TED Case Studies

Olestra, Health and Trade

Case Number: 500
Case Mnemonic: OLESTRA
Case Name: Olestra, Health and Trade



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I. Identification

1. The Issue

Olestra, a fat substitue that provides zero fat to the human body, was approved for manufacturing of savory snacks by the United States Food and Drug Administration (FDA) on January 24, 1998. Unlike conventional fat substitutes, olestra does not deprive palatability of oil. Although this sounds a great invention, there are some serious tradeoffs. Since Olestra is indigestible, it takes some valuable nutrients that are dissolved in fat out of the body. Another major shortfall is that olestra causes gastrointestinal disturbances including diarrhea. Given that there are so many problems and uncertainties related to olestra consumption, its introduction to the market would need extensive reviews. Should the sale, labeling and advertising olestra-containing products be restricted? Should people outside the United States be protected from harms of olestra by limiting the trade of olestra?

2. Description

What does olestra do?

Olestra is the first approved fat replacer that can be used for fried foods. Since it is principally made with fat, it retains properties of ordinary oils, such as the rich taste and creamy texture. It can also withstand high temperatures. In addition, because olestra is indigestible, it provides totally no fat and no calories to the human body. (13)

Olestra is made from vegetable oils, such as soybeans and cottonseed oil, and table sugar (sucrose) through a special combination. While ordinal fats are made up of three fatty acid chains attached to a glycerol core, six to eight fatty acids are attached to the sucrose core of olestra. Since the sucrose core has too many fatty acids, the body's enzyme cannot break down the olestra molecule. (Click here to see the chemical properties of olestra)

FDA approved olestra in January 1996 for use in "savory snacks," including potato chips, tortilla chips, cheese curls, corn chips and crackers. FDA's judgment was based on the reviews of 150 studies conducted in the past 25 years and involved thousands of people. P&G named the product as "Olean."(13)

Why olestra was developed?

American Food and Chemical industries have developed a number of fat-free or reduced fat products since the start of this century in order to answer the rapidly rising demand for such products. This trend is resulted from the following characteristics of the modern American society:

In order to answer the high demand for no or low fat products, there have been numerous developments of fat substitutes. However, they tend to reduce both calorie and flavor altogether (See"Brief History of Fat Substitutes"). This made all the conventional fat substitutes imperfect and voices that desire low-calorie fatty foods that maintain fatty flavor have remained.

Rise in obesity rates

Recent US government studies found that 33% of adults and 27% of the children in the US are obese. About 40 million adults weigh more than 20% above their desirable weights, slightly below the total population in South Korea. (12) The National Center for Health Statistics found that, in the past decade, the proportion of U.S. adults who are overweight increased by 8% to 33%. A study conducted by the National Institute of Health found that the average weight of Americans age 25-30 jumped to 171 pounds in 1992-93 from 161 pounds in 1985-86. As for children, there has been a 6% increase in obesity rates since 1980, with 21% of teenagers considered significantly overweight. According to a survey reported by Calorie Control Council, 60% of Americans admit they need to lose weight and 37% of them admit they need to lose 10 pounds or more. (11)

Health Risks

Medical research reveals that obesity is related to a number of diseases. For example, if a person is 20% above desirable weight, this would lead to a 20% increase of the likelihood of death from all causes, a 25% increase of coronary artery diseases, a 10% increase from stroke, twice the risk of diabetes, and a 40% increase in gall bladder disease. In men 40% above desirable weight, there is a 55% increase in mortality from all causes, 70% increase from coronary artery disease, 75% increase from stroke, and 400% increase from diabetes.(12) In men, for each 10% increase in body weight there is approximately 20% increase in the incidence of coronary artery disease. Men whose weight is 130% or more above average are 2.5 times more likely to die of prostate cancer during a 20 year follow-up compared to men of average weight.

Menopausal women with upper body fat localization have an increased risk of developing breast cancer. Overweight women also have higher rates of cancer of tile uterus and ovaries. In addition, obesity causes endocrine abnormalities. Obesity women experience irregular menstrual cycles more often than normally-weighted women. Obese woman in the 20-30 years-old range have a six-fold increase in the risk of developing gall bladder disease compared to normal-weight women.

Increased conscious toward weight

Contrary to the fact the more Americans are overweight, "to be thin" has been "in" in American society. People's consciousness toward weight control is very high: 90% of consumers eat or drink lighter versions of their favorite foods on a regular basis.(11) Also, 71% adults say they are eating a healthier diet today than they were three years ago.(11) In addition, 40% of women (44% of them are high school girls) and 24% of men are trying to lose weight. Many of these people do not need to lose weight, and of those who do, the majority will fail. 62% say they always try to check the nutrition label to determine the fat content in foods and beverages they buy. And 55% say they always try to check for calories.

