LEDA at Harvard Law
School LEDA at Harvard Law
School
Testing Cosmetics on Animals: An Idea Who's Time Has Gone
Noah Lewis, Harvard Law School Class of 2005
Submitted in satisfaction of the course requirements for Food and Drug Law
Spring, 2004
Abstract
Despite tremendous progress in reducing animal testing in the assessment the safety of cosmetic products, it persists and there is no definitive end in sight. The reasons for this are not entirely clear because the major constituents, consumers, animal rights activists, and the corporations engaged in the testing all seem to want it to end. While the government still requires animal testing for drugs and other consumer products, there is no explicit requirement for the animal testing of cosmetics. The time is ripe for these constituencies to join forces and push for an outright ban on the testing of cosmetics on animals.
Animal rights campaigns against cosmetics testing began in earnest in 1980 with a publicity campaign that asked, "how many rabbits does Revlon blind for beauty's sake?"[1] The campaign ended when Revlon and other cosmetics companies helped set up a center for the study of replacements for animal tests.[2] Despite tremendous progress in finding such replacements for animals in cosmetics testing, it persists and there is no definitive end in sight. The reasons for this are not entirely clear because the major constituents, consumers, animal rights activists, and the corporations engaged in the testing all seem to want it to end. While the government still requires animal testing for drugs and other consumer products, there is no explicit requirement for the animal testing of cosmetics. The time is ripe for these constituencies to join forces and push for an outright ban on the testing of cosmetics on animals.
If nonhuman animals did not oppose testing, there would be no need for a ban on testing cosmetics on them. It seems an obvious point, but it bears repeating: nonhumans do not volunteer for cosmetics testing.[3] There is no informed consent and the animals receive no benefit from their participation. What animals do receive is confinement, oftentimes including immobilization in stocks, isolation from their peers, exposure to corrosive and irritating chemicals. Ultimately they are killed.
Descriptions of what animals endure may seem gratuitous, inconsequential, or designed solely to stir emotions. But animal suffering is easily ignored. It occurs out of the view of the public eye and therefore it is easy to forget, deliberately or otherwise. Here is one description of the lethal dose 50 (LD50) test in which animals are fed a substance until half of them die:
Because most cosmetic products are not especially poisonous, it necessarily follows that if a rat or a dog has to be killed this way, then very great quantities of cosmetic must be forced into their stomachs, blocking or breaking internal organs, or killing the animal by some other physical action, rather than by any specific chemical effect. Of course the procedure of force-feeding—even with healthy food—is itself a notoriously unpleasant procedure, as suffragettes and other prisoners on hunger-strike have testified. When the substance forced into the stomach is not food at all, but large quantities of face powder, makeup or liquid hair dye, then no doubt the suffering is very much greater indeed. If, for the bureaucratic correctness of the test, quantities great enough to kill are involved then clearly the process of dying itself must often be prolonged and agonizing.[4]
Thankfully, this type of test has been largely eliminated and is now confined to testing ingredients, which still involves force feeding and possibly more noxious chemicals. Other once-common tests that persist are the Draize eye and skin irritancy tests that involve placing chemicals in the eyes or on the shaved skin of rabbits or guinea pigs.[5]
Animal rights activists oppose all animal experimentation. The case for animal rights has been thoroughly laid out elsewhere.[6] The basic premise is that animals do not exist for human use. Because animals are sentient beings, they deserve equal consideration of their rights—there are no morally relevant reasons for drawing a line between humans and animals. When it comes to even medical experimentation on animals, animal rights advocates reject placing animals in that position: "[w]e must stop manufacturing conflicts in which we place animals in out hypothetical burning house because we regard them as our property, and then pretend to ask seriously whose interests we should prefer.[7] Once someone decides that animals "have a basic right not to be things, then we must stop thinking about them as our property, our resources."[8] From the animal rights perspective, animals start off as beings worthy of moral consideration and their use in experiments can be no more justified than using a group of despised humans to experiment on—all such instrumental uses of sentient beings are rejected for a very simple reason: you or I would not want to be experimented on without our consent, therefore we should not subject others to that treatment.
