Course:FNH200/Projects/2023/Olestra Regulation
Introduction
Olestra, also known as Olean as its brand name, is a fat substitute accidentally developed by two researchers working under the American company Proctor & Gamble (P&G) while they were researching ways to increase infant fat intake. When P&G originally discovered olestra, they intended to market it as a drug that could reduce cholesterol levels due to the sucrose polyester's ability to bind to fat-soluble molecules. However, olestra was unable to sufficiently lower cholesterol levels by the Food and Drug Administration's (FDA) standards, so P&G had to revise their plans. By 1987, the company repetitioned the FDA to allow olestra onto the market as a fat substitute.[1]
Chemical Composition
Olestra is an esterified sucrose attached to a maximum of eight fatty acids whereas most conventional fats are triglycerides, with an alcohol or glycerol backbone.[2] The sucrose in Olestra is esterified to be a mixture of octa-, hepta-, and hexaesters. Any other esters are isolated and removed via an acetic-acid methanol wash. The fatty acids of Olestra are long chained. Further preparation is done by altering and refining the substitute in order to remove colour and to ensure that it meets composition requirements as laid out by the fat industry.[3]
The chemical structure of Olestra also prevents it from being digested and absorbed by the body. While conventional fats consist of 3 fatty acids, Olestra is esterified with 6-8 long-chain fatty acids.[4] Olestra is not hydrolyzed by pancreatic lipases, and its larger structure prevents the molecule from being absorbed through the intestinal mucosa. As a result, rather than being absorbed in the small intestine like conventional triglycerides, Olestra passes through the small intestine into the colon and is excreted unchanged.[4]
Olestra has physical and sensory properties similar to conventional fats. Foods made with Olestra are almost identical in taste and texture to those made with typical triglycerides.[4] Olestra is also able to provide a rich taste and creamy texture due to it being primarily made from fat.[5] Miller et al. demonstrated this similarity by comparing the sensory characteristics of regular full-fat potato chips with potato chips made using Olestra. The sensory ratings of the two types of potato chips were not significantly different, suggesting that replacing conventional fats with Olestra can maintain similar sensory properties in foods such as potato chips.[6]

It has similar heat stability in comparison to triglycerides with its smoke, flash and fire points being the following approximate values: 480°F, 550°F, and 625°F or 250°C, 288°C and 330°C. Due to their fatty acid composition, Olestra and triglycerides react similarly when undergoing food preparation processes, such as frying, and no significant differences can be perceived in the final product.[3] Olestra differs from other fat substitutes in its ability to withstand high temperatures. Below is a comparison table of the effects of high temperature on Olestra, Simpleese and Maltrin.
| Fat Substituent | Base | Effect under high temperature | Suitable for high temperature? |
| Olestra | Fat | Similar “mouthfeel, appearance, flash point, heat stability, and oxidative stability to conventional fats” [7] | ✅ |
| Simplesse | Protein | Denatures when exposed to high-temperature food processing.[7] | ❌ |
| Maltrin | Carbohydrate | Binds to water to achieve a fat-like texture; therefore, at higher temperatures, it loses its functionality (e.g., creamy, fat-like properties).[7] | ❌ |
Other Fat Substitutes
| Property | Egg and milk protein (Simplesse®) | Maltodextrins (Maltrin®) | Olestra (Olean®) |
|---|---|---|---|
| Base | Protein | Carbohydrate | Fat |
| Calories | 1.0-1.3 Cal/g | 4 Cal/g | 0 Cal/g |
| Digestion | Partially digestible | Fully digestible | Indigestible |
| High-temperature cooking | Limited | Limited/moderate | Good heat stability |
| Example uses | Ice cream, yogurt, cheese spread, salad dressings, margarine, mayonnaise, coffee creamer, soups and sauces. | Margarine, salad dressings, frozen desserts, frostings, processed meat. | Salty, savory snacks and crackers |
Health Effects
Gastrointestinal Effects
Because olestra is not significantly digested or absorbed, it remains in the gastrointestinal tract and is eventually eliminated from the body. Consumption of larger amounts has been associated with gastrointestinal symptoms, including loose stools, abdominal cramping, diarrhea, and flatulence.[8] The occurrence and severity of symptoms can vary between individuals and can depend on the amount consumed. Long-term animal studies did not identify olestra as toxic, carcinogenic, or mutagenic under the conditions studied.[9] However, gastrointestinal effects became an important consideration during the development, marketing, and regulation of foods containing olestra.
