P96-2 Food and Drug Administration
FOR IMMEDIATE RELEASE Brad Stone (202) 205-4144
January 24, 1996 Home -- (703) 204-4497
FDA APPROVES FAT SUBSTITUTE, OLESTRA
The Food and Drug Administration today approved olestra -- a
fat-based substitute for conventional fats developed by Procter &
Gamble Co. -- for use in certain snack foods and required all
products containing olestra be labeled.
Because of its unique chemical composition, olestra adds no
fat or calories to food. Potato chips, crackers, tortilla chips or
other snacks made with olestra will be lower in fat and calories
than snacks made with traditional fats.
"Olestra may cause abdominal cramping and loose stools in some
individuals, and inhibits the body's absorption of certain fat-
soluble vitamins and nutrients," said Commissioner of Food and
Drugs David A. Kessler, M.D. "FDA is requiring Procter & Gamble
and other manufacturers who use olestra to label all foods made
with it, and, to protect the public health, to add essential
vitamins -- Vitamins A, D, E and K -- to olestra."
As a condition of approval, Procter & Gamble will conduct
studies to monitor consumption as well as studies on olestra's
long-term effects. The FDA will formally review these studies in
a public meeting of the Foods Advisory Committee within 30 months.
The approval today means that FDA has determined that the
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available data and information establish that olestra is safe for
use in savory snacks.
The following labeling statement will be required on all
products made with olestra: "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."
Like all food additives, olestra's safety was the primary
focus of FDA evaluation. For olestra, the safety evaluation
focused not only on its toxicity, but also on the product's effects
on the absorption of nutrients and on the gastrointestinal system.
Studies of olestra indicated it may cause intestinal cramps
and loose stools in some individuals. These gastrointestinal
effects do not have medical consequences. The required labeling
will give consumers needed information to discontinue this product
if appropriate.
Clinical testing also indicated that olestra absorbs fat-
soluble vitamins (Vitamins A, D, E and K) from foods eaten at the
same time as olestra-containing products. Studies also
demonstrated, however, that this effect could be compensated for by
replacing these essential nutrients in olestra-containing snacks.
This information will also be provided consumers in the product
labeling.
In addition to inhibiting the absorption of essential
vitamins, olestra reduces the absorption of some carotenoids --
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nutrients found in carrots, sweet potatoes, green leaf vegetables
and some animal tissue. The company's post-marketing monitoring of
olestra consumption levels and additional studies will provide FDA
with further information about olestra's effects on the absorption
of carotenoids. The role of carotenoids in human health is not
fully understood. FDA will continue to monitor all available
scientific research on the role of carotenoids in human health.
In addressing these questions, FDA evaluated more than 150,000
pages of data on olestra, drawn from more than 150 studies.
Procter & Gamble submitted these data in its original 1987 food
additive petition, and in several amendments filed since then to
that petition.
In addition, FDA sought advice from outside experts through
its Food Advisory Committee. A special working group of the
committee met in public in November 1995 to review and discuss the
safety questions regarding olestra. After evaluating data
presented by FDA, the company, and organizations and individuals
both opposing and supporting olestra's approval, a clear majority
of the working group agreed that all the major safety issues had
been identified and addressed by the FDA review, and that the data
provided reasonable certainty that the proposed use of olestra
would be safe. A majority of the full Food Advisory Committee,
which later reviewed the data in public, reaffirmed that judgment.
The company, based in Cincinnati, Ohio, plans to market the
product soon under the trade name Olean.
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This is a mirror of the page at http://www.fda.gov/bbs/topics/NEWS/NEW00524.html