Text 6564, 149 rader
Skriven 2006-10-15 10:19:08 av Sean Dennis (1:18/200.0)
Kommentar till en text av Jim Weller
Ärende: Olestra
===============
Hello, Jim.
Since you asked where olestra is from...
From: http://www.cspinet.org/olestra/history.html
In 1968 Procter & Gamble researchers F. Mattson and R. Volpenhein, in their
quest to create a way of increasing premature babies' intake of fat,
synthesized a fat substitute called sucrose polyester. Procter & Gamble named
its product "olestra." Chemically, olestra is a sucrose (table sugar) molecule
to which are esterified as many as eight fatty-acid residues. The exact melting
point, consistency, and functional utility of the large number of sucrose
polyesters that can be made depend upon the extent of esterification, the
length of the fatty acids, and the degree of saturation of the fatty acids.
Like fats and shortening, olestra can be used to fry foods.
Olestra molecules are so large and fatty that they cannot be metabolized by
enzymes and bacteria in the gut and are neither absorbed nor digested. So, far
from proving to be a means of increasing an infant's fat intake, olestra
offered a means of replacing fat and producing fat-free or low-fat foods. Also,
olestra, because it is fatty, can bind cholesterol, vitamins, and other
fat-soluble molecules. In fact, for about ten years, Procter & Gamble
considered marketing olestra as a cholesterol-removing drug, but apparently it
was not sufficiently effective in lowering cholesterol levels to be approved as
a drug.
In May, 1987, Procter & Gamble petitioned the Food and Drug Administration to
approve olestra as a general purpose fat substitute, replacing some or all of
the fat in shortenings, fast foods, chips, and other products. A Drexel Burnham
Lambert, Inc., stock analyst, Hercules Sagalas, proclaimed that olestra was
"the single most important development in the history of the food industry." He
predicted that it would generate $1.5 billion in annual sales and be the
biggest thing in Procter & Gamble's history.
In late 1987, the Center for Science in the Public Interest (CSPI) criticized
olestra on the grounds that the testing was inadequate (olestra was tested for
two years in only one rodent species, not the standard two) and it caused
possibly precancerous liver foci in rats. Procter & Gamble acknowledged that
olestra had caused "anal leakage" and interfered with the absorption of vitamin
E, but claimed to have solved both problems, the first by modifying the
structure of olestra and the second by supplementing olestra with the vitamin.
In August, 1990, possibly because of questions about safety raised by the FDA,
Procter & Gamble narrowed its petition to "savory snacks": potato, corn, and
tortilla chips; crackers; extruded fried snacks; and the like. In the next
several years, Procter & Gamble conducted another two-year rat test, two
two-year mouse tests, and other tests. It also invested a great deal of money
and effort in persuading nutritionists and consumer and health organizations of
the value and safety of olestra, in developing marketing campaigns, and in
developing products made with olestra.
In the early 1990s, olestra patents began running out, due to the fact that it
had taken the company such a long time to develop and test the product. Procter
& Gamble successfully lobbied for special legislation that extended the
lifetime of some of the patents; the bill was signed into law in December,
1993. One key patent was extended until January 25, 1996; because the FDA
approved olestra prior to that date, the law extended the patent for two
additional years.
By 1995, Procter & Gamble was pressing hard for final approval. In June, 1995,
a House subcommittee held hearings that focused on the FDA's slowness in
approving (or denying) food- additive petitions, and many of the industry
witnesses used olestra as an example of a beneficial food additive that was
languishing on bureaucrats' desks. In October, an FDA advisory committee met,
with 17 members endorsing olestra and 5 opposing it. The FDA said it would try
to issue a decision within two months.
On January 24, 1996, the FDA approved olestra for use in savory snacks such as
chips, crackers, and tortilla chips. Despite being approved as safe by the FDA,
all snacks containing olestra must carry a label that states:
This Product Contains Olestra. Olestra may cause abdominal cramping and loose
stools. Olestra inhibits the absorption of some vitamins and other nutrients.
