Olestra was approved by the Food and Drug Administration for use as a food additive in 1996 and was initially used in potato chips under the WOW brand by Frito Lay. In 1998, which was the first year Olestra products were marketed nationally after the FDA’s Food Advisory Committee confirmed a judgment it made 2 years earlier, sales were over $400 million (Nestle 338). However, by 2000 sales slowed to $200 million, largely caused by the unappealing side effects described on the FDA-mandated health warning label:
This condition (normally occurring only by excessive consumption in a short period of time) became popularly known as "anal leakage."
One of the main concerns of the FDA about Olestra was the irony that it would encourage consumers to eat more of the "top of the pyramid" foods due to the perception of it being more healthy; a paradox resulting in over-consumption thinking that Olestra allows that without consequence (Nestle, 339-340,2002). In light of this fact, approving Olestra as an additive would have meant that consumers would be consuming a food with a relatively high amount of an additive, and the long-term health effects were not documented. This fact is what made the FDA particularly hesitant to approve the product in addition to the side effects such as diarrhea and concern for the loss of fat-soluble vitamins (Nestle, 340).
The approval came on the heels of 30 years of research and development by Procter and Gamble. Olestra was originally filed as a drug with the FDA in 1975, but after not being able to prove the efficacy of olestra to lower blood cholesterol levels by at least 15%, Procter and Gamble abandoned the drug-approval petition and returned to try to approve olestra as a food additive (Nestle 341). P&G garnered congressional support in securing patents to maintain property rights on the product until approval in 1996 (Nestle, 347, 2002).
The FDA removed the warning requirement in 2003 as it had "conducted a scientific review of several post-market studies submitted by P&G, as well as adverse event reports submitted by P&G and the Center for Science in the Public Interest (a particularly outspoken critic). The FDA concluded that the label statement was no longer warranted in spite of having received over 20,000 complaints.
Since it contains fatty acid functional groups, Olestra is able to dissolve lipid-soluble vitamins such as vitamin D, vitamin E, vitamin K, and vitamin A, along with carotenoids. Fat soluble nutrients consumed along with Olestra products are excreted along with the undigested Olestra molecules. To counteract this loss of nutrient, products made with Olestra are fortified with oil soluble vitamins to compensate for this loss to fecal matter.
When removing the Olestra warning label, the FDA cited a 6-week Procter & Gamble (makers of Olestra) study of more than 3000 people showing that an Olestra-eating group experienced only a small increase in bowel movement frequency.
P&G also worked hard in its publicity campaigns to highlight the positives of the additive, even working directly with the health-care community (Nestle, 351, 2002). But, outside of the popular culture disapproval of the product, many consumers simply did not see the speedy results for which they had hoped from a product they saw as being a cure all. This was because Olestra only dealt with the fat component of the overall dietary pattern of Americans. Foods containing olestra do contain calories and many Americans believed that they could just eat more of them to compensate for the less "saved" (Nestle 353). Eating olestra chips was not a particularly efficient way to improve one's diet overall.
In 1999, researchers discovered that Olestra helps facilitate the removal of dioxins from the body, as it apparently binds to dioxins in a manner similar to that of normal fats. This unexpected side effect may make the substance useful in treating victims of dioxin poisoning.