What is
Aspartame?
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 and is primarily responsible for
the growth of the sugar-free market in the last two decades. Its excellent taste and
suitability for a wide variety of products make it an appropriate choice for people who
desire a sweet taste without the calories.
Discovered in
1965, aspartame is a low-calorie sweetener, which is approximately 200 times sweeter than
sucrose. It is sold in the United States by Ajinomoto USA, Daesang America The Holland
Sweetener Company, and The NutraSweet® 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 and is primarily responsible for the growth over the last two decades in the
sugar-free market -- a testimonial to aspartame's excellent taste and suitability for a
wide variety of products. The safety of aspartame has been affirmed 26 times in the past
23 years.
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.
BENEFITS
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. In fact, the safety of
aspartame has been confirmed on 26 separate occasions in the past 23 years alone, making
it one of the most thoroughly studied food ingredients ever.
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 about aspartame and other food products (which have been
declining since 1986) as a matter of prudence. Also, following the recommendation on
aspartame 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, 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 has
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:
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.
FUTURE
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.
For further information on aspartame, visit Aspartame Q & A
*** Information
provided courtesy of the Calorie Control Council.
