on the list of potential Pentagon bioweapons... associated with

cancer

and neurological disorders... banned for years until a firm run by

Donald

Rumsfeld lobbied his contacts in Washington to get it legalised... and

probably consumed by you within the last 24 hours.

Life after Aspartame - COVER STORY

Like Aspartame, artificial sweetener Sucralose is apparently 'safe'.

So why

is Tate & Lyle so keen to suppress any criticism of it?

http://www.wnho.net/the_ecologist_aspartame_report.htm

Aspartame-- the shocking story of the world's bestselling sweetener

The Ecologist by Pat Thomas

The Ecologist, September 2005

Cover Story, pages 35-46 2005/08/19 Author: Pat Thomas

ASPARTAME -- The Shocking Story of the World's Bestselling Sweetener

Aspartame is the most controversial food additive in history.

The most recent evidence, linking it to leukaemia and lymphoma,

has added substantial fuel to the ongoing protests of doctors,

scientists

and consumer groups who allege that this artificial sweetener should

never

have been released onto the market

and that allowing it to remain in the food chain is killing us by

degrees.

Pat Thomas reports:

Once upon a time, aspartame was listed by the Pentagon as a

biochemical

warfare agent.

Today it's an integral part of the modern diet.

Sold commercially under names like NutraSweet and Canderel,

aspartame can be found in more than 5,000 foods,

including fizzy drinks, chewing gum, table-top sweeteners, diet and

diabetic

foods, breakfast cereals, jams, sweets, vitamins, prescription and

over-the-counter drugs. This means that there is a good chance that

you and

your family are among the two thirds of the adult population and 40

per cent

of children who regularly ingest this artificial sweetener.

Because it contains no calories,

aspartame is considered a boon to health-conscious individuals

everywhere;

and most of us, if we think about it at all, think it is safe.

But independent scientists say aspartame can produce a range of

disturbing

adverse effects in humans,

including headaches, memory loss, mood swings, seizures, multiple

sclerosis

and Parkinson's-like symptoms, tumours and even death.

Concerns over aspartame's toxicity meant that for eight years,

the US Food and Drug Administration (FDA) denied it approval,

effectively keeping it off the world market.

This caution was based on compelling evidence,

brought to light by numerous eminent scientists, litigators and

consumer

groups, that aspartame contributed to serious central nervous system

damage

and had been shown to cause cancer in animals.

Eventually, however, political muscle, won out over scientific

rigour, and

aspartame was approved for use in 1981 (see timeline for details).

The FDA's about-turn opened the floodgates for aspartame's swift

approval by

more than 70 regulatory authorities around the world.

But, as the remarkable history of the sweetener shows,

the clean bill of health given to it by government regulators --

whose raison d'être should be to protect the public from harm --

is simply not worth the paper it is printed on.

DECEMBER 1965

While working on an ulcer drug, a chemist at pharmaceutical

manufacturer GD

Searle accidentally discovers aspartame, a substance that is 180 times

sweeter than sugar, yet has no calories.

SPRING 1967

Searle begins safety tests, necessary for FDA approval.

AUTUMN 1967

GD Searle approaches eminent biochemist Dr Harry Waisman,

director of the University of Wisconsin's Joseph P Kennedy Jr Memorial

Laboratory of Mental Retardation Research and a respected expert in

the

toxicity of phenylalanine (which comprises 50 per cent of the

aspartame

formula),

to conduct a study of the effects of aspartame on primates.

Of seven monkeys fed aspartame mixed with milk,

one dies and five others have grand mal epileptic seizures.

SPRING 1971

Dr John Olney, professor of neuropathology and psychiatry at

Washington

University in St Louis School of Medicine,

whose research into the neurotoxic food additive monosodium glutamate

(MSG, a chemical cousin of aspartame)

was responsible for having it removed from baby foods,

informs Searle that his studies show that aspartic acid,

one of the main constituents of aspartame,

causes holes in the brains of infant mice.

One of Searle's researchers, Ann Reynolds,

confirms Olney's findings in a similar study.

FEBRUARY 1973

Searle applies for FDA approval and submits over 100 studies it claims

support aspartame's safety.

Neither the dead monkeys nor the mice with holes in their brains are

included in the submission.

12 SEPTEMBER 1973

In a memorandum, Dr Martha M Freeman of the FDA Division of Metabolic

and

Endocrine Drug Products criticises the inadequacy of the information

submitted by Searle with particular regard to one of the compound's

toxic

breakdown products, diketopiperazine (DKP).

She recommends that marketing of aspartame be contingent upon the

sweetener's proven clinical safety.

26 JULY 1974

FDA commissioner Dr Alexander Schmidt grants aspartame its first

approval as

a 'food additive' for restricted use in dry foods.

This approval comes despite the fact that his own scientists found

serious

deficiencies in the data submitted by Searle.

AUGUST 1974

Before aspartame can reach the marketplace,

Dr John Olney, James Turner

(attorney, consumer advocate and former 'Nader's Raider'

who was instrumental in removing the artificial sweetener cyclamate

from the

US market),

and the group Label Inc (Legal Action for Buyers' Education and

Labeling)

file a formal objection to aspartame's approval with the FDA,

citing evidence that it could cause brain damage, particularly in

children.

JULY 1975

Concerns about the accuracy of test data submitted to the FDA by

Searle for

a wide range of products prompt Schmidt to appoint a special task

force to

examine irregularities in 25 key studies for aspartame and Searle

drugs

Flagyl, Aldactone and Norpace.

5 DECEMBER 1975

Searle agrees to an inquiry into aspartame safety concerns.

Searle withdraws aspartame from the market pending its results.

The sweetener remains off the market for nearly 10 years while

investigations into its safety and into Searle's alleged fraudulent

testing

procedures are ongoing.

However, the inquiry board does not convene for another four years.

24 MARCH 1976

The FDA task force completes its 500 page report on Searle's testing

procedures.

The final report notes faulty and fraudulent product testing,

knowingly misrepresented product testing,

knowingly misrepresented and 'manipulated' test data,

and instances of irrelevant animal research in all the products

reviewed.

Schmidt says: '[searle's studies were] incredibly sloppy science.

What we

discovered was reprehensible.'

JULY 1976

The FDA forms a new task force,

headed by veteran inspector Jerome Bressler,

to further investigate irregularities in Searle's aspartame studies

uncovered by the original task force.

The findings of the new body will eventually be incorporated into a

document

known as the Bressler Report.

10 JANUARY 1977

FDA chief counsel Richard Merrill formally requests the US Attorney's

office

to begin grand jury proceedings to investigate whether indictments

should be

filed against Searle for knowingly misrepresenting findings

and 'concealing

material facts and making false statements' in aspartame safety tests.

This is the first time in the FDA's history that it requests a

criminal

investigation of a manufacturer.

26 JANUARY 1977

While the grand jury investigation is underway,

Sidley & Austin, the law firm representing Searle,

begins recruitment negotiations with Samuel Skinner,

the US attorney in charge of the investigation.

