FDA Now Requires Animal Testing For Personal Lubricants

BY BTL STAFF

WASHINGTON D.C. - The U.S. Food and Drug Administration has changed testing regulations for personal lubricant to require that all products undergo animal testing.

As of Dec. 31, 2015 all personal lubricants must undergo mammalian safety testing. The FDA's Center for Devices and Radiological Health informed personal lubricant industry stakeholders last year that 100 percent of products would be required to submit premarketing notifications that would include irritant and hypersensitivity safety testing in rabbits and guinea pigs.

The new FDA required tests now include injecting guinea pigs and rabbits with the lubricant to look for evidence of skin allergy and vaginal irritation. However, the People for the Ethical Treatment of Animals say that humans and these small animals have "very different physiologies."

"We've been in touch with a number of lubricant companies, and none of them are pleased with the new rules that require testing products on animals. Nevertheless, there are non-animal test methods that can replace the use of animals in some of the tests FDA is requiring, and PETA has been working to clarify how companies can put these non-animal methods to use," Jeffrey Brown, research associate with PETA's Regulatory Testing Department, wrote to BTL in an email.

PETA scientists have been working with lubricant companies, including Oregon-based Good Clean Love, to persuade the FDA into amending their new requirements. After being told of the alternative science, GCL conducted the non-animal test and shared the results with the FDA. According to PETA, the results of the non-animal test demonstrated that this approach should be accepted by the FDA in place of using animals.

"Good Clean Love, in partnership with PETA, has proven that non-animal methods are not just good for animals: they are also good science. We will work with any company that has the tenacity and vision to make their products cruelty-free," says PETA Vice President of Regulatory Testing, Jessica Sandler.

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