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Olestra: a new food additive

D M Prince1, M A Welschenbach

  • 1Office of Special Investigations, US Food and Drug Administration, Rockville, MD 20857, USA.

Journal of the American Dietetic Association
|May 23, 1998
PubMed
Summary

Olestra, a fat substitute, is approved for savory snacks by the FDA. While safe, it may cause digestive issues and affect fat-soluble vitamin absorption, requiring fortification and labeling.

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Area of Science:

  • Food Science
  • Toxicology
  • Regulatory Affairs

Background:

  • Procter and Gamble petitioned the FDA in 1987 to approve olestra (sucrose esterified with fatty acids) as a fat replacement.
  • The petition was later restricted to savory snacks, leading to extensive review by the FDA.

Purpose of the Study:

  • To evaluate the safety and efficacy of olestra as a fat substitute in savory snacks.
  • To determine the necessary conditions for the safe use of olestra in food products.

Main Methods:

  • Review of petitioner's evidence, expert opinions, and FDA Food Advisory Committee proceedings.
  • Toxicological assessments including carcinogenicity, genotoxicity, and teratogenicity evaluations.
  • Nutritional studies on the impact of olestra on nutrient absorption.

Main Results:

  • Olestra was deemed safe for use in savory snacks, with no evidence of toxicity.
  • Potential side effects include gastrointestinal symptoms like cramping and loose stools.
  • Olestra affects the absorption of fat-soluble vitamins (A, D, E, K) but not water-soluble nutrients.

Conclusions:

  • FDA approved olestra for savory snacks with mandatory fortification of fat-soluble vitamins.
  • Products containing olestra require labeling detailing vitamin compensation and potential gastrointestinal effects.
  • Further studies on consumption patterns and long-term human effects are mandated.

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