Skinner removes himself form the investigation

and the case is passed to William Conlon.

8 MARCH 1977

Searle hires prominent Washington insider Donald Rumsfeld as its new

CEO

to try to turn the beleaguered company around.

A former member of Congress and defence secretary in the Ford

administration, Rumsfeld brings several of his Washington colleagues

in as

top management.

1 JULY 1977

Samuel Skinner leaves the US Attorney's office

and takes a job with Searle's law firm. Conlon takes over Skinner's

old job.

1 AUGUST 1977

The Bressler Report is released.

It focuses on three key aspartame studies conducted by Searle.

The report finds that in one study 98 of the 196 animals died but

weren't

autopsied until later dates, making it impossible to ascertain the

actual

cause of death.

Tumours were removed from live animals and the animals placed back in

the

study.

Many other errors and inconsistencies are noted.

For example, a rat was reported alive, then dead, then alive, then

dead again.

Bressler comments:

'The question you have got to ask yourself is:

why wasn't greater care taken?

Why didn't Searle, with their scientists, closely evaluate this,

knowing full well that the whole society, from the youngest to the

elderly,

from the sick to the unsick, will have access to this product.'

The FDA creates yet another task force to review the Bressler Report.

The review is carried out by a team at the FDA's Center for Food

Safety and

Applied Nutrition and headed by senior scientist Jacqueline Verrett.

28 SEPTEMBER 1977

The FDA publishes a report exonerating Searle of any wrongdoing in its

testing procedures.

Jacqueline Verrett will later testify to the US Senate that her team

was

pressured into validating data from experiments that were clearly

a 'disaster'.

8 DECEMBER 1977

Despite complaints from the Justice Department,

Conlon stalls the grand jury prosecution for so long that the statute

of

limitations on the aspartame charges runs out

and the investigation is dropped.

Just over a year later Conlon joins Searle's law firm, Sidley &

Austin.

1978

The journal Medical World News reports that the methanol content of

aspartame is 1,000 times greater than most foods under FDA control.

In high concentrations methanol, or wood alcohol, is a lethal poison.

1 JUNE 1979

The FDA finally establishes a public board of inquiry (PBOI),

comprising three scientists whose job it is to review the objections

of

Olney and Turner to the approval of aspartame and rule on safety

issues

surrounding the sweetener.

1979

In spite of the uncertainties over aspartame's safety in the US,

aspartame becomes available, primarily in pharmaceutical products, in

France.

It is sold under the brand name Canderel and manufactured by the food

corporation Merisant.

30 SEPTEMBER 1980

The FDA's PBOI votes unanimously against aspartame's approval, pending

further investigations of brain tumours in animals.

The board says it 'has not been presented with proof of reasonable

certainty

that aspartame is safe for use as a food additive'.

1980

Canderel is now marketed throughout much of Europe (but not in the

UK) as a

low-calorie sweetener.

JANUARY 1981

Rumsfeld states in a Searle sales meeting that he is going to make a

big

push to get aspartame approved within the year.

Rumsfeld vows to 'call in his markers' and use political rather than

scientific means to get the FDA on side.

20 JANUARY 1981

Ronald Reagan is sworn in as president of the US.

Reagan's transition team, which includes Rumsfeld,

nominates Dr Arthur Hull Hayes Jr to be the new FDA commissioner.

21 JANUARY 1981

One day after Reagan's inauguration, Searle re-applies to the FDA for

approval to use aspartame as a food sweetener.

MARCH 1981

An FDA commissioner's panel is established to review issues raised by

the PBOI.

19 MAY 1981

Arthur Hull Hayes Jr, appoints a five-person commission to review the

PBOI's

decision.

Three of the five FDA scientists on it advise against approval of

aspartame,

stating on the record that Searle's tests are unreliable and not

adequate to

determine the safety of aspartame.

Hayes installs a sixth member on the commission,

and the vote becomes deadlocked.

15 JULY 1981

Hayes ignores the recommendations of his own internal FDA team,

overrules the PBOI findings and gives initial approval for aspartame

to be

used in dry products on the basis that it has been shown to be safe

for its

proposed uses.

22 OCTOBER 1981

The FDA approves aspartame as a tabletop sweetener and for use in

tablets,

breakfast cereals, chewing gum, dry bases for beverages, instant

coffee and

tea, gelatines, puddings, fillings, dairy-product toppings and as a

flavour

enhancer for chewing gum.

1982

The aspartame-based sweetener Equal, manufactured by Merisant, is

launched

in the US.

15 OCTOBER 1982

The FDA announces that Searle has filed a petition for aspartame to be

approved as a sweetener in carbonated beverages, children's vitamins

and

other liquids.

1983

Searle attorney Robert Shapiro gives aspartame its commercial name,

NutraSweet.

The name is trademarked the following year.

Shapiro later becomes president of Searle.

He eventually becomes president and then chairman and CEO of

Monsanto, which

will buy Searle in 1985.

8 JULY 1983

Aspartame is approved for use in carbonated beverages and syrup bases

in the

US and, three months later, Britain.

Before the end of the year Canderel tablets are launched in the UK.

Granular Canderel follows in 1985.

8 AUGUST 1983

James Turner, on behalf of himself and the Community Nutrition

Institute,

and Dr Woodrow Monte, Arizona State University's director of food

science

and nutritional laboratories,

file petitions with the FDA objecting to aspartame approval based on

possible serious adverse effects from the chronic intake of the

sweetener.

Monet also cites concern about the chronic intake of methanol

associated

with aspartame ingestion.

SEPTEMBER 1983

Hayes resigns as FDA commissioner under a cloud of controversy about

his

taking unauthorised rides aboard a General Foods jet (General Foods

was and

is a major purchaser of aspartame).

He serves briefly as provost at New York Medical College,

and then takes a position as senior scientific consultant with

Burston-Marsteller, the chief public relations firm for both Searle

and

Monsanto.

AUTUMN 1983

The first carbonated beverages containing aspartame go on sale in the

US.

17 FEBRUARY 1984

The FDA denies Turner and Monte's requests for a hearing,

noting that aspartame's critics had not presented any unresolved

safety

questions. Regarding aspartame's breakdown components,

the FDA says that it has reviewed animal, clinical and consumption

studies

submitted by the sweetener's manufacturer,

as well as the existing body of scientific data,

and concludes that 'the studies demonstrated the safety of these

components'.

MARCH 1984

Public complaints about the adverse effects of aspartame begin to

come in.

The FDA requests that the US agency the Centers for Disease Control

and

Prevention (CDC) begins investigations of a select number of cases of

adverse reactions to aspartame.

30 MAY 1984

The FDA approves aspartame for use in multivitamins.

JULY 1984

A study by the state of Arizona Department of Health into aspartame is

published in the Journal of Applied Nutrition.

It determines that soft drinks stored at elevated temperatures

promote more

rapid deterioration of aspartame into poisonous methanol.

2 NOVEMBER 1984

The CDC review of public complaints relating to aspartame culminates

in a

report, Evaluation of Consumer Complaints Related to Aspartame Use,

which reviews 213 of 592 cases and notes that re-challenge tests show

that

sensitive individuals consistently produce the same adverse symptoms

each

time they ingested aspartame.

