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Nutrasweet - Is it Safe?

In 1981, aspartame became the first low-calorie sweetener approved by the Food and Drug Administration in more than 25 years. Today, aspartame has established itself as an important component in hundreds of foods and beverages. Discovered in 1965, aspartame is a low-calorie sweetener which is approximately 180 times sweeter than sucrose. It is sold in the United States under the brand name NutraSweet® by Monsanto, and is also sold by Holland Sweetener Company. Aspartame is made from two amino acids (protein components) -- L-phenylalanine and L-aspartic acid. The U.S. Food and Drug Administration (FDA) approved aspartame in 1981 for use in tabletop sweeteners and various foods and dry beverage mixes, making it the first low-calorie sweetener approved by FDA in more than 25 years. In 1983, FDA approved it for use in carbonated beverages; today aspartame has established itself as an important component in many low-calorie, sugar-free foods and beverages.

Currently, more than 100 million people around the world consume aspartame-containing products. The sweetener is available in the U.S. for use in more than 1,500 products, including: tabletop sweeteners (including bulk package form), baked goods and baking mixes, dry beverage mixes, chewable multi-vitamins, hot and cold breakfast cereals, chewing gum, gelatins, puddings and fillings, dry mixes for dessert toppings, carbonated beverages, carbonated beverage syrups, refrigerated and nonrefrigerated ready-to-drink beverages, frozen stick-type confections and novelties, breath mints, yogurt-type products, frozen desserts, ready-to-eat cheesecakes, fruit spreads, toppings and syrups, frozen dairy and nondairy frostings and toppings, fruit wine beverages, hard and soft candies, cough drops, malt beverages and pharmaceuticals.


The rapid rise in aspartame's popularity can be attributed to the many benefits aspartame provides to calorie-conscious consumers, including:

Helps Control Caloric Intake -- Aspartame is a nutritive sweetener, but very small amounts are needed (due to its intense sweetness) for a sweet taste. The calories contributed by aspartame are so few it is considered virtually non-caloric. By substituting aspartame for sugar in foods and beverages, calories can be reduced substantially, and in many products practically eliminated.

Tastes Sweet and Clean -- Studies conducted with taste-test panels show that many believe aspartame's taste is very similar to the taste of sugar.

Does Not Promote Tooth Decay -- The American Dental Association has noted it "welcomes the development and FDA approval of new artificial sweeteners that are shown to be safe and non-contributory to tooth decay. . . . Aspartame is an FDA-approved, safe sweetening agent and flavor enhancer that can be substituted for sugar in the diet."

Enhances and Extends Flavors -- Aspartame has the ability to intensify and extend fruit flavors, such as cherry and orange, in foods and beverages. For example, aspartame makes chewing gum taste sweet up to four times longer than sugar-sweetened gum.

Is Acceptable for Diabetic Diets -- The American Diabetes Association has found aspartame to be acceptable as a sweetener for products that may be included in diabetic meal plans. ADA recommends that children and adults with diabetes consult their physicians and health professionals concerning the use of low-calorie sweeteners in their daily meal plans.

Safety Review

FDA and almost all scientists who are familiar with the data conclude that aspartame, and its use in a wide variety of products, is a safe and useful option for those individuals who prefer a low-calorie sweetener. Aspartame has been extensively studied in animals and humans for more than two decades in more than 200 studies. Persons born with a rare disease called phenylketonuria (PKU), numbering about 15,000 in the total U.S. population, know to restrict their intake of phenylalanine from all dietary sources. Because aspartame-containing products are a source of phenylalanine in the diet, they carry the labeling, "Phenylketonurics: Contains Phenylalanine." (Phenylalanine is found in much greater quantities in meats, milk and other protein foods.)

When FDA approved aspartame, the FDA Commissioner noted: "Few compounds have withstood such detailed testing and repeated, close scrutiny, and the process through which aspartame has gone should provide the public with additional confidence of its safety."

The Commissioner found that evidence indicated aspartame to be safe at expected levels of consumption and at the highest conceivable levels of consumption.

Approval Upheld

Objections regarding aspartame's safety were raised prior to, and following, the sweetener's 1983 approval in carbonated beverages. FDA noted, however, that these objections had been "fully dealt with in the earlier proceeding leading to the approval of aspartame for dry uses." The safety questions primarily concerned the potential harmful effects of aspartame's breakdown components (e.g., methanol, aspartic acid, phenylalanine) and alleged that adverse reactions would result from aspartame consumption. The allegations were the basis for requests for a public hearing on the safety issues concerning aspartame.

In a 59-page opinion (published in the February 22, 1984, Federal Register), FDA denied the requests for a hearing, noting that aspartame's critics had not presented any unresolved safety questions. Regarding aspartame's breakdown components, FDA said that it had reviewed animal, clinical and consumption studies submitted by the sweetener's manufacturer, as well as the existing body of scientific data, and "concluded that the studies demonstrated the safety of these components."

