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OLESTRA.
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Fat-free food additive. Development, testing, FDA approval, chemistry, uses, market issues, safety & side effects.... More...
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Paper Abstract:
Fat-free food additive. Development, testing, FDA approval, chemistry, uses, market issues, safety & side effects.
Paper Introduction:
OLESTRA
Olestra is a chemical fat-free food additive which was conditionally approved by the Food and Drug Administration (FDA) on January 24, 1996 for use in savory snack foods. A major new food product developed by Proctor & Gamble (P&G) at great expense, potato chips containing olestra underwent test marketing in supermarkets in three American cities, Eau Claire, Wisconsin, Cedar Rapids, Iowa and Grand Junction, Colorado in May and June, 1996). Olestra potato chips will soon to be introduced on a mass-marketing basis in retail stores throughout the nation. This latest addition to the junk food market has generated considerable controversy because of concerns expressed in health and scientific quarters regarding its possibly deleterious effects on human health.
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Olestra: just say no. 6 said its experiments showed it"tasted pretty respectable" (1996, Olestra: still, p. Palma,Georgetown University pediatric gastroenterologists, said the doses givenchildren in the P&G tests were unrealistic. FDA Commissioner David Kessler tookthe unusual step of forming a special Working Group on Olestra whichreported its findings to Kessler followingpublic meetings in November, 1995 of the FDA Food Advisory Council (FAC).In considering whether or not to approve olestra, FDA had to determineunder the Food, Drug and Cosmetic Act of 1938, as amended in 1958, whetherthere was "a reasonable certainty of no harm from the use of Olestra ascontemplated" (Blackburn, 1996, p. B8). A 19). Narisetti, R. (1996, January 8). Thesuccessful bidder in that competition was Frito-Lay, which agreed to investtoward the $16 million cost of a new P&G plant to manufacture the productin Cincinnati. A12). The most vocal and persistentcritic of olestra, during the FDA approval process and subsequently, hasbeen an organization associated with Ralph Nader, the Center for Science inthe Public Interest (CSPI). However, FDA conditionedits approval on P&G continuing to conduct studies to monitor the effects ofolestra consumption, the results of which will be reviewed by FAC withinthirty months after January 24, 1996. A 19. This latest addition to thejunk food market has generated considerable controversy because of concernsexpressed in health and scientific quarters regarding its possiblydeleterious effects on human health. 985). Miller, H. (Hunter, 1996, p. In a nation pre-occupied with theproblem of obesity, olestra, says Narisetti (P&G is ready, 1996, p. DuringP&G's summer 1996 test marketing trials, many people reported that theysuffered from diarrhea after ingesting olestra potato chips (Miller &Springer, 1996, p. He and the CSPI have criticized FDA for being toopartial to industry findings and interests. A3). In terms of its commercial importance and itspotential for harm to human health, it appears to stand out from theothers. Carotenoids such as beta caroteneserve as important antioxidants which may help protect against cancer andheart disease. An ounce ofregular potato chips contains 75-15 calories and up to 1 grams of fat. P&G was also required to affix alabel to packages of food products containing olestra which provides asfollows: "The product contains Olestra. Wall Street Journal, B6, B8. 6 ). FDA banned mineraloil as a food additive in 1946. Diarrhea occurred among a statisticalsignificant sample of users. Development of Olestra Since 1971, Procter & Gamble, the world's largest foodmaker, hasinvested approximately $3 million in developing olestra (Miller &Springer, 1996, p. Hunter said that P&G's own tests showed that olestra can reducedaily carotenoid absorption by 1 percent. Drs. 6 -61.----------------------- 9 Frank, R., & Narisetti, R. 6 ), "'healthy' junk-food is the fastest growing segment of the $15billion per annum snack food industry." Sales of potato chips increased twoand one half percent in the United States in 1995 but sales of potato chipswith low fat substitutes doubled (Frank & Narisetti, 1996, p. P&G filed a new petition for approval of olestra byFDA in 199 as a fat substitute in all foods, which it later narrowed tosavory snack foods. Shapiro &Associates believes the net financial effects of sales of productscontaining olestra will on balance financially benefit P&G. 2). Clinical trials and test marketing have shownthat olestra potato chips resemble the mouth feel and flavor of fat-richpotato chips. 