The reported symptoms include:

aggressive behaviour, disorientation, hyperactivity, extreme numbness,

excitability, memory loss, loss of depth perception, liver impairment,

cardiac arrest, seizures, suicidal tendencies and severe mood swings.

The CDC nevertheless concludes that aspartame is safe to ingest.

On the same day that the CDC exonerates aspartame,

Pepsi announces that it is dropping saccharin

and adopting aspartame as the sweetener in all its diet drinks.

Others quickly follow suit.

1 OCTOBER 1985

Monsanto, the producer of recombinant bovine growth hormone,

genetically engineered soya beans, the pesticide Roundup and many

other

industrial and agricultural chemicals, purchases Searle for $2.7

billion.

21 APRIL 1986

The US Supreme Court,

headed by Justice Clarence Thomas,

a former Monsanto attorney,

refuses to consider arguments

from the Community Nutrition Institute and other consumer groups that

the

FDA has not followed proper procedures in approving aspartame, and

that the

liquid form of the artificial sweetener may cause brain damage in

heavy

users of low-calorie soft drinks.

16 OCTOBER 1986

Turner files another citizen's petition,

this time concerning the risk of seizures and eye damage from

aspartame.

The petition argues that medical records of 140 aspartame users show

them to

have suffered from epileptic seizures and eye damage after consuming

products containing the sweetener and that the FDA should ban

aspartame as

an 'imminent hazard to the public health'.

21 NOVEMBER 1986

The FDA denies Turner's new petition, saying:

'The data and information supporting the safety of aspartame are

extensive.

It is likely that no food product has ever been so closely examined

for

safety. Moreover, the decisions of the agency to approve aspartame

for its

uses have been given the fullest airing that the legal process

requires.'

28 NOVEMBER 1986

The FDA approves aspartame for non-carbonated frozen or refrigerated

concentrates and single-strength fruit juice, fruit drinks, fruit-

flavoured

drinks, imitation fruit-flavoured drinks, frozen stock-type

confections and

novelties, breath mints and tea beverages.

DECEMBER 1986

The FDA declares aspartame safe for use as an inactive ingredient,

provided labelling meets certain specifications.

1987

An FDA report on adverse reactions associated with aspartame states

the

majority of the complaints about aspartame -- now numbering 3,133 --

refer

to neurological effects.

2 JANUARY 1987

NutraSweet's aspartame patent runs out in Europe, Canada and Japan.

More companies are now free to produce aspartame sweeteners in these

countries.

12 OCTOBER 1987

United Press International, a leading global news-syndication

organisation,

reports that more than 10 federal officials involved in the decision

to

approve aspartame have now taken jobs in the private sector that are

linked

to the aspartame industry.

3 NOVEMBER 1987

A US Senate hearing is held to address the issue of aspartame safety

and

labelling. The hearing reviews the faulty testing procedures and the

'psychological strategy' used by Searle to help ensure aspartame's

approval.

Other information that comes to light includes the fact that

aspartame was

once on a Pentagon list of prospective biochemical-warfare weapons.

Numerous medical and scientific experts testify as to the toxicity of

aspartame.

Among them is Dr Verrett, who reveals that, while compiling its 1977

report,

her team was instructed not to comment on or be concerned with the

overall

validity of the studies.

She states that questions about birth defects have not been answered.

She also states that increasing the temperature of the product leads

to an

increase in production of DKP,

a substance shown to increase uterine polyps and change blood

cholesterol

levels.

Verrett comments: 'It was pretty obvious that somewhere along the

line, the

bureau officials were working up to a whitewash.'

1989

The FDA has received more than 4,000 complaints from consumers about

adverse

reactions to the sweetener.

14 OCTOBER 1989

Dr HJ Roberts, director of the Palm Beach Institute for Medical

Research,

claims that several recent aircraft accidents involving confusion and

aberrant

pilot

behaviour were caused by ingestion of products containing aspartame.

20 JULY 1990

The Guardian publishes a major investigation of aspartame and

delivers to

government officials 'a dossier of evidence' that draws heavily on the

transcripts of the Bressler Report and demands that the government

review

the safety of aspartame. No review is undertaken. The Guardian is

taken to

court by Monsanto and forced to apologise for printing its story.

1991

The US National Institutes of Health publishes Adverse Effects of

Aspartame:

January '86 through December '90, a bibliography of 167 studies

documenting

adverse effects associated with aspartame.

1992

NutraSweet signs agreements with Coca-Cola and Pepsi stipulating that

it is

their preferred supplier of aspartame.

30 JANUARY 1992

The FDA approves aspartame for use in malt beverages, breakfast

cereals, and

refrigerated puddings and fillings and in bulk form (in large

packages like

sugar) for tabletop use. NutraSweet markets these bulk products under

the

name 'NutraSweet Spoonful'.

14 DECEMBER 1992

NutraSweet's US patent for aspartame expires, opening up the market

for

other companies to produce the substance.

19 APRIL 1993

The FDA approves aspartame for use in hard and soft candies, non-

alcoholic

flavoured beverages, tea beverages, fruit juices and concentrates,

baked

goods and baking mixes, and frostings, toppings and fillings for

baked goods.

28 FEBRUARY 1994

Aspartame now accounts for the majority (75 per cent) of all the

complaints

in the US adverse-reaction monitoring system.

The US Department of Health and Human Services compiles a report that

brings

together all current information on adverse reactions attributed to

aspartame.

It lists 6,888 complaints, including 649 reported by the CDC

and 1,305 reported by the FDA.

APRIL 1995

Consumer activist, and founder of anti-aspartame group Mission

Possible,

Betty Martini uses the US's Freedom of Information Act to force the

FDA to

release an official list of adverse effects associated with aspartame

ingestion.

Culled from 10,000 consumer complaints, the list includes four

deaths and more than 90 unique symptoms, a majority of which are

connected

to impaired neurological function.

They include: headache; dizziness or problems with balance;

mood change; vomiting and nausea; seizures and convulsions;

memory loss; tremors; muscle weakness; abdominal pains and

cramps; change in vision; diarrhoea; fatigue and weakness; skin

rashes;

deteriorating vision; joint and musculoskeletal pain.

By the FDA's own admission, fewer then 1 per cent of those who have

problems

with something they consume ever report it to the FDA.

This means that around 1 million people could have been experiencing

adverse

effects from ingesting aspartame.

12 JUNE 1995

The FDA announces it has no further plans to continue to collect

adverse

reaction reports or monitor research on aspartame.

27 JUNE 1996

The FDA removes all restrictions from aspartame use, and approves it

as a

general-purpose sweetener', meaning that aspartame can now be used in

any

food or beverage.

NOVEMBER 1996

Drawing on data compiled by the US National Cancer Institute's

Surveillance,

Epidemiology and End Results programme, which collects and

distributes data

on all types of cancer, Olney publishes peer-reviewed research in the

Journal of Neuropathology and Experimental Neurology.

