Animal Testing
Animal testing is used to develop medical treatments, determine the toxicity of medicine, check the safety of products destined for human use, and for other biomedical, commercial, and healthcare reasons. Research on living animals has been practiced since at least 500 BC.[2]
Explore the ProCon debate
Early History
Descriptions of the dissection of live animals have been found in ancient Greek writings from as early as circa 500 BC. Physician-scientists such as Aristotle, Herophilus, and Erasistratus performed the experiments to discover the functions of living organisms. Vivisection (dissection of a living organism) was practiced on human criminals in Alexandria (ancient Egypt) and ancient Rome, but prohibitions in ancient Greece against the mutilation of the human body led to a reliance on animal subjects. Aristotle believed that animals lacked intelligence, and so the notions of justice and injustice did not apply to them. Theophrastus, a successor to Aristotle, disagreed, objecting to the vivisection of animals on the grounds that, like humans, they can feel pain, and causing pain to animals was an affront to the gods. [79][80]
Roman physician and philosopher Galen (130–200 AD), whose theories of medicine were influential throughout Europe for 15 centuries, engaged in the public dissection of animals (including an elephant), which was a popular form of entertainment at the time. Galen also engaged in animal vivisection in order to develop theories on human anatomy, physiology, pathology, and pharmacology. In one of his experiments, he demonstrated that arteries, which were believed by earlier physicians to contain air, actually contained blood. Galen believed that animal physiology was very similar to that of human beings, but despite this similarity he had little sympathy for the animals on which he experimented. Galen recommended that his students vivisect animals “without pity or compassion” and warned that the “unpleasing expression of the ape when it is being vivisected” was to be expected. [80][81][82]
French philosopher René Descartes (1596–1650), who occasionally experimented on live animals, including at least one rabbit, as well as eels and fish, believed that animals were “automata” who could not experience pain or suffer the way that humans do. Descartes recognized that animals could feel, but because they could not think, he argued, they were unable to consciously experience those feelings. [66][83]
English physician William Harvey (1578–1657) discovered that the heart, and not the lungs, circulated blood throughout the body as a result of his experiments on living animals. [84][85]
Animal Testing (1800s through mid-1900s)
There was little public objection to animal experimentation until the 19th century, when the increased adoption of domestic pets fueled interest in an anti-vivisection movement, primarily in England. This trend culminated in the founding of the Society for the Protection of Animals Liable to Vivisection in 1875, followed by the formation of similar groups. [79][87]
One of the first proponents of animal testing to respond to the growing anti-testing movement was French physiologist Claude Bernard in his Introduction to the Study of Experimental Medicine (1865). Bernard argued that experimenting on animals was ethical because of the benefits to medicine and the extension of human life. [79]
Queen Victoria was an early opponent of animal testing in England, according to a letter written by her private secretary in 1875: “The Queen has been dreadfully shocked at the details of some of these [animal research] practices, and is most anxious to put a stop to them.” Soon the anti-vivisection campaign became strong enough to pressure lawmakers into establishing the world’s first law regulating the use of live animals in scientific research: Great Britain’s Cruelty to Animals Act of 1876. [15][88]
Russian physiologist Ivan Pavlov (1849–1936) demonstrated the “conditioned reflex” by training dogs to salivate upon hearing the sound of a bell or electric buzzer. In order to measure “the intensity of the salivary reflex,” wrote Pavlov, the dogs were subjected to a “minor operation, which consists in the transplantation of the opening of the salivary duct from its natural place on the mucous membrane of the mouth to the outside skin.” A “small glass funnel” was then attached to the salivary duct opening with a “special cement.” [75][86]
In The Principles of Humane Experimental Technique (1959), zoologist William Russell and microbiologist Rex Burch established the “Three Rs” of humane experimentation: Replacement (replacing the use of animals with alternative research methods), Reduction (minimizing the use of animals whenever possible), and Refinement (reducing suffering and improving animals’ living conditions). The “Three Rs” were incorporated into the United States’ federal Animal Welfare Act (AWA) of 1966 and formed the basis of many international animal welfare laws. [89][90][91]
Animals in Space and the Military
Since as early as 1948, animals have been used by the U.S. space program for testing such aspects of space travel as the effects of prolonged weightlessness. After several monkeys died in unmanned space flights in the 1940s, the first monkey to survive a space flight was Yorick, recovered from an Aerobee missile flight on September 20, 1951. However, Yorick died several hours after landing, possibly due to heat stress. The first living creature to orbit Earth was Laika, a stray dog sent into space on the Soviet spacecraft Sputnik 2 on November 3, 1957. Laika died of “overheating and panic” early in the mission, according to the BBC. The record for the most animals sent into space was set April 17, 1998, when more than 2,000 animals, including rats, mice, fish, crickets, and snails, were launched into space on the shuttle Columbia (along with the seven-member human crew) for neurological testing. [7][8][92][116]
Since the Vietnam War, animals have also been used by the U.S. military. The U.S. Department of Defense, for example, used 488,237 animals for research and combat trauma training (“live tissue training”) in fiscal year 2007, which included subjecting anesthetized goats and pigs to gunshot wounds, burns, and amputations for the training of military medics. In February 2013, after an escalation of opposition by animal rights groups such as People for the Ethical Treatments of Animals (PETA), Congress ordered the Pentagon to present a written plan to phase out live tissue training. The U.S. Coast Guard, however, which was at the center of a 2012 scandal involving videotaped footage of goats being mutilated as part of its live tissue training program, said in May 2013 that the program will continue. [6][93][94][95]
The Modern Anti-Testing Movement
In Animal Liberation: A New Ethics for Our Treatment of Animals (1975), Australian philosopher Peter Singer galvanized the animal rights and anti-testing movements by popularizing the notion of “speciesism”—the belief that some species should be treated as more important than other species—as something akin to racism, sexism, and other forms of prejudice. Addressing animal testing specifically, Singer predicted that “one day . . . our children’s children, reading about what was done in laboratories in the twentieth century, will feel the same sense of horror and incredulity . . . that we now feel when we read about the atrocities of the Roman gladiatorial arenas or the eighteenth-century slave trade.” [66]
