Despite consumer demand for cruelty-free products, companies manufacturing and marketing personal lubricants are confronted by regulatory requirements to demonstrate that their products pass specific experiments conducted on animals. These regulatory requirements often include the rabbit vaginal irritation test. The PETA Science Consortium International, the personal lubricant industry, the Institute for In Vitro Sciences, and the FDA are collaborating on a validation project to demonstrate that in vitro human tissue models can replace the use of rabbits in these tests.
To this end, personal lubricant companies are sharing historical in vivo and in vitro data. Following analysis of the collected data, targeted in vitro testing using the human in vitro tissues models will be conducted as necessary. The study design is being finalized with the participation of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) before any new in vitro testing is conducted to ensure all regulatory requirements are met. Once the study is complete, the results will be submitted to the FDA. If the agency approves the results of the study, the in vitro tissue model methods will be permitted in place of the rabbit vaginal irritation test for personal lubricants. The longer-term goal of the project is to expand the use of the human in vitro tissue models to meet the regulatory testing requirements for additional products, such as tampons, menstrual cups, and other relevant medical devices.
Companies interested in participating in this validation project should contact [email protected] for more information.
The FDA CDRH oversees the regulation and marketing of personal lubricant products. All personal lubricants are classified by CDRH as class II medical devices. Medical devices in this class can be cleared for marketing through a 510(k) submission showing that a new personal lubricant product is “at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to [premarket approval]. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims”.
Approaches to Reducing the Use of Animals
Before conducting any new testing in general, it is important that companies intending to market a personal lubricant product consult with the CDRH Office of Device Evaluation about using alternatives to animal tests. In its guidance document Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff, CDRH encourages medical device manufacturers and developers to contact the agency during the earliest stages of planning a premarket submission through a formal request for feedback, referred to as a “Q-Submission” or “Q-Sub”. Discussions with CDRH through the Q-Sub programme are an ideal context in which to address questions about replacing and reducing animal use.
When discussing testing requirements with CDRH in the context of a Q-Sub, companies may request feedback on non-animal testing options, such as the following:
- The human repeat insult patch test (HRIPT), which has been accepted by CDRH to assess the sensitisation potential of personal lubricant products in place of the guinea pig maximisation sensitisation test, per ISO 10993-10:2010.
- The modified HRIPT, which has been accepted by CDRH to assess the irritation potential of personal lubricant products in place of the rabbit vaginal irritation test, per ISO 10993-10:2010.
- The ongoing project described above, to validate the use of in vitro human tissue models in place of the rabbit vaginal irritation test, per ISO 10993-10:2010.
Alternative methods that can be used to meet regulatory requirements can be found here, and more specifically, non-animal methods for testing medical devices are summarised in this factsheet.