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Cleft lip and palate is due to tissues of the face not properly joining together during development. They are a type of birth defect. The cause in most cases is unknown. Risk factors include smoking during pregnancy, diabetes, an older mother, obesity, and certain medications such as some used to treat seizures.
A role of IRF6 in causing cleft lip and/or palate is further supported by analysis of IRF6 mutant mice which exhibit a hyper-proliferative epidermis that fails to undergo terminal differentiation, leading to multiple epithelial adhesions that can occlude the oral cavity and result in cleft palate.