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FDA/CFSAN Cosmetics--Animal Testing
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
Revised May 3, 1999
ANIMAL TESTING
Although the Food, Drug & Cosmetic Act does not specifically mandate
animal testing for cosmetic safety, FDA strongly urges cosmetic
manufacturers to conduct whatever tests are appropriate to
establish that their cosmetics are safe. In the United States,
manufacturers bear a responsibility to ensure their products are safe
for consumer use. In fact, cosmetic products that have not been
adequately tested for safety must have warning statement on the front
label which reads,
"WARNING--The safety of this product has not been
determined."
FDA continues to work with other governments and private organizations
to develop validated alternatives to animal testing in assessing
cosmetic safety and considerable progress has been made in some areas.
Nevertheless, until a method has been proven to be reliable and accepted
by the scientific community, FDA believes that the use of animals
remains necessary to ensure the safety of cosmetic ingredients and
products.
The 1992 position paper reprinted below provides additional
information.
U.S. FOOD AND DRUG ADMINISTRATION
Position Paper
October 1992
ANIMAL USE IN TESTING FDA-REGULATED PRODUCTS
Current laws administered by FDA--including the Federal Food, Drug
and Cosmetic (FD&C) Act--are intended to ensure product safety and
effectiveness, thereby protecting consumer's health. These laws
place responsibility on FDA to ensure that human and animal drugs,
biologics and medical devices are safe and effective and that food
products are safe and wholesome.
Animal testing by manufacturers seeking to market new products is
often necessary to establish product safety. FDA supports and
adheres to the provisions of applicable laws, regulations, and
policies governing animal testing, including the Animal Welfare Act
and the Public Health Service Policy on Humane Care and Use of
Laboratory Animals. Moreover, in all cases where animal testing is
used, FDA advocates that research and testing derive the maximum
amount of useful scientific information from the minimum number of
animals and employ the most humane methods available within the
limits of scientific capability.
FDA advocates the use of validated non-whole animal techniques,
which may include such screens and adjuncts as in vitro (e.g.,
tissue culture) methodologies and biochemical assays. As an
example, FDA announced in the Federal Register of Feb. 19, 1988,
the availability of guidelines for the Limulus Amebocyte Lysate
(LAL) test as an end product endotoxin test for human injectable
drugs (including biological products), animal injectable drugs and
medical devices. The guidelines inform manufacturers of acceptable
methods of validating the LAL test so that it can be used as an
alternative to the rabbit pyrogen test. At present many other
procedures intended to refine, reduce or replace animal testing are
still in the relatively early stages of development. FDA
encourages all efforts to develop and implement non-animal models
and believes that these procedures will ultimately result in
significant reductions and refinements in animal testing.
With respect to cosmetic products, the FD&C Act does not
specifically require that cosmetic manufacturers test their
products for safety in the context of premarket approval by the
Agency. However, FDA, strongly urges cosmetic manufacturers to
conduct toxicological or other tests necessary to substantiate the
safety of a particular cosmetic product.
If the safety of a cosmetic product is not adequately
substantiated, the product is considered misbranded and may be
subject to regulatory action unless the principal display panel
bears the statement,
"Warning--the safety of this product has not
been determined."
Much of the attention given to animal testing has focused on the
LD50 tests. FDA does not require LD50 test data to establish
levels of toxicity, and in 1988, published a policy statement in
the Federal Register to clarify this position.
The Draize eye and skin irritancy tests continue to be considered
among the most reliable methods currently available for evaluating
the safety of a substance introduced into or around the eye or
placed on the skin. Non-animal tests, such as in vitro tests, may
be useful as screening tools to indicate the relative toxicity or
safety of a substance that comes into contact with the eye or skin.
However, the responses and results of in vitro tests alone do not
necessarily demonstrate the safety of a substance. The effects of
a substance on a biochemical reaction or on a specific cell or
tissue in culture may differ from its effect on a specific organ
system in the animal as a whole.
The precise nature of testing needed to determine the safety or
effectiveness of a specific product regulated by FDA depends upon
the characteristics and intended use of the product. More
specific guidance may be obtained through consultation with FDA
scientists on a case-by-case basis.
U.S. Food and Drug Administration
October 1992
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