Before we GRAS, Let’s Sharpen Our Axe

By George A. Burdock, Ph.D. and Mr. Johnel Lagabon

Occasionally, a GRAS needs to be amended. Other than expanding the list of food categories in which the ingredient may be used (a welcome reason), the need for amending a GRAS is often that the identity or specification of the primary ingredient has changed for one reason or another – an unfortunate circumstance. If the ingredient has changed to the point it no longer conforms to the original specifications, the GRAS is no longer valid, nor is the data supporting the safety of that ingredient; that is, while the original ingredient may have demonstrated safety in animal tests, those same tests are not valid for a changed ingredient because of a difference in purity, different naturally-present contaminants resulting from a new habitat or growing conditions or “side reactions” taking place during processing – to name only a few.  

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