At first glance, one might think that products labeled "cruelty-free" or "not tested on animals" would be good choices. Unfortunately, this is not always true. The problem is that "cruelty-free" is not clearly defined by law, so it can be used to mean just about anything a manufacturer wants it to mean. Further complicating the issue is the fact that many personal care products not labeled "cruelty-free" are tested for safety using non-animal methods, the same methods used by those companies marketing their products as "cruelty-free."

This edition of Issues & Answers will look at "cruelty-free" products as more than a matter of labeling or public relations, and help you make well-informed decisions about which products to buy.

What is Cruelty-Free?
While some personal care products labeled "cruelty-free" are manufactured by companies dedicated to testing for safety without the use of animals, others are produced by manufacturers with little or no real commitment to developing and promoting alternative test methods. Similarly, a company's public statement about its decision to end animal use in product-safety testing shouldn't be the only measure of its real commitment to alternative tests.

Eventually, the two things that will make a permanent difference for laboratory animals are pressure from concerned consumers and the efforts made by some personal-care product manufacturers both to develop sound alternative test methods and to convince the government to accept these methods as evidence of product safety.

Today, several of the larger companies - most of which still do some limited animal testing - are making the most progress toward the time when animal use in safety tests can be further reduced or completely eliminated.

Product Safety Testing - A Brief History
In 1933, at least 17 American women were blinded by, and one eventually died of complications resulting from the use of, a new mascara called Lash Lure. At that time, there were no laws or regulations governing the safety of consumer products. Manufacturers were free to market almost anything.

As a result of this and several other tragic incidents related to untested products, the U.S. Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which required that food, drugs, and cosmetics be safe for human use before they could be sold.

Today the federal government still requires manufacturers to establish product safety. Personal care products covered by federal laws include shampoo, deodorant, eye shadow, lipstick, nail polish, hair spray, perfume, toothpaste, shaving cream, sunscreen, and hand lotion. Some of these products are regulated as cosmetics; others - including sunscreen, fluoride toothpaste, and antiperspirants that claim some medicinal value - are regulated as over-the-counter drugs.

Manufacturers test for both the immediate risk of exposure (through normal use, accidental contact with the eyes or skin, and accidental ingestion) and more long-term risks (such as potential to cause cancer or birth defects). In some cases, animal tests are specifically required by a federal regulatory agency. In other cases, only the "best available" safety information is requested.

Many regulatory agencies, however, still believe that traditional animal tests are the "best available." And for many kinds of products and ingredients, traditional animal tests are still the only ones available.

The Role of Animals in Risk Assessment 
Animals came into widespread use for testing the safety of personal care products in the United States after World War II - on the theory that animals are similar enough to people to be used as models for human response.

The animals most commonly used to test product safety are mice, rats, rabbits, guinea pigs, and hamsters. These animals are exposed to test substances by application to the eyes or patches of bare skin, by injection, by inhalation, or by feeding. The information obtained from these tests is then used to substantiate a company's claim that a new product is safe for human use.

Alternatives to Animals
While truly reliable figures are not available, it is estimated that the number of animals used to test the safety of personal care products in the U.S. might be about 50,000 per year - less than one percent of all animals used in U.S. laboratories. This represents nearly a 90 percent reduction since 1980, when a public outcry arose over animal use in product safety testing.

Leading the charge, animal activist Henry Spira formed the Coalition to Abolish the LD50 and Draize Tests. He ran full-page newspaper ads charging Revlon and other cosmetics companies with perpetuating animal cruelty simply for the sake of beauty. As a result, Revlon became the first U.S. cosmetics company to fund a major research program aimed at developing alternatives to the use of animals in eye-irritancy testing. Avon quickly followed suit with a similar commitment. A few months later, the Cosmetics, Toiletries, and Fragrance Association (CTFA) - whose members include all major U.S. cosmetics companies - announced a $1 million grant to develop alternatives. The funding was given to the Johns Hopkins School of Hygiene and Public Health to establish the Center for Alternatives to Animal Testing (CAAT), whose mission it is to encourage the development, use, and acceptance of alternatives.

In the last fifteen years, many manufacturers have dramatically reduced their reliance on animal use in product safety testing through increased use of computers to search ever-expanding data banks for information about the safety of ingredients and product formulations. Many new in vitro (test tube) toxicology testing techniques also assist scientists in replacing or reducing the number of animals used. Non-animal eye- and skin-tissue irritancy tests have attracted particular interest.

Increased use of alternative testing methods as safety screens has also helped to reduce the number of animals needed to test a product or ingredient. Now toxicologists are often able to test directly on human volunteers, eliminating the need for animal testing altogether.

Many industry executives have found that alternatives make good business sense. Non-animal tests are not only more humane and faster, but can also be cheaper and more predictive of human response than traditional animal tests.

Corporate Commitment to Alternatives 
Today, corporate commitment to alternatives varies widely. In recent years, several new companies such as Beauty Without Cruelty, Kiss My Face, and Tom's of Maine have sprung up to meet public demand for products that use no animal ingredients and safety-test their products without the use of animals.

Several larger cosmetics companies have announced a permanent or temporary halt in their animal testing programs. Included are such widely known cosmetics companies as Avon, Revlon, and Mary Kay. L'Oreal has announced that it will no longer test its finished products on animals. Colgate-Palmolive also has publicly committed itself to the long-term goal of complete replacement of animals with alternative test methods.

Most manufacturers of personal care products today have adopted at least some alternative testing methods. But the efforts of a few deserve particular recognition for major corporate commitments to developing and promoting in vitro systems and other alternative tests. These include L'Oreal, Avon, Unilever (maker of Chesebrough-Pond's products), Procter & Gamble, Bristol-Myers Squibb, Colgate-Palmolive, Johnson & Johnson, and Gillette.