It shows that brain-tumour rates have risen in line with aspartame

consumption

and

that there has been a significant increase in the conversion of less

deadly

tumours into much more deadly ones.

DECEMBER 1996

The results of a remarkable study conducted by Dr Ralph G Walton,

professor

of clinical psychology at Northeastern Ohio Universities, are

revealed.

Commissioned by the hard-hitting US national news programme 60

Minutes, it

sheds some light on the absurdity of aspartame-safety studies.

Walton reviewed 165 separate studies published in the preceding 20

years in

peer-reviewed medical journals.

Seventy-four of the studies were industry-funded, all of which

attested to

aspartame's safety.

Of the other 91 non-industry funded studies, 84 identified adverse

health

effects.

Six of the seven non-industry funded studies that were favourable to

aspartame

were from the FDA, which has a public record of strong pro-industry

bias.

To this day, the industry-funded studies are the ones that are always

quoted to

the

press and in official rebuttals to aspartame critics.

They are also the studies given the greatest weight during the

approval process

and in official safety reviews.

10 FEBRUARY 1998

Monsanto petitions the FDA for approval of a new tabletop sweetener

called

Neotame. It is around 60 times sweeter than aspartame and up to

13,000 times

sweeter than sugar. Neotame is less prone to breaking down in heat

and in

liquids than aspartame because of the addition of 3,3-dimethylbutyl, a

poorly studied chemical with suspected neurotoxic effects.

Strengthening the

bond between aspartame's main constituents eliminates the need for a

health

warning directed at people suffering from PKU.

13 MAY 1998

Independent scientists from the University of Barcelona publish a

landmark

study clearly showing that aspartame is transformed into formaldehyde

in the

bodies of living specimens (in this case rats),

and that this formaldehyde spreads throughout the specimens' vital

organs,

including the liver, kidneys, eyes and brain.

The results fly in the face of manufacturers' claims that aspartame

does not

break down into formaldehyde in the body, and bolster the claims of

aspartame

critics that

many of the symptoms associated with aspartame toxicity are caused by

the

poisonous and cumulative effects of formaldehyde.

OCTOBER 1998

The UK's Food Commission publishes two surveys on sweeteners.

The first shows that several leading companies, including St Ivel,

Müller and

Sainsbury's, have ignored the legal requirement to state 'with

sweeteners'

next to the name of the product.

The second reveals that aspartame not only appears in 'no-sugar

added' and

'light' beverages but also in ordinary non-dietetic drinks because

it's three

times cheaper than ordinary sugar.

8 FEBRUARY 1999

Monsanto files a petition with the FDA for approval of the general

use of

Neotame.

20 JUNE 1999

An investigation by The Independent on Sunday reveals that aspartame

is made

using a genetic engineering process.

Aspartame component phenylalanine is naturally produced by bacteria.

The newspaper reveals that Monsanto has genetically engineered the

bacteria to

make them produce more phenylalanine.

Monsanto claims that the process had not been revealed previously

because no

modified DNA remains in the finished product, and insists that the

product is

completely safe; though scientists counter that toxic effects cannot

be ruled

out in

the absence of long-term studies.

A Monsanto spokeswoman says that while aspartame for the US market is

often made

using genetic engineering,

aspartame supplied to British food producers is not.

The extent to which US brands of low-calorie products containing

genetically

engineered aspartame have been imported into Britain is unclear.

MAY 2000

Monsanto, under pressure -- not least from the worldwide resistance to

genetically manipulated food and ongoing lawsuits --

sells NutraSweet to JW Childs Associates, a private-equity firm

comprised of

several former Monsanto managers, for $440 m.

Monsanto also sells its equity interest in two European sweetener

joint

ventures, NutraSweet AG and Euro-Aspartame SA.

10 DECEMBER 2001

The UK's Food Standards Agency requests that the European Commission

Scientific Committee on Food conducts an updated review of aspartame.

The committee is asked to look carefully at more than 500 scientific

papers

published between 1988 and 2000 and any other new scientific research

not

examined previously.

9 JULY 2002

The FDA approves the tabletop and general use of Neotame.

The 'fast-track' approval raises eyebrows because, historically,

the FDA takes at least 10 years to approve food additives.

Neotame is also approved for use in Australia and New Zealand,

but has yet to be approved in the UK.

10 DECEMBER 2002

The European Commission Scientific Committee on Food publishes its

final

report on aspartame.

The 24-page report largely ignores independent research and consumer

complaints,

relying instead on frequently cited articles in books and reviews put

together

by employees or consultants of aspartame manufacturers.

When independent research is cited,

it is generally refuted with industry-sponsored data.

An animal study showing aspartame's disruption of brain chemistry,

a human study linking aspartame to neurophysiological changes that

could

increase seizure risk,

another linking aspartame use with depression in individuals

susceptible to mood

disorder,

and two others linking aspartame ingestion with headaches

are all dismissed.

The report's conclusion amounts to a single sentence:

'The committee concluded that.there is no evidence to suggest that

there is a

need to revise the outcome of the earlier risk assessment or the

[acceptance

daily intake]

previously established for aspartame.'

As with the FDA, there are concerns about the neutrality of some of

the

committee's members and their links with the International Life

Sciences

Institute (ILSI), an industry group that funds,

among other things, research into aspartame.

ILSI members include Monsanto, Coca-Cola and Pepsi.

19 FEBRUARY 2003

Members of the European Parliament's Environment, Public Health and

Consumer

Policy Committee approve the use of sucralose (see page 50) and an

aspartame-acesulfame salt compound (manufactured in Europe by the

aspartame-producing Holland Sweetener Company and sold under the name

Twinsweet), agreeing to review of the use of both in three years'

time.

At the same time, a request by European greens that the committee re-

evaluate

the safety of aspartame and improve the labelling of aspartame-

containing

products is rejected.

MAY 2004

The feature-length documentary Sweet Misery is released on DVD (see

http://www.soundandfuryproductions.com).

Part-documentary, part-detective story, it includes interviews with

people who

have been harmed by aspartame, as well as credible testimony from

advocates,

doctors, lawyers and long-time campaigners, including James Turner,

HJ Roberts

and renowned neurosurgeon Dr Russell Blaylock. UK orders: Namaste

Publishing,

info

SEPTEMBER 2004

US consumer group the National Justice League files a $350 m class

action

lawsuit against the NutraSweet Corporation (the current owner of

aspartame

products), the American Diabetes Association and Monsanto. Some 50

other

defendants have yet to be named, but mentioned throughout the lawsuit

is the

central role of Donald Rumsfeld in helping to get aspartame approved

through

the FDA. The plaintiffs maintain that this litigation will prove how

deadly

aspartame is when it is consumed by humans. Little progress has been

made so

far in bringing the action to court. [ The suits, claimed by conmen,

were

phoney. ]

The NutraSweet Company reopens its plant in Atlanta, Georgia,

(dormant since

2003) in order to meet increased demand for its sweetener.

