An HTML version of this document is available at
http://www.cfsan.fda.gov/~lrd/fats.html
------------------------------------------------------------
(FDA Consumer 1990) Fat Substitutes:
A Taste of the Future.?
by Marian Segal
"Ice cream is the nectar of the gods. This is a fat-free nectar." According to
USA Today, that's what its reporter Pat Guy had to say about the new frozen
dessert Simple Pleasures.
Mark Memmott of the same paper was less enthusiastic. "The chocolate leaves a
rather unpleasant aftertaste," he said. "I wouldn't serve it to my dog. I'd
give it to the cat. I don't like the cat." Editor Ray Goldbacher's verdict was
more middle-of-the-road: "I don't think anyone will mistake this for
super-premium ice cream, but it's not bad."
Pronouncements on the taste of this new dessert varied similarly among others
present at the press conference held in February 1990 to introduce the product
to the public.
What's all the fuss about? It's about ice cream without fat. Ice cream without
guilt. (Well, maybe some guilt even though it's fat-free, it's not
calorie-free.)
Simple Pleasures is a frozen dessert made with Simplesse, the first fat
substitute approved by the Food and Drug Administration. In fact, legally,
Simple Pleasures cannot be called ice cream because FDA's standards of
identity require that ice cream contain at least 10 percent butterfat. Both
Simple Pleasures and Simplesse are products of NutraSweet Co., a subsidiary of
Monsanto Co. of St. Louis, Mo. (NutraSweet also makes aspartame, the sugar
substitute widely used in low-calorie beverages and other products.)
Simplesse is promoted as a competitor for premium ice creams. In petitioning
FDA for approval of Simplesse, NutraSweet compared the fat, cholesterol and
caloric content of a super-premium vanilla ice cream containing 16 percent
butterfat with a frozen dessert using Simplesse. A 4-ounce serving of the ice
cream provided 19 grams of fat, 97 milligrams of cholesterol, and 274
calories, whereas the same size serving of Simple Pleasures contained less
than 1 gram of fat, 14 milligrams of cholesterol, and 120 calories. Regular
ice cream, with approximately 10 percent fat, contains about 7 grams of fat,
30 milligrams of cholesterol, and 135 calories per 4-ounce serving. (Simple
Pleasures is not yet available in vanilla because, the company says, it hasn't
yet been able to get the taste just right. It now offers toffee crunch,
chocolate, strawberry, coffee, peach, and rum raisin.)
Generally Recognized as Safe
----------------------------
Simplesse is made from egg white and milk protein blended and heated in a
process called microparticulation, in which the protein is shaped into
microscopic round particles that roll easily over one another. The aim of the
process is to create the feel of a creamy liquid with the texture of fat.
It works. Because its components have long been used as foods, FDA, on Feb.
23,1990, affirmed Simplesse as "generally recognized as safe" (GRAS) for use
as a thickener or texturizer in frozen dessert products. Safety studies were
not required.
NutraSweet plans to seek FDA approval for use of Simplesse in additional
products, such as mayonnaise, salad dressing, yogurt, dips, sour cream,
butter, margarine, and cheese spreads. Simplesse cannot be used in cooking
because baking or frying causes it to lose its creaminess. NutraSweet says,
however, that "products made with Simplesse can be enjoyed with many hot
foods." For example, it can be used in an imitation butter spread on toast or
in a sour cream-type sauce used to top a baked potato.
NutraSweet estimates that full use of Simplesse has the potential to decrease
total dietary fat consumption by Americans by 14 percent and dietary
cholesterol intake by 5 percent.
Others Being Developed
----------------------
Other fat substitutes are under development or awaiting FDA approval. Kraft
General Foods has petitioned the agency for GRAS approval of Trailblazer,
which, like Simplesse, is made from egg and milk protein processed to mimic
the "mouth feel" of fat.
Procter and Gamble's fat substitute Olestra, however, is a different matter.
Developed for use in hot foods as well as cold, it is a new substance that,
according to the company, is "almost a carbon copy of regular fat, but with a
molecule of sugar at its core instead of glycerine, and up to eight fatty
acids attached to the core instead of the customary three."
Because it is a new molecular structure that does not break down to its
component parts during digestion, Olestra must be approved as a new food
additive rather than as a GRAS substance, which means that studies must be
done to ensure its safety.
Procter and Gamble says its product looks, tastes, feels, and behaves like
fat. It cooks without breaking down under heat, yet it cannot be digested and
absorbed, so it passes through the body "contributing no calories, no
cholesterol, and no fat." The company is asking for approval of Olestra for
deep-frying savory snacks such as chips and puffs made from potatoes and corn.
Help for the Health-Conscious
-----------------------------
Health- and weight-conscious consumers are expected to welcome fat-free
products that taste like the real thing. In fact, a recent survey by the
Calorie Control Council, an association of low-calorie and diet food
manufacturers, found that 57 percent of adult Americans believe there is a
need for fat substitutes.
