What it Means to be Cruelty Free

Introduction to cruelty free

In medicine and cosmetics, the topic of cruelty free frequently comes up as a potential selling point for many products. Similar to terms like clean or vegan, cruelty free aims to convey that a brand or product might be superior—either in objective physical qualities or in subjective moral qualities—because it doesn’t conduct any testing of its products on animals. If a brand declares its products to be cruelty free, however, what are the requirements for making that claim? What does the claim actually mean, and what does it imply? Further still, if any brand transgresses that claim, what are the consequences and who holds the brand accountable? Read on to learn more about the history and implementation of cruelty free in consumer products.

How do we define cruelty free?

According to the FDA, there’s currently no restriction on the usage of the phrase cruelty-free in the cosmetics industry because no legal definition exists for the terms. Additionally, cosmetics companies may choose to selectively apply the phrase cruelty free to its products in the following ways:

• A company may label its finished product as being cruelty free. Though it’s a semantic difference, the underlying raw materials may still be tested on animals by suppliers, distributors, or contract laboratories in order to confirm the necessary safety profile of the product.. In this case, the “last mile” is effectively cruelty free, but the supply chain and R&D that contribute to the finished article being sold may not be.
• A company may label its product as being cruelty free despite using ingredients that were once tested on animals, but are no longer currently being tested on animals. This could be because the compound in question has been in existence for enough time that additional testing is no longer required.

From the perspective of animal rights groups like PETA, a company is truly cruelty free if it:

• Bans animal tests on ingredients, formulations and finished products, both locally and globally, so as to avoid circumventing local animal testing restrictions in some states and national markets.
• Verifies that all suppliers, contractors, and distributors do not “conduct, commission, pay for, or allow” any tests on animals.
• Pledges that these commitments will carry on indefinitely.
• Refuses to use any animal-derived ingredients, falling in line with the principles of veganism. Examples of animal-derived ingredients include honey, beeswax, and carmine as less obvious cases that everyday consumers might overlook.

According to the MSPCA, when used by businesses, cruelty free may suggest any of the following points (perhaps deceptively, as indicated by MSPCA themselves):

• The product—as well as its ingredients—has never been tested on animals.
• The product or its ingredients have not been tested on animals within a certain timeframe, such as the past 5-20 years.
• Constituent ingredients may have been tested on animals, but the finished article has not been tested on animals.
• The company in question did not conduct any animal tests, but instead may have relied on an intermediary to conduct the results—potentially at their instruction—or on prior outcomes of animal tests.
• Animal testing was not done in the United States so as to avoid running afoul of stronger American animal cruelty laws.

The history of cruelty free

In the late 19th century, the issue of animal experimentation began to gain traction as a social justice issue, with many anti-vivisectionist societies, or groups against the performance of experimental surgeries on live animals, popping up worldwide. The first formal organization to advocate against animal cruelty involved five of these societies coalescing into the British Union—now Cruelty Free International—in 1898, founded by Frances Power Cobbe. Due to the efforts of the British humanitarian Lady Muriel Dowding, the phrase cruelty free came into common parlance in the late 1950s following the 1959 founding of Beauty Without Cruelty, an organization which advocated for an end to both products made with animal fur and the involvement of animal testing in cosmetics.

Why do we test products on animals in the first place?

As we detailed in our piece on FDA approval, new treatments and medicines must often undergo trials that prove safety and efficacy in humans. Before reaching the phases where it’s considered safe to involve human volunteers, preliminary testing is often undergone either in silico using computer modeling, in vitro using tissue samples outside of a living organism in a test tube or similar, or in vivo by testing in whole organisms like animals. Because of the stark consequences of negative results occurring on human subjects, animal testing in organisms like mice, rats, pigs, dogs, and non-human primates is seen as a more appealing alternative.

Because all animals descend from a common ancestor, many species possess similar genes, metabolic pathways, and organ systems to humans. Animal models are seen to be additionally advantageous because animals suffer from many of the same diseases as humans, as well as possessing a shorter life cycle that allows researchers to collect a full spectrum of data in a shorter amount of time.

When it comes to animal testing, science is often seen as the problem; however, it’s working to become part of the solution and eliminate the need for animal testing altogether. Recent advances in technology and computing power have seen the development of power in silico tools that can accurately model the activity of living systems, while physical tools like organ-on-a-chip technology can allow for human organs and tissues to be represented without the need to harm any living creature. Unfortunately, the accuracy of these technologies remains far from where they need to be in order to be true replacements.