In 1981, an early victory by then-fledgling animal rights group PETA served to revitalize the anti-testing movement. A PETA activist working undercover at the Institute for Biological Research in Silver Spring, Maryland, took photographs of monkeys in the facility that had engaged in self-mutilation due to stress. The laboratory’s director, Edward Taub, was charged with more than a dozen animal cruelty offenses, and an especially notorious photo of a monkey in a harness with all four limbs restrained became a symbolic image for the animal rights movement. [96]
In 2001, controversy erupted over animal experiments undertaken by a veterinarian at Ohio State University. Dr. Michael Podell infected cats with the feline AIDS virus in order to study why methamphetamine users deteriorate more quickly from the symptoms of AIDS. After receiving several death threats, Dr. Podell abandoned his academic career. Over 60 percent of biomedical scientists polled by Nature magazine say “animal-rights activists present a real threat to essential biomedical research.” [35][97]
Global Bans on Animal Testing
A 2007 report by the National Research Council of the National Academy of Sciences called for a reduction in the use of animal testing, recommending instead the increased use of in vitro methods (tests done on human cells or tissue in a petri dish) using human cells. Though the report touted new technologies that could eventually eliminate the need for animal testing altogether, the authors acknowledged that “For the foreseeable future … targeted tests in animals would need to be used to complement the in vitro tests, because current methods cannot yet adequately mirror the metabolism of a whole animal.” [104]
In March 2013, the European Union banned the import and sale of cosmetic products that use ingredients tested on animals (after 2004 and 2009 bans on cosmetics animal testing on domestic products). Some proponents of animal testing objected, arguing that some animal tests had no non-animal equivalents. A spokesman for the trade association Cosmetics Europe stated it is likely “that consumers in Europe won’t have access to new products because we can’t ensure that some ingredients will be safe without access to suitable and adequate testing.” India and Israel have also banned animal testing for cosmetic products, while the United States has no such ban in place. [98][99][157][158]
China is the only major market where testing all cosmetics on animals has been required by law, and foreign companies distributing their products to China must also have them tested on animals. China announced that its animal testing requirement will be waived for shampoo, perfume, and other “non-special use cosmetics” manufactured by Chinese companies after June 2014. “Special use cosmetics,” including hair regrowth, hair removal, dye and permanent wave products, antiperspirant, and sunscreen, will continue to warrant mandatory animal testing. China’s National Medical Products Administration announced that animal testing for “ordinary” cosmetics (those that do not make claims such as “anti-aging”) would no longer be required as of May 2021. [43][65][114][149]
On September 2, 2021, Mexico became the 41st country and first in North America to ban cosmetics testing on animals, according to the Humane Society International. [150]
U.S. Government Reduction in Animal Testing
After ceasing to breed chimpanzees for research in May 2007, the U.S. National Institutes of Health announced in June 2013 that it would retire most of its chimpanzees (310 in total) over the next several years. While the decision was welcomed by animal rights groups, opponents said the decision would have a negative impact on the development of critical vaccines and treatments. The Texas Biomedical Research Institute released a statement claiming that the number of chimps to be retained (up to 50) was “not sufficient to enable the rapid development of better preventions and cures for hepatitis B and C, which kill a million people every year.” On November 18, 2015, the U.S. National Institutes of Health announced that its remaining 50 research chimpanzees will be retired to the Federal Chimpanzee Sanctuary System. Gabon remains the only country in the world that still experiments on chimpanzees. [4][100][117]
The Environmental Protection Agency (EPA) released a plan on September 10, 2019, to reduce studies using mammal testing by 30 percent by 2025 and to eliminate the mammal testing altogether by 2035. In November 2019, the FDA enacted a policy allowing some lab animals used for animal testing to be sent to shelters and sanctuaries for adoption. The National Institutes of Health (NIH) adopted a similar policy in August 2019 and the Department of Veterans Affairs (VA) did so in 2018. [131][146]
An April 29, 2025, New York Times report found that 300 lab animals at the National Institute for Occupational Safety and Health lab in Morgantown, West Virginia, had to be euthanized due to budget cuts. The lab’s employees successfully relocated about 600 animals, mostly mice. Researchers at Harvard faced a budget freeze in April and were only able to save the rhesus macaques being used to develop a new tuberculosis vaccine with private funding. The reaction is split. On one hand, many are concerned about euthanizing animals for no reason other than a lack of funds and slowing down research. On the other hand, some approve of euthanizing the animals before they can be experimented on.[153]
That same day, the National Institutes of Health announced it would “reduce use of animals in NIH-funded research.” NIH director Jay Bhattacharya said, “This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.” Furthermore, in a May 5, 2025, interview on Fox News, Bhattacharya said the NIH would end all beagle experiments on the NIH campus.[154][155]
Animal Testing and COVID-19
The COVID-19 (coronavirus) global pandemic brought attention to the debate about animal testing as researchers sought to develop a vaccine for the virus as quickly as possible. Vaccines are traditionally tested on animals to ensure their safety and effectiveness. News broke in March 2020 that there was a shortage of the genetically modified mice that were needed to test coronavirus vaccines. [133]
Meanwhile, other companies tried new development techniques that allowed them to skip animal testing and start with human trials. Moderna Therapeutics used a synthetic copy of the virus genetic code instead of a weakened form of the virus. The FDA approved an application for Moderna to begin clinical trials on a coronavirus vaccine on March 4, 2020, and the first participant was dosed on March 16, 2020. [143][147]
A shortage of monkeys, including pink-faced rhesus macaques, threatened vaccine development at the beginning of the pandemic and as variants of COVID-19 were found. The monkeys were previously flown in from China, but a ban on wildlife imports from China forced researchers to look elsewhere, a difficult task as China previously supplied over 60 percent of research monkeys in the United States. [148]
Pros and Cons at a Glance
| PROS | CONS |
|---|---|
| Pro 1: Animal testing contributes to life-saving cures and treatments for humans and animals alike. Read More. | Con 1: Animal testing is cruel and inhumane. Read More. |
| Pro 2: Animals are appropriate research subjects because they are similar to human beings. Read More. | Con 2: Animal tests do not reliably predict results in human beings. Read More. |
| Pro 3: Animal research is highly regulated, with laws in place to protect animals from mistreatment. Read More. | Con 3: Alternative testing methods now exist that can replace the need for animals. Read More. |
Pro Arguments
(Go to Con Arguments)Pro 1: Animal testing contributes to life-saving cures and treatments for humans and animals alike.
