Drugs

New Dietary Ingredient Notification Guidance Out

FDA has published a draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry, to help manufacturers and distributors of dietary ingredients and dietary supplements decide whether to submit a premarket safety notification to FDA for a product that is or contains a new dietary ingredient (NDI). The guidance also is to help manufacturers and distributors prepare NDI notifications, so that agency staff can review them more efficiently and respond more quickly.

The major topics addressed in the document are: (1) the qualities of an NDI; (2) when an NDI notification is required; (3) the procedures for submitting an NDI; (4) the types of data and information FDA recommends be considered when a company evaluates the safety of NDIs and dietary supplements containing an NDI; and (5) what FDA recommends be included in an NDI notification.

The guidance also contains questions and answers about parts of the definition of “dietary supplement” that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.

An agency statement announcing release of the draft says that FDA estimates that there are more than 55,000 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year. However, it says, the agency has received fewer than 1,000 NDI notifications since the Dietary Supplement Health and Education Act was passed in 1994. The current draft guidance revises one that was issued in 2011 to clarify several important points that were misunderstood or not fully explained, to describe the public health significance of the recommendations, and to request additional comment before publishing a final guidance, FDA says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome