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The U.S. Food and Drug Administration (FDA) approves a sugar substitute for use only after it has been shown to be safe and effective. The amount of a sweetener that is deemed safe for daily use is referred to as its acceptable daily intake. This represents a level of daily consumption considered to be safe by a wide margin.

Concerns have been raised about the potential safety of some sugar substitutes. However, the FDA has found that nearly all of these substances are safe when used as recommended. The health concerns raised about individual sugar substitutes include the following:

• Acesulfame-K. There is some controversy about this substitute, as skeptics claim it produces tumors in rats. The FDA has countered that such tumors are typical of those found in rats during studies and were not the result of acesulfame-K. More than 90 studies have shown acesulfame-K to be safe in humans, according to the FDA.
  
  
• Aspartame. Numerous studies have documented the safety of aspartame, and the FDA approved it for use in 1981. However, this sugar substitute contains the amino acid phenylalanine, and, therefore, should not be used by people who have the inherited disease phenylketonuria (PKU).  According to the FDA, a small segment of the population is sensitive to one of the sweeteners byproducts and therefore,  intake should be restricted.  In limited amounts, phenylalanine is necessary for normal growth and development. Too much phenylalanine is toxic to the nervous system and can result in irreversible brain damage.
  
  People with PKU cannot properly dispose of excessive levels of phenylalanine and thus should limit their exposure to it. People with advanced liver disease, women with certain genetic traits (i.e., phenylketonuria), and pregnant women with high levels of phenylalanine in the blood also may have difficulty metabolizing phenylalanine.  The FDA requires all products containing aspartame to be labeled to alert consumers to the presence of phenylalanine.
  
  Aspartame also contains aspartic acid, which has been associated with brain damage and other neurotoxic effects. However, the FDA has found aspartic acid poses no threat to people who consume this substance at normal levels. The average person who uses aspartame only consumes about 4 to 7 percent of the acceptable daily intake, according to the FDA.
  
  In 2005, a European study reported that aspartame caused leukemia and lymphoma in laboratory rats. The study’s authors suggested reevaluating the use of aspartame in humans. FDA officials say they are standing by research showing that aspartame is safe in humans. However, the agency is also reviewing the findings of the European study and will announce its conclusions at a future date.  
  
  
• Neotame. Like aspartame, it contains the amino acids phenylalanine and aspartic acid and a methyl group. However, neotame has additional molecules that prevent digestive enzymes from separating phenylalanine. As a result, this amino acid is not absorbed, which allows people with PKU to safely use neotame.
  
  
• Saccharin. In the late 1970s, concern arose after experiments found that saccharin caused bladder cancer in laboratory rats. For a brief time, saccharin was banned from the U.S. market. However, this order was later rescinded pending further investigation. Although experts have not been able to prove that saccharin is safe when used by humans, large studies have failed to reveal a significant link between saccharin use and cancer in humans. It is believed that saccharin does not pose a threat to humans when consumed at normal levels. In 2001, federal legislation removed the requirement that saccharin contain a health-warning label.
  
  
• Sucralose. The body does not recognize sucralose as a carbohydrate, so it passes through the digestive tract without being broken down or absorbed. It does not affect blood sugar levels or insulin production, and therefore may be safely used by people with diabetes.

Questions remain about the impact of sugar substitutes on a person’s weight. Most studies have found that these substitutes help people to lose weight or maintain their present weight level. However, other studies have indicated that some sugar substitutes may stimulate appetite, potentially causing increased weight gain. Most experts maintain that a diet containing modest levels of sugar substitutes, in addition to regular exercise, is likely to affect weight loss or maintenance.

Sugar substitutes may benefit people with certain health conditions. For example, patients with diabetes may use sugar substitutes without having to worry about its effect on insulin or blood sugar levels. This allows people with diabetes to satisfy their taste for sweets without having to worry about hyperglycemia. However, as with any carbohydrate-containing food, sugar substitutes must be worked into a patient’s meal plan. Use of these sweeteners can also help manage calorie intake.

Pregnant and breastfeeding women can safely consume foods with certain types of sugar substitutes. This allows pregnant or breastfeeding women to enjoy the occasional sweet treat without excess calories. However, these women should be careful with the use of saccharin during pregnancy because saccharin can cross the placenta and may remain in fetal tissues. Pregnant women with high levels of phenylalanine in the blood also may have difficulty metabolizing the phenylalanine found in aspartame.

Consuming large amounts of sucrose or fructose can result in elevated levels of triglycerides. Some people with high triglyceride levels (hypertriglyceridemia) may be advised to cut back on sugary foods, especially if they are diagnosed with insulin resistance. Such people may benefit from using sugar substitutes. To lower triglycerides, it is also important to achieve and maintain a healthy body weight, which is best accomplished through a healthy diet and regular exercise.

Children should only occasionally use sugar substitutes. Children require ample amounts of calories and nutrients to provide adequate levels of energy and help them grow.

The FDA has established acceptable daily intakes (ADI) for artificial sweeteners.  They are as follows: