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Per the recent draft guidance[1] released December 4, 2009 by the Center for Food Safety and Applied Nutrition (CFSAN), there is a new take by the agency on the court’s decision. That is, the draft guidance indicates that “if a structure/function claim promotes a product for a use other than providing taste, aroma or nutritive value…the claim may cause the product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 food is being consumed for something other than “taste, aroma or nutritive value,” therefore the intended use being something other than a food and therefore asserting the purpose for consumption was for a drug effect. That is, the intended use is as a drug, according to the FDA construct.
However, a close look at the court’s wording reveals the intended use of the word “primarily.”[2] That is, the court said, “[D]efining food as articles used primarily for taste, aroma, or nutritive value…” clearly indicates the court was using the adverb “primarily” to modify “articles” i.e., the components of a food. “Articles” have been defined in the Act as being “articles used for components of any such article” (see §201(f)(3)). Therefore, food is composed of “articles” which although primarily contributing “taste, aroma or nutritive value” may also contain articles that contribute other effects. The term “article” in this sense includes food additives (or GRAS or prior sanctioned substances), which can further be defined as “…any substance the intended use of which results or may reasonably result in its becoming a component or otherwise affecting the characteristics of any food” (see §321(s)). Further, if FDA was to ban all substances that did not contribute to “taste, aroma or nutritive value” most of the articles used for the technical effects in 21CFR170.3(o) could not be used.
Section 201(g)(1) of the Act clearly states that if a food is in compliance with other provisions of the Act, it is not a drug simply because certain structure/function claims are made. FDA’s torturous interpretation of the 7th Circuit’s decision by insisting claims may only be made on the basis of taste, aroma or nutritive value is not in the best interests of the consumer – yogurt should not be considered a drug.
References
[1]http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm