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http://www.cfsan.fda.gov/~lrd/fats.html                                                                                             
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(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                                                                                                  
                                                                                                                                    
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