|March 1998 U.S. Edition|
by Michael Jacobson & Leila Corcoran
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,
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.
A Big Experiment
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:
"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.
In One End
Since mid-1996, when foods with olestra were first test-marketed, more than a thousand people have phoned 1-888-OLESTRA, a hotline set up by the Center for Science in the Public Interest (CSPI) to gather reports of digestive problems from people who tried olestra. (CSPI is the publisher of Nutrition Action Healthletter.) About the same number of people have complained to P&G (1-800-OLESTRA). You need a strong stomach to listen to some of the calls.
One 63-year-old Indianapolis woman ruined three pair of underwear and had no friends for two days after eating olestra chips. A 43-year-old Indianapolis nurse had to "get in a fetal position to deal with the cramps."
Eighteen of the people who called CSPI or P&G had to go to the hospital, and dozens of others called or went to their doctors.
Ignoring the results of its own research, P&G maintains that the hotline calls represent everyday gastrointestinal upsets, not harm caused by eating olestra.
Don't tell that to Karl Klontz. In 1995 the FDA medical officer reviewed a P&G study delicately titled "Measurement of Selected Fecal Parameters in Subjects Consuming Increasing Levels of Olestra."
For seven days, 15 volunteers who had previously reacted to the fake fat were fed meals with zero, ten, or 20 grams a day of hidden olestra. That's about one to two ounces' worth of potato chips.
"There was a steady increase in the number of subjects who reported diarrhea with increasing dose of olestra consumed," Klontz reported. The same was true of "severe" diarrhea as well as "loose stools." In fact, severe diarrhea only showed up when the volunteers ate olestra.
P&G dosn't like to talk about it, but that study builds on previous research by the company. In one of its 1993 eight-week studies -- the best done to date on olestra and GI symptoms -- a third of the volunteers reported suffering diarrhea at least once when they ate 20 grams of olestra a day.2,3 Only one out of 17 people who ate no olestra reported diarrhea.
Procter & Gamble claims that its more recent research shows that olestra snacks cause no more problems than non-olestra snacks. But P&G s evidence is weak:
The company says that those results vindicate olestra. But the study wasn't powerful enough to detect the rate of GI problems seen in P&G's longer 1993 studies.
But exposure to olestra was minimal. And the group may not have included those who were the most sensitive to olestra. (Many people who contacted CSPI after severe reactions said they would never eat olestra again.)
The FDA says that its (industry-heavy) Food Advisory Committee will reexamine olestra's safety this summer.
In the meantime, CSPI has petitioned the Federal Trade Commission to require that olestra's food label notice (about loose stools, cramping, etc.) appear in ads for foods made with the fake fat, and to halt deceptive ads that portray olestra as natural and safe. CSPI also has appealed olestra's original FDA approval and called for more prominent labeling about its adverse effects.
Maybe getting the runs from olestra is a blessing in disguise. People who can eat olestra without suffering stomach troubles could be snacking their way to a higher risk of cancer, heart disease, and blindness.
"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."
She may be one of the lucky ones.
[The FACTS About Olestra (olean)]
1 N. Eng. J. Med. 334: 984, 1996.
2 Final Report: Assessment of the Dose-Response Effect of Olestra on the Status of Fat-Soluble Vitamins and Other Marker Nutrients in Humans. Submitted by P&G to the FDA on January 29, 1993.
3 An Eight-Week Vitamin Restoration Study in Humans Consuming Olestra. Submitted by P&G to the FDA on June 2, 1993.
4 Amer. J. Clin. Nutr. 62: 591, 1995.
5 J. Nat. Cancer Inst. 87: 1767, 1995.
6 J. Amer. Med. Assoc. 279: 150, 1998 U.S. Edition.
7 Interim Report: Randomized, Double-Blind, Placebo-Controlled Consumer Rechallenge Test of Olean Salted Snacks, Procter & Gamble, June 25, 1997.