Nearly every medical breakthrough in the last 100 years has resulted directly from research using animals, according to the California Biomedical Research Association. To name just a few examples, animal research has contributed to major advances in treating conditions including breast cancer, brain injury, childhood leukemia, cystic fibrosis, multiple sclerosis, and tuberculosis. Testing on animals was also instrumental in the development of pacemakers, cardiac valve substitutes, and anesthetics. [9][10][11][12][13]
Scientists racing to develop a vaccine for coronavirus during the 2020 global pandemic needed to test on genetically modified mice to ensure that the vaccine did not make the virus worse. Nikolai Petrovsky, professor in the College of Medicine and Public Health at Flinders University in Australia, said testing a coronavirus vaccine on animals is “absolutely essential” and that skipping that step would be “fraught with difficulty and danger.” [119][133]
Researchers have to test extensively to prevent “vaccine enhancement,” a situation in which a vaccine actually makes the disease worse in some people. “The way you reduce that risk is first you show it does not occur in laboratory animals,” explains Peter Hotez, dean for the National School of Tropical Medicine at Baylor College. [119][141]
Further, animals themselves benefit from the results of animal testing. Vaccines tested on animals have saved millions of animals that would otherwise have died from rabies, distemper, feline leukemia, infectious hepatitis virus, tetanus, anthrax, and canine parvovirus. Treatments for animals developed using animal testing also include pacemakers for heart disease and remedies for glaucoma and hip dysplasia. [9][21]
Animal testing has also been instrumental in saving endangered species from extinction, including the black-footed ferret, the California condor and the tamarins of Brazil. The American Veterinary Medical Association (AVMA) endorses animal testing to develop safe drugs, vaccines, and medical devices. [9][13][23]
Pro 2: Animals are appropriate research subjects because they are similar to human beings.
Chimpanzees share 99 percent of their DNA with humans, and mice are 98 percent genetically similar to humans. All mammals, including humans, are descended from common ancestors, and all have the same set of organs (heart, kidneys, lungs, etc.) that function in essentially the same way with the help of a bloodstream and central nervous system. Because animals and humans are so biologically similar, they are susceptible to many of the same conditions and illnesses, including heart disease, cancer, and diabetes. [9][17][18]
Animals often make better research subjects than humans because of their shorter life cycles. Laboratory mice, for example, live for only two to three years, so researchers can study the effects of treatments or genetic manipulation over a whole lifespan, or across several generations, which would be infeasible using human subjects. Mice and rats are particularly well-suited to long-term cancer research, partly because of their short lifespans. [9][29][30]
Further, animals must be used in cases when ethical considerations prevent the use of human subjects. When testing medicines for potential toxicity, the lives of human volunteers should not be put in danger unnecessarily. It would be unethical to perform invasive experimental procedures on human beings before the methods have been tested on animals, and some experiments involve genetic manipulation that would be unacceptable to impose on human subjects before animal testing. The World Medical Association Declaration of Helsinki states that human trials should be preceded by tests on animals. [19][20]
A poll of 3,748 scientists by the Pew Research Center found that 89 percent favored the use of animals in scientific research. The American Cancer Society, American Physiological Society, National Association for Biomedical Research, American Heart Association, and the Society of Toxicology all advocate the use of animals in scientific research. [36][37][38][39][40][120]
Pro 3: Animal research is highly regulated, with laws in place to protect animals from mistreatment.
In addition to local and state laws and guidelines, animal research has been regulated by the federal Animal Welfare Act (AWA) since 1966. As well as stipulating minimum housing standards for research animals (enclosure size, temperature, access to clean food and water, and others), the AWA also requires regular inspections by veterinarians. [3]
All proposals to use animals for research must be approved by an Institutional Animal Care and Use Committee (IACUC) set up by each research facility. Most major research institutions’ programs are voluntarily reviewed for humane practices by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). [24][25]
Animal researchers treat animals humanely, both for the animals’ sake and to ensure reliable test results. Research animals are cared for by veterinarians, animal husbandry specialists, and animal health technicians to ensure their well-being and more accurate findings. Rachel Rubino, attending veterinarian and director of the animal facility at Cold Springs Harbor Laboratory, says, “Most people who work with research animals love those animals….We want to give them the best lives possible, treat them humanely.” At Cedars-Sinai Medical Center’s animal research facility, dogs are given exercise breaks twice daily to socialize with their caretakers and other dogs, and a “toy rotation program” provides opportunities for play. [28][32]
Pro Quotes
The National Association for Biomedical Research
The Food, Drug and Cosmetic Act was enacted in 1938 after the drug sulfanilamide, marketed for strep throat in the U.S. without human or animal research data establishing its safety or its efficacy, killed and sickened hundreds of people due to toxic levels of antifreeze it contained. Additional animal research safety and efficacy data became required under the Act in 1963 to prevent incidents like the thalidomide incident in Europe and other parts of the world.
Animal testing followed by human clinical trials currently remains the best way to examine complex physiological, neuroanatomical, reproductive, developmental and cognitive effects of drugs to determine if they are safe and effective for market approval.
The overwhelming majority of drugs on the market today relied on safety and efficacy data from multiple animal models before being allowed to move to human clinical trials as demonstrated by the Foundation for Biomedical Research’s Top 25 Drugs and Animal Model study. [176]
Tara Rabin, Public Affairs Specialist at the Food and Drug Administration
While the F.D.A. is committed to doing all that it can to reduce the reliance on animal-based studies, there are still many areas where animal research is necessary. Without the use of animals, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases. [177]
Con Arguments
(Go to Pro Arguments)Con 1: Animal testing is cruel and inhumane.
Animals used in experiments are commonly subjected to force feeding, food and water deprivation, the infliction of burns and other wounds to study the healing process, the infliction of pain to study its effects and remedies, and “killing by carbon dioxide asphyxiation, neck-breaking, decapitation, or other means,” according to Humane Society International. The U.S. Department of Agriculture reported in 2024 that research facilities used over 300,000 animals in activities involving pain in just one year. [47][102][178]
Plus, most experiments involving animals are flawed, wasting the lives of the animal subjects. A peer-reviewed study found serious flaws in the majority of publicly funded U.S. and UK animal studies using rodents and primates: “Only 59 percent of the studies stated the hypothesis or objective of the study and the number and characteristics of the animals used.” A 2017 study found further flaws in animal studies, including “incorrect data interpretation, unforeseen technical issues, incorrectly constituted (or absent) control groups, selective data reporting, inadequate or varying software systems, and blatant fraud.” [64][128]
Only 5 percent of animals used in experiments are protected by U.S. law. The Animal Welfare Act (AWA) does not apply to rats, mice, fish, and birds, which account for 95 percent of the animals used in research. The types of animals covered by the AWA account for fewer than one million animals used in research facilities each year, which leaves around 25 million other animals without protection from mistreatment. The U.S. Department of Agriculture, which inspects facilities for AWA compliance, compiles annual statistics on animal testing but only includes data on the small percentage of animals subject to the Act. [1][2][26][28][135]
Even the animals protected by the AWA are mistreated. Violations of the Animal Welfare Act at the federally funded New Iberia Research Center (NIRC) in Louisiana included maltreatment of primates who were suffering such severe psychological stress that they engaged in self-mutilation, infant primates awake and alert during painful experiments, and chimpanzees being intimidated and shot with a dart gun. [68]
Con 2: Animal tests do not reliably predict results in human beings.
Some 94 percent of drugs that pass animal tests fail in human clinical trials. Over 100 stroke drugs and over 85 HIV vaccines failed in humans after succeeding in animal trials. Plus, nearly 150 clinical trials (human tests) of treatments to reduce inflammation in critically ill patients have been undertaken, and all of them failed, despite being successful in animal tests. While roughly the same percentage of drugs not tested on animals also fail in human trials, the failure rate of animal tests highlights the lack of need for them. If non-animal clinical trials are just as successful as animal testing, there is no need for animal testing. [57][58][59]
Drugs that pass animal tests are not necessarily safe. The 1950s sleeping pill thalidomide, which caused 10,000 babies to be born with severe deformities, was tested on animals prior to its commercial release. Later tests on pregnant mice, rats, guinea pigs, cats, and hamsters did not result in birth defects unless the drug was administered at extremely high doses. Animal tests on the arthritis drug Vioxx showed that it had a protective effect on the hearts of mice, yet the drug caused more than 27,000 human heart attacks and sudden cardiac deaths before being pulled from the market. [5][55][56][109][110]
Plus, animal tests may mislead researchers into ignoring potential cures and treatments. Some chemicals that are ineffective on (or harmful to) animals prove valuable when used by humans. Aspirin, for example, is dangerous for some animal species. Intravenous vitamin C has shown to be effective in treating sepsis in humans, but makes no difference to mice. Fk-506 (tacrolimus), used to lower the risk of organ transplant rejection, was “almost shelved” because of animal test results, according to neurologist Aysha Akhtar. A report on Slate.com stated that a “source of human suffering may be the dozens of promising drugs that get shelved when they cause problems in animals that may not be relevant for humans.” [105][106][127]
Con 3: Alternative testing methods now exist that can replace the need for animals.
Other research methods such as in vitro testing (tests done on human cells or tissue in a petri dish) offer opportunities to reduce or replace animal testing. Technological advancements in 3D printing allow the possibility for tissue bioprinting: a French company is working to bioprint a liver that can test the toxicity of a drug. Artificial human skin, such as the commercially available products EpiDerm and ThinCert, can be made from sheets of human skin cells grown in test tubes or plastic wells and may produce more useful results than testing chemicals on animal skin. [15][16][50][51]
As reported by Michael Bachelor, Senior Scientist and Product Manager at the biotech company MatTek, “We can now create a model from human skin cells — keratinocytes — and produce normal skin or even a model that mimics a skin disease like psoriasis. Or we can use human pigment-producing cells — melanocytes — to create a pigmented skin model that is similar to human skin from different ethnicities. You can’t do that on a mouse or a rabbit.” The Environmental Protection Agency is so confident in alternatives that the agency intends to end chemical testing on mammals altogether by 2035. [61][134][140]
Scientists are also able to test vaccines on human volunteers. Unlike animals used for research, humans are able to give consent to be used in testing and are a viable option when the need arises. The COVID-19 (coronavirus) global pandemic demonstrated that researchers can skip animal testing and go straight to observing how vaccines work in humans. One company working on a COVID-19 vaccine, Moderna Therapeutics, worked on developing a vaccine using new technology: instead of being based on a weakened form of the virus, it was developed using a synthetic copy of the COVID-19 genetic code. [142][143]
Con Quotes
PETA (People for the Ethical Treatment of Animals)
The FDA Modernization Act 2.0, added to the omnibus spending bill, was just passed and has been signed into law by President Biden.
This signals a radical shift in the way drugs and treatments are developed. The U.S. Food and Drug Administration (FDA) will be allowed to consider superior, non-animal drug testing methods, instead of requiring deadly and scientifically bogus animal tests. It’s a change that mirrors a request that PETA scientists made of the FDA in 2020….
PETA’s undercover investigation into laboratory supplier Envigo’s dog-breeding factory led to the release of 4,000 beagles to be adopted into loving homes. But this massive victory is where the real work begins. We must put an end to tests on animals—or else more dogs, cats, mice, monkeys, rabbits, and others will suffer and die in laboratories. [179]
Andrew Wheeler, administrator of the Environmental Protection Agency
We can protect human health and the environment by using cutting-edge, ethically sound science in our decision-making that efficiently and cost-effectively evaluates potential effects without animal testing. [180]
U.S Animal Testing Regulations
A public outcry over animal testing and the treatment of animals in general broke out in the United States in the mid-1960s, leading to the passage of the AWA in 1966. An article in the November 29, 1965, issue of Sports Illustrated about Pepper, a farmer’s pet Dalmatian that was kidnapped and sold into experimentation, is believed to have been the catalyst for the rise in anti-testing sentiment. Pepper died after researchers attempted to implant an experimental cardiac pacemaker in her body. [74][75]
Animal testing in the United States is regulated by the AWA, which was amended in 1970, 1976, and 1985. The AWA defines “animal” as “any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm blooded animal.” The AWA excludes birds, rats and mice bred for research, cold-blooded animals, and farm animals used for food and other purposes. [3][27]
The AWA requires that each research facility develop an internal Institutional Animal Committee (more commonly known as an Institutional Animal Care and Use Committee, or IACUC) to “represent society’s concerns regarding the welfare of animal subjects.” The IACUC must comprise at least three members. One member must be a veterinarian and one must be unaffiliated with the institution. [3][27]
While the AWA regulates the housing and transportation of animals used for research, it does not regulate the experiments themselves. The U.S. Congress Conference Committee stated at the time of the bill’s passage that it wanted “to provide protection for the researcher . . . by exempting from regulations all animals during actual research and experimentation. . . . It is not the intention of the committee to interfere in any way with research or experimentation.” [66]
Animal studies funded by U.S. Public Health Service (PHS) agencies, including the National Institutes of Health (NIH), are further regulated by the Public Health Service Policy on Humane Care and Use of Laboratory Animals. [27]
All PHS-funded institutions must base their animal care standards on the AWA and the Guide for the Care and Use of Laboratory Animals (also known as “the Guide”), prepared by the Institute for Laboratory Animal Research at the National Research Council. Unlike the AWA, the Policy on Humane Care and Use of Laboratory Animals and the Guide cover all vertebrate animals used for research, including birds, rats and mice. The Guide “establishes the minimum ethical, practice, and care standards for researchers and their institutions,” including environment and housing standards and required veterinary care. The Guide stipulates that “the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative.” [71]
The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) reports the number of animals used for research each year, though it excludes animals not covered by the AWA. For fiscal year 2023 (the latest year for which data are available as of March 27, 2025), 774,065 animals were reported. Since the data excludes cold-blooded animals, farm animals used for food, and birds, rats, and mice bred for use in research, the total number of animals used for testing is unknown. Estimates of the number of animals not counted by APHIS range from 85 percent to 96 percent of the total of all animals used for testing. [1][2][26][65][72][152]
The USDA breaks down its data by three categories of pain type: animals that experience pain during their use in research but are given drugs to alleviate it; animals that experience pain and are not given drugs; and animals that do not experience pain and are not given drugs. [26]
The U.S. Food and Drug Administration (FDA), which regulates the development of new medications, states that “At the preclinical stage, the FDA will generally ask, at a minimum, that sponsors . . . determine the acute toxicity of the drug in at least two species of animals.” [73]
On December 29, 2022, President Joe Biden signed the FDA Modernization Act 2.0. Sponsored by Senator Rand Paul (R-KY), the law updates the U.S. Federal Food, Drug, and Cosmetic Act by eliminating the requirement that pharmaceutical companies test new drugs on animals before human trials. The amendment does not prevent companies from performing animals tests, but it makes the tests the choice of the company. [151]
Number of Animals Used for Testing in the United States
The table below lists the animals used for testing in the United States during the 2023 fiscal year. The USDA Animal and Plant Health Inspection Service collected the data in the “Research Facility Annual Usage Summary Report.”
The animals are listed as the research facilities reported them to the USDA; some are listed “species unknown,” or an animal called by two names may appear twice in the list.
The list is divided into a few categories:
- animals held but not used for testing,
- animals used for testing that experienced no pain as a result of the test,
- animals used for testing that may cause pain but the animals were given pain medication or other management before, during, and/or after the test, and
- animals used for testing that may cause pain but the animals’ pain was not mediated.
Animals not covered by the Animal Welfare Act (AWA) were excluded by the USDA, including cold-blooded animals (such as reptiles and most fish), farm animals used for food, and birds, rats, and mice specifically bred for use in research.
In the table below, ARS stands for Agricultural Research Service. Part of the U.S. Department of Agriculture, the ARS is the department tasked with “finding solutions to agricultural problems that affect Americans every day from field to table.”
State-by-State Cosmetics Animal Testing Bans
California
“Notwithstanding any other law, it is unlawful for a manufacturer to import for profit, sell, or offer for sale in this state, any cosmetic, if the cosmetic was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020.”
Exceptions:
“(c) The prohibitions in subdivision (a) do not apply to the following:
(1) An animal test of any cosmetic that is required by a federal or state regulatory authority if all of the following apply:
(A) The ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function.
(B) A specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation.
(C) There is not a nonanimal alternative method accepted for the relevant endpoint by the relevant federal or state regulatory authority.
(2) An animal test that was conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in California by the manufacturer.
(3) An animal test that was conducted on any product or ingredient subject to the requirements of Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.).
(4) An animal test that was conducted for noncosmetic purposes in response to a requirement of a federal, state, or foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in California by the manufacturer. A manufacturer is not prohibited from reviewing, assessing, or retaining evidence from an animal test conducted pursuant to this paragraph.”
Penalties: $5,000 fine, with an additional $1,000 per day for each additional day of violation.
Hawaii
“Notwithstanding any other law to the contrary, and except as otherwise provided in this section, it shall be unlawful for a manufacturer to import for profit, sell, or offer for sale in the State any cosmetic for which the manufacturer knew or reasonably should have known that an animal test was conducted or contracted, by or on behalf of the manufacturer or any supplier of the manufacturer, on or after January 1, 2022, in a cruel manner, as identified in section 711-1108.5(1)(a).”
Exceptions:
“This section shall not apply to: (1) An animal test of a cosmetic that is required by a federal or state regulatory authority if all of the following apply:
(A) The cosmetic or an ingredient in the cosmetic that is being tested is in wide use and cannot be replaced by another cosmetic or ingredient capable of performing a similar function;
(B) A specific human health problem relating to the cosmetic or ingredient is substantiated and the need to conduct animal tests is justified and is supported by a detailed research protocol proposed as the basis for the evaluation of the cosmetic or ingredient; and
(C) There is no non-animal testing method accepted for the relevant purpose by the applicable federal or state regulatory authority
(2) An animal test that was conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from that test was relied upon to substantiate the safety of a cosmetic sold within the State by the manufacturer;
(3) An animal test that was conducted on any product or ingredient subject to the requirements of subchapter V of the Federal Food, Drug, and Cosmetic Act (21 United States Code 351 et seq.), as amended;
(4) Except as otherwise provided in this subsection, an animal test that was conducted for purposes unrelated to cosmetics pursuant to a requirement of a federal, state, or foreign regulatory agency; provided that no evidence derived from the testing was relied upon to substantiate the safety of a cosmetic sold within this State by the manufacturer; provided further that if evidence from such testing was relied upon for that purpose, the prohibition in paragraph (1) does not apply if:
(A) Documentary evidence exists of the intent of the test that was unrelated to cosmetics; and
(B) The ingredient that was the subject of the testing has been used for purposes unrelated to cosmetics for not less than twelve months prior to the reliance;
(5) A cosmetic if the cosmetic in its final form was tested on animals before January 1, 2022, even if the cosmetic is manufactured on or after that date;
(6) An ingredient in a cosmetic if the ingredient was sold in this State and tested on animals before January 1, 2022, even if the ingredient is manufactured on or after that date; or
(7) A manufacturer reviewing, assessing, or retaining evidence from animal testing as defined in this section.”
Penalties: $5,000 fine, with an additional $1,000 per day for each additional day of violation.
Illinois
“Notwithstanding any other law, it is unlawful for a manufacturer to import for profit, sell, or offer for sale in this State any cosmetic, if the cosmetic was developed or manufactured using an animal test that was conducted or contracted by the manufacturer, or any supplier of the manufacturer, on or after January 1, 2020.”
Exceptions:
“(c) The prohibitions in subsection (b) do not apply to the following:
(1) An animal test of any cosmetic that is required by a federal or State regulatory authority, if each of the following apply:
(A) an ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function;
(B) a specific human health problem is substantiated and the need to conduct animal tests is justified and supported by a detailed research protocol proposed as the basis for the evaluation; and
(C) there is not a nonanimal alternative method accepted for the relevant endpoint by the relevant federal or State regulatory authority.
(2) An animal test that was conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic being sold in Illinois by the manufacturer.
(3) An animal test that was conducted on any product or ingredient subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act.
(4) An animal test that was conducted for noncosmetic purposes in response to a requirement of a federal, State, or foreign regulatory authority, if no evidence derived from the test was relied upon to substantiate the safety of the cosmetic sold in Illinois by the manufacturer. A manufacturer is not prohibited from reviewing, assessing, or retaining evidence from an animal test conducted under this paragraph.”
Penalties: $5,000 fine for the first day of each violation, with an additional $1,000 per day for each additional day of violation.
Louisiana
“Notwithstanding any provision of law to the contrary, it is unlawful for a manufacturer to sell or offer for sale in this state a cosmetic that utilized cosmetic animal testing during the development or manufacture of the cosmetic, if the cosmetic animal testing was conducted by the manufacturer, any supplier of the manufacturer, or any person or business hired or contracted by the manufacturer.”