Fat-soluble Vitamin Absorption
Another concern surrounding olestra is its potential to interfere with the absorption of fat-soluble vitamins. Vitamins A, D, E, and K are fat-soluble vitamins, meaning that dietary fat plays an important role in their absorption.
Because olestra can interact with fat-soluble compounds while passing through the digestive tract, consuming olestra can reduce the absorption of some fat-soluble vitamins and carotenoids. This concern influenced the FDA's original regulatory requirements for foods containing olestra. In the United States, manufacturers were required to add certain vitamins to products containing olestra to compensate for potential losses in vitamin absorption.
Appetite Behaviour
In a study done with rats, Olestra was found to promote weight gain. Due to Olestra having a similar mouthfeel to fat but having no calories, it may disrupt the ability to understand the sensory properties of food and predict the calories, therefore leading to overeating and weight gain within a mixed fat diet. This was shown when the introduction of Olestra caused the animals to not have the ability to perceive fatty foods as high in calories. Rats that were fed a mixed fat diet ended up with more adiposity, weight gain and food intake. However, rats that were fed a fat diet of only Olestra did not experience negative effects on their ability to correlate calories and food properties.[10]
Lipid Levels and Cholesterol
Olestra was originally studied because researchers thought it might help lower cholesterol. Since olestra is not digested or absorbed by the body, it can replace regular fat without adding the same amount of absorbed fat and calories. However, studies have shown that olestra does not greatly reduce the absorption of other dietary fats. A human study found that consuming 32 g of olestra reduced triglyceride absorption by only about 1.2%, which researchers considered a very small effect.[11]
Other studies have found lower cholesterol levels in people who consumed olestra-containing foods. In one study of 335 adults, people who consumed more olestra also ate less total fat and saturated fat. The highest olestra consumers had an average decrease in total cholesterol of about 21 mg/dL, compared with about 5 mg/dL among people who did not consume olestra. However, this does not necessarily mean that olestra alone caused the decrease in cholesterol. The study explained that several factors could contribute, including reduced absorption of dietary cholesterol, replacing saturated fat with olestra-containing foods, and lower energy intake.[12] Another nine-month study compared a regular diet, a reduced-fat diet, and a diet where one-third of the fat was replaced with olestra. The group eating the olestra-containing diet lost more body weight and body fat than the other groups, which suggests that some of the health changes linked to olestra diets may also be related to weight loss.[13] Overall, while olestra-containing foods may be associated with lower cholesterol when they replace regular higher-fat foods, these changes may also be influenced by lower saturated fat intake, lower energy intake, and changes in body weight.
Regulation
| Place/Organization | Regulation |
|---|---|
| United States | In 1987, the Procter and Gamble Company submitted a petition to the FDA, seeking an amendment to the existing regulations governing food additives regarding fat substitutes. This petition aimed to secure authorization for the use of olestra as a viable alternative to conventional fats in food products. The FDA later approved Olestra in savoury snacks for in 1996. Due to Olestra affecting fat soluble vitamin absorption, the FDA requires that products that contain Olestra have those vitamins be added back. The products must also contain a label that warns potential consumers of digestive issue that the Olestra products can cause.[2] However, this labelling requirement has been amended since August 2003 due to an appeal by Procter and Gamble. In the federal ruling, the FDA stated that olestra meets the safety standards as outlined by food regulation guidelines on additives, and that the original labelling requirement was to inform consumers about the potential effects of the fat substitute, not to identify illness or health risks. By the FDA's standards, unlabelled food containing olestra are not considered health risks.[14] |
| Canada | Health Canada has not approved olestra as a food additive. The agency’s List of Permitted Emulsifying, Gelling, Stabilizing, or Thickening Agents does not include olestra, indicating its use is not permitted in Canadian food products.
Olestra was rejected for use in the Canadian food industry in 2000. This is because P&G did not provide sufficient proof that reintroducing vitamins into food products containing olestra was enough to offset the consequence of the consumer's impaired ability to absorb fat soluble vitamins.[15] Since then, no further appeals were made to Health Canada as the company decided to prioritize the American market. In terms of consumer reactions, olestra was met with outcry and mild reactions. Certain nutritional scientists argued that letting a plastic fat (also known as a trans fat) would have negative affects on our food systems. Others say that a small serving of products containing olestra has minimal effects and while consumers could overeat, the messy gastrointestinal consequences can function as a signal to stop eating.[16] |
| Europe | The EFSA has not authorized olestra for use as a food additive within the European Union. Consequently, products containing olestra are not permitted in EU member countries. |
| WHO (World Health Organization) | The WHO, through the Joint FAO/WHO Expert Committee on Food Additives (JECFA), has evaluated sucrose oligoesters, which are chemically related to olestra. However, JECFA has not specifically assessed olestra, and thus, the WHO has not established guidelines or an acceptable daily intake for this additive. |
The Rise of Olestra-Containing Foods
Consumer Concerns and the Decline of WOW Products
Olestra today
Potential Exam Questions
Question from Summer 2026
Questions from Summer 2023
Question 1 is a call back to Lesson 3, and tests us on learning objective "compare and contrast the different types of fat replacers and alternative sweeteners used in foods". Simplesse is a protein-based fat substitute and cannot withstand heat, while Maltrin (maltodextrins) and Olestra have similar burning points at 240°C and 250°C respectively.
