What is Needed for a Successful GRAS? Part II

“It is not remarkable that consumer confidence in food safety has decreased markedly in the past few years.” (Howard Roberts, Acting Director of the Bureau of Foods, 1976[1])

In his drop-quote below, Director Roberts actually refers to food ingredient safety – and GRAS. Even 18 years after the act passed, FDA and industry still struggled with the meaning of “generally recognized as safe.” By the 1970s, the “easy” GRAS determinations had been added into FDA GRAS lists, and FDA worked on anything missing an agreed upon and clear understanding.

Complicating matters was the recent finding that cyclamate (long held to be GRAS), was a carcinogen and that at least one corrupt animal testing facility had faked data. Accord-ing to Roberts, “the ranks of anti additive consumers are [increasing] every day by constant pressure from activists and a barrage of … misinformation from the media.”

GRAS was under constant attack and FDA couldn’t offer definition for “generally recognized,” nor could the legislative history. Like art or pornography, everyone knew it when they saw it, but no one could describe it to the satisfaction of all. Over time, there have been attempts to redefine GRAS. Most recently, FDA uses the term “technical element” when discussing technical evidence of safety (e.g., animal studies, etc.) and “common knowledge element” when discussing general knowledge and safety acceptance.

In this context, publication of “technical elements” might fulfill the “general knowledge” component, but is still inadequate to demonstrate GRAS because acceptance had not yet been demonstrated. It could well be that “acceptance” would assume primacy in a GRAS determination. This conundrum has been revived in the GRAS Notification proposal wherein criteria for rejection of a Notification includes “… (3) does not convince the agency that there is the requisite expert consensus about the safety of the substance for its intended use or, (4) is