1 ). He said in 1996that: "there will be some people who are going to avoid these productsbecause they feel uneasy about them . Newsweek, p. Shapiro, L. What's wrong with 'fat free' olestra.Consumers' Research, 79, 1 -14. Blackburn also said that "FDAdoes not have the research laboratories or staff, nor is it supported bythe policies or funds it would need, to carry out extensive independenttests of food additives" (p. 5 and chart; Olestra: just, 1996, p. Consumer Reports,pp. A12.) Attractiveness and Commercial Significance Other fat substitutes are added to snack foods by a baking processwhich distorts the taste. Wall Street Journal, p. B8). Olestra and the FDA. . In addition to P&G's studies, FDAreceived comments, mostly of a critical nature, from 275 physicians, 4 scientists and organizations such as the American Public HealthAssociation, the American Academy of Ophthalmology and the NationalAssociation for the Visual Handicapped. Washington Post, p. Olestra isthe latest such product. Hunter (1996) said that P&G did not conductany studies on adults over the age of 44 who were in good health or onthose with nutritional problems (p. NewEngland Journal of Medicine, 334, 984-986. Jacobson, M. GeorgeRosenbaum of the Chicago marketing research firm of Leo J. P & G is ready to fight back for olestra. Dr. Sheldon Margen, the editor of the Berkeley Wellness Letter, andone of the most severe critics of olestra, argues that "the evidence forpotentially adverse effects from olestra is overwhelming" (Olestra: just,1996, p. 6 andgraphic). FDA as well as P&G came under criticism from various quarters.Blackburn (1996) said "last fall's Olestra meetings carried the sense of afait accompli, or at least a juggernaut moving inevitably toward FDAapproval" (p. Harper's, p. 984)conceded that "there is almost no relevant scientific literature of itspotential health effects."lacking is adequate epidemiologic evidence --data on population-wideeffects attributable to long-term exposure. 5 ). (1996, July). 14). Olestra inhibits the absorption of some vitamins and other nutrients. 1). Dr. Margen points out that mineral oil and olestra are"virtually identical" and have similar effects as laxatives and indepleting the body of nutrients (Hunter, 1996, p. 6). F. Fake fat: miracle or menace? CSPI tracked P&G's steps inthe cities mentioned above. (1996,September 23). No one knows whetherthe controversy over the adverse health effects of olestra and the sale ofolestra products will harm or help the price of P&G's common stock. A 13). In Olestra: just (1996), the Berkeley WellnessLetter reports that "in one study, half the subjects developed diarrheaafter eating three ounces of potato chips made with olestra" (p. 13). Colon and J.S. Blackburn criticized P&G for conducting an inadequate study of thegastro-intestinal and nutritional effects of olestra consumption. The company argued, however, that in1993 tests, due to improvements which have the effect of stiffening theolestra, such results occurred in less than 2 to 27 percent of the cases(A fat substitute's, 1996, p. B8). Olestra: still some question marks. 6-7. Under its deal with Frito-Lay, P&G reserved the right tomarket olestra under its own brand name Olean in its Pringle potato chipsand to license others to make and sell non-potato chip food productscontaining olestra (Frank & Narisetti, 1996, p. OLESTRA Olestra is a chemical fat-free food additive which was conditionallyapproved by the Food and Drug Administration (FDA) on January 24, 1996 foruse in savory snack foods. 11). A primary area of concern isdepletion of fat soluble vitamins and carotenoids caused by the attachmentof these chemical substances to the olestra molecule as it passes throughthe body. The olestra molecule is much largerthan the fatty molecule for which it is a substitute. (1996, April). P & G originallyintended olestra as a new cholesterol reducing investigatory drug in 1971.In 1975, P&G filed a petition with FDA for approval on that basis, butwithdrew it in 1988. 1).P&G says this is a problem only if one eats olestra with every meal and atthe same time as carotenoid-rich foods. A19) says that "olestra is a no-fat fat that can putthe taste, but not the calories, back in chips." Olestra, which has been approved for use in all savory snacks, can beused in other snack products, such as corn chips, tortilla chips, cheesecurls, Ritz crackers and in cooking oil. Consumer Reports (1996), p. Competition among potato chips retailers to gain rights to purchaseolestra potato chips under their brand name has been intense. Olestra is a sucrose polyester, which is made bycombining sugar with fatty acids (six triglycerides). 