Aspartame, sold commercially as NutraSweet, Equal, Equal-Measure,

Spoonful,

Canderel and Benevia, is currently available in more than 100

countries and used

in more than 5,000 products by at least 250 million people every day.

Worldwide, the aspartame industry's sales amount to more than $1

billion yearly.

The US is the primary consumer.

JULY 2005

The Ramizzini Institute in Bologna, a non-profit, private institution

set up

to research the causes of cancer, releases the results of a very

large,

long-term animal study into aspartame ingestion.

Its study shows that aspartame causes lymphomas and leukaemia in

female animals

fed aspartame at doses around 20 milligrams per kilogram of body

weight, or

around half the accepted daily intake for humans. [ Also, rats are as

much as

20 times more resistant to methanol (formaldehyde) toxicity as

humans. ]

Page 47

ASPARTAME REACTIONS: A HIDDEN EPIDEMIC

Aspartame has been linked to a host of devastating central nervous

system

disorders

When aspartame was approved for use, Dr HJ Roberts, director of the

Palm

Beach Institute for Medical Research, had no reason to doubt the FDA's

decision. 'But my attitude changed,' he says, 'after repeatedly

encountering

serious reactions in my patients that seemed justifiably linked to

aspartame.' Twenty years on, Roberts has coined the phrase 'aspartame

disease' to describe the wide range of adverse effects he has seen

among

aspartame-guzzling patients.

He estimates: 'Hundreds of thousands of consumers, more likely

millions,

currently suffer major reactions to products containing aspartame.

Today, every physician probably encounters aspartame disease in

everyday

practice, especially among patients with illnesses that are

undiagnosed or

difficult

to treat.'

As a guide for other doctors, Roberts, a recognised expert in

difficult

diagnoses, has published a lengthy series of case studies, Aspartame

Disease: an ignored epidemic (Sunshine Sentinel Press), in which he

meticulously details his treatment of 1,200 aspartame-sensitive

individuals,

or 'reactors', encountered in his own practice. Following accepted

medical

procedure for detecting sensitivities to foods, Roberts had his

patients

remove aspartame from their diets. With nearly two thirds of reactors,

symptoms began to improve within days of removing aspartame, and

improvements were maintained as long as aspartame was kept out of

their

diet.

[ Rich Murray: More accurately, page 66, " Aspartame Disease: An

Ignored

Epidemic:

This book focuses on the first 1,200 aspartame reactors in the

author's data

base. These persons include the following:

* 188 private patients and other individuals who were personally

interviewed.

* Complainants who described their aspartame-asssociated reactions to

Aspartame Victims and Their Friends (295),

The Community Nutrition Institute (68), and

Dr. Woodrow Monte of Arizona State University (28)

* The remainded supplied details of their reactions to the author or

to

Mission Possible, a volunteer consumer organization (Chapter I). Of

this

group, 697 (58%) completed the 9-page survey questionaire (Section 4).

page 80: A chemist who developed migraine from certain foods and

additives

performed six double-blind studies on himself. He found that as

little as 4.0

mg aspartame in a capsule predictably induced headache (Strong 2000)

[ This dose

is only 2% of a diet soda. Abstract given below. ] ]

Roberts' case studies parallel much of what was revealed in the FDA's

report

on adverse reactions to aspartame -- that toxicity often reveals

itself

through central nervous system disorders and compromised immunity.

His casework shows that aspartame toxicity can mimic the symptoms of

and/or

worsen several diseases that fall into these broad categories (see

the box

above).

[ sidebar ] CONDITIONS MIMICKED BY ASPARTAME TOXICITY

multiple sclerosis

Parkinson's disease

Alzheimer's disease

fibromyalgia

arthritis

multiple chemical sensitivity

chronic fatigue syndrome

attention deficit disorder

panic disorder

depression and other psychological disorders

lupus

diabetes and diabetic complications

birth defects

lymphoma

Lyme disease

hypothyroidism

Case studies, especially a large series like this, address some of the

issues surrounding real-world use in a way that laboratory studies

never

can; and the conclusions that can be drawn from such observations

aren't

just startling, they are also potentially highly significant.

In fact, Roberts believes that one of the major problems with

aspartame research

has been the continued over-emphasis on laboratory studies.

This has meant that the input of concerned independent physicians and

other

interested persons, especially consumers, is 'reflexively discounted

as

" anecdotal " '.

Many of the diseases listed by Roberts fall into the category of

medicine's

'mystery diseases' -- conditions with no clear aetiology and few

effective

cures. And while no one is suggesting that aspartame is the single

cause of

such diseases, Roberts' research suggests that some people diagnosed

with,

for example, multiple sclerosis, Parkinson's or chronic fatigue

syndrome may

end up on a regimen of potentially harmful drugs that could have been

avoided if they simply stopped ingesting aspartame-laced products.

TIME FOR ACTION

The story of aspartame is the story of the triumph of corporate might

over

scientific rigour.

It shines a spotlight on the archaic and unbalanced procedure for

approving food

additives.

We ingest food additives daily,

yet their approval does not require the same scientific thoroughness

as drug

approval; and, unlike drugs,

there is no requirement for surveillance of adverse effects that crop

up

once

the additive is in use.

Approval does not involve looking at what people are already eating

and

whether the proposed substance will interact with other additives.

Nor does it take into account whether the additive exacerbates damage

caused by

other aspects of the modern lifestyle (for instance, the neurological

damage

caused by pesticide ingestion or exposure).

Nor does it look for subtle chronic effects (for instance, the

gradual build-up

of methanol in the body with regular aspartame ingestion).

There are other problems. Most studies into aspartame are animal

studies,

which are notoriously difficult to relate to humans.

So why bother performing them in the first place?

The answer is, manufacturers and regulators use animal research as a

double-edged sword. If an animal study reveals no evidence of harm,

the

manufacturer can use it to support its case.

If it reveals harm, however, the manufacturer is free to flip-flop

into the

argument that the results of animal studies are inconclusive in

relation to

humans.

Faced with inconclusive evidence regulators will always err on the

side of the

manufacturer, who has after all demonstrated proper bureaucratic

procedure by

funding and submitting its animal tests for consideration.

The approval process for any substance that humans put in their

mouths on

a daily basis should be based on solid human data and on the

precautionary

principle when such data is not available.

But, as it stands, the regulation of food additives in the US, the UK

and

elsewhere leaves the burden of proof of harm on average people,

despite the fact

that most of us are either too detached or too timid to complain or

simply don't

have the energy to take on multinational corporations.

The history of aspartame is all the more remarkable because of the

number of

motivated people who have refused to accept the mantra 'if it's

approved by

the government it must be safe'.

Nearly every piece of independent research shows the outrage of these

people,

who have had to withstand threats of litigation and being vilified in

the media

as 'hysterics', is justified.

After 30 years of aspartame's commercial success, it would be easy to

conclude it is too late to act.

And yet earlier this year hundreds of products were swept off

supermarket

shelves on the chance that they might have contained minuscule

amounts of a

potentially carcinogenic dye, Sudan 1.

