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Fats / The Problems with Olestra
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 When I suspected the next morning that the olestra was the cause of the diarrhea," says Jean Medonic, "I took those bags and I put them in the trash. I didn't allow anyone in my family to eat those." |
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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 & Gamble’s 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 (“Olestra may cause loose stools and abdominal cramping) 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). That’s more reports than for all other food additives in history combined. The FDA planned to make a decision on labeling in 2000.
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| When I suspected the next morning that the olestra was the cause of the diarrhea," says Jean Medonic, "I took those bags and I put them in the trash. I didn't allow anyone in my family to eat those." |
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One night in the fall of 1996, 49-year-old Jean Medonic of Marion, Iowa, tried some potato chips made with the fat substitute olestra as she watched the 10 o'clock news.
Normally I can eat anything without becoming sick, she says.
An hour after turning in, she suffered gas pains so sharp and of such a magnitude that I would say it was almost like the beginning of labor.
The pain finally subsided just before the waves of diarrhea hit. She says she was severely ill for 13 or 14 hours. Medonic is one of thousands of people who appear to have had messy run-ins with olestra, a fake fat that's touted as a way to help you stay slim and cut your risk of heart disease. While there's no direct evidence that it can do either, there is a chance that it will send some people scooting for the nearest bathroom. It will also flush out of your body substances that could help protect you against cancer, heart disease, and blindness.
Until now, the problem has been confined to central Indiana, the Columbus (Ohio) area, and three other cities where olestra chips and crackers have been test-marketed.
By the end of March, though, foods made with olestra may be staring you in the face at your local supermarket. That's when Frito-Lay plans to start selling its WOW brand of olestra-containing Lay's, Ruffles, and Doritos nationwide. It's licensing the use of olestra under the trade name Olean from consumer products giant Procter & Gamble.
P&G says that its own Fat Free Pringles, which are still being test-marketed, will go national later this year. Products by Nabisco (it's test-marketing Wheat Thins and Ritz crackers made with olestra) and other companies may follow.
At first blush, olestra sounds like a dieter's dream. While it tastes like fat, its molecules are too big for the body to digest. So they leave no calories behind as they pass straight through the digestive tract.
Presto! Rich-tasting junk food that doesn't go to your hips. An ounce of potato chips (about 18) made with olestra, for example, has no fat and just 75 calories (all from the potato), compared to 10 grams of fat and 150 calories in an ounce of regular chips.
But passing through the digestive tract unabsorbed has a downside. In some people, olestra acts as a laxative.
What's more, as it journeys through the gut, olestra snares fat-soluble vitamins (A, D, E, and K) from any foods that may be there and drags them out of the body. Ditto for carotenoids, which may help prevent disease. The Food and Drug Administration requires Procter & Gamble to fortify olestra with the four vitamins to help compensate for the losses. But it doesn't make the company add back any carotenoids. And that's a problem.
"Olestra has the potential to do significant harm," says Ernst Schaefer of the Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging at Tufts University in Boston.
P&G researchers developed olestra in 1968. They were looking for something to provide extra calories to premature babies (a dead end, as it turned out). It's made by chemically combining sugar with the fatty acids obtained from vegetable oils.
In November 1995, an FDA advisory panel voted 17 to 5 to approve olestra. The committee, which didn't include a single expert on carotenoids, was stacked in favor of P&G. At least nine of the 17 yea votes came from food industry consultants.
"The olestra meetings carried the sense of a fait accompli, or at least a juggernaut moving inevitably toward FDA approval," wrote Henry Blackburn of the University of Minnesota School of Public Health in the New England Journal of Medicine.1
"The FDA staff members had already concluded that olestra was safe and were acting as proponents. . ." wrote Blackburn, one of the five panel members who voted against approval.
In January 1996 P&G got the FDA's go-ahead to sell olestra for use in "savory snacks" like potato chips, tortilla chips, and crackers. The feds' only concession to safety concerns: All olestra products must carry a label notice that warns of "abdominal cramping" and "loose stools." It also warns that olestra "inhibits the absorption of some vitamins and other nutrients."
"I don't think the adverse health effects of olestra were given a reasonable public hearing," says Ian Greaves of the University of Minnesota School of Public Health. "It was a triumph of marketing over health concerns. The marketing people out-shouted the health people."
Carotenoids are the plant pigments that make fruits and vegetables red, yellow, or orange. They're also found in green leafy vegetables.
"There are dozens of studies indicating that carotenoids protect against cancer, heart disease, and macular degeneration, the most common form of blindness that strikes the elderly," says Walter Willett, head of the nutrition department at the Harvard School of Public Health.
And olestra and carotenoids don't mix: In two 1993 P&G studies, 39 people who ate eight grams a day of olestra the equivalent of 16 chips with meals for eight weeks had a 50 percent drop in their total blood carotenoids. 2,3
In 1995, researchers at Unilever, a Dutch company that was considering manufacturing its own form of olestra, gave 53 men and women margarine containing three grams of olestra a day -- about six chips worth -- with their main meal. After four weeks, the volunteers had 40 percent less lycopene in their blood.4 Lycopene is a carotenoid found largely in tomatoes. Men who eat more appear to have a lower risk of prostate cancer.5
In January 1996, Willett and Harvard colleague Meir Stampfer estimated that olestra's widespread use in snack foods would cause hundreds of cases of blindness and thousands of deaths each year from heart disease and prostate and lung cancer.
"Even modest reductions [in carotenoids] could potentially translate to many cases of serious illness," they wrote in a letter to then-FDA commissioner David Kessler.
Procter & Gamble (along with the FDA) maintains that there's no proof that carotenoids are protective. Never mind that the government's own Dietary Guidelines for Americans cites carotenoids "potentially beneficial role in reducing the risk for cancer and certain other chronic diseases." Or that it lists "Some Good Sources of Carotenoids."
"Frankly," say Willett and Stampfer, "we consider it ironic that the government has approved a chemical that lowers carotenoid levels while at the same time it is encouraging the public to eat more fruits and vegetables in part to obtain more carotenoids."
Even if carotenoids were beneficial, P&G argues, there's no problem because people usually don't eat olestra and carotenoid-rich foods together.
In other words, no olestra chips or crackers with tomatoes, salsa, or spaghetti sauce (they contain lycopene), or with spinach, broccoli, or other leafy greens (they've got lutein), or with carrots, sweet potatoes, or cantaloupe (they've got alpha- or beta-carotene).
"Eat them with olestra and some of those carotenoids will pass through your body unabsorbed," says Willett.
But eating olestra between meals isn't harmless, either. In one study in which pigs were fed olestra three hours before or after a meal, it still washed out carotenoids, though only about a third as much as when it was part of a meal.
In January 1996, a week before the FDA approved olestra, Willett and Stampfer strongly urged it not to. "Avoid submitting the U.S. population, including children and pregnant women, to a massive uncontrolled experiment with potentially disastrous consequences," they wrote to the FDA.
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