FDA’s 2016 New Dietary Ingredient Draft Guidance: Promise and Challenge for Dietary Supplement Innovation

On August 12, 2016, FDA issued a new Draft Guidance (Draft Guidance) on its interpretation of the New Dietary Ingredient (NDI) notification requirement in Section 413 of the Federal Food, Drug, and Cosmetic Act (FDCA). The Draft Guidance contains provisions that have the potential both to facilitate and to impede innovation in the dietary supplement and functional food industries.