The High Cost of a “Cheap” GRAS

There is no requirement in the law or in the regulations that a generally recognized as safe (GRAS) determination (so-called “self-GRAS”) must be reported to the Food and Drug Administration (FDA); in fact the Federal Register notice describing the GRAS Notification program[1] makes it abundantly clear that GRAS notification is a voluntary process. However, because of a provision in the Food Safety Modernization Act,[2] evidence supporting the GRAS status of a substance may soon be required to be available for review if or when demanded by FDA. Conceivably, GRAS status could also be negated for a substance if, in the opinion of FDA, the opinion of an expert panel (on whose opinion the GRAS determination is based) is “no more substantive than the decorative umbrella in a tropical cocktail.”[3] Further, who would be held accountable for an inadequate GRAS? Lately, FDA has been trending toward assigning blame to executives behind the action, not exclusively their contractors. How did this happen and how did we get to this point?

In the early 1950’s it was determined by Congress that an approval process was needed for ingredients added to food. However, because there were hundreds of ingredients already being added to food, a food additive petition process to address hundreds of ingredients was deemed impractical, in addition to which many ingredients (such as spices) had been in use for hundreds of years with no reported safety issues. At this point, Congress decided that it would be most effective to divide these food ingredients into two categories: food additives, which would require a formalized approval process by FDA, and substances that are determined GRAS, the vetting of which would be carried out by appropriately trained and experienced experts. The expert opinion could be based on safe use of the ingredient prior to January 1, 1958 or for an ingredient not used before the 1958 cut-off date, scientific procedures (e.g., animal testing) were to be employed in order to determine safety. No ingredients were grandfathered; even those in use prior to the cut-off date had to be reviewed for safety and as determined somewhat later by FDA, the data supporting the safety of the GRASed ingredient had to be published, although the actual public declaration of a GRAS determination was not required.