FDA Creates PEB Lubricant Category for TTC Couples2018-04-24T16:48:10+00:00

New FDA Category for Fertility Friendly Lubricants Helps Inform TTC Couples

When it comes to personal and intimate lubricants, there are many options from which to choose. But, when you are trying to conceive its important to select a lubricant that is verified to be fertility friendly, and won’t negatively impact your chances of conceiving. How do you know if a lubricant is fertility-friendly, and what sets a Fertility Lubricant apart from other intimate lubricants? Dr. Joanna Ellington, PhD, addresses these question in this published article.

Gamete, Fertilization and Embryo Compatible Lubricants: The New FDA Product Code ‘PEB’ Updates the Standard of Care for Trying-to-Conceive Couples.

Published: November 20, 2017

Abstract

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.

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