Personal lubricants are defined by the US Food and Drug Administration (FDA) as Class II medical devices. As such, they require clinical testing before commercialization.
Currently, this involves conducting a Rabbit Vaginal Irritation (RVI) Test, which is the most commonly used method to assess the potential of a personal lubricant to cause irritation.
During the test, rabbits are exposed to lubricants for at least five days before being euthanized and dissected.
“The goal [of the project] is to validate a three-dimensional human tissue model so the FDA can use data from that method, instead of the RVI, to determine biocompatibility,” Erin Hill, president of the Institute for In Vitro Sciences, Inc. (IIVS) told Outsourcing-Pharma.com.
"We have been successful in the past in bringing consortia of industry together with regulatory bodies to design non-animal testing approaches that meet both of their needs," she added.
The project is the result of collaboration between IIVS, industry, the PETA International Science Consortium Ltd., and the Consumer Healthcare Products Association (CHPA).
An FDA spokesperson told us the project has received the go-ahead from the agency as part of its effort to modernize the tests used to develop and evaluate medical devices. The FDA recently issued a guidance on its new program to assess medical device development tools, such as the one being developed by IIVS.
“IIVS has a long history of standardizing and validating non-animal models for industry and regulatory decision making. IIVS scientists – who are very familiar with the 3D reconstructed human vaginal tissue models, contacted manufacturers to see if they would be interested in such a project,” said Hill.
“Several manufacturers would like to register personal lubricants without the use of animals,” she added.
IIVS will serve as the project’s technical lead and will design the testing strategy.
If the method is proved successful and receives FDA approval, the in vitro tissue models will be made available for industry use.