Great Olestra Blunder:
How Did It Happen?
Charles R. Attwood, M.D., F.A.A.P.
he last meeting of the FDA's Food Advisory Committee (FAC) was underway at a Holiday Inn in Alexandria, Virginia. Twenty-three experts from universities and research centers throughout the country had met there the previous 3 days for working sessions. It was November 17, 1995 and they would be making a decision whether or not to recommend that the FDA approve Proctor & Gamble's new fat substitute, Olestra. It was a cloudy, chilly day in Washington but this FAC meeting was especially well attended by both working members of the committee and other invited experts. Their sole objective, they were reminded repeatedly by FDA Commissioner, Dr. David Kessler, who was there the last two days, would be a "reasonable certainty of no harm" from this product. "That is not the same thing," he told them, "as concluding that it is not dangerous."
Olestra had been under development for 25 years at a total cost of over $200 million. It had all the qualities of fat, but wasn't absorbed and therefore left behind no calories and no fat. It was heat-stable and could be used for both frying and baking. But there were caveats. Dr. Fred H. Mattson, the co-discoverer and former employee of P&G--now with the University of California -- said later in an interview for Time Magazine about his work on the product, "we had a great deal of trouble with what we called 'anal leakage'" It seems that in some individuals this new substance, a sucrose molecule, a polyester, with six to eight long-chain fatty acids attached, was so large and dense that enzymes couldn't break it down. It went through the gastrointestinal tract without absorption and actually stained the underwear of test subjects. Though this risk of "anal leakage" and underwear staining has been reduced, according to researchers at P&G, by making changes or "stiffening" the molecule, it hasn't been abolished. The final product continues to cause bloating, cramping, and diarrhea in many individuals eating as little as the 10 grams contained in a small, one ounce bag of potato chips. There is also evidence that this effect is greater in patients with chronic inflammatory bowel disease.
Other problems discussed by the Food Advisory Committee were the disturbing findings by P&G that fat soluble vitamins, A,D,E,and K, apparently attached themselves to this large fatty acid polyester molecule and were carried out with it instead of being absorbed. Several subgroups may be at high risk, such as persons on anticoagulant medication, children and the elderly, pregnant women, and persons with chronic inflammatory bowel disease; none of these groups have been adequately studied.
Olestra also interfered with the absorption of of carotenoids, some of which are also fat-soluble. Here's where the FAC encountered uncertainty. One study conducted in Holland and reported in the American Journal of Clinical Nutrition (62:591, 1995) showed that after one month of eating just 3 grams of Olestra daily (an amount contained in only 6 potato chips) the blood levels of lycopene, a carotenoid found in tomatoes, and suspected of preventing prostate cancer, was 40 percent less than controls who didn't eat Olestra-containing foods. The committee suggested that products made with Olestra should have added fat-soluble vitamins to counteract their concurrent depletion. Carotenoids, however, they felt had not been proven to be of value in preventing cancer or other disorders.
The long-term effects of carotenoid depletion is unknown, but an increased cancer risk is feared by most experts studying this nutrient. There has also been a link between carotenoid deficiencies and macular degeneration, which results in permanent blindness among the elderly. Unlike the cramps and diarrhea, consumers cannot monitor this long-term risk. Yet, some members of the FAO suggested that the public will "vote at the cash register."
Among the members of the Food Advisory Committee who strongly urged the approval of Olestra from the beginning was Dr. Ronald Kleinman, a Harvard pediatrician and frequent spokesman for the American Academy of Pediatrics. During the committee meetings on November 16 and 17, he acknowledged the fact that children eating food containing this substance may have cramping or diarrhea. If children get sick from it, he suggested, they can stop eating Olestra containing foods. "They may not wish to tolerate 4 or 5 bowel movements a day, but I don't see that that has an adverse effect on their health if they stop that food. I don't believe I am hard-hearted."
Another member of the committee, Dr. Henry Blackburn, of the University of Minnesota, seemed to have strong reservations about this product throughout the discussions. Later, he would say, "...it appears that to prevent approval, there would have to be absolute proof that a food additive is harmful. It shifts the burden of proof from the company to the public." He also complained that several committee members have worked as consultants to the food industry. He later repeated these concerns in an editorial for the New England Journal of Medicine.
When the November 17th meeting ended, three members didn't vote, citing a conflict of interest, five voted against approval, and fifteen voted for approval for use in salty snacks, potato chips, corn chips, and crackers, with the following warning displayed on the package:
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 words diarrhea or anal leakage were not recommended and no mention was made about the inhibition of carotenoid absorption.
During the time between the committee's adjournment on November 19th and the December 1st deadline for public comments -- a deadline which was later extended -- nearly 800 letters poured into the Rockville, MD, Dockets Management Branch of the FDA. Most, according to New York Times food columnist Marion Burros, were from nutritionists and scientists recommending that the product not be approved. Strong objections were spearheaded by the Washington, DC based consumer advocacy group, Center For Science In The Public Interest, led by Dr. Michael Jacobson. The American Public Health Association, the American Academy of Ophthalmology, the Lifestyle Medicine Institute, and the National Women's Health Network all came out against approval. Several well-known nutritionists sent letters recommending rejection, including Dr. Marian Nestle, NYU's chief nutritionist. Dr. Walter Willett and Meir Stampfer of the Harvard School of Public Health wrote to Commissioner Kessler: "...the fact that P&G wishes to proceed with the introduction of Olestra into U.S. diets is appalling...over fifty studies have found, with remarkable consistency, that diets rich in carotenoids are associated with lower risk of cancer at many sites." The decision was now totally up to Commissioner Kessler.
Meanwhile, P&G, who, according to former employees, had been prepared to spend another $800 million if necessary to get this potential $1 billion a year product on the market, was apparently becoming concerned by this influx of new mail to the FDA. They would take no chances. Victory, it seemed, was near. So on December 15th the company asked dozens of scientists to write letters to the FDA on its behalf. They were actually given a guideline of points to make, including (1) your area of expertise, (2) Olestra's general or GI safety, or benefit, (3) reasonable certainty of no harm, and that FDA should approve it, (4) the carotenoid and GI effects have been fully addressed by the FDA's Food Advisory Committee, (5) Olestra's health benefits, and (6) commend the FDA on its thorough process. Of the 26 scientists who complied with P&G's request and wrote letters to the FDA urging approval of the product, some were or had been consultants to P&G, others had been a part of the FDA Food Advisory Committee, and still others had attended the public committee meeting on November 17th.
On January 25th 1996 Olestra was approved for marketing. Five days later a copy of the required warning label was filed in the Federal Register, still with no mention of the words diarrhea or carotenoids. Test marketing began in April in three cities, Cedar Rapids, Iowa, Eau Clair, Wis, and Grand Junction, CO by Frito Lay in their Max potato chips. P&G's Pringles prepared with the product will follow. So is it all over? Not exactly. The approval is based on a required ongoing study of side effects by the company, which will be reviewed by the same FAC in 30 months. After that P&G is prepared to ask for approval to market Olestra, despite a number of disappointing taste tests, under the brand name Olean, to all food companies for use in hundreds, even thousands of products. But already the giant leap has been made from the laboratory to 250 million test subjects.
So what is the typical consumer saying? As I travel and speak, I find most people highly suspicious of Olestra, but not without humor. In Kalamazoo, Michigan a college student said, "Proctor & Gamble makes this food product that causes anal leakage. They also make a laundry detergent."
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