Still excessive calorie intake

Although people are getting more conscious of body image and health, and reduced and zero-fat foods become prevalent, American people still eat too much. According to Calorie Control Council, Only 27% of adults (54 million people) are currently dieting.(11) Americans get 34% of their daily calories from fat, as opposed to a recommended intake limit of 30% al tough the figure has been improved from a decade ago, when Americans got 40% of calories from fat. Calorie intake keeps going up. According to the latest National Health and Nutrition Examination Survey (NHANES), total caloric intake by adults increased from 1,969 calories in 1978 to 2,200 in 1990.

Insufficient exercise

The most serious problem would be that Americans do not exercise enough. Only 40% of Americans exercise on a regular basis. In addition, American lifestyles are getting more sedentary. Sports participation is declined by 10% during 1985-90, and as manufacturing jobs decline, people move around at lesser degree at work.

Due to all these reasons, Americans are now strongly paying attention to fat contents of a food product. According to a 1995 survey by the Food Marketing Institute, an organization of grocery retailers and wholesalers, 65% of the consumers surveyed consider fat as their biggest nutrition concern. More than three-fourth of the consumers said they stopped buying a specific food because of the amount of fat listed on the nutrition panel.(4)

A national survey conducted in 1996 by Booth Research Services for the Calorie Control Council revealed that nearly 90% of the adult U.S. population consume low- or reduced- fat foods and beverages. Another Council survey shows that two-thirds of adults believe that there is a need for fat substitutes. 2,076 new low- or reduced- fat products were introduced in 1996.(12)

Pros

Producers of olestra-contained products ( P&G, Frito-Lay, Nabisco), governmental agencies and many scientists and dietitians support the use and sale of olestra. P&G's strongest allies include two former Secretaries of the U.S. Department of Health and Human Services (Otis Bowen; Luis Sullivan) and former president of the American Dietetics Association.(2) Also, major organizations, such as the American Medical Association, the American Dietetics Association, the American Academy of Pediatrics, and the National Consumer League support the FDA's determination on olestra.(10)

Olestra is introduced as a "miracle" fat substitute that provides no fat and still retain palatability of oil. Olestra can be used for a variety of dishes, including fried foods and dressings, thereby increasing food choices of obese people.

Supporters of olestra claim that nutrition loss caused by olestra is substitutable and will not have significant impact on human health. Lost fat-soluble nutrients, such as Vitamin A, D, E and K are supplemented artificially, and studies did not show any significant difference between artificial nutrients and natural counterparts. Also, they maintain that other fat-soluble nutrients, such as Carotenoids , do not have significant benefits on human health.

Supporters of olestra insist that incidence of gastro intestinal disturbances does not significantly increase by consuming olestra. According to P&G, out of 2,453 of consumers of olestra who are older than 10, only 2.5% reported any digestive effects, while 2.0% of full-fat chips eaters have similar effects. Similarly, out of 904 children (age 2-10) who ate olestra, 1.7% reported digestive effects, while 1.5% of full-fat counterparts had same experiences.

As described earlier, obesity is associated with numerous health and social problems. Consumption of olestra would help lower fat intake and possibly reduce weight. Thus, substantial monetary and qualitative benefit can be expected for obese people.

Cons

A number of organizations, such as Center for Science in the Public Interest (CSPI) and Harvard School of Public Health have been vigorously opposing the widespread sale of olestra-containing products. Problems related to the consumption of olestra are depletion of nutrients, gastrointestinal disturbances, and other minor health and environmental effects.

Depletion of fat-soluble nutrients

Olestra depletes fat-soluble nutrients, such as Vitamins and carotenoids. Numerous studies have been conducted by producers, consumer groups and scientific community. Procter & Gamble have found that the consumption of 8 gm/day (16 chips) of olestra-containing potato chips caused dramatic depletion of fat-soluble vitamins within two weeks. They also found that olestra caused significant declines in all carotenoids monitored and 50% to 60% declines in total serum carotenoids by the fourteenth day of olestra consumption. Further, they tested 32 gm/day consumption of olestra-contained chips, which revealed that olestra reduced total serum carotenoids by 70% over the eight weeks. (1)

A study conducted in Holland found that 3 gm/day consumption of sucrose polyester (the general name for olestra-like chemicals) caused 20% decline in beta-carotene levels and a 38% decrease in lycopene, another key carotenoids. Three clinical studies found that 8 gm/day of olestra reduced lutein levels by 20% to 40%. (1)

Olestra depletes nutrients when it is consumed together with other meals. According to Procter & Gamble's survey, 79% of the savory snacks are consumed during mealtimes. (1)