Unlike animal rights activists, animal welfarists think it is OK to use animals to serve human ends when it is necessary to do so, but the animals must be treated humanely.[9] Most people are welfarists. Even those who exploit animals believe it should be done "humanely." The American Meat Institute, for example states, "[p]eople want animals handled humanely, and we feel we have an ethical obligation to do that."[10] The Foundation for Biomedical Research (FBR), is an industry nonprofit "dedicated to improving human and animal health by promoting public understanding and support for the humane and responsible use of animals in medical and scientific research."[11] FBR notes that researchers are required to "justify their need for animals; select the most appropriate species and use the fewest number of animals possible to answer a specific question."[12] They describe the using animals in research as an "essential need" that provides " invaluable and irreplaceable insights."[13] Another industry group, Americans for Medical Progress, "supports the use of only those animals that are necessary for reliable research results, non-animal research methods when approved for specific types of studies, and the highest standards of animal care, including those for housing, environmental enrichment, research procedures, pain management and euthanasia, among others."[14] The incurably ill For Animal Research (iiFAR) "realizes the importance of Product Safety Testing toward preventing serious injuries and recognizes that tests on animals are necessary. However, iiFAR joins with all concerned parties in encouraging the scientific community to search for additional non-animal methods to help deter-mine the toxicity of new products."[15] Corporations also share welfarist ideals. Johnson & Johnson applies the 3Rs to animal testing: replacement, reduction and refinement.[16] It is their policy to use animals to the "minimum extent necessary" to assess the safety of their products, to treat them "humanely" and to cause no "unnecessary pain."[17] These positions all represent the classic articulation of the welfarist position—humane use of animals when necessary. Given that everyone seems to be opposed to unnecessary use of animals, one must figure out what is necessary.
Conceiving of cosmetics as "necessary" is difficult. Wearing cosmetics may be considered desirable, preferable, or a positive aspect of society, but that does not make it necessary. Some women may consider wearing cosmetics "necessary." Women face enormous social pressure to wear makeup. Their jobs may also depend up wearing makeup.[18] Even if these things are conceded, however, this does not justify testing new cosmetics on animals. There are thousands of cosmetics already on the market and over 3,000 ingredients that can be readily used to formulate new cosmetics.[19] An end to animal testing will, at worst, slow the introduction of new products until replacements for the few remaining animal tests are found.
Another potential source of "necessity" is corporations. Because corporations have a duty to shareholders to make a profit and attempting to sell women new formulations of cosmetics is traditionally how cosmetics companies increase profits.[20] Corporations could, however, continue to make profits by selling their tried and true formulas, however. This point in time presents another avenue to dramatically increase profits by catering to a large, untapped market—men. Currently sales to men comprise a small percentage of overall sales, but that percentage is growing rapidly.[21]
Moreover, corporations profess a desire to eliminate animal testing. "Unilever is committed to the elimination of animal testing for our business."[22] Proctor & Gamble (P&G) has spent more than $170 million over the past 20 years on replacements for animal tests and currently spends $10-13 million annually.[23] P&G has eliminated animal testing for 80% of its products.[24] Although more costly, the replacement tests "achieve better results."[25]
Advances have yielded impressive progress. "Animal use for skin irritation testing is not necessary today, with currently available and accepted methodology, except for regulatory reasons."[26] Clinical trials on humans represent one advance that not only allows in vitro tests to be validated, but represent a direct product test on the species of concern, humans.[27]
Many Americans are opposed to using animals in cosmetics testing. Only thirty-one percent of Americans think it is right to test cosmetics on animals.[28] Another poll showed 58% of Americans think "using animals for cosmetics research" should be prohibited by law and another 23% disapprove but don't feel it should be illegal.[29] Among women, 63% oppose animal testing for health and beauty products.[30] Thirty-eight percent of people would support a ban on all product testing on laboratory animals.[31]
In addition to simply being opposed to animal testing in theory, consumers often desire to avoid purchasing products tested on animals. Nine percent of women specifically look for "not tested on animals" claims when buying health and beauty care (HBC) products.[32] Twenty-two percent of women have purchased HBC products because "advertising indicated it was not tested on animals."[33] Moreover, 47% said they would be somewhat or much more likely to buy an HBC product that indicates it has not been tested on animals."[34] This data reveals that the claim "not tested on animals" has power to add value to a product and that consumers make choices based on their beliefs about whether or not a company tests on animals.
