olestra
olestra

Olestra

Common names: Sucrose polyester, Fat substitute, Olean (brand name), E473 (European food additive code, categorized under sucrose esters of fatty acids).
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KIDSADVISORY SAFETY RATING
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Risky
Olestra, marketed under the brand name Olean, is a fat substitute developed by Procter & Gamble.[1] Chemically, it is a sucrose polyester that mimics the taste and texture of natural fats but passes through the gastrointestinal tract undigested, contributing no calories or cholesterol to the diet.[2] Approved by the U.S. Food and Drug Administration (FDA) in 1996, olestra has been used in various snack foods, including potato chips and crackers, to reduce or eliminate their fat content.[3]
Despite its benefits in reducing dietary fat intake, olestra has been associated with gastrointestinal side effects such as abdominal cramps and loose stools.[4] Additionally, it can inhibit the absorption of fat-soluble vitamins (A, D, E, and K) and carotenoids, essential nutrients for the body.[1] Consequently, products containing olestra are often fortified with these vitamins to offset potential losses.[5] Due to these concerns and mixed consumer reception, the use of olestra in food products has declined over the years.[1]

Safety Overview


Regulatory Bodies

FDA (US)
The FDA permits the use of olestra as a food additive under specific conditions outlined in 21 CFR 172.867. To address potential interference with the absorption of fat-soluble vitamins, manufacturers are required to add specified amounts of vitamins A, D, E, and K to foods containing olestra.[5]
Health 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.[6]
EFSA (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.[7]
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.[8]

FDA GRAS

U.S. Food and Drug Administration – Generally Recognized as Safe (GRAS)
Current Status
Not Classified
Olestra is not classified as “Generally Recognized as Safe” (GRAS) by the U.S. Food and Drug Administration (FDA). Instead, it is approved as a food additive under specific regulations.[5]

EWG Rating

Environmental Working Group
EWG Rating: None
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More about Olestra

  • Savory Snack Foods: Potato chips, tortilla chips, cheese puffs.
  • Baked Snack Products: Crackers, pretzels, baked chips.
  • Fried Snack Foods: French fries, onion rings, breaded mozzarella sticks.

Historical Use
Olestra, a non-absorbable fat substitute developed by Procter & Gamble, received FDA approval in 1996 for use in savory snacks such as potato chips and corn chips. Despite extensive testing confirming its non-toxicity, olestra's association with gastrointestinal symptoms and reduced absorption of fat-soluble vitamins led to its decline in popularity and eventual market withdrawal.[9]
Current Exposure
As of 2025, olestra is no longer used in food products in the United States, resulting in negligible consumer exposure.[10]

Gastrointestinal Distress
Consumption of olestra has been associated with gastrointestinal symptoms such as diarrhea, loose stools, abdominal cramps, and flatulence.[9]
Reduced Absorption of Fat-Soluble Vitamins
Olestra can interfere with the body's absorption of fat-soluble vitamins (A, D, E, and K) and carotenoids, potentially leading to deficiencies if not adequately managed.[11]
Altered Serum Lipid Levels
Some studies suggest that olestra consumption may reduce serum cholesterol concentrations by inhibiting dietary cholesterol absorption and replacing dietary saturated fats.[12]
Potential Weight Gain
Research indicates that consumption of fat substitutes like olestra may lead to increased weight gain in certain contexts, possibly due to altered energy compensation mechanisms.[13]

Toxicological Studies
Extensive animal and human studies have demonstrated that olestra is not absorbed or metabolized by the body, indicating a lack of systemic toxicity even at high consumption levels.[14] Research has shown that olestra does not cause injury to the gastrointestinal mucosa, as histological evaluations after long-term feeding studies revealed no adverse effects.[15]
Long-Term Safety
Long-term studies have indicated that olestra consumption does not result in significant adverse health effects, even when included as part of the diet for extended periods.[15] However, olestra can inhibit the absorption of some fat-soluble nutrients, such as vitamins A, D, E, and K, and carotenoids, which may lead to deficiencies if not properly managed.[16]

High-Risk Groups
Individuals with chronic inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease, have been studied to assess the impact of olestra consumption on their condition. A randomized, double-blind study involving 89 patients with mild to moderate IBD in remission found that olestra consumption did not exacerbate disease activity or worsen symptoms.[17]
Health Impacts
While olestra is generally considered safe for the general population, its consumption can lead to gastrointestinal discomfort, including symptoms like abdominal cramps and diarrhea. These effects are typically mild and transient but may be more pronounced in sensitive individuals.[18]

Recommended Intake
Regulatory bodies, including the U.S. Food and Drug Administration (FDA), have not established a specific Acceptable Daily Intake (ADI) for olestra. However, studies have shown that consumption of up to 32 grams per day over an 8-week period did not result in significant adverse health effects, though some gastrointestinal symptoms were reported.[19]

General Safety Level
Extensive studies have demonstrated that olestra is not absorbed or metabolized by the body, indicating a lack of systemic toxicity even at high consumption levels. Research has shown that olestra does not cause injury to the gastrointestinal mucosa, as histological evaluations after long-term feeding studies revealed no adverse effects.[20]
Sensitive Individuals
While olestra is generally considered safe, some individuals may experience mild gastrointestinal symptoms, such as abdominal cramping and loose stools, particularly with high intake. These effects are typically transient and subside upon reducing or discontinuing consumption.[21]

FAQ

What is olestra used for in food?

Olestra is a fat substitute used in snack foods like potato chips to reduce calorie and fat content.

