August 2016

FDA Releases New Dietary Ingredient Draft Guidance

The U.S. Food & Drug Administration (FDA) has released revised draft guidance for new dietary ingredient (NDI) notifications. The initial draft was released back in 2011.

Under the Dietary Supplement Health and Education Act (DSHEA), passed in 1994, a manufacturer or distributor is required to notify the FDA at least 75 days before marketing a supplement that contains an NDI. These notifications are the only opportunity the FDA has to assess potential safety concerns before a product reaches consumers.

Following the release of the first draft guidance, several points of disagreement emerged between the FDA and dietary supplement industry. Among those addressed in this new draft is the FDA's stance on synthetic forms of natural compounds. While the new draft maintains the position that a substance that is synthesized in a laboratory and never part of an herb or botanical is not a dietary ingredient, it does allow for synthetic natural compounds that have been used historically as "lawfully marketed ingredient[s] in the conventional food supply," such as vanillin and cinnamic acid.

The FDA is seeking feedback on this revised draft before the guidance is finalized.

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