In an effort to help consumers make informed choices, several animal rights groups produce guides to companies that do and do not test on animals.[35] To become listed on PETA's "don't test" list, the company must agree not to "conduct or commission any nonrequired animal tests on ingredients, formulations, or finished products and that they pledge not to do so in the future."[36] In 1996 a group of animal protection groups formed the Coalition for Consumer Information on Cosmetics (CCIC) to promote a single comprehensive standard for animal testing claims as well as an internationally recognized "leaping bunny" logo.[37] The standard provides that neither a company or its suppliers conducts animal testing after a fixed cut off date.[38] The program differs from the PETA standard in that it applies to suppliers and requires an annual recommitment. The program is doing well, with 33 new companies being certified in 2004 alone.[39] While a sophisticated consumer might know that CCIC is the gold-standard to look for when purchasing a cruelty-free product, there are a multitude of non-CCIC companies making animal testing claims on their labels.
A survey of 85 cosmetic and soap products that make some type of claim about animal testing on their label highlights the confusing nature of animal testing claims on labels.[40] The results of this survey are presented in a separate spreadsheet. Of the 85 products surveyed, only 19 (22%) appeared on the CCIC list. Seventeen (20%) appeared on the PETA list, but not the CCIC list. Five (6%) appeared on PETA's "do test" list but still carried "don't test" labeling claims.[41] The remaining 44 (52%) appeared on no list at all, thus even a consumer armed with the PETA list and the CCIC list would have no way to evaluate these claims without contacting each company. Taking CCIC as the gold-standard that most consumers think they are purchasing—no new animal testing—these claims are deceptive 78% of the time (66 out of 85).
The labels themselves carry a wide varied of differently worded claims. Here is a sample of some of the different types of claims made on labels:
In addition to text slogans, the products also featured all manner of bunny logos. Bunnies sitting, bunnies with slashes over them, and bunnies in boxes, triangles and ovals. Not to be left out is one company's "seal" of approval, represented by said sea mammal.[42] Despite the fact that PETA and CCIC both have different official bunny logos, these appeared on only a couple of products. Of the companies entitled to use the CCIC leaping bunny, only one (Jason Natural Cosmetics) used it, perhaps because there is fee associated with using the logo, but not with becoming CCIC certified.[43] The plethora of bunnies can be misleading if consumers think the bunny is some sort of official symbol of approval or have been instructed by animal rights groups to look for the leaping bunny logo and they mistake the bunny on the product for the official CCIC logo,[44] which looks like this:
Labels like those outline above can be misleading—even sophisticated consumers are unable to distinguish between animal testing claims. In one survey, half of consumers though "not tested on animals" meant that neither the product nor the ingredients were tested on animals, although that is seldom the case.[45] The carefully worded labels provide plenty of leeway to hide the fact that a company may be involved in animal testing. This can happen in many ways: 1) Almost all ingredients, including water, have been tested on animals at some point. The Cosmetic, Toiletry & Fragrance Association believes that "not tested on animals" claims are confusing to consumers because of that point.[46] 2) Even if finished products have not been tested on animals, the ingredients may have been. 3) Even if that product was not tested on animals, the company may have tested earlier, very similar products. 4) Some companies use a rolling cut-off date for ingredients. For example, they may not use ingredients that have been tested on animals in the last five years, so they are in effect letting others do the dirty work for them but still profiting from the new ingredients developed through animal testing.[47] 5) The company itself may not conduct tests, but it may contract it out, rely on testing from trade associations, or rely on testing from outside of the US.[48] Given all of these loopholes, disingenuous companies can slap a "not tested on animals" label on its product, attract more customers than a competitor, and face little repercussion because of the difficulty in consumers finding out the specifics of a company's testing policy, and even if they did, there is little legal resource for consumers, as outlined in Section III below.
