A BRIEF HISTORY OF OLESTRA

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, but didn't.

As of 2002, olestra is a moribund, if not totally dead, product. Procter and Gamble annouunced several years ago that it would not seek FDA approval to use olestra is products other than snack foods. In February 2002, P&G even sold its Cincinnati olestra factory to Twin Rivers Technologies of Quincy, Massachusetts, though P&G retained the Olean brand name. Finally, sales of Frito-Lay's WOW chips and Fat-Free Pringles crisps have declined steadily. Sales of WOW have declined more than 60 percent since their peak.