Contribution of carotenoids to health are not well known, but there are growing evidences that intake of carotenoids is associated with important health benefits. For example, a recent case-control study found that lutein (along with zeaxanthin) concurs with a lower risk of macular degeneration, the most common cause of blindness in the elderly.(1) Sedon, M.D. et al. (1994) explain how lutein and zeaxanthin protect the eye. "The dominant pigments in the macula are lutein and zeaxanthin, which are selectively accumulated in the retina from plasma. These yellow pigments, lutein and zeazanthin, can filter out visible blue light, which theoretically can cause photic damage. Ultraviolet light is filtered by the cornea and lens in the anterior aspect of the eye, but visible blue light reaches the retina. Therefore, lutein and zeaxanthin might serve to protect the retina from photic damage or other oxidative insults.(9)"

Other possible contribution of carotenoids is cancer prevention. Scientists have found that beta-carotene and other carotenoids reduced cancer incidence in animals exposed to carcinogens. Many epidemiological studies have linked high carotenoids intake to lower risk of cancers of lung, esophagus, pharynx, mouth, stomach, colon, rectum, and bladder. (1)

Some people also assert that beta-carotene protect the immune system.

CSPI points out that supplementing olestra with selected vitamins will not solve all of olestra's nutrient-depletion. For example, fluctuations of vitamin K might have negative effect on 1.5 million patients who take the anticoagulant drug Coumadin. No animal or clinical studies have proven that those patients' olestra consumption is safe. (1)

Also, the Physicians Committee For Responsible Medicine (PCRM) points out that fortifying olestra with vitamins will not be sufficient to supplement all the nutrients depleted by olestra because there is no way to determine the full range of vitamins and other compounds olestra removes. (3)

Furthermore, the amounts of nutrients required to supplement are quite small. For example, the amount of vitamin A added is roughly the amount found in one-third serving of a fortified breakfast cereal, and the amount of vitamin K added is equivalent to the amount in one-fourth cup of broccoli.

Embarrassment

Olestra causes gastrointestinal disturbances, such as diarrhea, fecal urgency, and more frequent and looser bowel movements. A number of studies have reported that daily consumption of one ounce (16chips) of olestra cause various gastrointestinal symptoms.(1) CSPI's survey in 1996 revealed that 58% of people who had experienced gastrointestinal problems had mild effects; 23% of them had moderate effects, and 19% of them had severe effects. Based on the results, CSPI estimated that about 3% of US population would suffer severe symptoms by consumption of olestra.(6) As of February 1998, CSPI received reports from more than 2,000 people who had gastrointestinal symptoms. At least 18 people experience such severe symptoms that they went to the hospital.(7)

Table 1: GI Effects With Olestra
DurationDosageEffects
Test 18 weeks8gm/day• Incidence of diarrhea: Subjects: 5/17
  Controls: 1/17
• TNGS: increased from 40 to 66% (65% increase)
Test 28 weeks32gm/dayIncidence of diarrhea: Subjects: 9/17
Controls: 4/21
Test 38 weeks 32gm/dayIncidence of diarrhea: Subjects: 13/24
Controls: 1/17
Test 48 weeks32gm/dayTNGS: doubled
Notes:
All studies are conducted by Procter & Gamble.
TNGS: total number of incidents of gastrointestinal symptoms, including diarrhea, loose stools, nausea, gas and Others.
Source: (1)

Also, olestra sometimes causes underwear staining due to the greasy fecal matters and a phenomenon called "anal leakage (leakage of liquid olestra through anal sphincter)." (click here to see stained underwear)

In a study conducted by Procter & Gamble, anal leakage was reported by one subject who consumed 32gm/day of olestra. Although only single occurrence was reported, this implies that olestra may cause anal leakage among some heavy consumers, given that the study was conducted with a small group. (1)

Olestra increases appetite

According to a study reported in The American Journal of Clinical Nutrition, olestra consumption was found to increase appetite. In the study, sixteen healthy male subject were tested their appetite after eating sucrose polyester-contained (SPE) food and after conventional foods. SPE food and the conventional food had total energy of 2700 kcal and 2300 kcal, respectively. Subjects not only increased their fat intake, but also their total carbohydrate intake the day after the SPE test day, eventually increasing their calorie intake by 1255 kJ. (9)

Another study, however, showed that olestra does decrease cholesterol and saturated fat intake of obese people. The study used ten obese patients who were required to consume SPE-contained meals for 20 days. The study revealed that the patients did not feel more hungry while consuming SPE food and reduced calories associated with snacks by 23%. The study resulted in average weight loss of about 0.41 lb/day. The study also showed that SPE reduced dietary saturated fat content by 50%, polyunsaturated fat content by 54%, and dietary cholesterol by 25%. (9)

General Concerns For Fat Substitute

Fat has many important functions to maintain good health, and lowered fat intake might impair those beneficial functions of fat. Fats not only carry the fat-soluble vitamins, but also they help those nutrients to be absorbed in the intestine. In addition, they are the only source of the linoleic acids and linolenic acids, essential fatty acids in the body. They are an important source of calories for many adults and infants, who have high energy requirement. Fat provides 9 calories per gram, compared with 4 calories per gram for protein and carbohydrates. (4)

Impacts on environment

Since olestra is indigestible, consumption of olestra increase the amount of oils released to the environment. Olestra increase the quantity of solid waste and sludge that have to be treated at wastewater treatment plants. This will directly increase costs of cleaning the wastewater. Besides, olestra in sludge and solid waste in waterways cannot be completely removed, contributing water contamination. With more frequent use of olestra, water pipes in households would be frequently congested because of the solidification of oil.