In the process, these companies have dramatically reduced the number of animals they use in their safety-testing programs. Their efforts to establish the reliability of the alternatives they have developed offer new hope for animals in laboratories worldwide. And their struggle to persuade U.S. and foreign governments to accept valid alternatives as evidence of product safety is essential, since until alternatives are officially accepted by national and international regulatory agencies, further progress toward eliminating animal use in product safety testing completely will slow dramatically.

Some animal advocates believe that no company has done more overall to develop and promote the use of alternatives to date than Procter & Gamble. Its willingness to testify before the U.S. Congress on the value of alternative tests and the need for their acceptance and use has been especially encouraging.

"Cruelty-Free" Labels Can Be Misleading
Consumers also need to be aware that labels that read "cruelty-free" and "not tested on animals" may not always mean what we think they do. Since no government agency currently defines these terms, nor are standards set for their usage, it is left up to each company to determine what its "cruelty-free" label means. Many scientists - including those who support alternatives - believe that the ambiguities involved make these labels totally meaningless.

Taken at face value, "cruelty-free" can be used to mean that neither the product nor its ingredients have ever been tested on animals. This is highly unlikely however, as almost all ingredients in use today have been tested on animals somewhere, at some time, by someone-and could be tested again.

"Cruelty-free" can also be used to mean that, though the ingredients have been tested on animals, the final product has not. Or it can mean that the manufacturer itself did not conduct animal tests but instead relied on a supplier to test for them - or relied on another company's previous animal-test results. It can mean that the testing was done in a foreign country, where laws protecting animals are weaker than those in the U.S. Or it can mean that either the ingredients or the product have not been tested on animals within the last five or ten or twenty years (but were before that, and could be again).

Conscientious consumers are left to make some very complex choices among products made by companies that do no animal testing themselves but rely on animal-tested safety data gathered elsewhere, companies that have made commitments of one degree or another to alternatives research, and companies that do neither.

What You Can Do
Until the federal government acts to establish guidelines that define "cruelty-free" labels, it is up to conscientious consumers to learn all they can about the manufacturers of their personal care products. The Center for Laboratory Animal Welfare urges you to choose products made by those companies you feel are acting most responsibly in their entire approach to safety testing, including their commitment to developing and promoting alternatives to animal tests.

Consumers interested in obtaining further information can write or call the manufacturers of their personal care products to ask for a definition of their "cruelty-free" labels, ask for information about their investment in alternatives development, and ask what they are doing to promote national and international regulatory acceptance of alternative methods. In addition, concerned citizens can urge their representatives in Washington to introduce federal legislation defining and setting standards for "cruelty-free" labels.

Sidebar -- Why Can't All Products be Tested Without Animals?
The answer lies in a key word - validation. Over the past fifteen years, many alternatives have been developed to replace whole animal tests, but scientists have only recently begun to determine which tests produce the most reliable safety information and which tests work best for different kinds of products and ingredients.

Once scientists are convinced that a new alternative does provide sound safety information for a product like hair color, the government agency responsible for assuring hair color safety must then be persuaded to accept the new test as a valid alternative to the existing whole animal test. To date, regulatory agencies at both the national and international level have been very slow to respond.

That is why it is not only critical that manufacturers of personal care products develop new alternatives but it is also essential for both consumers and manufacturers to put pressure on government to accept (or validate) those alternatives that have already been developed.

Until alternatives are officially accepted by national and international regulatory agencies, further progress toward eliminating animal use in product safety testing completely will slow dramatically.

In fact, there is a danger that companies currently investing in the development of alternative testing methods might be discouraged from continuing if government regulatory agencies do not provide a workable validation system for the new tests. Concerned consumers can contact the National Toxicology Program at (919) 541-0530 to express concern for the need to speed the validation process.

U.S. Regulatory Agencies: An Overview 
The following federal agencies play the most significant roles in regulating personal care products in the U.S. today:

Food and Drug Administration (FDA) - Regulates the safety of prescription and over-the-counter drugs, medical devices, food additives, and cosmetics through the Food, Drug, and Cosmetic Act.

The FDA requires scientific data from manufacturers documenting that any new prescription or over-the-counter drug product is both safe and effective before it can be sold in the U.S. FDA regulations also say that "each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing."

Occupational Safety and Health Administration (OSHA) - Governs worker health and safety. OSHA guidelines ensure that workers are not exposed to harmful levels of chemicals in the workplace.

Consumer Product Safety Commission (CPSC) - Enforces safety labeling regulations for common household and office products under the Federal Hazardous Substances Act (FHSA). This law requires that a manufacturer determine if a product should be labeled "harmful or fatal if swallowed" or "is a skin or eye irritant."

For More Information

Center for Alternatives to Animal Testing, Johns Hopkins University (111 Market Place, Suite 840, Baltimore, MD 21202)

"Comments on Labeling Related to the Animal Testing of Cosmetics Ingredients and Products Manufactured and/or Marketed Within the European Economic Community," by Michael Balls, reprinted from Alternatives to Laboratory Animals 19, 302-307, 1991, by the Fund for the Replacement of Animals in Medical Experiments (Russell & Burch House, 96-98 N. Sherwood Street, Nottingham NG1 4EE, England)

The Animal Research Controversy, by Andrew N. Rowan and Franklin M. Loew (210 pages), 1995, Center for Animals and Public Policy (Tufts University School of Veterinary Medicine, 200 Westboro Road, N. Grafton, MA 01536)

Animal Testing and Consumer Products, by Heidi J. Welsh (167 pages), 1990, Investor Responsibility Research Center (1350 Connecticut Avenue, NW, Suite 700, Washington, DC 20036).