What are the health risks of olestra?

Olestra can cause digestive issues such as diarrhea, stomach cramps, and reduced absorption of fat-soluble vitamins.

Is olestra approved by the FDA?

Yes, olestra is FDA-approved for use in certain snack foods, but it must include a label warning about potential digestive effects.

References

  1. Schneeman BO Dwyer JT 1996 Olestra and the FDA The New England Journal of Medicine 334(15) 994-996 Available at: https://www.nejm.org/doi/full/10.1056/NEJM199604113341511 ↩︎
  2. Calorie Control Council 2010 Ingredient Spotlight Olestra Available at: https://caloriecontrol.org/ingredient-spotlight-olestra/ ↩︎
  3. Food and Drug Administration 1996 Food Additives Permitted for Direct Addition to Food for Human Consumption Olestra Federal Register 61(20) 3118-3173 Available at: https://www.federalregister.gov/documents/2004/05/24/04-11502/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-olestra ↩︎
  4. Center for Science in the Public Interest 2019 Olestra Olean Available at: https://www.cspinet.org/article/olestra-olean ↩︎
  5. US Food and Drug Administration FDA n.d. Code of Federal Regulations Title 21 Olestra Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-172/subpart-I/section-172.867 ↩︎
  6. Health Canada 2024 List of Permitted Emulsifying Gelling Stabilizing or Thickening Agents Lists of Permitted Food Additives Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/4-emulsifying-gelling-stabilizing-thickening-agents.html ↩︎
  7. European Food Safety Authority 2010 Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings EFSA Journal 8(3) 1512 Available at: https://www.efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2010.1512 ↩︎
  8. World Health Organization 2019 SUCROSE OLIGOESTERS TYPE I AND TYPE II - Chemical and Technical Assessment CTA Available at: https://openknowledge.fao.org/server/api/core/bitstreams/c093bc13-5b42-4e9a-8341-dcaa87bdfa36/content ↩︎
  9. Prince DM Welschenbach MA 1998 Olestra a new food additive Journal of the American Dietetic Association 98(5) 565-569 Available at: https://pubmed.ncbi.nlm.nih.gov/9597030/ ↩︎
  10. Institute of Medicine US Food Forum 1999 Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies Workshop Summary Washington DC National Academies Press US APPENDIX A Legal Aspects of the Food Additive Approval Process Available at: https://www.ncbi.nlm.nih.gov/books/NBK224037/ ↩︎
  11. Peters JC et al. 1997 Assessment of the nutritional effects of olestra a nonabsorbed fat replacement summary Journal of Nutrition 127(8 Suppl) 1719S-1728S Available at: https://pubmed.ncbi.nlm.nih.gov/9237967/ ↩︎
  12. Patterson RE Kristal AR Peters JC 2000 Changes in Diet Weight and Serum Lipid Levels Associated With Olestra Consumption JAMA Internal Medicine 160(17) 2600-2604 Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/485450 ↩︎
  13. Swithers SE Ogden SB Davidson TL 2011 Fat substitutes promote weight gain in rats consuming high-fat diets Behavioral Neuroscience 125(4) 512-518 Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC3144274/ ↩︎
  14. Bergholz CM 1992 Safety evaluation of olestra a nonabsorbed fatlike fat replacement Regulatory Toxicology and Pharmacology 15(3) 314-328 Available at: https://pubmed.ncbi.nlm.nih.gov/1515040/ ↩︎
  15. Thomson AB Hunt RH Zorich NL 1998 Review article olestra and its gastrointestinal safety Alimentary Pharmacology & Therapeutics 12(12) 1185-1200 Available at: https://pubmed.ncbi.nlm.nih.gov/9882026/ ↩︎
  16. Blackburn H 1996 Olestra and the FDA The New England Journal of Medicine 334 984-986 Available at: https://www.nejm.org/doi/full/10.1056/NEJM199604113341511 ↩︎
  17. R S Sandler N L Zorich T G Filloon H B Wiseman D J Lietz M H Brock M G Royer R K Miday A randomized double-blind study of the effect of olestra on disease activity in patients with quiescent inflammatory bowel disease Gastroenterology 103(5) 389-399 Available at: https://pubmed.ncbi.nlm.nih.gov/9375707/ ↩︎
  18. S J Savery 1998 The Trials of Olestra The Health Safety Issue Nutrition Noteworthy 1(1) Available at: https://escholarship.org/uc/item/48m731w1 ↩︎
  19. Schlagheck TG Riccardi KA Zorich NL et al. 1997 Olestra dose response on fat-soluble and water-soluble nutrients in humans Journal of Nutrition 127(8 Suppl) 1646S-1665S Available at: https://pubmed.ncbi.nlm.nih.gov/9237961/ ↩︎
  20. Freston JW Ahnen DJ Czinn SJ Earnest DL Farthing MJ Gorbach SL Hunt RH Sandler RS Schuster MM 1997 Review and analysis of the effects of olestra a dietary fat substitute on gastrointestinal function Regulatory Toxicology and Pharmacology 26(2) 210-218 Available at: https://pubmed.ncbi.nlm.nih.gov/9356284/ ↩︎
  21. Cheskin LJ Miday R Zorich N 1998 Gastrointestinal symptoms following consumption of olestra or regular triglyceride potato chips a randomized double-blind controlled trial JAMA 279(2) 150-152 Available at: https://jamanetwork.com/journals/jama/fullarticle/1150330 ↩︎

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