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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 which the substance is added (one such list is provided in 21 CFR 170.3(n)) and, just as important, the use levels. These latter two aspects are important because food categories and use levels bear direct relevance to the safe use of the substance – the specific food categories and use levels are the two factors that determine exposure.

To oversimplify, exposure to a substance is based on the level of substance approved for a particular food category multiplied by the amount of food consumed per day in that particular category.  The Estimated Daily Intake (EDI) is simply the sum of the amount of substance potentially consumed from all the categories on a daily basis. The Acceptable Daily Intake (or ADI) represents the amount of the substance that may be safely consumed, which is based on safety data. Obviously, the EDI must always be less than or equal to the ADI.  The “extra-regulatory” use of substances becomes a problem when these additional uses cause the EDI to increase to the level where the ADI is exceeded and the safe use by the public may become an issue. That is, the additional uses may lead to a level of consumption that may no longer be considered safe.

The technical effect for which an ingredient is added is potentially more of a regulatory issue than one of safety. For example, in the case when a food additive or GRAS ingredient is used in an application that would confer color and therefore require a Color Additive Petition. There are very few food ingredients allowed for any intended use and with no restriction other than current Good Manufacturing Practice (21 CFR 110.5), although some examples might be found among flavor ingredients and multipurpose food additives listed in 21 CFR 182.1-60 and 182.1047 et sequentia, respectively. Although in the first example (flavors), the GRAS determinations of food flavor categories and use levels by the Flavor and Extracts Manufacturers Association (FEMA) may be at variance with the desired application. An example here is in the use of rosemary extract (approved for flavor use), but at higher than flavor use levels, has potential to function as an antioxidant – an unapproved use.

The question often arises that if a substance is approved for use via a food additive petition, must additional uses be approved as amendments to the petition? The answer is generally no – even though a substance has been approved as a food additive, additional uses may be added through the GRAS process, although the reverse is not true.

Clearly, CFSAN is firing a warning shot across the bow of producers of potential violative products. In an atmosphere of continual criticism of FDA on food safety, FDA has an opportunity to demonstrate its consumer protection credentials simply by checking product labels. Checking labels of retail products goes along way to demonstrate vigilance and has the added attraction of a very low cost threshold.


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