However, no critics of olestra attacks environmental aspect of olestra. The environmental assessment conducted by P&G concluded that olestra will not have any significant negative effects on environment. Studies showed that olestra was not toxic to aquatic organisms including bacteria, algae, zooplankton, and fish nor to terrestrial organisms including bacteria, plants, earthworms and nine mammalian species. The company reports that because of its very low water solubility and sorptive nature, the vast majority of olestra that enters environment will be associated with wastewater solids and sludges, which can be removed by 91 to 94% at primary and secondary treatment plants. Furthermore, the company maintains that olestra was shown to be mineralized at a rate sufficient to prevent significant accumulation in soil.(18)

Analysis

Reliability of scientific data

P&G conducted 150 studies on olestra's safety. FDA's Food Advisory Committee considered four areas in reviewing the P&G's studies: (1) olestra's chemistry and consumption, (2) toxicology and potential interference with drug absorption, (3) gastrointestinal effects and labeling, and (4) nutritional effects. The Committee concluded that, in all four areas, the relevant issues had been identified and the data were sufficient to address the relevant issues. Also, most of the reviewers agreed that the data provided a "reasonable certainty of no harm" from olestra. (8)

However, various uncertainties with regard to effects of olestra consumption on human health remain. For example, effects on children are rarely examined, while studies are chiefly conducted with healthy people over 44 years of age. Children are expected to be major consumers of olesra-contained chips, but few studies are conducted so far. (1)

In addition, no studies has been conducted to see long-term health effects of olestra consumption. Studies with the longest duration lasted for only eight weeks, hardly long enough to see all health effects that might have on lifetime olestra consumers. (1)

Furthermore, olestra's possible carcinogenicity has not been resolved yet. Two animal studies found that olestra consumption may cause liver foci, which may be precursors of cancer. One animal study showed that there was a statistically significant increase in lung tumors in mouse groups that were fed high dosages of olestra. (1)

Finally, there is no threshold level of adverse health effect of olestra on health. Some people had any kinds of adverse health effects by consuming 8 gm/day of olestra, the least amount of olestra tested, while others did not. Even if 8gm/day is determined as the threshold, Acceptable Daily Intake (ADI) would be calculated as 0.8gm/day, far below the likely consumption levels for olestra. (1)

Cost-Benefit analysis

Benefits

Monetary benefits of olestra consumption can be calculated from the sum of reduced costs for weight loss efforts, reduced costs for medical treatment of obesity and related diseases, productivity gain due to reduced obesity rates, and so on.

The overall costs incurred through efforts to lose or control weight involve investment in weight-loss and exercise programs, diet foods and exercise equipment, as well as the costs of pharmacological or surgical treatment. On this basis, the overall cost for the obese population was estimated at $30 billion a year in the United States. Few financial assistances are available for these efforts; patients shoulder most of such costs by themselves. A diagnosed obese patient is estimated to spend $5,994 annually for weight control.In many countries, the direct costs of obesity amount to about 4% to 7% of the total health care budget.

Obesity also creates significant indirect costs, such as loss of productivity and lowered quality of life. For example, an obese individual has functional impairment in the activities of daily living. This dysfunction is related to sleep, recreation, work and social interactions. Obese patients also have physical incapacity due to back and joint problems and shortness of breath. This contributes to absenteeism, sick leaves and fatal accident at work. In addition, impairment of the body image might lead to psychological problems, such as depression.(12) Furthermore, the government and companies have to pay disability pensions for extremely obese people.(15)

Costs

Costs of olestra consumption involve increased diseases caused by loss of vitamins, minerals and carotenoids, hospital charges for severe gastrointestinal symptoms, loss of productivity, costs for wastewater solids and sludge treatment, and any unknown costs that have not been proven scientifically. In addition, consumption of olestra might increase the number of obese in the country, thereby incurring costs associated with obese patients. Dr. Walter Willett, chairman of the nutrition department at the Harvard School of Public Health and his colleague have told the FDA that they estimate that widespread use of olestra in snack foods alone could cause several thousands deaths annually.

Efficacy

Does olestra consumption effectively solve overweight problem in the United States? Evidences seem not to support this. Olestra might lead snack lovers to eat more chips, just like smokers of low nicotine cigarette smoke more than they did with conventional cigarette. The experience with sugar substitutes has shown that they cannot mitigate obesity problem in the U.S. Indeed, the obesity rates jumped by 30% since 1980s. (5)

Olestra-contained snacks are more likely to be consumed by teenage boys than any other age and sex category. This means that the cutting-edge fat free products are not likely widely consumed by those who need to reduce fat intake most.

