Anonymous
Anonymous asked in Science & MathematicsBiology · 1 decade ago

What does the FDA think about Olestra?

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  • Chez
    Lv 4
    1 decade ago
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    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

    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 --

    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.

  • 1 decade ago

    The FDA released it for use in potato chips and etc.

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