Europe will ban the testing of cosmetics on animals in 2009.[49] The ban includes a ban on the marketing of cosmetics—final products and ingredients—that have been tested on animals and so will apply to any company wishing to do business in Europe.[50] Corporations perceive the US government's failure to recognize non-animal replacements as a stumbling block for US companies who wish to participate in the European market.[51]
A cosmetic is misbranded if "its labeling is false or misleading in any particular."[52] The FDCA prohibits the introduction of misbranded cosmetics into interstate commerce.[53] The FDA has the authority to seize, detain, or obtain an injunction against the distribution of any such misbranded products.[54] Violations can also result in imprisonment and criminal and civil fines.[55] There is no private right of action of any sort under the federal Food Drug and Cosmetic Act (FDCA).[56] Although there is additional authority to regulate labels under the Fair Packaging and Labeling Act of 1992, that Act applies mainly to things like the identity of the product and the quantity of the product[57] and it is unlikely that claims about animal testing could fit under that law.[58]
The FDCA protects consumers' economic interests as well as health and safety interests. The FDCA has applied to cases of economic adulteration where an ingredient of lesser value has been marketed as one with greater value even if the product itself is not harmful.[59] Because of the FDCA's intention to protect consumers,[60] the standard is not one of the sophisticated consumer or even the reasonable consumer, but rather "a consuming public which includes "the ignorant, the unthinking and the credulous."[61] Similarly, other courts have found that the standard by which misleading statements were be to be judged was not of "overly skeptical buyers," but "actual customers who cannot be presumed to have special expertness or to be unduly cautious."[62] One might argue that animal rights activists are the prime market for cruelty-free products and they are in fact highly skeptical and educated about the subject. Animal rights groups produce numerous guides with which consumers can arm themselves and use to purchase cruelty-free cosmetics.[63] There are several problems with this argument. First, the very fact that guides need to be produced indicates how difficult it is to purchase products that are strictly not tested on animals. Second the guides cannot be comprehensive and they are not as indicated by the large number of products in my survey that made animal testing claims but did not appear on PETA's list.[64] Third, teenage girls often seek out cruelty free products and companies wishing to tap into this large market must pay attention to those preferences.[65] Although some teens probably are much more sophisticated consumers than many adults, it is unfair to hold teenagers to adult scrutiny standards. Finally, it is not just animal rights activists who seek to purchase cruelty-free products. As poll data indicates, up to sixty percent of the public might wish to purchase such products.[66]
The failure to disclose the fact that animal testing has occurred could be considered misleading. In deciding whether a label is misleading, the FDA can take into consideration "the extent to which the labeling or advertising fails to reveal facts material in the light of such representations."[67] Thus if a product is labeled "not tested on animals," but all of the ingredients have been separately tested on animals, the label fails to reveal this material fact and is thus misleading.
By failing to enforce the misbranding portion of the FDCA, the FDA may be abusing its discretion. Because economic harm is part of the statutory mandate and consumers are being harmed, consumers' rights under the FDCA are "'nullified by FDA inactivity."[68]
The FDA could approach the issue on a remedial, case-by-case basis. As shown above, however, the labeling problem is widespread. The FDA could, for example, send a letter to each company notifying them that their product was potentially misbranded and ask for clarification of what the company means by the label along with proof that they comply with their own claim. Virtually every company could come up with a reasonable definition of their claims. If a company merely didn't test the final product on animals, they could say that's all they implied. If a company contracts out the testing of its products, they could claim they were referring to the fact that they themselves did not test on animals. If a company uses a rolling cut-off date for ingredients, they could still claim that the testing was not done to create that product, so it is acceptable to claim there was no animal testing. Some companies might be moved to remove their labeling claims about animal testing, but given all of these ambiguities, they probably feel they could prevail in court that their products are not misbranded. They might also correctly believe that the issue was a low priority for the FDA and the chances of enforcement through a lawsuit were minimal. Absent uniform definitions of these labeling claims, the FDA would be unable to give clear direction as to how to eliminate the risk that their products are misbranded.
