Food Regulation. Neal D. Fortin

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3.1 INTRODUCTION

      Labeling, perhaps surprisingly, has been at the center of many aspects of food regulation. Incorrect labeling consistently ranks as the leading cause of food recalls and import denials. This chapter examines food labeling regulation that is designed to protect the economic expectations of both consumers and the food industry. In Chapter 4, we will cover the regulation of the nutritional content and labeling of food. In Chapter 8, we will cover the regulation of the identification of foods in more depth, including the standards of identity requirements and the requirement for common and usual names.

The food labeling requirements designed to protect economic expectations cover both prohibitive and affirmative regulation. The prohibitive requirements protect against fraud and deception. Prevention of false and misleading statements is at the historical foundation of labeling regulation. On the other hand, the affirmative requirements mandate that food manufacturers provide information on their labels that they otherwise might not include.

      The affirmative requirements are intended to provide consumers with information they need to make informed choices about the food. What information has been deemed material to informed choice is a surprisingly small set that has remained relatively stable.

      This chapter provides:

3.2 LEGAL AUTHORITIES

      FDA’s authority to compel the labeling of food products primarily derives from the Food, Drug, and Cosmetic Act (FD&C Act). Many of the statutory labeling requirements come from section 403 of the FD&C Act, which lists circumstances when a food will be considered “misbranded.” The definition of “misbranded” contains the major misbranding requirements:

      The Fair Packaging and Labeling Act (FPLA), 15 U.S.C. 1451 et seq., was enacted in 1966 to prevent unfair and deceptive trade practices, and to provide consumers with accurate information regarding the quantity and value of products. The FPLA is administered by the FDA for labels on foods, drugs, and cosmetics, while the Federal Trade Commission (FTC) administers the FPLA for most other consumer commodities.

      FDA’s labeling regulations are located in 21 C.F.R. 101 and cover both the requirements of the FD&C Act and the FPLA.

      Labeling of meat, poultry, and egg products is regulated under separate laws by the United States Department of Agriculture (USDA). The major principles and many of the specifics are the same in both sets of requirements. This chapter provides an overview of the differences.

3.3 LABELING TERMINOLOGY

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       Federal Food, Drug, and Cosmetic Act

       Chapter II—Definitions

      SEC. 201. [321] For the purposes of this Act—

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       Food Labeling

       21 C.F.R. Part 101

       § 101.1 Principal display panel of package form food

      The term “principal display panel” as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel ….

       § 101.2 Information panel of package form food