BIO/LAW: FDA and Olestra

From: Chris Rasch (
Date: Sat Feb 17 2001 - 00:02:15 MST

The Cutting Edge of Cutting Calories
By Henry I. Miller
The Scientist 15[4]:39, Feb. 19, 2001

   The sad truth is that we're a bunch of fatsos, and getting
fatter. Sixty-one percent of adults are now overweight, anall-time
high, and more than a quarter are actually obese, or grossly
overweight, according to the 1999 National Health and Nutrition
Examination Survey just released by the Centers for Disease Control and

   But while we get fatter and suffer from diabetes and high
cholesterol in record numbers, federal regulators aredrastically
limiting the availability of an important tool for controlling
calories. Five years ago the Food and DrugAdministration approved a
formidable weapon in the war against dietary fat: a cooking oil called
olestra, which adds no fat or calories to food. Simply a molecule of
table sugar linked to soybean or cottonseed oil, it is too large for
the body to absorb or digest. In 1996, after analyzing copious data,
consulting outside experts, and becoming convinced of the product's
safety during an eight-year review, the FDA permitted Procter & Gamble's
olestra for use in chips,crackers, and other "savory snacks."

   Since then, fat-free and low-fat olestra-containing versions of
five of the most popular chip brands in the United States have been
introduced by Frito Lay and Procter & Gamble. Olestra has been a
considerable success, with morethan 3 billion servings sold in the
United States. If those consumers had chosen instead to eat regular,
full-fat chips instead of olestra-cooked chips, they would have
consumed an additional 225 billion calories and 33,000 tons of
fat.Olestra is a potential boon to public health in this country,
where diets are dominated by fat and three of the top four biggest
health concerns--heart disease, cancer, and elevated blood
cholesterol--are related to fat consumption.Olestra can help to lower
the proportion of fat and saturated fat in the diet, as well as cut

   How widely might olestra be used? Consider that four of the top
five lunch/dinner entrees consumed in American homes could be made
lower in fat with such a versatile fat substitute: pizza (#1) could be
made with olestra oil; ham and turkey sandwiches (#2 and #5,
respectively) could contain olestra mayonnaise; peanut butter (on a
sandwich, #3)could be made with olestra substituted for peanut oil;
and hot dogs (#4) could contain leaner meat, with olestra added for
the satisfying "mouthfeel" of fat.

While olestra causes mild gastrointestinal symptoms in a small number
of consumers, the frequency is no greater than with regular, full-fat
chips. A large clinical studyconducted by Johns Hopkins University
researchers, for example, showed no statistically significant
differences in reports of digestive symptoms in 1,000 movie goers
whoconsumed either olestra-cooked potato chips or full-fat chips
(without knowing which they were eating). Like the rest of us, these
test subjects couldn't eat just one: Median chip consumption was
greater than two ounces for both groups, and more than a quarter of
the test subjects ate more than four ounces of chips. (The typical
single-serving bag of chips is about one ounce.) This definitive study
was peer-reviewed before being published in 1998.1

   To further compare the gastrointestinal effects of olestra to
another common food, researchers recently tested the effects of eating
five servings of olestra chips (five ounces) to eating less than two
servings of high-fiber bran cereal (a half cup). The persons eating
the wheat bran cereal experienced more digestive effects than those
eating the olestra chips.2
 Other minor problems associated with olestra are similar to those of
many common foods. For example, milk and tea also bind vitamins and
minerals. Moreover, studies inprogress at the Fred Hutchinson Cancer
Center in Seattle have found that the addition of the vitamins to
olestra snacks (which is done routinely) prevents any reduction in
overall vitamin availability.

   Beyond olestra's safety, recent research has revealed that eating
olestra-containing snacks correlates with various measures of improved
health. A study conducted by researchers at the Fred Hutchinson Cancer
Center found that people eating olestra snacks ate lower levels of
both total dietary fat and saturated fat, and they had lower levels of
unfavorable LDL cholesterol in their blood. The level of cholesterol
reduction (8 percent) was similar to that achieved with a high-fiber

   Researchers at the Nebraska Medical Center recently studied subjects
with early signs of heart disease who were fed either a high-fat meal or
an olestra-containing meal.4 The results showed that eating foods made
with olestra can provide significant benefits: After eating the meal
made with olestra, subjects had dramatic increases in cardiac blood flow
and a statistically significant reduction in blood triglyceride. While
similar results might have been achieved with a fat-free meal made
without olestra, we cannot ignore the importance of providing foods that
people will actually eat because they taste good instead of unpalatable
low-fat foods.

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

 More bad news is that the FDA continues to require labels on
olestra-containing foods, warning about possible gastrointestinal
symptoms, in spite of repeated demonstrations that such problems are no
more frequent than for full-fat snacks. Such labels mislead consumers
and discourage wider use of olestra-containing products. As long ago as
June 1998, an FDA advisory committee criticized the warning label as
inappropriate. The FDA's promise to fix or eliminate the label by the
end of last year has gone unmet. If FDA won't be an actual advocate for
wider use of this boon to public health, they should at least "do no

   Why would federal health regulators unnecessarily restrict such a
desirable and popular product? They seem to have responded to the
opposition of a single radical group, the Washington, D.C.-based Center
for Science in the Public Interest. For more than a decade, CSPI has
forsworn both common sense and overwhelming scientific evidence in
attacking olestra.

   We should not forget that CSPI is the brown rice and carrot juice
crowd that has warned us of the health horrors lurking in Mexican,
Chinese, and Greek food, and in movie theater popcorn--largely because
of the fat content. How ironic that this "consumer" group continues to
vilify a product that can help people reduce fat consumption in a
society where high-fat diets rank among the leading threats to public

   Widespread use of olestra could enable more people to adhere to the
American Heart Association's recommendation to consume less than 30
percent of total calories from fat. In public health impact, more
olestra in our diets could be tantamount to the recognition that
lowering blood pressure reduces heart disease and stroke. As a realistic
solution to Americans' constantly expanding waistlines and fat
consumption, olestra is the closest thing to a free lunch.

   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.

   Henry Miller (, a physician, is a fellow
at the Hoover Institution and the Competitive Enterprise Institute, and
the author of To America's
   Health: A Proposal to Reform the Food and Drug Administration (Hoover
Institution Press, 2000). He was an official at the NIH and FDA from
1977 to 1994.


   1. L.J. Cheskin et al., "Gastrointestinal symptoms following
consumption of olestra or regular triglyceride potato chips--A
controlled study," JAMA Journal of the American
   Medical Association, 279:150-2, 1998.

   2. J. McRorie et al., "Effects of wheat bran and olestra on objective
measures of stool and subjective reports of GI symptoms," American
Journal of Gastroenterology,
   95:1244-52, 2000.

   3. R.E. Patterson et al., "Changes in diet, weight, and serum lipid
levels associated with olestra consumption," Archives of Internal
Medicine, 160:2600-4, Sept. 25, 2000.

   4. Study presented at the Institute for Clinical PET's 12th Annual
International Conference, Washington, D.C., Oct. 17, 2000.

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