The FDA could promulgate standards for labeling claims such as "cruelty-free" and "not tested on animals" to ensure that such labels are not misleading consumers. [69] Ideally, the standards would mirror those used by the CCIC.[70] The FDA should allow each company to choose a cut-off date to encourage as many companies as possible to cease animal testing and be able to label their products as such without attempting to go back and remove ingredients tested after a nationwide cut-off date. Such interpretive rules would put companies on notice about what the FDA's position is with respect to misbranding and animal testing claims. The FDA could enforce this by requiring companies to submit their animal testing policies upon request, or make it mandatory for any company wishing to make such a claim on its label.
FDA might lack the authority to promulgate standards, however. In 1974, the FDA promulgated standards that defined "hypoallergenic," but the regulations were struck down as arbitrary and capricious.[71] Given that the FDA received a petition in 1996 on this subject, which it characterized as "through," but did not begin rulemaking proceedings, this seems to indicate that either the FDA lacks the resources to give this issue priority or it does not feel it has authority or a factual basis that would withstand judicial review.
The Lanham Act allows competitors to sue one another for false labeling.[72] There are three elements to a Lanham Act claim:[73] (1) that the advertising in question is conveying a particular message (that the product and/or its ingredients were not tested on animals—this is not mere puffery as polls show people look for it); (2) that the message is false (most ingredients have been tested on animals, or the testing may have been contracted out, etc.); (3) that the plaintiff is likely to be injured as a result of the advertiser's false claim (poll data showing consumers are more likely to choose a product that has not been tested on animals).
Suits could occur in two ways. First, companies that comply with the CCIC standards could sue the companies that claim "no animal testing" but do not comply with CCIC. They could present the arguments made above and show how the competitor is being deceptive and therefore is engaging in unfair competition. Second, this could be used by companies that do not comply with the CCIC and label any of their products as "not animal tested." Corporations like P&G that engage in huge amounts of research on replacements and have substantially reduced the number of animal tests that they perform choose not to label their products because they believe such claims are misleading given the history of animal testing for most ingredients.[74] These corporations could sue companies claiming not to engage in animal testing but who actually do in some form.
States also have various unfair competition laws under which corporations could bring suit. California's even has a private cause of action for any individual harmed by the unfair competition so consumers or animal rights activists could bring suits directly.
The FDA lacks statutory authority to outright ban animal tests, so ultimately such a directive would have to come from Congress. In addition to banning animal tests, Congress could increase the FDA's authority over cosmetics regulation and mandate human clinical testing of cosmetics.
Another possibility would be to institute state or local bans on animal cosmetic tests. There is probably no preemption problem given that the FDA does not require animal tests. Similarly, The federal Animal Welfare Act regulates treatment of animals only and does not go to the substance of experiments.[75]
A final way in which Congress could foster an end to animal testing would be to ban the use of animal testing data in product liability suits and to limit liability for unforeseeable harms from cosmetics. This latter solution is not ideal, however, because companies should be encouraged to pursue wider clinical testing.
Due to the limitations of the above-described legal tools, activists cannot rely on the law to create social change. When Spira began his activism in 1979, a ban on cosmetics testing would have been dramatic. Now that replacements for animal tests are in place, particularly in the area of cosmetics, it is time for animal rights advocates to vigorously, publicly call for nothing less than a ban the testing and marketing of any product that uses animal testing after a prescribed cutoff date.
[1] Henry Spria, Should You Take an Activist to Breakfast , 49 Food and Drug Law Journal, 291, 295 & 295 n.8 (1994).
[2] Id. at 295.
[3] Berke Breathed, Night of the Mary Kay Commandos Featuring Smell O-Toons , 1989 (cartoon character Opus visits a cosmetics testing lab in search of his mother. He was initially reassured by his visit to the lab, until he had the a revelation).
