A "Natural" Stand off between the Food and Drug Administration and the Courts: The Rise in Food-Labeling Litigation & the Need for Regulatory Reform

By Goodman, Amy-Lee | Boston College Law Review, January 1, 2019 | Go to article overview

A "Natural" Stand off between the Food and Drug Administration and the Courts: The Rise in Food-Labeling Litigation & the Need for Regulatory Reform


Goodman, Amy-Lee, Boston College Law Review


INTRODUCTION

Six out of ten adults in the United States suffer from a chronic disease that is linked to lifestyle and food consumption, such as heart disease, type two diabetes, arthritis, or obesity.1 A mere 100 years ago, these chronic conditions were considered degenerative diseases, which only affect the elderly.2 As of 2018, two out every three twelve-year-olds have atherosclerosis, and children as young as eleven are displaying the first signs of heart disease.3 These health conditions come with a hefty price, totaling nearly $750 billion in direct medical costs annually.4 The costs related to obesity alone total a staggering $190.2 billion per year.5 Given this current health crisis, consumers are demanding healthier food products and increased transparency regarding the ingredients in their food.6

Food labels provide the primary means for businesses to communicate with customers about their food products.7 Properly labeled products allow consumers to make more informed and healthier food choices.8 In response to consumer demand for healthier products, food companies are stocking grocery store shelves with products claiming to be "wholesome," "natural," and "healthful."9 Many of these products, however, are not as healthy or natural as purported.10 Although both consumers and food manufacturers place importance on the term, "natural," the Food and Drug Administration (FDA) has refused to define the term.11 In the absence of a legally enforceable definition, there has been a rise in class action litigation against allegedly mislabeled "all natural" food products.12 Some consumers assert that these labels are misleading because the products are made with artificial, synthetic, or genetically modified ingredients.13 Although mislabeling cases are often criticized as frivolous, businesses are changing their practices by removing "natural" claims from their products and reformulating their products to match consumer desires for healthier food.14

In addition to the courts, congressional action seeks to fill this regulatory void.15 Congress has twice attempted to pass labeling laws that would cure the FDA's inaction by defining the term "natural."16 In response to mounting pressure from the courts, industry, and consumers, the FDA initiated a public comment process that closed in May of 2016 concerning whether the agency should define the term "natural."17 Since closing comments, the FDA has remained silent on issuing a definition, sustaining a disagreement among the courts over whether primary jurisdiction should apply and litigation should be stayed due to possible agency action.18

Part I of this Note discusses reasons for the rise in food mislabeling litigation, provides an overview of the regulatory agencies and laws governing food labeling, and discusses the causes of actions that some consumers are bringing against food manufacturers.19 Part II discusses the impact of the FDA's decision to not define the term "natural," leaving a substantial grey area ripe for litigation and congressional attempts at regulation.20 Part III analyzes the impact of courts determining food-labeling laws rather than the regulatory agency and argues for the FDA to define what "natural" means to provide certainty for consumers, the industry, and the courts.21

I. OVERVIEW OF FDA FOOD LABELING REGULATIONS & THE RISE OF FOOD-LABELING LITIGATION

A. The Federal Food & Drug Administration: The Agency & Laws Behind the Food Labels

In 1901, twelve government volunteers, nicknamed "The Poison Squad" agreed to eat food laced with the most commonly used-but untested-food additives, including toxins such as borax, copper sulfate, and formaldehyde.22 Dr. Harvey Wiley, dubbed the "Father of the FDA" headed the experiment with the goal of showing the effects of adulterated food and the need for food regulation and proper labeling.23 Historically, states were charged with regulating food.24 With the increase in interstate commerce and technological innovations, reformers called for Congress to provide federal regulations to prevent potentially dangerous adulterated food additives from infiltrating the food market nationally. …

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