For many consumers, the modem food label serves as the sole source of information regarding any individual food product. While it may be considered informative in some respects, it is often enigmatic in others. The present debate regarding the creation of a federal regulation to define use of the term "healthy" exemplifies the difficulties associated with seemingly subjective food labeling claims. The law requires manufacturers to include certain facts on food labels. However, they are permitted to include additional voluntary statements related to the healthfulness of the food product, the presence or absence of certain ingredients, and information related to production and growing methods, among other things. These claims have the potential to cause consumers a great deal of confusion, particularly with regard to their veracity. Many scholars have analyzed First Amendment limits on the Food and Drug Administration's (FDA) ability to restrict specific types of claims, yet few have addressed the issue of whether the agency can and should restrict claims unable to be supported by significant scientific agreement due to the inherent subjectivity of the claim. This Essay proposes FDA adopt such an approach as a means of effectuating the Federal Food, Drug, and Cosmetic Act's purpose of protecting consumers from false or misleading food product labels. As an alternative, if FDA is unwilling to restrict those claims altogether, this Essay suggests the agency could require curative disclaimers on labels, as they do for qualified health claims, that are not supported by significant scientific agreement.
INTRODUCTION 544 II. FOOD AND DRUG ADMINISTRATION'S AUTHORITY TO PROHIBIT MISLEADING LABEL CLAIMS UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 548 III. FIRST AMENDMENT CONCERNS OVER LIMITS TO FOOD LABELING LANGUAGE 551 IV. A BAN ON SUBJECTIVE CLAIMS 555 I. INTRODUCTION
The American food label may be most aptly described as informative in some respects, yet utterly confounding in others. Currently, the debate over how to appropriately craft a federal regulation to define use of the term "healthy" serves as a useful illustration of the potential for difficulty, particularly with regard to seemingly subjective claims. (1) While manufacturers are required to include certain facts on food labels, (2) they are also permitted to include additional voluntary statements regarding the healthfulness of the food product, (3) the presence or absence of certain ingredients, (4) and information related to production methods, (5) among other things. Consequently, marketers include information on labels that can be grouped into a few different categories, including claims about certain product attributes. (6) Research demonstrates that consumers do, in fact, use this information when making purchasing decisions (7) but may not fully understand or trust the veracity of certain claims. (8) Moreover, consumers may falsely perceive labels as the result of a regulatory process involving significant agency oversight. (9)
In turn, consumers simultaneously drive industry to develop front of the package statements in response to demand for certain food product attributes, yet often lack knowledge or access to evidence about whether those claims actually meet their expectations. This is further complicated by the dearth of political consensus in policy discussions over the propriety of government intervention in labeling--whether to create a uniform federal requirement for the labeling of genetically engineered foods serves as an illustration of this issue. (10) Consequently, the resulting regulatory environment consists largely of inconsistent standards. (11) Because certain claims have specific regulatory definitions whereas others may be influenced by nonbinding agency guidance or subject to agency oversight only when the statement is allegedly misleading, even the most discerning consumers would likely experience difficulty when attempting to assess an individual labeling claim.
Recently, consumer demand for greater food product transparency related to a number of factors has received increasing attention, (12) particularly from industry as it struggles to respond quickly and adapt. (13) Yet this phenomenon is not necessarily new, as demand for accurate and truthful food labels drove consumer advocacy efforts when Congress enacted the Federal Food, Drug, and Cosmetic Act of 1938 (14) (the Act). (15) Without question, however, modern consumers have a number of means by which to gain product information beyond the food label. (16) Accordingly, consumers are inundated with statements on the food label, in addition to the myriad sources explaining what those claims mean and whether they may be trusted, creating an uncertain environment. (17)
Fundamentally, FDA is a "science-based regulatory agency" (18) with delegated authority to ensure food labels are not misleading. (19) Yet, the evidence appears to demonstrate consumers are confused, particularly when labeling statements like "healthy" or "natural" remain seemingly subjective even if defined through federal regulation. (20) For the category of labeling claims which FDA has defined, certain claims remain unclear due to the agency's inability to craft an objective definition capable of scientific substantiation. FDA's allowance of labeling claims both capable of and lacking scientific agreement has led to a host of issues with which the agency is presently grappling. Specifically, many of the present issues confronting the agency in the form of lawsuits, (21) petitions, and requests for rulemaking regarding specific and arguably subjective labeling claims could be resolved by a prohibition on statements unable to be substantiated with significant scientific agreement due to their inherent subjectivity. (22)
While many scholars have analyzed First Amendment limits on FDA's ability to restrict specific types of claims, (23) few address the issue of whether the agency should restrict claims that cannot be supported by significant scientific agreement due to the inherent subjectivity of the claim. Likely, this is due to the vastness of the issue. Yet precedent seems far from clear that the agency is constitutionally constrained, (24) and given the increase in petitions for rulemaking regarding specific labeling claims, (25) such a restriction appears to be both a logical and consistent regulatory approach. Consequently, this Essay proposes FDA adopt this approach as a means of effectuating the Act's purpose of protecting consumers from false or misleading food product labels. Alternatively, if FDA is unwilling to restrict those claims altogether, this Essay suggests the agency could require curative disclaimers, as they do for qualified health claims that are not supported by significant scientific agreement. To that end, this Essay proceeds in three Parts. Part II addresses FDA's authority to regulate food labels under the Act, with particular emphasis on the provisions of the statute and accompanying regulations dedicated to misbranding. (26) Part III considers the First Amendment implications of restricting labeling language unsubstantiated by significant scientific agreement, arguing that the courts have not squarely addressed the issue. Finally, Part IV concludes by suggesting that all relevant actors--the agency, industry, and consumers--stand to benefit from a consistently applied approach.
FOOD AND DRUG ADMINISTRATION'S AUTHORITY TO PROHIBIT MISLEADING LABEL CLAIMS UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
The history surrounding passage of the Federal Food, Drug, and Cosmetic Act demonstrates that the provisions related to preventing consumer deception through misleading labeling statements are at the core of the statute. (27) During the hearings on various versions of the bill, legislators expressed concern about consumers, with one stating:
The purpose of the bill is to protect the public, to protect the mothers and the children, to protect the citizens; and the fact that regulation is needed is not because the reputable concerns are unwilling to conform to high standards; it is because there are those in the country who are exploiting the public and desirous of imposing their products upon the public for gain. (28) Debates over how best to protect consumers from unscrupulous manufacturers aided in the creation of a separate definition for "labeling" which includes "labels," (29) as well as any "other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." (30) By including within the definition of "labeling" any materials that might also accompany the product, the Act included within its reach pamphlets and related materials that might include information intended to induce consumers to purchase the product but might also contain potentially misleading statements. (31) Additionally, the Act acknowledged that while misleading labeling may result from the inclusion of untruths or misrepresentations, a consumer might also be misled due to omissions. (32) To that end, the Act specifies that FDA should consider "the extent to which the labeling or advertising fails to reveal [material] facts" when determining whether the labeling is false or misleading. (33)
Labeling claims on food products are also divided into a few major categories for the purposes of regulation. First, health...