Question 2 compares regulation of olestra between the United States and Canada, as its important to have the Canadian viewpoint of what's approved and to be able to contrast that with American regulators.
References
- ↑ "A BRIEF HISTORY OF OLESTRA". Nov 1996. Archived from the original on 5 Dec 2022. Retrieved 4 Aug 2023.
- ↑ 2.0 2.1 Prince, Diane; Welschenbach, Marilyn (May 1998). "Olestra: A New Food Additive". Journal of the American Dietetic Association. 98: 565–595 – via Elsevier Science Direct.
- ↑ 3.0 3.1 Lawson, Kenneth; Middleton, Suzette; Hassall, Christopher (Aug 1997). "Olestra, a Nonabsorbed, Noncaloric Replacement for Dietary Fat: A Review". Drug Metabolism Reviews. 29: 651–703. doi:10.3109/03602539709037594 – via Taylor & Francis Online.
- ↑ 4.0 4.1 4.2 Jandacek, R.J., Kester, J.J., Papa, A.J. et al. August 1999.https://link.springer.com/article/10.1007/s11745-999-0423-3 Olestra Formulation and the Gastrointestinal Tract. Accessed August 10, 2026.
- ↑ Chan, Judy. 2026. 3.1.1 Types of Fat Substitutes. Canvas. University of British Columbia. Accessed August 10, 2026.
- ↑ Miller et al. October 2000.https://doi.org/10.1016/S0031-9384(00)00319-X Effects of dietary fat, nutrition labels, and repeated consumption on sensory-specific satiety. Accessed August 10, 2026.
- ↑ 7.0 7.1 7.2 Thomas. P. O’Connor, Nara M. O’Brien. 2016 https://doi.org/10.1016/B978-0-08-100596-5.00648-X. Fat Replacers. Accessed August 10, 2026.
- ↑ Center for Science in the Public Interest (February 3, 2022). [“Olestra (Olean).”] Center for Science in the Public Interest. Accessed August 9, 2026.
- ↑ Hunt, R.H., Zorich, N.L., and Thomson, A.B.R. (1998). [“Overview of olestra: a new fat substitute.”] Canadian Journal of Gastroenterology, 12(3):193–197. Accessed August 9, 2026.
- ↑ Swithers, Susan; Ogden, Sean; Davidson, Terry (Aug 1 2012). "Fat substitutes promote weight gain in rats consuming high-fat diets". Behavioural Neuroscience. 125: 512–518 – via PubMed Central. Check date values in:
|date=(help) - ↑ Daher, G.C., Cooper, D.A., Zorich, N.L., King, D., Riccardi, K.A., and Peters, J.C. (1997). [“Olestra Ingestion and Dietary Fat Absorption in Humans.”] The Journal of Nutrition, 127(8):1694S–1698S. Accessed August 9, 2026.
- ↑ Patterson, R.E., Kristal, A.R., Peters, J.C., et al. (2000). [“Changes in Diet, Weight, and Serum Lipid Levels Associated With Olestra Consumption.”] Archives of Internal Medicine, 160(17):2600–2604. Accessed August 9, 2026.
- ↑ Bray, G.A., Lovejoy, J.C., Most-Windhauser, M., et al. (2002). [“A 9-mo randomized clinical trial comparing fat-substituted and fat-reduced diets in healthy obese men: the Ole Study.”] The American Journal of Clinical Nutrition, 76:928–934. Accessed August 9, 2026.
- ↑ Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra, 68 Fed. Reg. 46399 (Aug. 5 2003).
- ↑ "Canadian Food Regulators Give Olestra A Thumbs Down". The Free Library. 2 July 2000. Retrieved August 9 2023. Check date values in:
|access-date=(help) - ↑ Driedger, Sharon (December 16 2013). "Olestra Controversy". The Canadian Encyclopedia. Check date values in:
|date=(help)