As the scientific community refines its focus on the “functionality” of food and as industry looks for ways to capitalize on that focus, there is a commensurate need for precision in discussing and describing the contours of applicable legal authority for assessing functionality. This short article examines one aspect of that authority: the Food and Drug Administration’s ability to demand a showing of functionality for a food additive. The limitations and possibilities we find may be surprising.
A major controversy accompanying the passage of the Food Additives Amendment of 1958 involved whether FDA’s premarket regulatory authority should include an evaluation of the functional “value” of an additive (Hutt and Merrill, 1991). By the mid-1950s, the idea or concept that food additives carry a certain degree of utility was commonplace here and abroad. Thus, not surprisingly, in the debate preceding the passage of the 1958 amendments, FDA took the strong view that “functional value” was a key attribute of a food additive except in those cases where the additive was “wholly innocuous under any circumstance of use” (Larrick, 1958). Industry, however, was leery of any “functional value” preclearance requirement and argued that the new legislation should deal only with safety and public health issues—and not with functional value or usefulness.
A compromise to the controversy was proposed by Bernard Oser, then Director of the Food and Drug Research Laboratories (Oser, 1958, p. 131). He suggested that the agency (1) limit any reliance on functional effect or value only to substances requiring a true safety tolerance and (2) agree that “rejection of a proposed food additive would not be based merely on its alleged lack of functional value” but rather on considerations related to safety for use under the conditions of use (Oser, 1958, p. 138).
The version of Section 409 enacted into law reflected the proffered compromise. Section 409(c) (4) provides that in the case of an additive that requires a tolerance limitation in order to assure safety, FDA may not establish a regulation authorizing such use unless it finds, upon a fair evaluation of the data before it, that such data do not establish that the use would “accomplish the intended physical or other technical effect.” Thus, as Oser suggested, under Section 409 functional effect only becomes an issue if needed to “warrant” (i.e., “justify”) the nominal margin of risk presented by the approval of an additive.
Legislative history explains that the phrase “physical or other technical effect” referred to the “objective effect which the additive may have on the appearance, flavor, texture, or other aspect of a food” and that whether such an effect is of any “value” was not intended to be part of FDA’s decision-making process (Anonymous, 1958). Thus, FDA was not empowered to “control” the issue of functionality by judging whether a particular effect met some standard of “value.” Moreover, as is clear from the literal language of the statute, if no tolerance is required to assure the safety of an additive FDA is simply not authorized to consider functionality as a component of the approval process (note, however, that Section 409 affords FDA the right to demand that information regarding functionality be submitted with any food additive petition and to delay the approval of any food additive petition for a use that would promote deception).
To assist it in evaluating the functional effects of a food ingredient when Section 409 permits, FDA relies on definitions (e.g., “emulsifier”) that were primarily developed in 1972. The definitions are codified at 21 CFR 170.3. FDA as a general rule prefers, for understandable reasons of simplicity and consistency, that the use of a food additive results in an effect that falls within one or more of these listed definitions. As the foregoing makes clear, this preference, although reasonable, is not always accompanied by a legal requirement. Moreover, although the definitions largely apply to technical effects in food, at least one applies to an “other aspect of food”—nutrition. Section 170.3(o) (20) defines “nutrient supplements” as substances “that are necessary for the body’s nutritional and metabolic processes.”
As science informs us more about the effects of food additives on the structure and function of the human body, it might not be implausible—and in fact may be sensible—to construe the “intended physical or technical effect” language of Section 409 as reasonably encompassing such effects. An assessment of the “value” of any such effect would, consistent with the language of Section 409, be an issue for consideration outside the food additive rubric (e.g., as in the context of a health claim, a structure/function claim, or even a drug claim), as the food industry seeks new opportunities for food additives and other food ingredients.
by FRED H. DEGNAN
Partner, King & Spalding
Distinguished Lecturer, Catholic University
School of Law
Anonymous. 1958. H.R. Report 2284, 85th Cong., 2nd Sess.
Hutt, P.B. and Merrill, 1991. “Food and Drug Law: Cases and Materials,” 2nd ed., pp. 322-323. Foundation Press, Westbury, N.Y.
Larrick, G.P. 1958. Hearings before the Subcommittee on Interstate and Foreign Commerce, H.R. Rep., 85th Cong., 2nd Sess. H.R.4474, pp. 468-470.
Oser, B. 1958. The functional value of food additives. Food Drug Cosmet. Law J. 13: 131.