[4] Tom Regan, Empty Cages: Facing the Challenge of Animal Rights 168-69 (2004), (quoting Richard Ryder, Victims of Science: The Use of Animals in Research 36 (1975)).
[5] Gary Francione, Introduction to Animal Rights: Your Child or the Dog 45 (2000).
[6] E.g. , Francione, supra note; Joan Dunayer, Speciesism (2004), Tom Regan, Empty Cages: Facing the Challenge of Animal Rights (2004).
[7] Francione, supra note 5 at 157.
[8] Id.
[9] Id. at xxii-xxiii.
[10] David Forster, Animal Rights Activists Getting Message Across: New Poll Findings Show Americans More in Tune with "Radical" Views , Chi. Trib. Jan. 26, 1996, at C8.
[11] Foundation for Biomedical Research, About the Foundation for Biomedical Research , Dec. 8, 2003, http://www.fbresearch.org/about.
[12] Foundation for Biomedical Research, FBR's Position on Animal Research , Sept. 5, 2002, http://www.fbresearch.org/about/position.htm.
[13] Id.
[14] Americans for Medical Progress, AMP's Statement on Humane Animal Use , http://www.amprogress.org/About/AboutList.cfm?c=9 (last visited May 22, 2005).
[15] incurably ill For Animal Research, About Us - Position Statement: Product Safety Testing , http://www.iifar.org/ps_testing.html (last visited May 22, 2005).
[16] Johnson & Johnson, Statement on Product Safety & Laboratory Research Animal Testing , May 14, 2004, http://www.jnj.com/community/policies/animal_testing/statement.htm.
[17] Johnson & Johnson, Policy on the Humane Care & Use of Laboratory Research Animals , May 14, 2004, http://www.jnj.com/community/policies/animal_testing/policy.htm.
[18] Jespersen v. Harrah's Operating Co., Inc. , 392 F. 3d 1076, 1078 (9th Cir. 2004) (upholding an employee appearance policy requiring that women wear makeup and men do not).
[19] Unwanted Effects
[20] Christina Passariello, Sales to Men Lifts Beauty Market , Wall Street Journal, April 7, 2004, at 1.
[21] Molly Prior, Men's Grooming Moves from Metrosexual to Average Joe , Drug Store News, Mar. 1, 2004 at 38 ("Retail sales of men's skin care products alone have nearly tripled in the last 10 years."); Passariello supra note 20 ("It's a very buoyant market with very fast growth.").
[22] Unilever, Unilever's position on animal testing , http://www.unilever.com/ourvalues/environmentandsociety/issues/animalTesting.asp (last visited May 22, 2005).
[23] Carmen Fleetwood, In Vitro Testing is Coming to Aid, If Not Yet Succeed, the Guinea Pig , Wall Street Journal, Sept. 19, 2004 at 1.
[24] Tonya Vinas, P&G Seeks Alternative to Animal Tests , Industry Week, July 2004 at 60.
[25] Id.
[26] Katherine A. Stitzel, Tiered Testing Strategies—Acute Local Toxicity , 43 Institute for Laboratory Animal Research Journal S21 (2002), http://dels.nas.edu/ilar_n/ilarjournal/43_supp/V43suppStitzel.shtml. See also M.K. Robinson et al., Non-animal Testing Strategies for Assessment of the Skin Corrosion and Skin Irritation Potential of Ingredients and Finished Products , 40 Food and Chemical Toxicology 573-592 (2002) (noting that the Draize test for skin irritation and corrosion is incredibly inaccurate and reliable non-animal replacements exist).
[27] Michael K. Robinson, John P. McFadden, and David A. Basketter. Validity and Ethics of the Human 4-h Patch Test as an Alternative Method to Assess Acute Skin Irritation Potential , 45 Contact Dermatitis 1 (2001) (authors include scientists from P&G and Unilever).
[28] Associated Press Poll, Question ID: USAP.945K Q3B 005, Dialog Poll database, Nov. 14, 1995 (Do you think the use of animals to test cosmetics is always right (2%), right under some circumstances (29%), seldom right (21%), or never right (46%)? Don't know: 2%.)