No studies existed to show that Sudan 1 could cause cancer in humans.

The likelihood of any one person's exposure to Sudan 1 being high

enough to

produce a tumour was minute.

Nevertheless, on the basis of the precautionary principle, action was

taken.

Aspartame is not a life-saving drug.

It is not even a very effective diet aid, as shown by widespread

obesity in the

West.

Until the many concerns about it have been examined in 'corporate-

neutral',

large-scale, long-term, randomised, double-blind, placebo- controlled

human

trials (the gold standard of scientific proof) it should be taken out

of our

food.

CONDITIONS MIMICKED BY ASPARTAME TOXICITY

* multiple sclerosis

* Parkinson's disease

* Alzheimer's disease

* fibromyalgia

* arthritis

* multiple chemical sensitivity

* chronic fatigue syndrome

* attention deficit disorder

* panic disorder

* depression and other psychological disorders

* lupus

* diabetes and diabetic complications

* birth defects

* lymphoma

* Lyme disease

* hypothyroidism

Pages 48-49

Roberts' research suggests that some people diagnosed with, for

example,

multiple sclerosis, Parkinson's or chronic-fatigue syndrome may end

up on a

regimen of potentially harmful drugs that could have been avoided if

they

simply stopped ingesting aspartame

PHENYLALANINE

The essential amino acid phenylalanine comprises 50 per cent of

aspartame,

In people with the genetic disorder, phenylketonuria (PKU), the liver

cannot

metabolise phenylalanine, causing it to build up in the blood and

tissues.

Chronically high levels of phenylalanine and some of its breakdown

products

can cause significant neurological problems, which is why foods and

beverages containing aspartame must carry a warning for PKU sufferers.

But according to Dr HJ Roberts, sensitivity to aspartame is not

limited to

PKU sufferers.

PKU carriers -- people who inherited the gene for the disorder but do

not

themselves have the condition (around 2 per cent of the general

population) --

are also more prone to adverse effects.

In Roberts' data there is also a high incidence of aspartame

reactions among the

close relatives of patients who cannot tolerate aspartame.

Furthermore, there is evidence that ingesting aspartame,

especially along with carbohydrates,

can lead to excess levels of phenylalanine in the brain

even among those not affected by PKU.

Athough phenylalanine is sometimes used as a treatment for depression,

excessive amounts in the brain can cause levels of the mood regulator

serotonin to decrease,

making depression more serious or likely.

Build-up of phenylalanine in the brain can also worsen schizophrenia

or make

individuals more susceptible to seizures.

Moreover, decrease in serotonin levels can result in carbohydrate

craving.

This could explain aspartame's lack of effectiveness as a diet aid.

DKP

DKP is a breakdown product of phenylalanine that forms when

aspartame-containing liquids are stored for prolonged periods.

In animal experiments it has produced

brain tumours,

uterine polyps and

changes in blood cholesterol.

Before the FDA approved aspartame, the amount of DKP in our diets was

essentially zero.

So no claim of DKP's safety can be accepted as genuine until good-

quality long-

term studies have been performed.

No such studies have been done.

ASPARTIC ACID

Aspartic acid (also known as aspartate) is a non-essential amino acid

that

comprises 40 per cent of aspartame.

In the brain, it functions as a neurotransmitter -- facilitating the

transfer of

information from one nerve cell (neuron) to another.

Both human and animal experiments have demonstrated a significant

spike in

blood-plasma levels of aspartate after the administration of

aspartame in

liquids.

Too much aspartate in the brain produces free radicals,

unstable molecules that damage and kill brain cells.

Humans are five times more sensitive to the effects of aspartic acid

(as well as glutamic acid, found in MSG) than rodents,

and 20 times more sensitive than monkeys,

because we concentrate these excitatory amino acids

in our blood at much higher levels and for a longer period of time.

Aspartic acid has a cumulative harmful effect on the endocrine and

reproductive

systems.

Several animal experiments have shown that excitotoxins can penetrate

the

placental barrier and reach the foetus.

In addition, as levels of aspartic acid rise in the body so do levels

of the

key neurotransmitter norepinephrine (also known as noradrenaline),

a 'stress hormone' that affects parts of the human brain where

attention and

impulsivity are controlled.

Excessive norepinephrine is associated with symptoms

such as anxiety, agitation and mania.

METHANOL

Methanol (wood alcohol) comprises 10 per cent of aspartame.

[ Exactly, 11 % by weight ] It is a deadly poison that is liberated

from

aspartame at temperatures in excess of 86 Fahrenheit (30 centigrade) -

- for

instance, during storage or inside the human body.

The US Environmental Protection Agency considers methanol a

'cumulative poison due to the low rate of excretion once it is

absorbed',

meaning that even small amounts in aspartame-containing foods can

build up

over time in the body.

The most well known problems from methanol poisoning are

vision disorders, including misty or blurry vision, retinal damage and

blindness.

Other symptoms include

headaches, tinnitus, dizziness, nausea, gastrointestinal

disturbances, weakness,

vertigo, chills, memory lapses, numbness and shooting pains in the

extremities,

behavioural disturbances, and neuritis.

The EPA tightly controls methanol exposure, allowing only very minute

levels

to be present in foods or in environmental exposures.

But Blaylock says:

'The level allowed in NutraSweet is seven times the amount that the

EPA will

allow anyone else to use.'

FORMALDEHYDE

The methanol absorbed from aspartame is converted to formaldehyde in

the

liver. Formaldehyde is a neurotoxin and known carcinogen.

It causes retinal damage and birth defects,

interferes with DNA replication,

and has been shown to cause squamous-cell carcinoma, a form of skin

cancer, in

animals.

Several human studies have found that chronic, low-level formaldehyde

exposure has been linked with a variety of symptoms,

including headaches, fatigue, chest tightness, dizziness, nausea, poor

concentration and seizures.

[ Fully 11% of aspartame is methanol-- 1,120 mg aspartame in 2 L diet

soda,

almost six 12-oz cans, gives 123 mg methanol (wood alcohol). If 30% of

the methanol is turned into formaldehyde, the amount of formaldehyde

is 18

times the USA EPA limit for daily formaldehyde in drinking water, 2

mg in 2

L water.

aspartameNM/message/835

ATSDR: EPA limit 1 ppm formaldehyde in drinking water July 1999:

Murray 2002.05.30 rmforall ]

FORMIC ACID

Formic acid is a cumulative poison produced by the breakdown of

formaldehyde. It concentrates in the brain, kidneys, spinal fluid and

other

organs, and is highly toxic to cells.

Formic acid can lead to accumulation of excessive acid in the body

fluids -- a

condition known as acidosis.

The small amounts of formic acid derived from the methanol absorbed

from

aspartame may or may not be dangerous;

there are no human or mammalian studies to enlighten us.

[ aspartameNM/message/1067

eyelid contact dermatitis by formaldehyde from aspartame, AM Hill & DV

Belsito, Nov 2003: Murray 2004.03.30 rmforall

Biochemical Pharmcacology 1979: 28; 645-649.