In September 1985, the U.S. Court of Appeals for the District of Columbia Circuit affirmed FDA's action in approving the use of aspartame in liquids, as well as the agency's denial of requests for a public hearing. The court ruled that a government hearing on the safety of aspartame was not justified. FDA's approval of aspartame was again confirmed by a June 1987 General Accounting Office report. The report noted, "FDA adequately followed its food additive approval process in approving aspartame."

FDA again reaffirmed the safety of aspartame in November 1986. In a letter denying a petition to restrict aspartame's use, FDA noted: "The data and information supporting the safety of aspartame are extensive. It is likely that no food product has ever been so closely examined for safety. Moreover, the decisions of the agency to approve aspartame for its uses have been given the fullest airing that the legal process requires."

On November 3, 1987, then-FDA Commissioner Frank Young testified before a Senate Committee that the agency has not seen "any medical or scientific evidence that undermines our confidence in the safety of aspartame. This confidence is based on years of study, analysis of adverse reactions, and research in the scientific community, including studies supported by FDA.

On June 27, 1996, FDA approved the use of aspartame as a "general purpose sweetener," meaning that aspartame can now be used in any food or beverage where standards of identity do not preclude its use. This approval marked the 26th time that FDA affirmed the safety of aspartame over a period of 23 years.

Safety Supported

A number of anecdotal reports have suggested that some consumers have had adverse reactions following consumption of products containing aspartame. However, there is no conclusive scientific evidence that aspartame is linked to adverse reactions in humans.

In 1984, the FDA commissioned the Centers for Disease Control (CDC) to review consumer complaints related to the use of aspartame. After a four-month review of 517 complaints, the CDC found that the complaints "do not provide evidence of the existence of serious, widespread, adverse health consequences attendant to the use of aspartame." The CDC further noted that "the majority of frequently reported symptoms were mild and are symptoms that are common in the general populace."

In July 1985, the American Medical Association's Council on Scientific Affairs reported, "Available evidence suggests that consumption of aspartame by normal humans is safe and is not associated with serious adverse health effects." Also, FDA has noted that "as with any food going into large-scale use, there is the possibility that there could be an occasional sensitivity to the substance or to the food sweetened with it."

FDA continues to review consumer complaints (which have been declining since 1986) as a matter of prudence. Also, following the recommendation of the CDC, focused clinical studies have been conducted in an attempt to identify any possible sensitivities to aspartame. This ongoing safety review has found no causal link between aspartame consumption and adverse reactions.

Questions have been raised regarding aspartame consumption levels, particularly whether or not individuals may exceed levels considered safe. The Acceptable Daily Intake (ADI) for aspartame set by FDA and reevaluated and reaffirmed several times is 50 milligrams of aspartame per kilogram (mg/kg) of body weight. (FDA defines an ADI as the amount of a compound that can be safely consumed each day on a chronic, lifetime basis.)

Aspartame's ADI is based on a broad array of data. The data include clinical studies in which humans who received single doses of aspartame up to 200 mg/kg of body weight -- equal to consuming 70 cans of aspartame-sweetened soft drink in one sitting -- showed no ill effects. FDA recently noted that "all post-marketing surveillance data concerning actual consumption [of aspartame] indicate that even high level consumers are well within the established ADI."

In addition to FDA, the Joint Expert Committee on Food Additives (JECFA) of the World Health Organization, the Scientific Committee for Food of the European Community, and regulatory agencies in more than 100 countries have reviewed aspartame and found it safe for use.

More Information on Safety:

Correcting Internet Myths About Aspartame "Aspartame (NutraSweet): No Danger" (from the Multiple Sclerosis Foundation)

Multiple Sweetener Approach

The increasing calorie consciousness of Americans has sparked a growing consumer demand for low-calorie foods and beverages. The number of people who consume low-calorie products has nearly doubled during the past decade. The availability of aspartame, acesulfame potassium, saccharin and sucralose has expanded the low-calorie food and beverage market by allowing manufacturers to use the most appropriate sweetener, or combination of sweeteners, for a given product.

This multiple sweetener approach allows the low-calorie and diet food and beverage industry to meet the growing consumer demand for new, good-tasting, reduced-calorie products. No low-calorie sweetener is perfect for all uses. On the other hand, a wide variety of low-calorie sweeteners provides products with improved taste, increased stability, lower manufacturing costs, and ultimately, more choices for the consumer.


Consumer research shows that low-calorie foods and beverages have become part of the lifestyle of millions of men and women who want to stay in better overall health, control their weight, or simply enjoy the many low-calorie products available. Aspartame has helped provide calorie-conscious consumers with a wide variety of good-tasting, low-calorie products that are easily incorporated into a healthy lifestyle.

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