NDIs—Is everything old new again?
By Loren Israelsen, President, UNPA
On August 11, 2016, the FDA published its latest revised Draft NDI Guidance, which the agency notes is an expanded and clarified version of its 2011 Draft NDI Guidance. The FDA also notes that the dietary supplement industry’s comments and objections have been considered and taken into account.
But, in fact, we have been presented a document that envisions a dietary supplement world quite different from the one we currently live in.
How did we get here? Let’s set the stage for the 22-year saga of NDIs. It is summer 1994. The Dietary Supplement Health and Education Act (DSHEA) has exploded into a heated public and congressional debate. The House and Senate negotiators (senior staff of the Hatch, Harkin, Kennedy, Dingell, Waxman and Richardson offices), together with a small group of industry leaders, are grinding out a final set of issues in hopes of reaching a compromise bill capable of passage by late October.
The stickiest of sticking points was the question of safety, and rightly so. What standard should apply, and would it apply to all dietary ingredients and dietary supplements, or just some? CONTINUE →