985). P&G says that "long-term mouse studies have found no evidenceof [liver] cancer" (Olestra: just, 1996, p. (1996, April 11). (1996, July 19).Wall Street Journal, p. Raspberry, W. Vitamins A, D., E and K have been added." (Blackburn, 1996, p. In approving the product for use in savory snacks, FDACommissioner Kessler concluded that there was no significant medicalevidence that olestra caused serious health risks. The Naderites big fat problem. (1996,July 31). Anounce of potato chips containing olestra has only 7 calories and no fat(Olestra: still, 1996, p. Will fake fat play in Peoria? 2). (1996, July 11). Over 25 years P & G claims tohave conducted more than 15 studies, including 43 clinical trials, on theeffects of olestra on animals and on humans (Shapiro, 1996, p. Olestra potato chips will soon to be introduced on a mass-marketingbasis in retail stores throughout the nation. According to Hunter (1996), five out of the 2 members of FAC "expressed strong reservations about olestra's provensafety" (p. More is known about the short-term than about the long-term effects of olestra consumption. Narisetti, R. 24. (1996, June3). Wall Street Journal, B1, B8. Olestra, which withstands high cookingtemperatures, can be fried. 1). A.R. As such, it cannot bedigested and passes through the body and out. P&G has launched one of its most expensive advertisingcampaigns ever this fall which costs about $1 million. Low-fat snackers' high-risk problem. 5 ).Raspberry (1996, p. the countermotivation to avoidfat is so strong that people will take other health risks to avoid thelarger health risks of fat" (Narisetti, Anatomy, 1996, p. (1996, January29). WallStreet Journal, p. References A fat substitute's slight problem. A13. Battle over FDA Approval FDA took 9 years and reviewed over 15, pages of data before itapproved olestra as a food additive. During that process, P&G's clinical trials showed that analleakage and underwear staining occurs. The ads, whichlargely consist of consumer testimonials on the product, are being aired onprime time television programs such as Melrose Place and Mad About You(Narisetti, P&G is ready, 1996, p. Frito-Lay puts up more than chips in dealfor olestra. . 985). A critic of CSPI's tactics, Henry Millerdecried the "politicizing of the [FDA] advisory process" (1996, p. Lycopene plays an important role in reducing the incidenceof prostate cancer, and low levels of it are implicated with opticneuropathy and other forms of visual impairment. A major new food product developed by Proctor &Gamble (P&G) at great expense, potato chips containing olestra underwenttest marketing in supermarkets in three American cities, Eau Claire,Wisconsin, Cedar Rapids, Iowa and Grand Junction, Colorado in May and June,1996). A3, A5. 6 ).Conservative supporter of olestra, Henry Miller, calls it the "most testedfood in history" (1996, p. The evidence concerning the long-term adverse effects of olestra isnot yet conclusive, one way or another. (1996, August). Hunter, B.T. The controversy over olestra continues. P&G argues that its surveys of consumers show thatsnacks containing olestra "caused no more gastrointestinal problems thanregular snacks" (Olestra: just, 1996, p. Can we have our fries and eat them too? In testmarkets, potato chips with olestra were sold for 6 -18 percent higherprices than regular potato chips (Olestra: still, 1996, p. It ran a television advertisment which displaysa dog food product with an olestra label and a caption questioning whetherolestra is fit for consumption by pets or humans (Narisetti, P&G is ready,1996, p. Shapiroquotes Harvard School of Public Health professors Walter Willett and MeirStampfer who in their 1995 letter to FDA said that there is "reason tosuspect that effects [of olestra consumption] will cause increases incancer, heart disease, stroke, and blindness" (1996, p. Michael Jacobson, Executive Director of CSPI says that "olestrainhibits absorption of nutrients-carotenoids-that almost certainly reducethe risk of cancer, heart disease and blindness" (1996, p. University of California at Berkeley WellnessLetter, 12, 1-2. 984). The Berkeley Wellness Lettersays that "in one of P&G's own studies, eating 16 olestra potato chips aday for eight weeks reduced blood carotenoid levels by 5 %" (1996, p. Miller, A., & Springer, K. Anatomy of a food fight: the olestra debate. 24). Blackburn, H., M.D. 5 . He saysthe principal company study was limited to 194 adults who were observed foronly 56 days (1996, p. B6), isP&G's "most promising new product in decades." According to Shapiro (1996,p. (Fake fat, 1996, p. Newsweek,pp. Olestra may cause abdominal cramping and loose stools. 984). Other P&Gtests results of experiments on rats showed that olestra use was linkedwith pituary tumors, leukemia and premature deaths in males; and abnormaland possibly premature and pre-cancerous liver changes in females (Hunter,1996, p. FDA critic Blackburn (1966, p. Conclusion Americans and other Western consumers have become increasinglyconditioned to accept ersatz chemical substitutes for real food. 1 ). 5 ). (1996, May 31). 6). A12.
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