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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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.