FDA WARNING_LETTER - Verdure Sciences, Inc. - July 12, 2024

Verdure Sciences, Inc. received an FDA Warning Letter on November 10, 2025, following an inspection conducted from June 25 to July 12, 2024. The inspection, part of the FDA’s Bioresearch Monitoring Program, revealed significant regulatory violations concerning the clinical investigation of the investigational drug Maplifa®. The primary issue identified was Verdure"s failure to submit an Investigational New Drug (IND) application before initiating Protocol 005, which evaluated the effects of Maplifa® on skin photoaging.

The FDA determined that Maplifa® was being investigated as a drug, as it was intended to affect the structure or function of the body by mitigating facial wrinkles and altering skin brightness. This classification necessitates an IND under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 of the Code of Federal Regulations, part 312. Verdure"s argument that the study was exempt from IND requirements, based on its cosmetic use and a proposed FDA rule, was rejected. The FDA emphasized that the investigational product was not lawfully marketed as a drug in the U.S. and did not meet exemption criteria.

The FDA requires Verdure to address these violations by submitting an IND for the clinical investigation and ensuring compliance with all applicable regulations. Verdure must also provide a detailed plan to prevent future violations and ensure the protection of human subjects in clinical trials. Failure to comply could result in further regulatory action.