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Verdure Sciences, Inc. failed to submit a required Investigational New Drug (IND) application before conducting a clinical investigation of Maplifa® (maple leaf extract for photoaging treatment) in human subjects, in violation of 21 CFR 312.20 and 312.40. FDA's Bioresearch Monitoring Program inspection conducted June-July 2024 found that the company did not adhere to applicable statutory requirements under the Federal Food, Drug, and Cosmetic Act and Title 21 Code of Federal Regulations Part 312 governing clinical investigations and human subject protection. The violation was significant enough that despite Verdure's July 2024 response to FDA's inspectional observations, the agency determined compliance failures remained unresolved.