- What are artificial sweeteners and how are
they regulated in the United States?
Artificial sweeteners, also called sugar substitutes, are substances that
are used instead of sucrose (table sugar) to sweeten foods and beverages.
Because artificial sweeteners are many times sweeter than table sugar, smaller
amounts are needed to create the same level of sweetness.
Artificial sweeteners are regulated by the U.S. Food and Drug Administration
(FDA). The FDA, like the National
Cancer Institute (NCI), is an agency of the Department of Health and Human
Services. The FDA regulates food, drugs,
medical devices, cosmetics, biologics, and radiation-emitting
products. The Food Additives Amendment to the Food, Drug, and Cosmetic Act,
which was passed by Congress in 1958, requires the FDA to approve food additives,
including artificial sweeteners, before they can be made available for sale
in the United States. However, this legislation does not apply to products
that are “generally recognized as safe.” Such products do not
require FDA approval before being marketed.
- Is there an association between artificial
sweeteners and cancer?
Questions about artificial sweeteners and cancer arose when early studies
showed that cyclamate in combination with saccharin caused bladder
cancer in laboratory animals. However, results from subsequent carcinogenicity
studies (studies that examine whether a substance can cause cancer) of these
sweeteners have not provided clear evidence of an association with cancer
in humans. Similarly, studies of other FDA-approved sweeteners have not demonstrated
clear evidence of an association with cancer in humans.
- What have studies shown about a possible
association between specific artificial sweeteners and cancer?
Saccharin
Studies in laboratory rats during the early 1970s linked saccharin with the
development of bladder cancer. For this reason, Congress mandated that further
studies of saccharin be performed and required that all food containing saccharin
bear the following warning label: “Use of this product may be hazardous
to your health. This product contains saccharin, which has been determined
to cause cancer in laboratory animals.”
Subsequent studies in rats showed an increased incidence
of urinary
bladder cancer at high doses
of saccharin, especially in male rats. However, mechanistic studies (studies
that examine how a substance works in the body) have shown that these results
apply only to rats. Human epidemiology
studies (studies of patterns, causes, and control of diseases in groups of
people) have shown no consistent evidence that saccharin is associated with
bladder cancer incidence.
Because the bladder tumors
seen in rats are due to a mechanism not relevant to humans and because there
is no clear evidence that saccharin causes cancer in humans, saccharin was
delisted in 2000 from the U.S. National Toxicology
Program’s Report on Carcinogens, where it had been listed since
1981 as a substance reasonably anticipated to be a human carcinogen
(a substance known to cause cancer). More information about the delisting
of saccharin is available at http://ntp.niehs.nih.gov/ntp/roc/eleventh/append/appb.pdf
on the Internet. The delisting led to legislation, which was signed into law
on December 21, 2000, repealing the warning label requirement for products
containing saccharin.
Aspartame
Aspartame, distributed under several trade names (e.g., NutraSweet® and
Equal®), was approved in 1981 by the FDA after numerous tests showed that
it did not cause cancer or other adverse
effects in laboratory animals. Questions regarding the safety of aspartame
were renewed by a 1996 report suggesting that an increase in the number of
people with brain
tumors between 1975 and 1992 might be associated with the introduction
and use of this sweetener in the United States. However, an analysis
of then-current NCI statistics showed that the overall incidence of brain
and central
nervous system cancers began to rise in 1973, 8 years prior to the approval
of aspartame, and continued to rise until 1985. Moreover, increases in overall
brain cancer incidence occurred primarily in people age 70 and older, a group
that was not exposed to the highest doses of aspartame since its introduction.
These data do not establish a clear link between the consumption of aspartame
and the development of brain tumors.
In 2005, a laboratory
study found more lymphomas
and leukemias
in rats fed very high doses of aspartame (equivalent to drinking 8 to 2,083
cans of diet soda daily) (1). However, there were some
inconsistencies in the findings. For example, the number of cancer cases did
not rise with increasing amounts of aspartame as would be expected. An FDA
statement on this study can be found at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108650.htm
on the Internet.
Subsequently, NCI examined human data from the NIH-AARP
Diet and Health Study of over half a million retirees. Increasing consumption
of aspartame-containing beverages was not associated with the development
of lymphoma, leukemia, or brain cancer (2).
Acesulfame potassium, Sucralose, and Neotame
In addition to saccharin and aspartame, three other artificial sweeteners
are currently permitted for use in food in the United States:
- Acesulfame potassium (also known as ACK, Sweet One®, and Sunett®) was
approved by the FDA in 1988 for use in specific food and beverage categories,
and was later approved as a general purpose sweetener (except in meat and
poultry) in 2002.
- Sucralose (also known as Splenda®) was approved by the FDA as a tabletop
sweetener in 1998, followed by approval as a general purpose sweetener in
1999.
- Neotame, which is similar to aspartame, was approved by the FDA as a general
purpose sweetener (except in meat and poultry) in 2002.
Before approving these sweeteners, the FDA reviewed more than 100 safety
studies that were conducted on each sweetener, including studies to assess
cancer risk. The results of these studies showed no evidence that these sweeteners
cause cancer or pose any other threat to human health.
Cyclamate
Because the findings in rats suggested that cyclamate might increase the
risk of bladder cancer in humans, the FDA banned the use of cyclamate in 1969.
After reexamination of cyclamate’s carcinogenicity and the evaluation
of additional data, scientists
concluded that cyclamate was not a carcinogen or a co-carcinogen (a substance
that enhances the effect of a cancer-causing substance). A food additive petition
was filed with the FDA for the reapproval of cyclamate, but this petition
is currently being held in abeyance (not actively being considered). The FDA’s
concerns about cyclamate are not cancer related.
- Where can people find additional information about artificial sweeteners?
For more information about artificial sweeteners, contact the FDA at:
| Address: |
10903 New Hampshire Avenue
Silver Spring, MD 20993
|
| Telephone: |
1-888-INFO-FDA (1-888-463-6332) |
| Internet Web site: |
http://www.fda.gov/ |
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