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FDA Announces Enforcement Discretion

On May 19, the US FDA announced it intends to exercise enforcement discretion on missing New Dietary Ingredient (NDI) notifications. The Agency also set up a portal to allow companies to come into compliance more easily by filing notifications they should have done before going to market. The FDA stated it is aware of many New Dietary Ingredients on the market whose safety hasn’t been assessed.  The FDA estimated that 4,600 notifications should have been submitted but were not, and only about 1,200 notifications have been received since the enactment of DSHEA (Dietary Supplement Health and Education Act). Some companies have filed GRAS notices instead.  FDA is allowing an amnesty period and released a six-page guidance for NDA notifiations.

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Posted on 24 May 2022