Exceptions:
“The provisions of this Part shall not apply to the following instances of cosmetic animal testing:
(1) Cosmetic animal testing conducted outside of the United States as required by a foreign regulatory authority, provided that no evidence derived from the testing was relied upon to substantiate the safety of the cosmetic ingredient or cosmetic product being sold by the manufacturer in this state.
(2) Cosmetic animal testing conducted for any cosmetic or cosmetic ingredient subject to regulation under 21 U.S.C. 351 et seq.
(3) Cosmetic animal testing conducted for a cosmetic ingredient intended to be used in a product that is not a cosmetic product and conducted pursuant to a requirement of a federal, state, or foreign regulatory authority, provided that no evidence derived from the testing was relied upon to substantiate the safety of a cosmetic sold in this state by a cosmetics manufacturer, unless all of the following apply:
(a) There is no nonanimal alternative method or strategy recognized by any federal or state agency or the Organisation for Economic Co-operation and Development for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent.
(b) There is documented evidence of the noncosmetic intent of the test.
(c) There is a history of use of the ingredient outside of cosmetics at least twelve months prior to reliance.
(4) Cosmetic animal testing requested, required, or conducted by a federal or state regulatory authority if all of the following apply:
(a) There is no nonanimal alternative method or strategy recognized by any federal or state agency or the Organisation for Economic Co-operation and Development for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent.
(b) The cosmetic ingredient or nonfunctional constituent poses a risk of causing a specific substantiated human health problem and the need to conduct cosmetic animal testing is justified and supported by a detailed research protocol proposed as the basis for the evaluation of the cosmetic ingredient or nonfunctional constituent.
(c) The cosmetic ingredient or nonfunctional constituent is in wide use and, in the case of a cosmetic ingredient, cannot be replaced by another cosmetic ingredient capable of performing a similar function.”
B. The provisions of this Part shall not apply to any of the following:
(1) A cosmetic in its final form, which was tested on animals before the effective date of this Part, regardless of whether the cosmetic is manufactured on or after the effective date of this Part.
(2) An ingredient in a cosmetic, which was tested on animals before the effective date of this Part, even if the ingredient is manufactured on or after the effective date of this Part.
(3) A cosmetic manufacturer reviewing, assessing, or retaining evidence from a cosmetic animal test.”
Penalties: A fine up to $1,000 for the first day of each violation, with an additional $500 per day for each additional day of violation.
Maine
“Notwithstanding any other provision of law to the contrary, a manufacturer may not sell or offer to sell in the State a cosmetic if the cosmetic was developed or manufactured using cosmetic animal testing that was conducted or contracted for by the manufacturer or any supplier of the manufacturer on or after November 1, 2021.”
Exceptions:
“This section does not apply to:
A. Cosmetic animal testing:
(1) Conducted outside of the United States and in order to comply with a requirement of a foreign regulatory authority as long as no evidence derived from the testing was relied upon to substantiate the safety of the cosmetic ingredient or cosmetic product being sold by the manufacturer in the State;
(2) Conducted for any cosmetic or cosmetic ingredient subject to regulation under Chapter V of the Federal Food, Drug, and Cosmetic Act, 21 United States Code, Section 351;
(3) Conducted for a cosmetic ingredient intended to be used in a product that is not a cosmetic product and conducted pursuant to a requirement of a federal, state or foreign regulatory authority as long as no evidence derived from the testing was relied upon to substantiate the safety of a cosmetic sold in this State by a manufacturer, unless all of the following apply:
(a) There is no nonanimal alternative method or strategy recognized by any federal or state agency or the International Organisation for Economic Cooperation and Development or its successor organization for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent;
(b) There is documented evidence of the noncosmetic intent of the test; and
(c) There is a history of use of the ingredient outside of cosmetics at least 12 months prior to the reliance; or
(4) Requested, required or conducted by a federal or state regulatory authority and all of the following apply:
(a) There is no nonanimal alternative method or strategy recognized by any federal or state agency or the International Organisation for Economic Cooperation and Development or its successor organization for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent;
(b) The cosmetic ingredient or nonfunctional constituent poses a risk of causing a specific human health problem that is substantiated and the need to conduct cosmetic animal testing is justified and is supported by a detailed research protocol proposed as the basis for the evaluation of the cosmetic ingredient or nonfunctional constituent; and
(c) The cosmetic ingredient or nonfunctional constituent is in wide use and, in the case of a cosmetic ingredient, cannot be replaced by another cosmetic ingredient capable of performing a similar function; [PL 2021, c. 160, §1 (NEW).]
B. A cosmetic if the cosmetic in its final form was tested on animals before November 1, 2021, even if the cosmetic is manufactured on or after that date as long as no new cosmetic animal testing in violation of this section occurred on or after November 1, 2021; [PL 2021, c. 160, §1 (NEW).]
C. A cosmetic ingredient if it was tested on animals before November 1, 2021, even if the ingredient is manufactured on or after that date as long as no new cosmetic animal testing in violation of this section occurred on or after November 1, 2021; or [PL 2021, c. 160, §1 (NEW).]
D. A cosmetic manufacturer reviewing, assessing or retaining evidence from a cosmetic animal test.”
Penalties: A fine up to $5,000 for the first day of the violation, with an additional fine of up to $1,000 for each additional day of violation.
Maryland
“(1) Except as provided in subsection (c) of this section, a person may not conduct or contract for animal testing in the development of a cosmetic.
(2) Except as provided in subsection (c) of this section, beginning July 1, 2022, a manufacturer may not sell or offer for sale in the State a cosmetic if the manufacturer knows or reasonably should have known that the final product or any individual component of the final product was developed or manufactured using animal testing that was conducted or contracted by or for the manufacturer or any entity that supplies, directly or through a third party, any ingredient used by a manufacturer in the formulation of a cosmetic on or after January 1, 2022.”
