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n 1968, Tom and Kate Chappell left Philadelphia and moved to Kennebunk, Maine in search of a simpler existence. The Chappells tried to incorporate natural, unadulterated products into their lives, but they were unable to find personal care items that suited their needs. So, in 1970, armed with an animal- and environmentallyfriendly philosophy and a $5,000 loan from a friend, they launched Tom’s of Maine. Five years later, Tom’s created the first natural toothpaste to reach the market, and in so doing, the company began an effort that represents the very beginnings of a David vs. Goliath scenario in which the modest company challenged the FDA and its mandate to use animal tests for products containing fluoride, an over-the-counter drug. As part of its regulatory authority, the FDA requires companies that manufacture drugs (whether prescription or over-the-

Many AV Magazine readers are probably familiar with Tom’s of Maine, a cruelty-free (and Leaping Bunny certified) natural products company that manufactures soap, deodorant, toothpaste, and more. However, you may not be aware of the company’s humble beginnings and its role in the precedent-setting Food and Drug Administration (FDA) decision that allowed a non-animal method to test fluoride in toothpastes.


counter) to attest for their safety and effectiveness before it grants permission to place them on the market. Historically it has required animal tests to do this.1 In 1995, the FDA established final rules for testing dental products containing fluoride, which included two in vitro tests to determine fluoride availability, as well as specifying the use of an animal caries (tooth decay) reduction test to measure the fluoride’s ability to prevent cavities. This experiment involves the use of rats who are “super infected with cariogenic bacteria and, unlike clinical subjects, swallow the fluoride toothpaste.”2 Steel clamps are used to force the rats’ jaws apart so that anticavity chemicals can be swabbed on their teeth, and after three weeks, the animals are killed and their teeth examined. But while many companies have used this regulatory requirement to justify their continued use of animal testing, some companies, like Tom’s of Maine, push the government to modify policy in order to continue to stand on their principles and bring consumers the products they desire, without the use of cruel and needless animal


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