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, gelatines,
puddings and fillings, dry mixes for dessert toppings, carbonated beverages,
carbonated beverage syrups, refrigerated and non-refrigerated 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 non-dairy 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
Centres 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 and
re-evaluated 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
More Information on Low-Calorie Sweeteners:
Benefits of Use
Health Professionals' Opinions
Multiple Ingredient Approach
Questions & Answers
