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3
Contextual Factors Affecting the Regulation of Misbranded Food

Any consideration of reforming the intergovernmental regulatory framework governing food labeling requires a basic understanding of the historical development of food regulation in general, the evolution of food manufacturing and marketing, and the impact of major public health events in the United States since the turn of the century. The shift in the balance of legal power from States to the Federal government has had a significant effect on the way foods are regulated. In addition, understanding the background to the current regulatory environment since passage of the Federal Food, Drug, and Cosmetic Act (FDCA) helps to identify the rationale for existing statutes and regulations in various jurisdictions and the need for reform.

Changes in food manufacturing and marketing have led to the increasing nationalization of the food supply, which has been accompanied by local economic protection of specific food commodities. Efforts to protect the public's health, have also increased the complexity of food laws and regulations. These changes also may be linked to determining the appropriate level of government at which to regulate food labeling. In some cases, a level of expertise or efficiency may be required that only the Food and Drug Administration (FDA) possesses. Merchandising practices, packaging, or other features of food marketing may require national rather than regional control. The nation's system of food regulation has, in effect, resulted as a response from State and Federal regulators to changes in food manufacturing and marketing and concerns about public health and consumer protection over time.

This chapter examines the major developments surrounding food labeling and provides the background for understanding the current food labeling regulatory environment and reform efforts, and their relation to the



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Food Labeling: Toward National Uniformity 3 Contextual Factors Affecting the Regulation of Misbranded Food Any consideration of reforming the intergovernmental regulatory framework governing food labeling requires a basic understanding of the historical development of food regulation in general, the evolution of food manufacturing and marketing, and the impact of major public health events in the United States since the turn of the century. The shift in the balance of legal power from States to the Federal government has had a significant effect on the way foods are regulated. In addition, understanding the background to the current regulatory environment since passage of the Federal Food, Drug, and Cosmetic Act (FDCA) helps to identify the rationale for existing statutes and regulations in various jurisdictions and the need for reform. Changes in food manufacturing and marketing have led to the increasing nationalization of the food supply, which has been accompanied by local economic protection of specific food commodities. Efforts to protect the public's health, have also increased the complexity of food laws and regulations. These changes also may be linked to determining the appropriate level of government at which to regulate food labeling. In some cases, a level of expertise or efficiency may be required that only the Food and Drug Administration (FDA) possesses. Merchandising practices, packaging, or other features of food marketing may require national rather than regional control. The nation's system of food regulation has, in effect, resulted as a response from State and Federal regulators to changes in food manufacturing and marketing and concerns about public health and consumer protection over time. This chapter examines the major developments surrounding food labeling and provides the background for understanding the current food labeling regulatory environment and reform efforts, and their relation to the

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Food Labeling: Toward National Uniformity goal of uniform food labeling. it presents those developments chronologically in periods; that is, up to 1900, 1900 to 1940, 1940 to 1970, and 1970 to 1990, with the recognition that developments may have occurred over a number of years and spanned more than one time period. DEVELOPMENTS BEFORE 1900 Food Production and Marketing Early in the nineteenth century, the development of shelf-stable food products in hermetically sealed containers was a major landmark in the history of food packaging. The use of tin cans to actually seal and cook a food began in England in the early 1800s (Sim, 1951). This convenient food package was a major step forward in packaging, providing a year-round food supply in three-piece sanitary containers with processing built in and preparation requiring only reheating and/or adding water. In the late 1800s, several innovations in packaging had developed as a result of the industrial revolution, including the metal can for heat-processed foods described above, the collapsible tube, the folding carton, the corrupted shipping case, and the crown closure (for hermetically sealing narrow-neck bottles). These developments led to the introduction and commercialization of the milk battle and canned condensed milk, which together with pasteurization had a positive impact on public health and infant mortality. Late in the 1880s, the Uneeda Biscuit package provided a consumer-sized quantity of crackers, undoubtedly leading to the self-serve era (Downes, 1989). At that time, bulk dry goods, such as flour and sugar, were sold in country and general stores. As the nation approached the twentieth century, specialty stores developed, with consumers making separate stops at the butcher shop, the bakery, and the produce stand—that is, if horse-and-wagon peddlers did not provide the items needed at the consumer's doorstep. The small retail food specialty store was run independently by the owner, and most items came in bulk form (FMI, 1986). The Great Atlantic and Pacific Tea Company, better known as A&P, is generally credited with creating the first chain grocery stores—the forerunner of the modern supermarket (Walsh, 1986). Established during the mid-1800s, early A&P stores resembled a typical specialty store: one person ran the whole operation, standing behind the counter and handing customers their orders from the shelves. However, in contrast to specialty stores, these chain operations had a direct link with suppliers, which allowed them to charge consumers lower prices than their competitors.