The table shows the estimated potential olestra intake under acute (single day) and chronic (lifetime average) conditions across a broad range of snack eaters by age and sex. According to the estimate, teenage boys are the heaviest consumers of snack foods, while seniors over age 65 have the lowest salty snack consumption. For the population as a whole, the mean consumption of olestra is predicted to be 10.2g or about one-ounce serving of potato chips.

Snack foods occupy only a small portion of total fat consumption in human diet. According to Calorie Control Council, 30% of fat is coming from meat, poultry and fish, 25% from grain products, 18% from milk and milk products. Fats and oils constitute only 11% of total fat intake, and most of edible oils are found in table spreads and salad dressings.

Fat free does not mean calorie free. It is important to remember that calories still count when making choices for one's diet. Although most low- or no-fat foods contain less calories (See Table 2), reduction in calories is not always as substantial as we tend to think. This is because extra carbohydrate has been added to maintain good taste, providing extra calories as well. According to P&G, a 1 ounce or 30g bag of ordinal potato chips contains about 10g of fat and 150 calories, while the same bag of chips made with olestra contains 0g of fat and 70 calories.

Table 2: Comparison of full/low/zero fat foods
Product Serving Size Calories Fat Carbohydrates
Whole milk 1 cup 150 8g 12g
Low-fat (2%) milk 1 cup 120 5g 12g
Skim milk 1 cup 80 0g 12g
Raspberry Danish Twist 1 slice(53g) 220 12g 27g
Fat-free Raspberry Twist 1 slice 140 0g 33g
Potato Chips 1 oz. 159 11g 15g
Low-fat Potato Chips 1 oz. 110 2g 23g
Fat-free Potato Chips 1 oz. 70 0g 16g
Premium Vanilla Ice Cream 1/2 cup 270 18g 21g
Light Vanilla Ice Cream 1/2 cup 100 4g 14g
Low-fat Strawberry Yogurt 1 cup 240 3g 46g
Non-fat Strawberry Yogurt 1 cup 160 0g 31g
Vanilla Creme Cookie 2 cookies 115 5.5g 16g
Vanilla Creme Reduced-fat Cookie 2 cookies 110 2.5g 21g
Peanut Butter 2 Tb sp. 190 16g 7g
Reduced-fat Peanut Butter 2 Tb sp. 190 12g 15g
Source: (14)

Alternatives

Current regulation allows olestra to be used in savory snack products and sold in supermarket together with conventional full-fat snacks. Olestra-contained snacks are required to label to warn people for the possible abdominal effects and nutrient depletion. Given that there are so many negative or uncertain health and environmental effects of olestra, its sale on the market would need to be more restricted. Possible alternatives for the current regulation would be:

Ban olestra from ordinal market

Taking account of all the negative impacts and uncertainties related to olestra consumption, it would be too early for olestra-containing products to be widely on the market. Consumption of olestra should be limited to those who need it most, i.e. obese patients, or should be guided properly by doctors and dietitians, so that children and the elderly do not recklessly consume olestra. However, to revert the FDA's decision to approve olestra for sale on the ordinal market would be difficult. Although this is the best option to protect American consumers, this option would not be feasible to implement.

Apply stricter requirement on labels

Current labeling requirement would be insufficient both in contents and size. CSPI requested the sentence "This Products Contains Olestra" to be highlighted by bold or extra-bold type. In addition, the message is proposed to appear inside a box on the principal display panel or on the information panel of the label.

Dr. Tim Byers, a professor of preventive medicine at the University of Colorado Health Sciences Center suggested that olestra-containing products should come with a warming label stating: "Do not eat this product with food."

Set guidance for advertisement

CSPI requested FDA that the Federal Trade Commission (FTC) require that all advertisements for olestra-containing products prominently display a statement same with that on food labels.

International Perspective

So far, we have seen potential hazard of olestra at a national level. Then, how about implications to the international trade of olestra? P&G already filed appeals to the Canadian and British governments in pursuit of the export of olestra. Given that obesity rates in these countries are high (See "Obesity rates in other industrial countries" ), it is very likely that olestra is approved for sale in their market. At this moment, there is no guidance on the trade of olestra, but in the near future, its status would be determined by the Codex Alimentarius , the organization that tries to harmonize international code of food safety. If olestra is determined as safe in the Codex, countries would have to import olestra even if it is restricted by national law, or have to endure retaliatory measures if they keep on restricting imports. On the other hand, if the Codex considers olestra to have significant harm on human health or environment and restrict its sale, P&G would likely lose trade disputes fought under WTO.

