A Disingenuous Interpretation of the Word “Primarily”

The Food and Drug Administration (FDA) was originally thwarted from preventing the marketing a food for any reason other than “taste, aroma or nutritive value,” in the Nutrilab v. Schweiker (713 F.2d 335 (7th Cir. 1983)). The circuit court held that the decision “[t]o hold as did the district court that articles used as food are articles used solely for taste, aroma or nutritive value is unduly restrictive since some products such as coffee or prune juice are undoubtedly food but may be consumed on occasion for reasons other than taste, aroma, or nutritive value.”

Per the recent draft guidance[1] released December 4, 2009 by the Center for Food Safety and Applied Nutrition (CFSAN), there is a new take by the agency on the court’s decision. That is, the draft guidance indicates that “if a structure/function claim promotes a product for a use other than providing taste, aroma or nutritive value…the claim may cause the product to be a drug by changing its primary use. In other words, because of the use promoted in the claim, the product may no longer be consumed as a food – primarily for taste, aroma or nutritive value – but rather as a drug for some other physiological effect.”

If this construct is vigorously enforced, several products will have to be taken off the market, including those that contain oligosaccharides and inulin (and other fibers and prebiotics),  probiotics, diacylglycerol, lutein, margarines containing phytosterols and even olestra – none of these ingredients are consumed for the purpose of “taste, aroma or nutritive value,” but for the physiological effect conferred. Further, it is not as if the products in which these ingredients are added are not otherwise available, but these substances are added to commonly consumed foods as “added value” ingredients, making the finished products more expensive than identical products without the ingredients.

The fault of this construct is in the FDA interpretation of the Nutrilab v. Schweiker decision, asserting that the adverb “primarily” modifies “consumed” or “use,” meaning that the fo