Lack of a role for formaldehyde in methanol poisoning in the monkey.

Kenneth E. McMartin, Gladys Martin-Amat, Patricia E. Noker

and Thomas R. Tephly

The Toxicology Center, Dept. of Pharmacology,

University of Iowa, Iowa City, Iowa 52242

K.E. McMartin and T.R. Tephly, authors of many pro-aspartame studies,

in

Biochemical Pharmacology (1979) remarked, " It is now generally

accepted

that the toxicity of methanol is due to the formation of toxic

metabolites,

either formaldehyde or formic acid. " They put damage doses of methanol

into the stomachs of three monkeys, and, using insensitive tests,

found no

formaldehyde in many tissues-- except for a single datum in the

midbrain,

1.5 times the detection limit. They did report widespread

accumulation of

formic acid in five tissues. The use of inadequate tests is common in

industry research that is funded to claim the safety of profitable

toxins.

Since then, industry scientists have been very wary of doing studies

on

primates, which all too easily show the dangers to humans.....

Monkeys B and C were normal, not extra vulnerable to methanol, and

were

given 3,000 mg/kg methanol, and samples taken at 18 hr. Formaldehyde

was

detected only in the blood of Monkey B, while formate was found in 8

and 10,

respectively, of the 10 fluid and tissue samples in Monkeys B and C.

For

instance, the lowest value of formate, except for zero-time blood,

for each

monkey was in the midbrain, 2.16 mmol/kg for Monkey B (24 times the

detection limit for the chromatropic acid method) and 1.02 mmol/kg

(1.3

times the detection for the dimedon method) for Monkey C. This shows

accumulation of formate in liver, kidney, optic nerve, cerebrum, and

midbrain. ]

Comment, page 49

ASPARTAME: TIME FOR ACTION

The story of aspartame is the story of the triumph of corporate might

over

scientific rigour. It shines a spotlight on the archaic and unbalanced

procedure for approving food additives.

We ingest food additives daily,

yet their approval does not require the same scientific thoroughness

as drug

approval; and,

unlike drugs, there is no requirement for surveillance of adverse

effects that

crop up once the additive is in use.

Approval does not involve looking at what people are already eating

and

whether the proposed substance will interact with other additives.

Nor does it take into account whether the additive exacerbates damage

caused by

other aspects of the modern lifestyle (for instance, the neurological

damage

caused by pesticide ingestion or exposure).

Nor does it look for subtle chronic effects (for instance, the

gradual build-up

of methanol in the body with regular aspartame ingestion).

There are other problems.

Most studies into aspartame are animal studies,

which are notoriously difficult to relate to humans.

So why bother performing them in the first place?

The answer is, manufacturers and regulators use animal research as a

double-edged sword. If an animal study reveals no evidence of harm,

the

manufacturer can use it to support its case.

If it reveals harm, however, the manufacturer is free to flip-flop

into the

argument that the results of animal studies are inconclusive in

relation to

humans.

Faced with inconclusive evidence, regulators will always err on the

side of the

manufacturer, who has after all demonstrated proper bureaucratic

procedure by

funding and submitting its animal tests for consideration.

The approval process for any substance that humans put in their

mouths on a

daily basis should be based on solid human data and

on the precautionary principle when such data is not available.

But, as it stands, the regulation of food additives in the US, the UK

and

elsewhere leaves the burden of proof of harm on average people,

despite the fact that most of us are either too detached or too timid

to

complain or simply don't have the energy to take on multinational

corporations.

The history of aspartame is all the more remarkable because of the

number of

motivated people who have refused to accept the mantra, 'if it's

approved by

the government it must be safe'.

Nearly every piece of independent research shows the outrage of these

people,

who have had to withstand threats of litigation and being vilified in

the media

as 'hysterics', is justified.

After 30 years of aspartame's commercial success, it would be easy to

conclude it is too late to act.

And yet earlier this year hundreds of products were swept off

supermarket

shelves on the chance that they might have contained minuscule

amounts of a

potentially carcinogenic dye, Sudan 1.

No studies existed to show that Sudan 1 could cause cancer in humans.

The likelihood of any one person's exposure to Sudan 1 being high

enough to

produce a tumour was minute.

Nevertheless, on the basis of the precautionary principle, action was

taken.

Aspartame is not a life-saving drug. It is not even a very effective

diet aid,

as shown by widespread obesity in the West.

Until the many concerns about it have been examined

in 'corporate-neutral', large-scale, long-term, randomised, double-

blind,

placebo-controlled human trials (the gold standard of scientific

proof)

it should be taken out of our food.

Pages 50-51

SUCRALOSE: LIFE AFTER ASPARTAME:

Aspartame should never have reached the marketplace. But even if the

authorities were to remove it from sale tomorrow, how much faith

should

consumers place in the other artificial sweeteners on the market?

PAT THOMAS REPORTS:

There is not a single artificial sweetener on the market that can

claim,

beyond all reasonable doubt, to be safe for humans to consume.

Saccharin, cyclamate and acesulfame-K have all been show to cause

cancer in

animals.

Even the family of relatively benign sweeteners known as polyols,

such as

sorbitol and mannitol, can cause gastric upset if eaten in quantity.

NutraSweet believes that its new aspartame-based sweetener, Neotame,

is

'revolutionary'; but, seemingly, it is only a more stable version of

aspartame.

This leaves the market wide open for sucralose.

Sucralose, sold commercially as Splenda, was discovered in 1976 by

researchers working for British sugar refiner Tate & Lyle.

Four years later, Tate & Lyle joined forces with Johnson & Johnson to

develop

and commercialise sucralose under the auspices of a new company,

McNeil Specialty Products (now called McNeil Nutritionals).

Sucralose has been approved by more than 60 regulatory bodies

throughout the

world, and is now in more than 3,000 products worldwide.

In the US, Coca-Cola has developed a new diet drink sweetened with

Splenda, and

other major soft drink manufacturers are expected to follow suit.

Splenda has had to rethink its slogan " made from sugar, so it tastes

like sugar "

in the wake of a heated US legal challenge and a recent ruling by the

New Zealand Advertising Standards Authority that said it confused and

misled

consumers.

While it is true that sugar, or sucrose, is one of the starting

materials for

sucralose, its chemical structure is significantly different from

that of

sucrose.

In a complex chemical process, the sucrose is processed with, among

other

things, phosgene (a chemical-warfare agent used during WWI,

now a common intermediary in the production of plastics, pesticides

and dyes),

and three atoms of chlorine are selectively substituted for three

hydroxyl

(hydrogen

and oxygen) groups naturally attached to the sugar molecule.

This process produces

1,6-dichloro-1,6-dideoxy-beta-D-fructofuranosyl-4-chloro4-deoxy-alpha-

D-galactop\

yranoside

(also known as trichlorogalactosucrose or sucralose),

a new chemical substance which Tate & Lyle calls a

'water-soluble chlorocarbohydrate'.

Accepting Tate & Lyle's classification of sucralose as a

chlorocarbohydrate

at face value raises reasonable concerns about its suitability as a

food

additive. Chlorinated carbohydrates belong to a class of chemicals

known as

chlorocarbons.

