Good Clean Love, a longtime PETA company, was included in a recent Forbes feature article (“Lube Maker, PETA at Odds with FDA over Animal Testing”) that challenges the need for lubricant companies to undergo mammalian safety testing.
A recent mandate by the U.S. Food & Drug Administration has demanded that in order for lubricant companies to get their products 510(k) approval, they are required to test their products on small animals including guinea pigs, rabbits, and mice to look for evidence of skin allergy and vaginal irritation. “510(k)” refers to section 510(k) of the Food, Drug and Cosmetic Act, which requires manufacturers of medical devices (which the FDA considers lubricant to be) to notify the FDA that a new product is safe and effective. In order to determine whether they are safe for humans, the FDA says that new products must be tested on animals.
Good Clean Love’s CEO and founder, Wendy Strgar, has been frustrated with the FDA mandates for animal testing because animal models do not provide any reliable evidence about toxicity in humans. There is no other vagina in the animal kingdom with similar physiology. The human vagina has a uniquely low pH and an immune response dependent on that acidic environment. Strgar notes that one positive step that came from negotiating with the FDA was that they did consent to replacing one animal test with the submission of one human tissue model test.
“The good news is that science has developed methods of using live human cells which shows what actually happens with personal lubricants on human vaginas,” Strgar remarked. “Most people are not aware of how much work PETA has done to further the scientific alternative models for product safety testing which is widely used throughout the world.”
The collaboration between PETA and Good Clean Love began when Good Clean Love asked PETA for guidance about non-animal tests that would be compliant with FDA requirements. Good Clean Love was the first lubricant company to submit a human tissue model test to the FDA. Results of the non-animal test demonstrated that this approach is a worthy replacement for animal tests as it provides more accurate data about toxicity of lubricant products.
PETA Vice President of Regulatory Testing, Jessica Sandler, said, “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.”
It is a long process for the FDA to change their testing requirements, but Strgar believes that this is a great first step. “We’re a certified B Corp and approved Co-op America Green company,” says Strgar. “We believe that the ‘good’ in Good Clean Love depends on our commitment to promote and implement sustainable practices every day, and to create products that are safe and cruelty-free to animals. We are proud to include the work of keeping animals safe as part of our mission, and working with PETA has been an amazing learning experience.” The worldwide scientific community agrees that testing methods with cultured human cells are more predictive of human safety than animal tests, so we trust it is just a matter of time before the FDA reconsiders this important initiative.