[29] Parents Magazine, Question ID: USKANE.89PM10 R02B 006, Oct. 10, 1989 ("Thinking about specific ways that humans assert their dominance over animals, please tell me if you think each of the following practices is wrong and should be prohibited by law (58%), if you personally disapprove but don't feel it should be illegal (23%), or if it is acceptable to you (13%). Not sure (5%)).
[30] Karyn Snyder, Terms of Ensnarement; Use of Animals in Testing , Drug Topics, Jan. 22, 1996, at 51 (quoting the National Consumers League).
[31] Gallup Poll, Question ID: USGALLUP.03M0005 R37B 004, Dialog Poll database, May 21, 2003 (proposal: "banning all product testing on laboratory animals" 13% strongly support, 25% somewhat support, 31% somewhat oppose, 30% strongly oppose, 1% no opinion.)
[32] Terms of Ensnarement , supra note 30.
[33] Id.
[34] Id.
[35] E.g. , People for the Ethical Treatment of Animals, Companies That Do/Don't Test on Animals , http://www.caringconsumer.com/searchcompany.asp (last visited May 22, 2005); National Anti-Vivisection Society, Personal Care for People Who Care , http://www.navs.org/ido/index.cfm?ido=product_testing_book&title=Product%20Testing%20Book (last visited May 22, 2005) (this book costs $13.50).
[36] People for the Ethical Treatment of Animals, Companies That Do/Don't Test on Animals , http://www.caringconsumer.com/searchcompany.asp (last visited May 22, 2005).
[37] Coalition for Consumer Information on Cosmetics, About Us , http://www.leapingbunny.org/about_us.htm (last visited May 22, 2005).
[38] Coalition for Consumer Information on Cosmetics, Industry , http://www.leapingbunny.org/industry.php (last visited May 22, 2005).
[39] Coalition for Consumer Information on Cosmetics, Newly Approved Companies , http://www.leapingbunny.org/approved-2004.htm (last visited May 22, 2005).
[40] I conducted this survey in March of 2004 by examining products at a Brooks drug store in Somerville, MA, The Harvest Co-op (a natural foods store) in Cambridge, MA, and a Whole Foods store, Cambridge, MA. The survey includes mostly cosmetics, a few soaps, but no household cleaners. Although soaps are not regulated under the FDA, but fall under the Consumer Product Safety Commission (CPSC), they are included because consumers generally have no knowledge of the different regulatory status of "cosmetics" versus "soaps" and the labeling issues are precisely the same. This paper confines discussion to the FDA, but the same analysis could easily be extended to the CPSC.
[41] This is most likely because the parent company tests on animals or other product lines are tested on animals. For example, Proctor and Gamble appears on PETA's "do test" list, but their Clairol Herbal Essences line is, evidently according to the label, not tested on animals. Perhaps this refers to the final product only.
[42] There are probably no instances of companies testing cosmetics on a seal.
[43] Coalition for Consumer Information on Cosmetics, Frequently Asked Questions , http://www.leapingbunny.org/faq.htm (last visited May 22, 2005).
[44] Coalition for Consumer Information on Cosmetics, welcome page, http://www.leapingbunny.org (last visited May 22, 2005).
[45] Animal Testing Claims Can Confuse , Times-Picayune (New Orleans, LA), Jan. 17, 1996, at E3 (referring to a survey by the National Consumers League).
[46] Terms of Ensnarement , supra note 30.
[47] Terms of Ensnarement , supra note 30.
[48] Id.
[49] CNN, EU to ban animal-tested cosmetics, Jan. 15, 2003, http://edition.cnn.com/2003/WORLD/europe/01/15/eu.testing.
[50] Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC), Article 4a, http://pharmacos.eudra.org/F3/cosmetic/Consolidated_dir.htm
[51] W. Richard Ulmer, Invitro's Aspirin Approval , Global Cosmetic Industry, April 2005, at 23 (calling on businesses to "speak with your regulatory agency as soon as you can").
[52] 21 U.S.C.A. § 362(a) (2005).
