As proposed by FDA, the New Dietary Ingredient guidance document could upend the ingredients and supplements world more profoundly than anything this side of 1994's DSHEA.
December 14, 2016
If it’s true that “United we stand, divided we fall,” then there is hope that FDA will heed the calls from the major ingredient and supplement trade groups, which stand united with major concerns in the agency’s New Dietary Ingredient (NDI) guidance document, public comment period of which ended Monday with a flurry of detailed critiques and suggestions.
The NDIs are the final piece of the 1994 Dietary Supplement Health and Education Act (DSHEA) to remain unfulfilled. DSHEA mandated that FDA come up with a guidance document in order to ensure safety of ingredient and supplement finished products.
Twenty-two years later and it’s still a work in progress. Industry groups are unanimous in their opinion that FDA, as ever, overstepped its authority and is seeking to conjure new pre-market approvals when that was not the intent of Congress in writing the 1994 law.