Vitamins A, D, E, and K have been added.
The FDA has said that it would consider revising the label statement, and
Procter & Gamble has lobbied to have it softened. CSPI and others urged a
longer, more explicit statement.
Beginning in April 1996, Frito-Lay test marketed Max-brand olestra snacks in
Cedar Rapids, Iowa, Eau Claire, Wisconsin, and Grand Junction, Colorado,
followed in 1997 by a much larger test of the renamed Wow chips in most of
Indiana. Procter & Gamble started test marketing its Fat Free Pringles in the
Columbus, Ohio, area in late 1996, with a larger test in most of Indiana
beginning in early 1997. Nabisco has test marketed Wheat Thins and Ritz
crackers in Marion, Indiana, and Grand Junction, Colorado.
By mid-1997, Procter & Gamble and CSPI each submitted more than one thousand
reports of adverse reactions to the FDA. (CSPI surveys show that only a small
minority of people who experienced adverse reactions reported their symptoms.)
Some of the reactions were for people who suffered severe diarrhea, fecal
incontinence, or abdominal cramps hours after eating olestra chips. Procter &
Gamble maintains that there was no proof that olestra was the cause of those
effects.
To bolster support for olestra and products in which it is used, Procter &
Gamble has hired countless allies, including two former Secretaries of the U.S.
Department of Health and Human Services (Otis Bowen; Louis Sullivan), the
former president of the American Dietetic Association, and many consulting
scientists and dietitians; it has invested millions in advertising campaigns;
and given grants to health and medical organizations and consulting fees to
members of those groups.
Frito-Lay began marketing its Wow chips and Procter & Gamble its Fat Free
Pringles nationally in spring, 1998. The companies and CSPI were flooded with
reports with adverse reactions. Initial sales were brisk, but, according to
trade journals, sales of Wow chips declined rapidly. Consumers probably
objected both to the high price and the adverse effects. In September, 1998,
Procter & Gamble began test marketing Eagle brand Crispy Corn Twists in
Portland, Maine.
In June, 1998, the FDA held an advisory committee meeting that reviewed the
safety and labeling of olestra. The committee was only permitted to consider
data developed since olestra was approved and not the older studies that
demonstrated harm. Procter & Gamble presented "real-life" studies that it said
exonerated olestra. FDA scientists, however, said that heavy consumers
experienced some gastrointestinal effects. CSPI presented its critique of
Procter & GambleAEs studies, which were designed not to find problems. CSPI
also described the almost 2,000 adverse reaction reports that it had received.
The committee (and FDA) ignored all the information about adverse reactions,
saying that complainers could not prove that olestra was the culprit. The
committee concluded that olestra should still be considered safe. There was
mixed opinion on the label notice ("Olestra may cause abdominal cramping and
loose stools"), with some members saying it should be eliminated, while others
recommended that it be put on the fronts of packages.
In 1999 and 2000, Procter and Gamble and Frito-Lay were demanding that the FDA
repeal its requirement that a health notice (oOlestra may cause loose stools
and abdominal crampingoe) be printed on packages of olestra containing
products. More than 18,000 people have submitted to the FDA reports of adverse
reactions that they attribute to olestra (CSPI submitted about 2,700 reports,
with the major companies submitting the rest). ThatAEs more reports than for
all other food additives in history combined. The FDA planned to make a
decision on labeling in 2000, but didn't.
As of 2002, olestra is a moribund, if not totally dead, product. Procter and
Gamble annouunced several years ago that it would not seek FDA approval to use
olestra is products other than snack foods. In February 2002, P&G even sold its
Cincinnati olestra factory to Twin Rivers Technologies of Quincy,
Massachusetts, though P&G retained the Olean brand name. Finally, sales of
Frito-Lay's WOW chips and Fat-Free Pringles crisps have declined steadily.
Sales of WOW have declined more than 60 percent since their peak.
Later,
Sean
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