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You are here: Home / ALL NEWS / Analytical Testing News & Updates | ADPEN Laboratories / FDA Releases New Dietary Ingredient Draft Guidance

FDA Releases New Dietary Ingredient Draft Guidance

July 7, 2011 By Steven Perez

The FDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to help industry prepare NDI notifications.

The draft guidance is laid-out in a Q&A format and explains the definition of an NDI, when an NDI notification is necessary, the procedures for submitting a NDI notification, the types of data and information that FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI, and what should be included in a NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.

Read the article at Natural Products Insider.

Filed Under: Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links Tagged With: dietary, FDA, guidance, NDI, release, safety, supplement

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