Ingredient Approval Has Never Been a Blank Check

In December of 2009, the Center for Food Safety and Applied Nutrition (CFSAN) offered some “Guidance for Industry” relative to the use of novel ingredients in food for purposes and use levels that are not approved.[1] Although the primary reference in the guidance is to beverages, other foods are cited as well:

“…ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods. This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use.”

This guidance is a very clear warning to all that the use of approved food ingredients for unapproved uses or use levels will not be tolerated. This guidance is similar to a warning issued in the Federal Register (39:34194-5, 1974) relative to Generally Recognized as Safe (GRAS).

“It has been too often assumed that the GRAS substance may be used in any food, at any level for any purpose. As a result, the uses of some GRAS food ingredients have proliferated to the point where the GRAS status was brought into serious question.”

The Food and Drug Administration (FDA) has been very consistent in its view that ingredient approval, whether as a food additive or GRAS, is all about “intended use” and the rationale for enforcement is based on public safety. Intended use is not just about the technical effect (or the purpose) for which the ingredient is added (21 CFR 170.3(o)).  Intended use also includes both the food groups to wh