Need to set guidance for olestra under the Codex Alimentarius

Trade restriction made under the Codex will be a first step to check unlimited flow of olestra to the international market. In addition to negative impacts reviewed under the national level, the negotiators need to be cautious about characteristics of international trade. Thus, international code of olestra would need to be more restrictive. Special characteristics of international trade include differences in cultural behaviors, physical properties, ethical and religious customs, and levels of economic development.

Nutrition depletion is more serious in other countries

Nutrition depletion may be a more serious problem in other countries than in the United States. Malnutrition has been a serious problem in most developing countries. Especially a lack of vitamin A intake among poor children has caused chronic diarrhea and increased their susceptibility to diseases. There is a correlation between low intake of vitamin A and low academic performance in those countries. Frequent occurences of diarrhea due to ill-managed hygienic facilities has been a major cause for death in the Third World. Requiring those countries to accept olestra products would aggravate these problems.

Olestra conceals negative aspect of easy lifestyle

Imports of olestra would lead countries also to import lazy lifestyles. By reducing fat content in food, people are encouraged to maintain, or pursue, American couch-potatoing. Hard-working people who sometimes replace snack foods with meals to save time might justify their act by consuming non-fat olean products. Couch-potatoing not only make people less active, but also the habit would reduce one's appetite for nutritional meals and lead to unbalanced nutrition intake. In addition, people would spend more time on watching TV rather than on talking with family. Inactivity causes not only weight-gain, but also lowered function of muscle and organs.

Therefore, olestra forms a makeshift solution to obese and hard-workers. However, true solution must be an exercise for the former and recruitment of new staff for the latter. However, by giving them a painless tool to these problems, people mistakenly justify their current situation and enhance the trend. Thus, countries should be more cautious in approving olestra for sale in their markets.

Codex standards must be upward trend

The international code of food safety should be the model which other countries pursue, rather than the lowest denominator of member countries. Given the assumption, olestra should be properly restricted under the Codex in order to avoid creating a trend of approving a whole list of the newly developed technologies, such as genetic engineering and meat irradiation.

Olestra is against ethics

To assume that human beings are able to control nature by engineering chemical or genetic properties of natural existing would be against our ethics toward nature. Every entity in the ecological system plays a certain role and follow certain rules. To interrupt this interaction

Olestra enfeeble human beings

Dependence on new, convenient technologies isolate human beings from the rest of the wildlife. Conventional oils have caused a variety of problems and human beings have been aware of them. However, olestra makes people feel easy to use oils in their diet without any caution. If individuals get accustomed to using olestra and consume fatty foods as much as they like, they are less likely to be able to maintain their health when olestra is not available.

Olestra disadvantage non-US vegetable oil producers

Companies outside the United States are disadvantaged if the share of olestra in the vegetable oil market become dominant in the US and other industrial countries. Poor countries, which do not possess the patent of olestra, would lose their competitiveness and will further be impoverished.

Due to all these reasons, the sale of olestra should be banned or significantly restricted at international level. Since current rules of international trade, governed by WTO, pursue uniform standards to solve trade disputes, it would be better for Codex Alimentarius to set food safety codes at the level that protect consumers who are the most vulnerable to the harms. If consensus cannot be achieved with this option, representatives of countries should vigorously advocate clear notification of information related to olestra on lables and advertisements, and better fortification of nutrients both in quantity and quality.

Conclusion

It is hard to measure which part, benefit or cost, outweighs the other especially in the United States where the high obesity rate is such a big problem. Obesity is accountable for higher occurrence of heart diseases, diabetes, hormone abnormalities, respiratory problems, and numerous other problems. If these problems are solved by the widespread consumption of olestra, benefits of olestra are likely to surpass the costs associated with harms brought by olestra.

However, we should be cautious when analyzing whole costs and benefits involved in the introduction of olestra to the market. For example, there are so many uncertainties in olestra's harms on certain categories of population, such as children, pregnant women, people on certain medication, and so on. Also, long-term effects of olestra on human health, such as birth defects and carcinogenicity, and on environment are not well known.

In addition, efficacy of olestra as a tool to reduce a country's obesity rates is dubious. Olestra might work well as a diet food for obese people, but might bring the opposite effect on people in good shape. While teenagers are the biggest consumers of olestra, the obese population is culminated in middle ages. Besides, harms of olestra on primary school children and teenagers who require more energy and nutrients than adults would be bigger than those on adults. Furthermore, as recent development of sugar and fat substitutes have shown, prevalence of those products has never lowered the obesity rate in the United States probably because people eat more fat-free fatty foods and still lack in exercise.

Ethical concerns tend to be neglected but are still important. Regarding human technologies as perfectly substitutable with nature's wisdom would be scientifically easy but ethically unacceptable. This is to challenge the nature's complicated matrices that human beings can never untangle. Also, introduction of convenient tools have enfeebled human beings. If people get accustomed to fat-free oils, their understanding of functions of oils will become obtuse and may not be able to make proper judgment when fat-free oils are not available.