Exceptions:
“(c) The provisions of subsection (b) of this section do not apply to animal testing that is:
(1) Conducted or contracted to comply with a requirement of a federal or state regulatory agency if:
(i) The cosmetic or ingredient in the cosmetic that is tested is in wide use and cannot be replaced by another ingredient that is capable of performing a similar function in the product;
(ii) A specific human health problem relating to the cosmetic or an ingredient in the cosmetic is substantiated and the need to conduct animal testing is justified and supported by a detailed protocol for research that is proposed as the basis for the evaluation of the cosmetic or ingredient in the cosmetic; and
(iii) Animal testing is the only method of testing that is accepted for the relevant purpose by the federal or state regulatory agency;
(2) Conducted or contracted to comply with the requirement of a regulatory agency of a foreign jurisdiction if: (i) No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; and (ii) The testing was not conducted in the State; (
3) Performed on a cosmetic or an ingredient in a cosmetic subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act;
(4) Conducted or contracted to comply with a requirement of a federal, state, or foreign regulatory agency for purposes unrelated to cosmetics testing if:
(i) No evidence derived from the testing was relied on to substantiate the safety of a cosmetic sold by the manufacturer within the State; or
(ii) 1. Documentary evidence demonstrates that the intent of the test that was performed was unrelated to cosmetics testing; and 2. The ingredient that was the subject of the testing has been used for purposes unrelated to cosmetics for at least 12 months; or
(5) Performed on:
(i) A cosmetic that, in its final form, was tested on animals before January 1, 2022, whether or not the cosmetic is manufactured on or after January 1, 2022; or
(ii) A cosmetic ingredient that was sold in the State and tested on animals before January 1, 2022, whether or not the ingredient is manufactured on or after January 1, 2022, if any animal testing of the cosmetic ingredient after January 1, 2022, is conducted or relied on in accordance with this section.”
Penalties: A fine up to $5,000 for the first violation, with an additional fine of up to $1,000 for each additional violation.
Nevada
“Except as otherwise provided in this section, a manufacturer shall not import for profit, sell or offer for sale in this State any cosmetic for which the manufacturer knew or reasonably should have known that animal testing was conducted or contracted by or on behalf of the manufacturer or any supplier of the manufacturer if the animal testing was conducted on or after January 1, 2020.”
Exceptions:
“2. The prohibition in subsection 1 does not apply to animal testing that is conducted:
(a) To comply with a requirement of a federal or state regulatory agency if:
(1) The cosmetic or ingredient in the cosmetic which is tested is in wide use and cannot be replaced by another ingredient which is capable of performing a similar function;
(2) A specific human health problem relating to the cosmetic or ingredient is substantiated and the need to conduct animal testing is justified and supported by a detailed protocol for research that is proposed as the basis for the evaluation of the cosmetic or ingredient; and
(3) There does not exist a method of testing other than animal testing that is accepted for the relevant purpose by the federal or state regulatory agency.
(b) To comply with a requirement of a regulatory agency of a foreign jurisdiction, if no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within this State by the manufacturer.
(c) On any product or ingredient in the cosmetic subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 351 et seq.
(d) Except as otherwise provided in this paragraph, for purposes unrelated to cosmetics pursuant to a requirement of a federal, state or foreign regulatory agency provided that no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within this State by the manufacturer. If evidence from such testing was relied upon for that purpose, the prohibition in subsection 1 does not apply if:
(1) Documentary evidence exists of the intent of the test which was unrelated to cosmetics; and
(2) The ingredient that was the subject of the testing has been used for purposes unrelated to cosmetics for not less than 12 months before the earliest date of the testing.”
Penalties:NRS 598.0999 Civil and criminal penalties for violations
New Jersey
“No person or manufacturer shall sell or offer for sale in the State any cosmetic that was developed or manufactured using an animal test, if the test was conducted or contracted by the manufacturer or any supplier of the manufacturer on or after… the effective date” of P.L. 2021, CHAPTER 272 [November 8, 2021].
Exceptions:
c. The prohibitions in subsection b. of this section do not apply to cosmetics developed or manufactured using an animal test if:
(1) The animal test is required by a federal or State regulatory authority and:
(a) the ingredient that requires an animal test is in wide use and cannot be replaced by another ingredient,
(b) a specific human health problem is associated with the ingredient and the need to conduct an animal test on the ingredient is justified and supported by a research protocol, and
(c) there is no non-animal test 1method or strategy1 that is accepted by the relevant federal or State regulatory authority as a means to gather the relevant data; (
2) The animal test is conducted 1outside of the United States to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test is relied upon to substantiate the safety of the cosmetic pursuant to federal or State regulations; or
(3) The animal test is conducted on a product or ingredient subject to the requirements of chapter V of the federal “Food, Drug, and Cosmetic Act,” 21 U.S.C. s.351 et seq. 1; or
(4) The animal test is conducted for non-cosmetic purposes pursuant to a requirement of a federal, State, or foreign regulatory authority. No evidence derived from animal testing after the effective date of [P.L. 2021, CHAPTER 272] may be relied upon to establish the safety of a cosmetic pursuant to federal or State regulation unless:
(a) there is no non-animal method or strategy recognized by any federal agency or the Organisation for Economic Co-operation and Development for the relevant safety endpoints for the ingredient;
(b) there is documented evidence of the non-cosmetic intent of the test; and
(c) there is a history of use of the ingredient outside of cosmetics at least one year prior to the reliance on the data.
(d) The prohibitions in subsection b. of this section do not apply to cosmetics that were sold in the State or tested on animals prior to January 1, 2020, even if the cosmetic is manufactured after that date The provisions of this section shall not apply to animal testing conducted on an ingredient or cosmetic if the testing took place prior to January 1, 2021 the effective date of [P.L. 2021, CHAPTER 272].
This section shall not prevent a manufacturer from reviewing, assessing, or retaining data resulting from animal testing.”
Penalties: A fine up to $1,000 for the first violation. “If the violation is of a continuing nature, each day during which it continues constitutes an additional, separate, and distinct offense.”
New York
“Except as otherwise provided in this section, it shall be unlawful for a manufacturer to import for profit, sell or offer for sale in the state, any cosmetic which the manufacturer knew or reasonably should have known that animal testing was conducted or contracted by or on behalf of the manufacturer or any supplier of the manufacturer if the animal testing was conducted after the effective date of this section.”
Exceptions:
“This section does not apply to animal testing that is conducted:
(A) as a requirement of any federal or state regulatory agency if:
(I) the cosmetic or an ingredient in the cosmetic which is being tested d is in wide use and cannot be replaced by another ingredient which is capable of performing a similar function; and
(Ii) a specific human health problem relating to the cosmetic or ingredient is substantiated and the need to conduct animal testing is justified and supported by a detailed protocol for research that is proposed as the basis for the evaluation of the cosmetic or ingredient; And
(Iii) there does not exist a method of testing other than animal testing that is accepted for the relevant purpose by a federal or state regulatory agency.
(B) as a requirement of any regulatory agency of a foreign jurisdiction, if no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within the state by the manufacturer.
(C) for any product or ingredient in a cosmetic which is subject to the requirements under 21 USC Subchapter V.
(D) for purposes not related to cosmetics as required by any federal, state or foreign regulatory agency, provided that no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within the state by the manufacturer, unless:
(I) documentary evidence exists that the intent of the animal testing was unrelated to cosmetics; and
(Ii) there is a history of the use of the ingredient unrelated to cosmetics for a minimum of twelve months.
