FDA’s reversal on olestra

When warnings were first required on food products containing the fat substitute olestra, manufacturers were disappointed. They maintained that the labels were misleading and alarmed consumers unnecessarily.

Now that the Food and Drug Administration has ruled that the labels need no longer mention potential “abdominal cramping and loose stools,” it’s nutritionists and consumer activists who are dismayed. They say that people will be unknowingly exposing themselves to potential digestive side effects.

“It’s introducing one more wild card into the dietary food chain,” said Greg Critser, author of “Fat Land: How Americans Became the Fattest People in the World.” The FDA made “a calculated bet that you’re going to get more economic benefits out of people losing weight than you are economic deficits of people getting sick.”

The competing views illustrate the balancing act food regulators face. When does a potential health effect become significant enough to require a warning, and when might the warning itself create a problem?

Olestra, a zero-calorie soybean and sugar concoction three decades in the making, tastes like real fat and has a similar feel in the mouth, but passes out of the body undigested. Developed and marketed by Procter & Gamble under the brand name Olean, it’s been one of the more controversial fat or sugar substitutes targeted to an increasingly obese American public. (Some substitutes, such as the sugar alcohols in many sugar-free candies, bear warnings about potential laxative effects.)

The agency began requiring the warning label in 1996 when it approved olestra’s use in such snack foods as potato chips, cheese puffs and crackers. It said that the information might be useful until the fat substitute became better-known in the marketplace.

The FDA based its decision on studies showing that eating the product in 156 consecutive meals could cause digestive distress; the greater the consumption, the greater the effect. But newer studies -- which were supposed to better represent real-life eating patterns -- found few, and sometimes no, differences when compared to full-fat versions.

In one study involving 3,300 people who took home as many bags of chips each week as they wanted, those eating olestra chips reported more frequent bowel movements than those eating full-fat chips. But that consequence amounted to “mild effects that didn’t affect their life,” said George Pauli, associate director of science and policy for the FDA’s Office of Food Additive Safety. He said the olestra label language sometimes did more harm than good, planting the notion in consumers’ minds that olestra caused their digestive woes when other conditions were to blame.

The FDA took into consideration how it treats other foods and products that sometimes produce gas, bloating and other effects, and concluded that olestra might have been unfairly singled out, Pauli said. That notion was underscored by a study that found olestra chips produced less gastric discomfort than psyllium fiber, high-fiber cereal and the sweetener sorbitol, all known for their gas-producing and bowel-loosening potential.

Noting that psyllium, high-fiber cereals and even full-fat chips send some people running to the bathroom but aren’t required by the FDA to bear health warnings, Pauli said: “You have to be consistent.”

He also said consumers were confused by other required label language, now also eliminated, that olestra can block absorption of vitamins A, E, D and K and that olestra-containing foods were fortified to compensate for that effect.

Procter & Gamble, which in late 1999 petitioned the FDA to drop the olestra labeling requirement, maintains that consumers were often turned off by the mention of abdominal cramping and loose stools, even though they might have saved fat and calories by eating foods prepared with olestra.

Eliminating the warning on these foods might mean “millions more have the confidence to try them where they didn’t have it before,” said Greg Allgood, associate director of Procter & Gamble’s Health Sciences Institute in Cincinnati.

But consumer activists point out that the warning will disappear at a time when consumers are demanding more nutritional information than ever. The FDA is about to require that food labels list artery-clogging trans fats, and it’s beginning to let food manufacturers make some qualified health claims before they’re fully proven, similar to those permitted for nutritional supplements.

The significance of olestra’s reported side effects remains disputed. Since olestra hit store shelves in 1996, the Center for Science in the Public Interest has received 2,000 reports of reactions such as diarrhea and cramps, said executive director Michael Jacobson, who favors banning olestra.

Procter & Gamble has received 18,000 reports, about which a team of doctors “concluded nothing was serious, nothing unexpected and nothing could be attributed to olestra other than common digestive effects,” Allgood said.

Jacobson said that the FDA tends to view consequences short of severe, permanent harm as “minor inconveniences.”

“Some of it gets down to philosophy,” he said. “How common do problems have to be? How severe do they have to be? There’s grounds for debate.”

Most nutritionists agree that people are unlikely to suffer ill effects from a single serving of Frito-Lay’s WOW! potato chips or tortilla chips, Procter & Gamble’s fat-free Pringles chips or Utz’s Yes! potato chips. “But let’s look at the eating and snacking habits of the American public,” said registered dietitian Leslie Bonci, a spokeswoman for the American Dietetic Assn. When diet-conscious consumers hear the magic words “fat-free,” she says, they often eat the whole bag.