The history of animal testing

Experimentation on animals has occurred throughout history, ranging from the experiments of Greek philosophers Aristotle and Erasistratus in the 4th century BC to the 12th century Arab physician Avenzoar practicing dissection and other surgical procedures on animals in preparation for applying the procedure to human patients.

In the United States, animal testing for new drugs became a prerequisite after the passage of the 1938 Federal Food, Drug, and Cosmetic Act. Why? The year prior, the Elixir Sulfanilamide Incident of 1937 saw a reformulation of the drug sulfanilamide in liquid form cause the deaths of more than 100 people, many of them children. By formulating the sulfa drugs in a liquid suspension of diethylene glycol—a compound that had been shown as early as 1930 to cause kidney failure in mammals—S.E. Massengill Company had contributed to the poisoning deaths of its customers by failing to do its due diligence. More than 75 years later, the same compound, diethylene glycol, was found in toothpastes and cough syrups bound for Latin America that had sourced raw materials from Chinese suppliers. Those suppliers, under lax regulations, had attempted to substitute diethylene glycol as a cheaper substitute for the sweetener glycerin.

In the 1960s, a similar crisis occurred following the introduction of the drug thalidomide. Tested in mice—though importantly, not in pregnant mice at the time—and found to be generally non-toxic, thalidomide was marketed as a sedative and antiemetic and was subsequently pitched to women as a treatment for morning sickness. In countries where thalidomide was marketed and made available, children were increasingly being born with missing or shortened limbs.

It was claimed that animal testing demonstrated that thalidomide was safe and didn’t result in abnormalities or birth defects; however, subsequent research showed that the timing of the dosage during pregnancy was significant in terms of causing particular birth defects. Additionally, it was also noted that because many laboratory animals often give birth at night—and, somewhat gruesomely, will cannibalize their deformed offspring—that the technicians returning to observe any outcomes in the morning would fail to notice any negative outcomes. Further studies that involved constant monitoring of the lab animals, as well as Caesarian sections, definitively demonstrated birth defects in the offspring. As a result, animal testing standards came to require testing in two separate species, as well as passage of the stricter FDA guidelines in 1966 around reproductive toxicity.

A review of research ethics and entities

We’ve seen the crises that led to recalls and reviews, but what rules or agencies have been put in place since in order to ensure that history doesn’t repeat itself?

What are the key components of ethical principles in research?

The Belmont Report

Issued in 1979, the Belmont Report was authored by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in order to define the guiding principles of research in human subjects. It details the following key components:

• Respect for Persons. Individuals must be capable of understanding the consequences of participation in research, and those that cannot understand the implications should be excluded from harm.
• Beneficence. Positive outcomes or benefits should be maximized, while detrimental outcomes should be minimized.
• Justice. Burdens and benefits of research in human subjects should not be disproportionately assigned. As an example, research in the 19th and 20th centuries was often conducted on poorer, less fortunate subjects while the research itself often only benefited those who were well-off enough to afford its beneficial outcomes.

• Informed Consent. Flowing forth from the principle of Respect for Persons, when participating in a trial, human subjects have a right to be informed about what may or may not happen to them and to choose whether or not to consent to the experiments.
• Assessment of Risks and Benefits. By assessing the data carefully, investigators should determine whether the benefits outweigh the risks for the trial in question, or whether the data could be gathered through other means.
• Selection of Subjects. Based upon the principle of justice, subjects should be drawn in a fair manner such that the benefits and burdens of the research are not unequally distributed. Certain classes of subjects that lack personal agency, like prisoners or the mentally incapacitated, should be involved as research subjects only under certain conditions. Similarly, because of their ability to give informed consent, adults should be preferentially selected as treatment subjects over children.

The Sundowner Report

Mirroring the points raised for human experimentation, the Sundowner Report was issued in 1996 and detailed NASA’s Principles for the Ethical Care and Use of Animals. The overall points are:

• Respect for Life. When possible, other methods—like modeling, computer simulation, and in vitro testing—should be used to prioritize the life of animal research subjects. If animals are used as research subjects, all possible efforts should be made to limit the number of animals used, as well as to ensure that the appropriate species is selected for the experiment at hand.
• Societal Benefit. The overall benefit to mankind should be considered before undertaking animal research. Do the benefits to humanity outweigh the costs to the animals being used in the experiments?
• Nonmaleficence. Distress and pain should be minimized as much as possible when using sentient animal subjects in order to limit undue suffering.

How is animal welfare guaranteed in modern research?