This class of chemicals includes a number of notorious human and

environmental

poisons,

including polychlorinated biphenyls (PCBs);

aliphatic chlorinated carbohydrates;

aromatic chlorinated carbohydrates such as DDT;

organochlorine pesticides such as aldrin and dieldrin; and

aromatic chlorinated ethers such as polychlorinated dioxins (PCDD) and

polychlorinated dibenzofurans (PCDF).

Most of the synthetic chlorinated compounds that we ingest, such as

the

pesticide residues in our food and water, bio-accumulate slowly in

the body;

and many cause developmental problems in the womb or are carcinogenic.

How do we know that sucralose is any different?

Tate & Lyle insists that sucralose passes through the body virtually

intact,

and that the tight molecular bond between the chlorine atoms and the

sugar

molecule results in a very stable and versatile product that is not

metabolised in the body for calories.

This doesn't mean, however, that sucralose is not metabolised in the

body at

all, and critics like HJ Roberts argue that, during storage and in

the body,

sucralose breaks down into among other things 1,6 dichlorofructose,

a chlorinated compound that has not been adequately tested in humans.

Tate & Lyle maintains that sucralose and its breakdown products have

been

extensively tested and proven safe for human consumption.

The company notes that in seeking approval from the US Food and Drug

Administration (FDA), McNeil Specialty Products submitted more than

110 studies

that attested to the safety of sucralose.

BUT CAN CONSUMERS TRUST THIS RESEARCH DATA?

The vast majority of studies submitted to the FDA were unpublished

animal

and laboratory studies performed by Tate & Lyle itself,

and therefore liable to charges of potentially unacceptable bias.

Only five involved human subjects,

and these were short-term, often single-dose, studies that clearly

could not adequately reflect the expected real-world usage of

sucralose.

After questions were raised by the FDA about the safety of sucralose

for

diabetics, and prior to approval, a further five human studies were

eventually submitted.

On 1 April 1998 the FDA approved sucralose for limited uses;

one year later it approved it as a general-purpose sweetener.

Some questions about sucralose's safety, arising from the data

submitted to

the FDA, remain unanswered.

These studies included unsettling findings about animals, which, when

exposed to

high doses of sucralose, experienced:

§ Shrunken thymus and spleen;

§ Enlarged liver and kidneys; and

§ Reduced growth rate in adults and newborns.

In the FDA's 'final-rule' report, several of the studies submitted by

McNeil

were found to have 'inconclusive' results or were 'insufficient' to

draw

firm conclusions from them. These included:

§ A test that examined the clastogenic activity (ability to break

chromosomes

apart) of sucralose, and a test that looked for chromosomal

aberrations in human

lymphocytes exposed to sucralose';

§ A series of three animal genotoxicity studies; and

§ Laboratory studies using lymphoma tissue from mice which showed that

sucralose was weakly mutagenic' (capable of causing cellular

mutations).

Clastogenic, genotoxic and mutagenic substances are all potential risk

factors in the development of cancer.

In addition to these, three studies that looked at very specific

'anti-fertility' effects of sucralose and its breakdown products,

especially with regard to sperm production were also deemed

insufficient;

this is particularly worrying, since other 'chlorosugars', such as

6-chloroglucose,

are currently being studied as anti-spermatogenic drugs.

Furthermore, the administration observed that McNeil had failed to

explain

satisfactorily a reduction in body weight seen in animals fed

sucralose and

that 'additional study data were needed to resolve this issue'.

Ironically for a product that 'tastes like sugar', McNeil argued that

weight

loss was

due to the 'reduced palatability of sucralose-containing diets'.

FDA reviewers also found that at mid to high doses there was a trend

towards

'decreasing white blood cell and lymphocyte counts with increasing

dose

levels of sucralose'.

This was dismissed as having no 'statistical significance' by the FDA;

in healthy animals and humans this may be so, but what happens when

already

immune-compromised individuals ingest sucralose?

Tate & Lyle says that any lingering concerns about sucralose are

unfounded and

that only a small amount, 15-20 per cent, of sucralose is absorbed

and broken down in the human gut. [ This is an alarming amount of

absorption.

Over the last three years, I have noticed about a dozen people who

have joined

the http://health.aspartame/ support group,

now 931

members, who report reacting to both aspartame and to sucralose. ]

The rest passes through the body unmetabolised

and is excreted in urine and faeces.

This in itself provokes important questions.

§ What happens to sucralose that is flushed down the toilet? Does it

remain

stable or react with other substances (for instance, the chlorine

used in

water-treatment plants, or microbial life) to form new compounds?

§ Is sucralose or any resulting chemical compound it may form safe

for the

environment? Is it harmful to aquatic life or wild animals?

§ Will sucralose begin to appear in our water supply, in the way that

certain drugs have, silently increasing our exposure to it? And would

that

increased exposure be safe?

PUBLISH AND BE SUED

In the face of emerging public criticism, lawyers for Tate & Lyle are

already gearing up for a battle.

According to attorney James Turner, a key player in the aspartame

drama,

'There's going to be a huge fight about Splenda in the next few

months.

[Tate & Lyle's] lawyers are already on the case trying to shut

everybody up'.

It's a tactic that worked well for Monsanto, which certainly used

legal

pressure against anyone who criticised NutraSweet.

Recently, the publisher of the local newspaper the Brighton Argus

considered it

prudent to publish an apology composed by Tate & Lyle (or their

lawyers) or face

a legal action for defamation and loss of sales after printing an

article

suggesting that sucralose was harmful to humans.

Tate & Lyle's first high-profile victim, however, was

www.mercola.com -- one of

the world's most visited internet health sites. Run by Dr Joseph

Mercola,

the site has been a vocal critic of sucralose for years. Instead of

carrying

freely available information on sucralose that might stimulate

spirited

public debate, it now carries the following message:

'Attorneys acting on behalf of the manufacturers of sucralose, Tate &

Lyle

Plc, based in London, England, have requested that the information

contained

on this page not be made available to internet users in England.'

At this point, concerned consumers should be asking themselves several

questions:

Does the story of sucralose sound familiar?

If sucralose is safe beyond any reasonable doubt, why is there such a

fervent

need to suppress any criticism of it?

Finally, whom do such tactics really serve?

Do they serve the consumer and the principles of choice, information,

safety and

redress?

Or do they serve the corporate machine and its need to keep

generating profits

without taking responsibility for the human cost of doing so?

**************************************************************

aspartameNM/message/1157

Sales volume: saccharin > sucralose > aspartame, Harold Brubaker

timesleader.com 2005.03.23: Murray rmforall

aspartameNM/message/1153

Opinion of the Scientific Committee on Food on sucralose, European

Union

2000.09.07 25 pages plain text: Murray 2005.02.08 rmforall

[ Comments by Rich Murray are in square bracketts. Only 4 of the 59

citations were to studies published in open mainstream, peer-reviewed

research journals.

At the end of this post I provide reviews about flaws in research

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