According to the 1988 Surgeon General's Report on Nutrition and Health, high
intake of fat is associated with increased risk for obesity, some types of
cancer (breast, colon, prostate, rectum, ovaries, and endometrium), and
possibly gallbladder disease. Studies also show strong evidence of a
relationship between high saturated fat intake and a high blood cholesterol
level, which is a risk factor for coronary heart disease.
The report also states that because obesity is a risk factor for several
chronic diseases, it is important to maintain a desirable weight. Obesity
increases the risk of high blood pressure and, consequently, stroke. It also
increases blood cholesterol and may, by itself, be a risk factor for coronary
heart disease.
Because fat contributes nine calories per gram, fat substitution would
significantly reduce the calorie content of a food. Excess calories from fat
are readily stored and cause weight gain.
A 1985 national survey by the U.S. Department of Agriculture found that fat
contributed 34 percent of total calorie intake for children ages 1 to 5, 36
percent for men ages 19 to 50, and 37 percent for women ages 19 to 50.
The National Cholesterol Education Program of the National Heart, Lung, and
Blood Institute, along with other health groups, recommends that all healthy
Americans 2 and older limit their total daily fat intake to no more than 30
percent of total calories and that less than 10 percent of the total calories
should be from saturated fat. Cholesterol should be kept to less than 300
milligrams per day, and the total calorie intake should be what is needed to
reach or maintain a desirable weight. (People with certain illnesses or
conditions may have different requirements.)
Health Outcome Unknown
----------------------
It remains to be seen, however, whether consumers will, indeed, become
healthier by using products with fat substitutes. According to the June
15,1990, issue of The Medical Letter, a professional publication on drugs and
therapeutics, no clinical studies have shown that use of either Simplesse or
Trailblazer leads to weight reduction or decreases blood lipid (fat)
concentrations.
Moreover, some nutritionists are concerned that people who eat products made
with fat substitutes will feel freer to eat more of other high-fat foods,
rationalizing that they are "saving" on those made with substitutes. Another
possibility experts anticipate is that people will eat more fat-free
double-dip ice cream cones, leaving less room for the more nutritious foods
they need.
A more basic, as yet unanswered, question is whether nonfat foods will satisfy
as well as the traditional foods they replace and, therefore, whether they
will really help people reduce fat consumption.
Lisa Lefferts, staff scientist with the Washington-based consumer advocacy
group Center for Science in the Public Interest, points to the experience with
sugar substitutes: "We're eating four times the amount of sugar substitutes as
we were in 1975, but sugar consumption has gone up as well, so clearly sugar
substitutes are not substituting for sugar." Lefferts says that the effect of
fat substitutes on the diet is unclear. "Fat substitutes such as Simplesse are
a step in the right direction," she says, "but we would encourage that their
use be monitored in order to assess their true impact."
FDA, too, has questions about the impact of fat substitutes in the food
supply. "There are two categories of fat substitutes to consider," says Walter
Glinsmann, M.D., associate director for clinical nutrition. "Products like
Simplesse are processed from substances already in the diet, and they are
digested and used by the body in the same way as the original substances.
Others, like Olestra, are new, undigestible molecules never before in the food
supply."
The possible health effects of consuming large amounts of a novel substance
must be carefully researched and reviewed before such a product can be
marketed. "When you consider that fat intake is about 35 to 40 percent of the
daily caloric intake and that half of that fat is derived from foods in which
the fat can be replaced with a substitute, you need to take a hard look at the
potential health effects," Glinsmann cautions.
Some of the questions to be considered are:
** If the materials are absorbed in the body even in very small amounts are
they toxic?
** If they are not absorbed, how do they affect gastrointestinal functions?
For example, could they interfere with the absorption of nutrients or drugs?
** Are the substitutes suitable for general use or only for subpopulations of
the general public?
The financial impact of fat substitutes may be easier to predict than the
health and dietary effects. In February 1990, The Wall Street Journal reported
that some estimates have Simplesse becoming a $500-million-a-year or bigger
business by the mid-199Os. It is not surprising that still more firms, in
addition to Kraft and Procter and Gamble, are entering the race for these
consumer dollars.
Marian Segal is a member of FDA ' s public affairs staff.
A REPRINT FROM FDA CONSUMER MAGAZINE, DECEMBER 1990
DHHS PUBLICATION NO. (FDA) 91-2245
We hope you found this reprint from FDA Consumer magazine useful and
informative. FDA Consumer, the magazine of the U.S. Food and Drug
Administration, provides a wealth of information on FDA-related health issues:
food safety, nutrition, drugs, medical devices, cosmetics, radiation
protection, vaccines, blood products, and veterinary medicine. For a sample
copy of FDA Consumer and a subscription order form, write to: Food and Drug
Administration, HFI-40, Rockville, Md. 20857.
U.S. GOVERNMENT PRINTING OFFICE 1991-281-809/40054