Re: BIO/LAW: FDA and Olestra

From: Harvey Newstrom (
Date: Sat Feb 17 2001 - 13:59:25 MST

At 12:02am -0700 2/17/01, Chris Rasch wrote:
>The Cutting Edge of Cutting Calories
>By Henry I. Miller
>The Scientist 15[4]:39, Feb. 19, 2001

>While olestra causes mild gastrointestinal symptoms in a small number
>of consumers, the frequency is no greater than with regular, full-fat

Olestra is a non-digestible oil. Like Castor Oil, it goes all the
way through the system and can cause uncontrollable diarrhea and
cramping. It is true that scientific studies show that the incidence
of this to no higher with Olestra than with regular chips. But for
some reason, consumers of regular chips don't seem to report this
phenomenon while consumers of Olestra do. The scientific studies do
not seem to match the experience of actual consumers.

>The bad news is on the political front. FDA regulators have been far
>too conservative with this nutritional aid. They granted limited
>approval, permitting olestra only for fried snacks, although the product
>is uniquely versatile and can be used instead of margarine, lard,
>butter, and other oils in frying, baking, and sautéing.

It is normal for the FDA to review consumer complaints for a new food
or drug product. If there is a high number of complaints, they
require these to be studied before use of the new product can be
expanded into higher-use applications.

>The agency has
>been unenthusiastic about additional uses, even though the safety and
>usefulness of the product are unquestioned.

It is not quite fair to say that the safety is unquestioned. FDA
procedures review customer complaints in addition to scientific
testing. New foods or drugs often encounter problems in the field
that are not detected by testing. We cannot just ignore a high
number of consumer complaints just because laboratory testing cannot
reproduce the problem. All recalled products, such as Thalidomide,
were first proven safe in the laboratory. Some of their effects were
not detected until a high number of problem reports started coming in
from the field.

> Olestra is the most tested
>food substance in history: Over the past 30 years, there have been more
>than 150 animal studies and 100 human clinical trials involving more
>than 24,000 adults and children--far more than the testing of most
>prescription drugs.

This is simply hyperbole. As the author of _The_Nutrients_Catalog_
<> , I
can confirm that there have been more than 150 animal tests and 100
human clinical trials performed on most vitamins, minerals, amino
acids, and basic foods. Olestra is not the most tested food
substance in history.

>Why would federal health regulators unnecessarily restrict such a
>desirable and popular product?

Because many people report severe, painful and embarrassing symptoms
within an hour of eating this substance. Although they can't
reproduce this in the lab, something is happening to many consumers
of this product.

> The FDA's failure to promote--let alone to permit--wider use of
>olestra represents the most lamentable kind of regulatory
>decision-making. The regulators have been cavalier toward public health,
>preemptive of consumers' freedom to choose, and punitive to a company
>that spent hundreds of millions of dollars in good faith to develop a
>safe and effective product.

Although I don't agree with the FDA on many issues, I am not sure
they have singled out this product for special treatment. They seem
to be following the same procedures that they use for any product.
Products that receive a high number of health complaints are not
likely to be allowed expanded usage until the reason for those
complaints are determined. Failure to reproduce these symptoms in
the lab does not explain what is happening in the field. The medical
explanation for these symptoms remains unexplained.

Harvey Newstrom <>

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