[53] 21 U.S.C.A. § 331 (2005).
[54] 21 U.S.C.A. § 334 (2005) (seizure and detainment); 21 U.S.C.A. § 332 (2005) (injunctions).
[55] 21 U.S.C.A. § 333 (2005).
[56] National Women's Health Network, Inc. v. A. H. Robins Co., 545 F. Supp. 1177, 1179 (D. Mass 1982) (denying remedial equitable relief in Dalkon Shield case and noting actions for damages or injunctions are also disallowed).
[57] 15 U.S.C.A. § 1453 (2005).
[58] Although the declared policy of the law was to ensure that packaging facilitates "value comparisons," 15 U.S.C.A. 1451 (2005), and claims about animal testing do affect the perceived value of the product for many.
[59] Federal Sec. Adm'r v. Quaker Oats Co., 318 U.S. 218, 230-31 (1943) (noting the FDCA mandated the creation of food identity standards because labeling requirements were insufficient to protect consumers from economic adulteration); United States v. Two Bags, Poppy Seeds , 147 F.2d 123, 127 (6 Cir. 1945) (noting the FDCA was "not designed primarily for the protection of merchants and traders; but was intended to protect the consuming public").
[60] United States v. An Article. . . Consisting of 216 Individually Cartoned Bottles, More or Less, of an Article Labeled In Part: Sudden Change , 409 F.2d 734, 740 n.6 (2nd Cir. 1969) (noting that the legislative history of the FDCA indicates concern about defrauding consumers).
[61] Sudden Change , 409 F.2d at 740 (holding that "face lift" claims made a cosmetic product a drug because consumers would expect it to change the structure of their bodies); United States v. Strauss, 999 F.2d 692, 696-97 (2d Cir. 1993) (applying the same standard to misbranded dog food).
[62] United States v. An Article of Drug Consisting of 47 Bottles, More of Less, Each Containing 30 Capsules of an Article Labeled in Part Jenasol RJ Formula "60" , 320 F. 2d 564, 572 (3rd Cir. 1963) (basing this on the fact that purchasers are "pathetically eager to find some simple cure-all for the diseases with which they are afflicted").
[63] E.g. , Companies That Do/Don't Test supra note 36; National Anti-Vivisection Society, Personal Care for People Who Care , http://www.navs.org/ido/index.cfm?ido=product_testing_book&title=Product%20Testing%20Book (last visited May 22, 2005) (this book costs $13.50).
[64] Companies That Do/Don't Test supra note 36.
[65] Targeting Teens , Chain Drug Review, Feb. 26, 1996 at S3 (noting that teenage girls spent $5.8 billion on cosmetics in 1994); Animal Testing Claims , supra note 45 (noting younger women "are twice as likely as older women to purchase a health and beauty aid with a not-tested-on animals claim on its label").
[66] Supra note 30 and accompanying text.
[67] 21 U.S.C.A. § 321(n) (2005) (emphasis added).
[68] Bryan A. Liang and Kurt M. Hartman, It's Only Skin Deep: FDA Regulation of Skin Care Cosmetics Claims , 8 Cornell J. L. & Pub. Pol'y 249, 276 (1999).
[69] 21 U.S.C.A. § 371 (2005) (granting the FDA rulemaking authority).
[70] Supra note 37 and accompanying text.
[71] Almay v. Califano , 569 F. 2d 674, 675, 683 (DC Cir. 1977).
[72] Thomas C. Morrison, The Regulation of Cosmetic Advertising under the Lanham Act , 44 Food Drug Cosm. L.J. 49, 49 (1989).
[73] Id. at 51.
[74] Proctor & Gamble, Our Commitment Our Approach: Procter & Gamble's Practices, Policy and Progress On Research Involving Animals , at 3, http://www.pg.com/science/Brochure%20on%20Research%20with%20Animals.pdf (last visited May 22, 2005).
[75] But see Larry T. Garvin, Constitutional Limits on the Regulation of Laboratory Animal Research , 98 Yale L.J. 369 (1988).