4. This section does not apply to a cosmetic:
(A) if in its final form, such cosmetic was tested on animals before the effective date of this section, even if the cosmetic is manufactured on or after such date.
(B) if an ingredient contained in such cosmetic was tested on animals and sold in New York State before the effective date of this section, even if such ingredient is manufactured on or after such date.”
Penalties: A fine up to $1,000. “If the violation is of a continuing nature, each day during which it continues constitutes an additional, separate, and distinct offense.”
Oregon
“A manufacturer may not sell or offer to sell in this state a cosmetic that was, on or after January 1, 2024, developed or manufactured using cosmetic animal tests conducted or contracted for by the manufacturer or any supplier of the manufacturer.”
Exceptions:
(2) This section does not apply to a cosmetic that has been developed through use of a cosmetic animal test if the cosmetic animal test was conducted
(a) Pursuant to a requirement of a federal or state agency and all of the following apply:
(A) A specific human health problem in relation to the cosmetic ingredient or nonfunctional constituent is substantiated;
(B) The need to conduct a cosmetic animal test is:
(i) Justified; and
(ii) Supported by a detailed research protocol, proposed as the basis for evaluation of the cosmetic ingredient or nonfunctional constituent;
(C) There is no nonanimal alternative method or strategy recognized by any federal or state agency or the Organization for Economic Cooperation and Development for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent; and
(D) The cosmetic ingredient or nonfunctional constituent is in wide use and, in the case of a cosmetic ingredient, cannot be replaced by another ingredient capable of performing a similar function.
(b) Outside of the United States, pursuant to a legal requirement of a foreign regulatory authority, provided that evidence derived from the testing was not relied upon to substantiate the safety of the cosmetic or cosmetic ingredient.
(c) Pursuant to a requirement established by 21 U.S.C. 351 to 360fff-8.
(d) For a cosmetic ingredient or nonfunctional constituent intended to be used in a product that is not a cosmetic and conducted pursuant to a requirement of a federal, state or foreign regulatory authority, provided that evidence from the cosmetic animal test is not relied upon to substantiate the safety or efficacy of the cosmetic or cosmetic ingredient unless all of the following apply:
(A) There is documented evidence of the noncosmetic intent of the test; and
(B) There is a history of use of the ingredient outside of cosmetics at least one year prior to any reliance on the cosmetic animal test to substantiate the safety or efficacy of the cosmetic or cosmetic ingredient.”
Penalties: A fine up to $5,000, with an additional $1,000 per day for each additional day of violation.
Virginia
“A. Except as provided in subsection B, no cosmetics manufacturer shall:
1. Conduct or contract for cosmetic animal testing that occurs in the Commonwealth on or after January 1, 2022;
2. Manufacture or import for profit into the Commonwealth any cosmetic or ingredient thereof, if the cosmetics manufacturer knew or reasonably should have known that the cosmetic or any component thereof was developed or manufactured using cosmetic animal testing that was conducted on or after January 1, 2022; or
3. Beginning July 1, 2022, sell or offer for sale within the Commonwealth any cosmetic, if the cosmetics manufacturer knows or reasonably should know that the cosmetic or any component thereof was developed or manufactured using cosmetic animal testing that was conducted on or after January 1, 2022.”
Exceptions:
“B. The prohibitions in subsection A shall not apply to cosmetic animal testing or a cosmetic for which cosmetic animal testing was conducted, if the cosmetic animal testing was conducted:
1. To comply with a requirement of a federal or state regulatory agency and (i) the tested ingredient is in wide use and cannot be replaced by another ingredient capable of performing a similar function; (ii) a specific human health problem related to the cosmetic or ingredient is substantiated that justifies the need to conduct the cosmetic animal testing, and such testing is supported by a detailed research protocol proposed as the basis for the evaluation of the cosmetic or ingredient; and (iii) there does not exist a method of testing other than cosmetic animal testing that is accepted for the relevant purpose by the federal or state regulatory agency;
2. To comply with a requirement of a regulatory agency of a foreign jurisdiction, so long as no evidence derived from such testing was relied upon to substantiate the safety of a cosmetic sold within Virginia by the cosmetics manufacturer;
3. On any cosmetic or cosmetic ingredient subject to the requirements of Subchapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 351 et seq.); or
4. Pursuant to a requirement of a federal, state, or foreign regulatory agency for a purpose unrelated to cosmetics, provided that either no evidence derived from such testing was relied upon to substantiate the safety of the cosmetic or there is (i) documented evidence of a noncosmetic intent of the test and (ii) a history of use of the ingredient outside of cosmetics for at least 12 months prior to such reliance.”
Penalties: A fine up to $5,000, with an additional $1,000 per day for each additional day of violation.
Washington
“Beginning January 1, 2025, it is unlawful for a manufacturer to sell or offer for sale in this state a cosmetic if the cosmetic was developed or manufactured using cosmetic animal testing that was conducted or contracted for by the manufacturer or any supplier of the manufacturer.”
Exceptions:
“RCW 69.05.020 does not apply with respect to cosmetic animal testing:
(1) Conducted outside of the United States in order to comply with a requirement of a foreign regulatory authority if no evidence derived from the testing was relied upon to substantiate the safety of the cosmetic ingredient or cosmetic product being sold by the manufacturer in Washington;
(2) Conducted for any cosmetic or cosmetic ingredient subject to regulation under 21 U.S.C. Sec. 351 et seq., of the federal food, drug, and cosmetic act;
(3) Conducted for a cosmetic ingredient intended to be used in a product that is not a cosmetic product and is conducted under a requirement of a federal, state, or foreign regulatory authority if no evidence derived from the testing was relied upon to substantiate the safety of a cosmetic sold in Washington by a cosmetics manufacturer, unless all of the following apply:
(a) There is documented evidence of the noncosmetic intent of the test; and
(b) There is a history of use of the ingredient outside of cosmetics at least 12 months before the reliance; or
(4) Requested, required, or conducted by a federal or state regulatory authority and each of the following apply:
(a) There is no nonanimal alternative method or strategy recognized by any federal or state agency or the organization for economic cooperation and development for the relevant safety endpoints for the cosmetic ingredient or nonfunctional constituent;
(b) The cosmetic ingredient or nonfunctional constituent poses a risk of causing a specific human health problem that is substantiated and the need to conduct cosmetic animal testing is justified and supported by a detailed research protocol proposed as the basis for the evaluation of the cosmetics ingredient or nonfunctional constituent; and
(c) That the cosmetic ingredient or nonfunctional constituent is in wide use and, in the case of a cosmetic ingredient, cannot be replaced by another cosmetic ingredient capable of performing a similar function.”
Penalties:A fine up to $5,000 for each violation.
