Suppliers and Ingredient Identity Testing

There are some very good reasons behind the importance of Ingredient Identity.  Most of these are obvious.  However, there are a couple of reasons that are less obvious and that are rooted deep in the implementation of Dietary Supplement GMPs.  These reasons fall to both the purchaser of the ingredient and a little more surprisingly to the supplier of the ingredient.  Looking at it from both perspectives the reasons are very clear.
For the purchaser of the ingredient, the Dietary Supplement GMPs are very clear.  The Final Rule requires manufacturers of Dietary Supplements to establish specifications for “identity, purity, strength and composition” of the ingredients used (empohasis added).  You as a manufacturer as required to do this.  The supplier of the ingredient is not so required.  Recall that in the transition from Proposed Rule to Final Rule the onus of regulations fell off of the manufacturers of dietary ingredients and shifted exclusively to the manufacturers of Dietary Supplements.  Also, the Final Rule also allows for the use of a Certificate of Analysis for assuring the identity of components.  But you must read the fine print.
As a manufacturer of a Dietary Supplement you must “Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient . . .” You see the Certificate of Analysis provision applies to components other than dietary ingredients.  Well, how are you going to test?  These answers point straight back to the supplier of the dietary ingredient.  The supplier of the dietary ingredient is nearly always the contact point but not always the manufacturer of the ingredient.
Thus the onus of how to test for identity of the dietary ingredient (the test that must be performed by the manufacturer of the Dietary Supplement) is going to come from the supplier of the dietary ingredient whether directly or from someone else further up the supply chain.
The supplier of the dietary ingredient, therefore, is not off the hook at all when it comes to Dietary Supplement GMPs.  They are going to be increasingly pressured by their customers (the manufacturers of Dietary Supplements) to establish and share the methods of testing the identity of their product. 
As time goes on with the full implementation of the Dietary Supplement GMPs it is going to be increasingly more incumbent upon the supplier of the dietary ingredient to insure that they have an appropriate test method to give over to their customers for identity determination.  Yes, the Manufacturer is going to be held accountable at inspection time, but rest assured that their reliance is going to shift that burden over to the supplier. 
The bottom line is that Suppliers and Consumers of dietary ingredients had best become familiar with the GMPs and what the requirements are.  The Suppliers especially had best become more familiar in order to keep their business flowing.  Stay Tuned.

 

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