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Home :: Professional / Government Regulation / FDA Requirements and Programs / Animal Testing
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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