Olestra

Olestra (also known by its brand name Olean) is a fat substitute food additive that adds no metabolizable calories to products. It has been used in the preparation of otherwise high-fat foods, thereby lowering or eliminating their fat content.

The Food and Drug Administration (FDA) approved olestra for use in the US as a replacement for fats and oils in prepackaged ready-to-eat snacks in 1996, concluding that such use "meets the safety standard for food additives, reasonable certainty of no harm". In the early 2000s, olestra lost popularity due to supposed side effects and is largely phased out, but products containing the ingredient are available in some countries.^{[citation needed]} As of 2024, no products using olestra are sold in the United States.^{[citation needed]}

Olestra was discovered accidentally by Procter & Gamble (P&G) researchers F. Mattson and R. Volpenhein in 1968 while researching fats that could be more easily digested by premature infants. In 1971, P&G met with the Food and Drug Administration (FDA) to examine what sort of testing would be required to introduce olestra as a food additive.

During the following tests, P&G noticed a decline in blood cholesterol levels as a side effect of olestra replacing natural dietary fats. Following this potentially lucrative possibility, in 1975, P&G filed a new request with the FDA to use olestra as a "drug", specifically to lower cholesterol levels. The lengthy series of studies that followed failed, however, to demonstrate the 15% reduction required by the FDA to be approved as a treatment. Further work on Olestra languished.

In 1984, the FDA allowed Kellogg to claim publicly that their high-fiber breakfast cereals were effective in reducing the risk of cancer. P&G immediately started another test series that lasted three years. When these tests were completed, P&G filed for approval as a food additive for up to 35% replacement of fats in home cooking and 75% in commercial uses.

One of the main concerns the FDA had about olestra was it might encourage consumers to eat more of the "top of the pyramid" foods because of the perception of its being healthier. This could result in consumers engaging in over-consumption, thinking the addition of olestra would remove negative consequences. In light of this possibility, approving it as an additive would have meant consumers would be consuming a food with a relatively high amount of an additive, whose long-term health effects were not documented. This made the FDA particularly hesitant to approve the product, as well as the side effects, such as diarrhea, and concern for the loss of fat-soluble vitamins. In August 1990, P&G narrowed their focus to "savory snacks", potato chips, tortilla chips, crackers and similar foods.

By this point, the original patents were approaching their 1995 expiration. P&G lobbied for an extension, which they received in December 1993. This extension lasted until 25 January 1996. With pressure from P&G, the approval was finally granted on 24 January, one day before the patent expired, automatically extending the patent by two years.

At the time of the 1996 ruling, FDA concluded that, "to avoid being misbranded... olestra-containing foods would need to bear a label statement to inform consumers about possible effects of olestra on the gastrointestinal system. The label statement also would clarify that the added vitamins were present to compensate for any nutritional effects of olestra, rather than to provide enhanced nutritional value". The FDA later removed the label requirement saying that the "current label does not accurately communicate information to consumers". The FDA also agreed with P&G that the "label statement could be misleading and cause consumers of olestra to attribute serious problems to olestra when this was unlikely to be the case".