In conclusion, widespread sale of olestra in both national and international level is undesirable. Especially the international food safety code being developed by the Codex Alimentarius Committee should not be based solely on data obtained from Americans because physical and cultural properties are different among countries. Although olestra is likely to make economic contribution to American society and other countries with high obesity rates, strict limitations on the sale of olestra would be needed.

Related Links

Pros

P&G's olestra homepage: http://www.olean.com/
Frito-Lay's homepage: http:www.fritolay.com/olestra.html

Cons

CSPI's homepage: http://www.cspinet.org
Harvard School of Public Health homepage: http://www.hsph.harvard.edu/academics/nutr/olestra/olestra.html

Scientific facts

http://www.newswise.com/articles/OLESTRA.JHM.html

Comedy sites related to olestra

http://www.zug.com/zug/pranks/olestra/day8.html
http://www.cis.umassd.edu/~jburke/gallery/olestra/oleopoetry.html

3. Related Cases

4. Draft Author:

Yoko Taniguchi, July 6, 1998

II. Legal Clusters

5. Discourse and Status:

Agreement and In Progress

6. Forum and Scope:

USA and Unilateral

7. Decision Breadth:

1 (for now)

8. Legal Standing:

Law

III. Geographic Clusters

9. Geographic Locations

a. Geographic Domain: North America

b. Geographic Site: Western North America

c. Geographic Impact: USA

10. Sub-National Factors:

No

11. Type of Habitat:

Temperate

IV. Trade Clusters

12. Type of Measure:

Import ban

13. Direct v. Indirect Impacts:

Direct

14. Relation of Trade Measure to Environmental Impact

a. Directly Related to Product: Yes (Olestra)

b. Indirectly Related to Product: No

c. Not Related to Product: No

d. Related to Process: No

15. Trade Product Identification:

Olestra or Oil

16. Economic Data

Estimated costs of obesity:
Estimated costs of obesity is $30 billion a year in the United States. Few financial assistances are available for these efforts; patients shoulder most of such costs by themselves. A diagnosed obese patient is estimated to spend $5,994 annually for weight control.(11) In many countries, the direct costs of obesity amount to about 4% to 7% of the total health care budget.

Estimated sale of olestra:
Stock analyst Hercules Sagalas predicted that it would generate $1.5 billion in annual sales while P&G spent $200 million to develop olestra. If all conventional fat in all savory snacks is replaced with olestra, as much as 228,000 tons (500 million pounds) of olestra could be consumed annually.(18) In the Indianapolis test market, which opened Spring 1997, 38% of people say they've purchased olestra snacks. Moreover, more than 70% of them say they've bought them again.(19)

17. Impact of Trade Restriction:

High

18. Industry Sector:

Food

19. Exporters and Importers:

USA and Many

V. Environment Clusters

20. Environmental Problem Type:

Health Risks

21. Name, Type, and Diversity of Species

Name:

Type:

Diversity:

22. Resource Impact and Effect:

Low and Regulatory

23. Urgency and Lifetime:

Low and Decades

24. Substitutes:

Like Products

VI. Other Factors

25. Culture:

Yes.

Olestra can rather be easily accepted in US society because of the high obesity rates. Also, the country traditionally has generous attitude to new technologies, as can be seen in the genetic engineering and meat irradiation disputes fought with EU. Japan also has stricter requirement to food than the United States.

26. Trans-Boundary Issues:

No

27. Rights:

No

28. Relevant Literature

  1. CSPI, online, "The Problems With Olestra," 1998
  2. CSPI, online, "A Brief History of Olestra," 1998
  3. PCRM, online, "Olestra Covers Up Problem, but Doesn't Solve It," 1998
  4. FDA, online, "Taking the Fat Out of Food," 1998
  5. CSPI, online, "Olestra: Procter Big Gamble" by Myra Karstadt & Stephen Schmidt, Nutrition Action Health Letters, March 1996.<
  6. CSPI, online, "letter to FDA Commissioner David Kessler," 1998
  7. CSPI, online, press releases, "P&G, Frito-Lay, Set to Unleash Diarrhea-causing Olestra on Americans," 1998
  8. FDA, online, "Olestra and Other Fat Substitutes," 1998
  9. the Health Psychology of Vanderbilt University, online, "Pass the Potato Chips!" 1998
  10. Frito-Lay company, online, "Olestra: The Facts (Brought to you by the Frito-Lay Company)," 1998
  11. The Calorie Control Council, online, "The Press Room," 1998
  12. Calorie Control Council, online, "Fat Replacers: Food Ingredients For Healthy Eating," 1998
  13. Calorie Control Council, online, "Ingredient Spotlight: Olestra," 1998
  14. Calorie Control Council, online, "Calories Still Count," 1998
  15. Dr J. C. Seidell, online, Obesity in Europe: Prevalence and consequences for use of medical care, 1998
  16. Procter & Gamble, online, "Estimating Consumption and Eating Frequency of Olestra from Savory Snacks Using Menu Census Data," 1998
  17. Procter & Gamble, online, "Effect of Two Weeks Fat Replacement by Olestra on Food Intake and Energy Metabolism," 1998
  18. Gregory S. Allgood, Drew C. McAvoy and Daniel M. Woltering, online, "Environmental Assessment of a New Food Ingredient, The Fat Replacer Olestra," 1996
  19. Procter & Gamble, online, "Safety of Olestra Supported By More Than 25 Years of Research," October 1995

