The Federal Food, Drug and Cosmetic (FD&C) Act of 1938 (21 U.S.C. §301) replaced the Food and Drugs Act of 1906. The FD&C Act broadened the Food and Drug Administration’s (FDA) authority with regard to the nutrient content of food (Hutt, 1995), and it strengthened the prohibition against economic adulteration of food and authorized FDA to establish mandatory food standards. With regard to labeling, it prohibited false or misleading statements in food labeling, required any imitation food to be labeled as such, required affirmative labeling of food with particular information specified in the statute (name and address of the manufacturer, net quantity of contents, name of the food, and statement of ingredients), authorized FDA to require additional label information for special dietary food, and required that food labels affirmatively reveal all facts material in light of any other representations made for the product (Hutt, 1984, 1995).

Following enactment of the FD&C Act, FDA worked to implement a provision that authorized additional label information for food for special dietary use (Hutt, 1995; IOM, 1990), and in 1941 it issued regulations governing the labeling of fortified food, vitamin and mineral supplements, and other explicit food categories (e.g., infant formulas and hypoallergenic food) (IOM, 1990). These new regulations specified how the manufacturer should list ingredients if it chose to do so, but the regulations did not restrict the type or quantity of nutrients in a food that could be included, nor did they limit other claims that could be made (IOM, 1990). For example, the regulations governing dietary supplements and fortified food required that the label include a declaration of the percent of the “minimum daily requirements” for a vitamin or mineral for which a specific representation was made when consumed in a specified quantity during a period of 1 day (Hutt, 1995). The Poultry Products Inspection Act of 1957 (21 U.S.C. §451) and the Egg Products Inspection Act of 1970 (81 U.S.C. §1620) provided regulatory authority for poultry products and processed egg products to the U.S. Department of Agriculture (USDA). While misbranding and adulteration provisions were similar for meat, poultry, and egg products, the inspection and compliance framework differed. The Wholesome Meat Act of 1967 (21 U.S.C. §601) and the Wholesome Poultry Products Act of 1968 (21 U.S.C. §467a) incorporated additional provisions against adulteration and misbranding with greater enforcement authority for USDA.

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