In February the FDA told the Natural Products Association that it would not enforce the NDI guidelines.
http://www.nutraingr...-draft-guidance
While last week they issued warning letters based on the NDI guidelines:
http://www.fda.gov/N...s/ucm302133.htm
The main issue concerns the synthetic item on the NDI guidance. The warning letters all state that the material used was synthetic and therefore adulterated. This 'synthetic' item is an item that the FDA stated they would not enforce according the February meeting, yet... the warning letters all state this as the reason they determined the product to be adulterated.
The FDA is creating new law in this instance, and if no one calls them on it... you will see many of your supplements disappear from market shelves.
I can see this as an attempt to insert a new "rule" in with an old warning letter "rule"... and there for give credence to the new rule if no one calls them on it.
A
Edited by Anthony_Loera, 01 May 2012 - 10:25 PM.














