Komputer for Alle 1998 #6/1998 CD 6 (Gul).iso/web/ffa/wwwenv~1.org/arrs/digest/news35~1.htm/text0020.txt

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testing in assessing cosmetic safety. Until such methods are proven to be
reliable and accepted by the
scientific community, FDA believes that the use of animals is necessary to
ensure the safety of cosmetic
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