USA new FDA guidance for NDIs

The US Food and Drug Administration (FDA) has recently published its long-awaited draft guidance on New Dietary Ingredient (NDI) notifications. A ‘new dietary ingredient, under the federal Food Drug and Cosmetic Act (FDCA) is defined as a dietary ingredient not marketed in the US prior to October 15th 1994. A ‘dietary ingredient’ is defined as a vitamin, mineral, herb or other botanical, amino acid, dietary substance…

USA New Guidance for NDIs

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