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Brief History of Fat Substitutes

Development of fat substitutes

About a century ago, people started developing fat substitute in response to rapidly rising demand for fat substitutes. In 1911, Crisco Shortening developed the first all-vegetable shortening that contained only 27% of saturated fat, in contrast to 51% of that of conventional lard. In 1961, Crisco Oil's saturated fat level was reduced to 14%.

The first fat substitutes that reached the market were made mainly of carbohydrate. FMC Corp. introduced a cellulose gel, called Avicel, in the mid-1960s, and National Starch and Chemical Co. brought N-Oil, a tapioca dextrin, to the market in the early 1980s. These types of fat substitutes are used in a variety of foods today.(8)

In the early 1990s, protein-based fat substitutes entered the market. These includes microparticulated proteins from egg white or dairy protein and whey protein concentrate. The protein-based fat substitutes provide better taste than carbohydrate-based ones and can be used in some cooked foods. However, they are not suitable for frying.(8)

Development of Olestra

In 1968, Procter & Gamble's researchers discovered a fat substitute that was not absorbed to human body, named Olestra. Meanwhile, the company succeeded in producing Puritan Canola Oil in 1985, which further reduced saturated fat to 6%.

Olestra is a fat-based substitute. It has a unique molecule structure; the glycerol molecule is replaced with sucrose and has 6-8 fatty acids attached. With this many fatty acids, digestive enzymes cannot get to the sucrose center where breakdown of the substance for absorption into the body would take place. Therefore, a consumer of olestra does not absorb any fat at all.(8)

In spite of the fact that products made with olestra are fat-free and low in calories, olestra has the same taste and texture of fat, and even retains this texture in deep frying. One ounce of potato chips with olestra contains only 70 calories, while conventional potato chips has 160 calories.(9)

In 1971, P&G began discussing Olestra with the FDA and after conducting 150 studies the company finally filed a petition for approval of Olestra with 150,000 pages of data supporting the request to use olestra in foods, the company. By January 24, 1996, the FDA approved Olestra for use in salty snacks. At this time, P&G named Olestra as "Olean" as a brand name.

FDA requires producers to label olestra-contained products as:

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 first snack foods made with Olean were introduced to Cedar Rapids, Iowa, Eau Claire, Wisconsin and Grand Junction, Colorado by Frito-Ray in April, 1996. P&G introduced its new Fat Free Pringles, made with Olean, to residents of Columbus, Ohio in September 1996. In February 1997, Frito-Lay start marketing snacks made with Olean such as WOW!, Ruffles WOW! And Doritos WOW!, in Indianapolis. In March 1997, fat-free Pringles were introduced in Indianapolis. In April 1997, the Nabisco Biscuit Company introduced Fat Free Ritz and Fat Free Wheat Thins crackers into selected stores in Marion, Indiana and Grand Junction, Colorado. In September 1997, several non-fat and reduced-fat products made with Olean, such as Tostitos, Sour cream and onion flavored Lays' and Cheddar, and sour cream flavored Ruffles.

Frito-Lay says that it will market olestra chips nationally by about March, 1998. P&G also announced that it would do the same thing later in 1998. The FDA is going to review the safety of olestra again in summer, 1998.(2)

P&G is also seeking approval for olestra in Canada and the United Kingdom.

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Obesity rates in other industrial countries

The common impression that obesity rate is by far higher in the United States than other countries is not true. For example, 10% of men and 15% of women are obese in Europe and at least half of European population is overweight. Particularly high prevalence of obesity can be seen in women from Mediterranean and Eastern European countries.(14) In the United Kingdom, obesity rate is increasing over the past 15 years. In France, Germany, Italy and the United Kingdom, at least 25% of all individuals are now considered overweight (BMI>=25). In Spain, more than 50% of the population is overweight or obese. Even in Japan, 16% of population is overweight or obese. Considering these high percentages of obesity population, the sale of olestra would likely be positively considered in those countries.



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Body Mass Index

Body Mass Index (BMI) measures the severity of obesity more accurately than body weight. BMI is calculated as the weight in kilograms divided by the square of the height in meters (kg/m2). Classification of weighting status is shown in the table.

Categories of BMI
Category BMI
Under weight Under 20
Normal weight 20-24.9
Overweight 25-29.9
Obese 30-39.9
Severely Obese Over 40
Source: (15)

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