Food Labeling

Regulation of food labeling in the United States is largely within the purview of the U.S. Food and Drug Administration (FDA), an agency within the Department of Health and Human Services. The Center for Food Safety and Applied Nutrition within the FDA is responsible for regulating the safety and accurate labeling of most foods; the major exceptions are the products of domesticated animals (such as cattle and poultry), alcoholic beverages, and drinking water. Meat, poultry, and related products containing them are the responsibility of the United States Department of Agriculture Food Safety and Inspection Service. Beverages containing more than seven percent alcohol are regulated by the Bureau of Alcohol, Tobacco, and Firearms, part of the U.S. Department of the Treasury. Nonbottled drinking water is regulated by the Environmental Protection Agency, a cabinet department within the federal government. Bottled water is regulated by both the FDA and state governments, and dietary supplements are regulated by the FDA as foods (meaning they are not subject to the same safety and efficacy testing applied to drugs). The Federal Trade Commission, an independent agency within the federal government, governs the regulation of claims made for food products or supplements in advertising.

The United States government's role in regulating food labeling dates back to the late 19th century. The FDA's origins lie in this era also, as its beginnings can be traced back to the Division of Chemistry created within the Department of Agriculture. One of the activities of the Division of Chemistry was research into the adulteration and mislabeling of foods and drugs; results from these investigations were issued in a series of reports from 1887 to 1902. These reports, reinforced by a general interest in increasing government regulation of matters concerning public health, and the work of crusading journalists such as Upton Sinclair, led to passage of the Food and Drugs Act, which became law in 1906. Among other things, this Act banned interstate transport in adulterated or misbranded food and drugs (the legal structure of the United States generally does not allow the federal government to regulate commerce within individual states). Federal regulatory oversight increased with the founding of the Food and Drug Administration in 1927, and was further strengthened in 1938 with passage of the Food, Drug and Cosmetic Act. This Act remains the basis of most of the FDA's regulatory powers to the present day, although specific regulations are regularly added and revised.

The Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) within the Center for Food Safety and Applied Nutrition is responsible for developing labeling policy, regulations, and standards; it was realigned in 2003 into units organized around product categories. Within the ONPLDS, the Division of Dietary Supplement Programs develops and implements policy, regulations, guidance documents and compliance activities related to dietary supplements, and reviews new dietary ingredients, labeling standards, and enforcement actions for adulterated or mislabeled dietary supplements. The Food Labeling and Standards Staff develops policy, regulations, guidance documents, and enforcement strategies concerning food labeling, and participates in international committees such as the Trilateral (United States, Canada, and Mexico) Technical Working Group on Food Labeling, Packaging, and Standards. The Nutrition Programs and Labeling Staff is concerned with scientific and regulatory review of nutrition labels, including health claims, nutrient content claims, and the information required to be provided by the Nutrition Facts panel; this staff also sets policy and creates guidance documents regarding nutritional labeling and promulgates and administers regulations. The Division of Research and Applied Technology provides expert advice to the Center for Food Safety and Applied Nutrition and evaluates the validity of dietary exposure estimates. [Page 294]The Infant Formula and Medical Foods Staff deals with issues related to infant formula.

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