Gamete, Fertilization and Embryo Compatible Lubricants: The New FDA Product Code ‘PEB’ Updates the Standard of Care for Trying-to-Conceive Couples
Recently, the U.S. Food and Drug Administration created a unique Product Code (“PEB”) for personal lubricants that are “gamete, fertilization and embryo compatible” for use by couples who are trying to conceive and by health care providers during fertility interventions. This designation falls under the Obstetrical and Gynecological Therapeutic Devices portion of the Code of Federal Regulations Title 21. These Class 2 lubricant devices differ from other patient and personal lubricants (e.g. not specifically gamete, fertilization and embryo compatible) with regards to the required biocompatibility and toxicology testing; lot release specifications; quality monitoring; and premarket FDA review process for device clearance. The PEB lubricants undergo premarket testing and ongoing monitoring more similar to Reproductive Media and Supplements, than to traditional lubricants. Inspite of the testing and regulatory requirements for this Product Code, many consumers, physicians, and medical-specialty societies remain unaware of this specific labeling, which can simplify optimal product selection for a unique patient group. This review briefly discusses: how PEB lubricants (e.g. “Fertility Lubricants”) differ from other types of lubricants; why product choice in lubricants matters for couples who are trying to conceive; and general formula differences between current PEB Lubricants. The awareness of a new regulatory code, which identifies lubricants that are gamete, fertilization and embryo compatible, remains lacking amongst healthcare providers and consumers. Public and reproductive health is better served if intended uses of lubricant products are read, understood and explained to patients.