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Innate Healthcare Institute was warned for misbranding umbilical cord mesenchymal stem cells (UC-MSCs) as a drug therapy without FDA approval, marketing the product for treating autism and other conditions through claims that it modulates the immune system and regenerates damaged tissue. The company violated the Federal Food, Drug, and Cosmetic Act by making disease treatment claims on its website while the product was held for sale and shipped in interstate commerce. The product qualified as a biologic subject to CBER jurisdiction and required proper regulatory authorization before being marketed for therapeutic use in humans.