Tuesday, June 2, 2009

Cyclamate




The invention: An artificial sweetener introduced to the American
market in 1950 under the tradename Sucaryl.
The person behind the invention:
Michael Sveda (1912-1999), an American chemist
A Foolhardy Experiment
The first synthetic sugar substitute, saccharin, was developed in
1879. It became commercially available in 1907 but was banned for
safety reasons in 1912. Sugar shortages during World War I (1914-
1918) resulted in its reintroduction. Two other artificial sweeteners,
Dulcin and P-4000, were introduced later but were banned in 1950
for causing cancer in laboratory animals.
In 1937, Michael Sveda was a young chemist working on his
Ph.D. at the University of Illinois. Aflood in the Ohio valley had ruined
the local pipe-tobacco crop, and Sveda, a smoker, had been
forced to purchase cigarettes. One day while in the laboratory,
Sveda happened to brush some loose tobacco from his lips and noticed
that his fingers tasted sweet. Having a curious, if rather foolhardy,
nature, Sveda tasted the chemicals on his bench to find which
one was responsible for the taste. The culprit was the forerunner of
cyclohexylsulfamate, the material that came to be known as “cyclamate.”
Later, on reviewing his career, Sveda explained the serendipitous
discovery with the comment: “God looks after . . . fools, children,
and chemists.”
Sveda joined E. I. Du Pont de Nemours and Company in 1939
and assigned the patent for cyclamate to his employer. In June of
1950, after a decade of testing on animals and humans, Abbott Laboratories
announced that it was launching Sveda’s artificial sweetener
under the trade name Sucaryl. Du Pont followed with its
sweetener product, Cyclan. A Time magazine article in 1950 announced
the new product and noted that Abbott had warned that
because the product was a sodium salt, individuals with kidney
problems should consult their doctors before adding it to their food.Cyclamate had no calories, but it was thirty to forty times sweeter
than sugar. Unlike saccharin, cyclamate left no unpleasant aftertaste.
The additive was also found to improve the flavor of some
foods, such as meat, and was used extensively to preserve various
foods. By 1969, about 250 food products contained cyclamates, including
cakes, puddings, canned fruit, ice cream, salad dressings,
and its most important use, carbonated beverages.
It was originally thought that cyclamates were harmless to the
human body. In 1959, the chemical was added to the GRAS (generally
recognized as safe) list. Materials on this list, such as sugar, salt,
pepper, and vinegar, did not have to be rigorously tested before being
added to food. In 1964, however, a report cited evidence that cyclamates
and saccharin, taken together, were a health hazard. Its
publication alarmed the scientific community. Numerous investigations
followed.
Shooting Themselves in the Foot
Initially, the claims against cyclamate had been that it caused diarrhea
or prevented drugs from doing their work in the body.
By 1969, these claims had begun to include the threat of cancer.
Ironically, the evidence that sealed the fate of the artificial sweetener
was provided by Abbott itself.
Aprivate Long Island company had been hired by Abbott to conduct
an extensive toxicity study to determine the effects of longterm
exposure to the cyclamate-saccharin mixtures often found in
commercial products. The team of scientists fed rats daily doses of
the mixture to study the effect on reproduction, unborn fetuses, and
fertility. In each case, the rats were declared to be normal. When the
rats were killed at the end of the study, however, those that had been
exposed to the higher doses showed evidence of bladder tumors.
Abbott shared the report with investigators from the National Cancer
Institute and then with the U.S. Food and Drug Administration
(FDA).
The doses required to produce the tumors were equivalent to an
individual drinking 350 bottles of diet cola a day. That was more
than one hundred times greater than that consumed even by those
people who consumed a high amount of cyclamate. A six-person panel of scientists met to review the data and urged the ban of all cyclamates
from foodstuffs. In October, 1969, amid enormous media
coverage, the federal government announced that cyclamates were
to be withdrawn from the market by the beginning of 1970.
In the years following the ban, the controversy continued. Doubt
was cast on the results of the independent study linking sweetener
use to tumors in rats, because the study was designed not to evaluate
cancer risks but to explain the effects of cyclamate use over
many years. Bladder parasites, known as “nematodes,” found in the
rats may have affected the outcome of the tests. In addition, an impurity
found in some of the saccharin used in the study may have
led to the problems observed. Extensive investigations such as the
three-year project conducted at the National Cancer Research Center
in Heidelberg, Germany, found no basis for the widespread ban.
In 1972, however, rats fed high doses of saccharin alone were
found to have developed bladder tumors. At that time, the sweetener
was removed from the GRAS list. An outright ban was averted
by the mandatory use of labels alerting consumers that certain
products contained saccharin.
Impact
The introduction of cyclamate heralded the start of a new industry.
For individuals who had to restrict their sugar intake for health
reasons, or for those who wished to lose weight, there was now an
alternative to giving up sweet food.
The Pepsi-Cola company put a new diet drink formulation on
the market almost as soon as the ban was instituted. In fact, it ran
advertisements the day after the ban was announced showing the
Diet Pepsi product boldly proclaiming “Sugar added—No Cyclamates.”
Sveda, the discoverer of cyclamates, was not impressed with the
FDA’s decision on the sweetener and its handling of subsequent investigations.
He accused the FDAof “a massive cover-up of elemental
blunders” and claimed that the original ban was based on sugar
politics and bad science.
For the manufacturers of cyclamate, meanwhile, the problem lay
with the wording of the Delaney amendment, the legislation that regulates new food additives. The amendment states that the manufacturer
must prove that its product is safe, rather than the FDAhaving
to prove that it is unsafe. The onus was on Abbott Laboratories
to deflect concerns about the safety of the product, and it remained
unable to do so.

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