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New draft NDIN guidance – Timeline

Dietary Supplement Health and Education Act of 1994 (DSHEA) enacted on October 14, 1994 and signed into law on October 25, 1994

Dividing line between old and new dietary ingredients: October 15, 1994 (not marketed in the US prior to: “new” dietary ingredient)

Federal Register Final Rule (62 FR 49886) “Premarket Notification for a New Dietary Ingredient,” including FDA’s expectation of receiving 0-12 NDI notifications annually (one for each of the up to 12 new ingredients expected to enter the market each year), published September 23, 1997

FDA’s Good Guidance Practices Rule (delineates laws and regulations from guidance documents which represent only the agency’s thinking on a matter), finalized Sept 2000

First Federal Register notice soliciting public comment on interpretation of NDI provision of DSHEA: October, 2004

Public meeting re the above, November 2004

Food Safety and Moderniz