When it comes to modern research, there are two institutional boards responsible for the oversight of experiments in live subjects: the Institutional Review Board (IRB) that concerns itself with research on human subjects, and the Institutional Animal Care and Use Committee (IUCAC), which oversees research on animal subjects.

Within an institution, the IUCAC is tasked with:

• Semiannual reviews of the animal care and use programs, including inspections of facilities and laboratories.
• Approving and overseeing the implementation of new experimental protocols involving animals, including the authority to revoke approval for said experiments.
• Preparation of an annual report to the Institutional Office (IO) or any and all IACUC findings.

Cruelty free: What it is & what it isn’t

Because there is no singular, agreed-upon definition of cruelty free, it can be difficult to accurately label what the cruelty free movement and branding officially signifies. In the most cynical sense, it conveys that the company in question has an awareness that its customer base cares about animals and would preferentially align with a brand that espoused those values. In a market research survey, 33% of respondents aged 35-54 in a 2017 poll said that they would “very likely stop purchasing from their favorite brand if they tested on animals.” If a brand doesn’t conduct any animal testing on its products, paying $350 to license the use of PETA’s global “Animal Test-Free” logo might be a beneficial branding exercise and marketing tactic to tap into this sentiment and conversation.

Just as there isn’t an easy way to pin down the definition of cruelty free, it’s equally challenging to assign value and importance to those decisions, either. Once an opinion is formed, the strength of that opinion can range from moral relativism to absolutism. Should we overlook individual ingredients that were once tested on animals, even if they no longer need to be tested to validate their results, so that animals weren’t sacrificed in vain at some point in the past? Should we stake out a claim that any testing, ever, is a scarlet letter and an absolutist position needs to be taken out of principle? Is it easier to excuse testing on some types of animals than others, and how might we come to create those stratifications? Those questions are difficult to answer, and that lack of certainty is problematic when the cruelty free symbol is meant to quickly provide moral clarity to consumers without much additional thought and evaluation.

What we can say is this: Cruelty free is an admirable goal that’s practical in some circumstances, but aspirational in others. In cosmetics, the stakes are certainly lower, but in certain cases that involve investigating groundbreaking treatments, the principle of being cruelty free could require the investigator to consider how we weigh human life against animal life, making the question even messier than it already is. Scientists can all certainly agree that animal testing shouldn’t be undertaken superfluously. Fortunately, that goal isn’t up to the whims of benevolent scientists: As we’ve highlighted, legal regulations and review boards at every institution are empowered, tasked, and mandated to conduct oversight and assure that institutions are compliant with animal welfare laws.

Closing thoughts

Let’s revisit and summarize the definitions of cruelty free that we laid out in our introduction:

• There is no legally recognized definition of cruelty free by the FDA, allowing for wider latitude in usage of the phrase.
• An ingredient in a product may be cruelty free if it isn’t tested on animals. By some standards, an ingredient must also not be derived from animal sources or byproducts in order to be truly cruelty free.
• A finished product may technically be cruelty free if it isn’t tested on animals; however, individual ingredients may or may not have been tested on animals throughout the supply chain, with different organizations holding different standards. Because companies must submit to animal testing for cosmetics in order to enter the Chinese market, some language in Western markets regarding animal testing may be muddied and obfuscated, suggesting that only legally required animal testing was undertaken.
• A cruelty free certification may have a flexible timeline: Some organizations grant recognition after a certain number of years have passed since any testing was conducted, while some are more stringent and require indefinite forward-looking commitments, as well.

So is cruelty free branding the solution to the ruthless, cold-hearted whims of scientific research, or is it a hollow marketing ploy that’s sufficiently vague so that consumers can be soothed into thinking they’re making the morally correct purchase? The truth is somewhere in between. Though cruelty free branding, because of the absence of legal enforcement, can be unclear and powerless, the existence of the cruelty free movement facilitates a conversation about the ethical imperatives that scientists face in research and development. It keeps the issues of animal welfare in the public consciousness and moves the goalposts forward.

By dragging those standards forward, the movement makes incremental progress and holds companies accountable in the court of public opinion—it’s imperfect and better than nothing, but it’s only as valuable as the consumers are savvy. In that way, requiring those consumers to do research on the different accrediting organizations and their different standards simultaneously creates an additional burden as it attempts to solve one. Unlike lactose-free milk alternatives or caffeine-free herbal teas, labeling a product cruelty free doesn’t guarantee the same all-or-nothing clarity that it might imply.