Animals and Product Testing
While the Federal Food, Drug and Cosmetic Act requires animal testing for pharmaceutical drugs and other chemical compounds that change the structure and function of the human body, it does not specifically require animal testing on cosmetics. However, it does require that manufacturers of cosmetics substantiate the safety of their products. Traditionally, manufacturers have used animal tests, such as the Draize and LD-50 tests, to provide this substantiation.
Rats, mice, rabbits and guinea pigs are the most commonly used species in product testing. Rabbits are used most extensively in eye irritancy tests because their eyes are large.
The tests attempt to determine the potential harm a substance can do to a living creature when ingested or inhaled, or otherwise comes into contact with the body. They include eye and skin irritancy tests, as well as tests which determine the internal effects of a substance.
The most frequently used animal tests for cosmetics include various versions of the Draize eye and skin irritancy tests, and the LD-50 test. All of these tests were designed in the mid-1900s and have long been criticized for their cruelty and subjectivity.
The Draize tests attempt to measure the potential harmfulness of chemicals to humans by observing the damage they cause to the eyes and skin of animals. In the Draize test for eye irritancy, various concentrations of products are applied directly into the animals’ eyes, which can cause intense burning, itching and pain.
In the Draize tests for skin irritancy, test substances are applied to shaved and abraded skin, which is then covered with plastic sheeting. (Skin is abraded by firmly pressing adhesive tape onto the animal's body and repeatedly stripping it off until several layers of skin have been removed.)
The LD-50 test is used to measure the acute toxicity levels of certain ingredients on live animals. LD-50 stands for Lethal Dose 50 Percent-the amount of concentration of a substance that will kill half of a test group of animals within a specified time period when that substance is forcibly ingested, inhaled or otherwise exposed to an animal.
Cosmetics are the noteworthy exception to the animal testing requirement.
Manufacturers of cosmetics do have the option of using non-animal methods to produce safety data. But as animal testing has become a standard, accepted practice, manufacturers use it as a convenient way to make sure they have the appropriate data to present in court in case of a lawsuit. In these litigious times, many companies continue to rely on animal testing as a legal safety net, even though it is not required by law.
Yet the use of animals in cosmetics testing remains controversial. The LD-50 test has been banned in parts of Europe, and animal testing on cosmetics is banned in the Netherlands, Belgium and the United Kingdom. In 2002, the European Union passed a law banning the sale of cosmetic products that have been tested on animals, whether or not they have been produced in the EU. Beginning in 2009, all companies will be required to use non-animal alternatives. Tests for which no non-animal method exists will be given a grace period until 2013.
In the U.S., the Environmental Protection Agency (EPA) no longer supports use of the LD-50 test. The FDA does not use the test any longer, although it continues to accept LD-50 test data from manufacturers.
One of the reasons why European countries have moved more quickly than the U.S. in banning product testing on animals is that they have issued laws, or directives, that companies are required to follow. While the FDA asserts that it is a strong advocate of methodologies for the refinement, reduction and replacement of animal tests, the agency continues to accept the results of animal tests to substantiate safety, and gives companies control over the decision as to whether or not to use animals. Thus, companies have no incentive to change their practices. An FDA statement reads:
Animal testing by manufacturers seeking to market new products may be used to establish product safety. In some cases, after considering available alternatives, companies may determine that animal testing is necessary to assure the safety of a product or ingredient.
Some progress has been made at the federal level with regard to fostering the development of alternatives to animal testing. In 1997, the FDA joined with 13 other federal agencies to form the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). ICCVAM and its supporting center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), coordinate the development, validation, acceptance and harmonization of alternative toxicological test methods through the U.S. federal government. However, because the process is long and arduous, only a handful of methods have been officially validated. Recently, a few states have taken the initiative in addressing animal testing and encourage the use of non-animal alternatives.California became the first state to enact legislation prohibiting the use of animal testing for which there has been a non-animal alternative testing method validated by ICCVAM. Arizona, New Jersey and New York have followed California's lead by introducing similar legislation. None of the legislation applies to any animal testing conducted for the use of medical research.
Setting a New Standard for Safety Testing
Manufacturers have claimed that animal testing of personal care and pharmaceutical products proves their safety in humans in case of a lawsuit. However, recent court rulings have significantly weakened their ability to use this argument.
A landmark case involving the reliance on scientific evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993), set a standard for review of that evidence that requires a greater degree of scientific accountability in presenting such data.
This standard, or test, identified four factors that can be considered in determining the admissibility of scientific evidence: 1) whether the theory or technique can be and has been tested; 2) whether it has been subjected to peer review and publication; 3) whether the technique has a high known or potential rate of error or whether there are standards controlling the technique's operation; and 4) whether it enjoys "general acceptance."
Since the Daubert test has been applied to animal research, admissibility of the evidence of animal testing has declined. In a recent case, Soldo v. Sandoz Pharmaceutical Corporation (2003), the court specifically found that "animal studies do not present a scientifically reliable basis for the causation opinion of plaintiff's experts." The court held that plaintiff's experts' failure to take into account critical differences between animal data and human experience–including but not limited to extrapolation in dosing–rendered their methodology scientifically invalid and unreliable.
Not all state courts apply the Daubert test to the admissibility of scientific evidence, but a vast majority of jurisdictions do. And the outcomes show promise in sparing animals as the courts articulate the unreliability of extrapolating the results of animal testing data to humans.
A New Perspective, NAVS, 2008