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Food Labeling: Toward National Uniformity Public Health The importance of public health measures applied to the community at large in reducing rates of illness and death cannot be overemphasized. During the nineteenth century, the isolation of illness was a significant step forward in limiting the spread of disease. In addition, expanding knowledge of bacteriology led to improvements in community cleanliness in the form of water purification and sewage disposal systems. The pasteurization of milk represented significant progress for the safety of this commodity, with related sanitary measures being instituted in the manufacturing, packing, and sale of other foods. In the 1800s, a series of publications documented adulteration of the food supply and the resulting negative impact on both the nation's economy and public health. In 1850, a landmark public health report by Shattuck documented the decrease in average life expectancy at birth in America's large urban centers and identified the adulteration of food and drugs as a matter of public health concern. The report recommended that local boards of health be established to ''endeavor to prevent the sale and use of unwholesome, spurious, and adulterated articles, dangerous to the public health, designed for food, drink, or medicine'' (Shattuck, 1850). Following that report, boards of health were established by cities, counties, and States throughout the country. State Departments of Agriculture were also established with authority to regulate the manufacture of food products. In 1888, Congress enacted the first broad food and drug legislation for the District of Columbia, which was subsequently strengthened in 1893 (Hate and Brown, 1985). Food Regulation Following the American Revolution, the nation was governed first under the Articles of Confederation, which permitted the States to regulate activities within their borders. However, the Articles ultimately failed to ensure a cohesive union because each State retained its own sovereign powers, leaving the national government without the authority to govern or resolve either domestic or foreign problems (Teller, 1983). A compromise made during the Constitutional Convention of 1789 allowed the States to retain their traditional powers, including the "police powers" under which they could act to protect the health and welfare of the public. At the same time, the Convention agreed that laws enacted by the Federal government under its enumerated powers would be supreme, including the laws regulating "commerce ... among the several States"

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Food Labeling: Toward National Uniformity (Article 1, Section 8, 119). The doctrine of Federal preemption originated with the supremacy clause of the Constitution, under which the laws of the Federal government "shall be the supreme law of the land," giving them priority over any State or local law (Article VI, 195). Under this clause, conflicts between Federal laws and State requirements (i.e., statutes and regulations) are settled by making the Federal law preemptive of those of the States. This power applies both to State provisions that are in direct conflict with Federal laws and those State laws that interfere with Congressional objectives. Under the commerce clause, the courts have also struck down inconsistent State laws for placing an unreasonable burden on interstate commerce. To those who opposed a strong central government and feared the demise of State governments at the time of the Constitutional Convention, James Madison argued that, for a number of practical reasons, including proximity to the people, State governments would not only survive but would remain a vital component of the Federal system. Madison further argued that the real issue was not the inherent correctness of granting power to a particular level of government but how best to carry out the will of the people. The purpose of government at both the Federal and State levels was to do the peoples bidding, and when the majority of the populace spoke through the Federal legislature, the prerogatives of the State governments must be superseded (Teller, 1983). Actual implementation of Federal preemption has been more complicated than the founding fathers envisioned, in part because of the early recognition that certain functions of government are local in nature. The preemption doctrine constitutes a recognition that Congress allocates decisionmaking power to different levels of government, either by assuming the power for the Federal government or leaving it to the States. Frequently, Congress is unclear in this delineation, which calls for a decision to be made by the courts. Under modern interpretation of the commerce clause, Congress had plenary authority to regulate food labels. If it chose, it could oust all State regulation of any label on any food. Ordinarily, it has not chosen this option, leaving States considerable freedom to regulate foods sold within their borders, including foods shipped out of State, so long as their requirements do not unreasonably burden interstate commerce. (The Nutrition Labeling and Education Act of 1990 [NLEA] is unique in that Congress has specified that it wanted to displace certain State labeling requirements and consider displacing others that are the subject of this study.) Consequently, during the 1800s, the Federal government addressed food problems surrounding imports and exports with statutes enacted by Congress to regulate foreign commerce in food as commercial food production and

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Food Labeling: Toward National Uniformity markets grew. States continued to regulate local activities of the food industry, such as retail food sanitation (Hile, 1984). By the turn of the century, Harvey Wiley was conducting studies on adulteration and labeling in the Division of Chemistry (forerunner of FDA) of the U.S. Department of Agriculture (USDA). However, there was no Federal statutory authority to regulate the interstate sale of adulterated or misbranded foods. Even in those early years of food marketing, health officials, regulators, and the food industry quickly recognized the value of national uniformity in the regulation of food labeling. As early as 1879, E.R. Squibb strongly recommended the enactment of a nationwide food and drug law in an address to the Medical Society of the State of New York, suggesting that "it is self-evident that a law to be most effective in preventing the adulteration of food and medicine should be general or national in order to secure universality and uniformity of action* (Squibb, 1988). Only 10 days later, the first comprehensive Federal legislation was introduced in Congress, but strong feelings on the matter of State and local versus Federal regulation led to protracted Congressional debate from 1879 to 1906. In 1903, the Director of the Bureau of Chemistry of the New York State Department of Health noted the need for national regulation of food labeling: [I]t is very certain that the widely differing statutes relating to our food supply in the different States have worked much mischief, been the cause of much confusion, and seriously embarrassed some useful industries. I think all who have studied the matter will be inclined to admit that uniformity in our food laws is much to be desired... (Hutt and Merrill, 1991, p. 996). Several organizations had been formed with at least one goal being to work toward the establishment of uniformity. The original 1884 constitution of the Association of Official Agricultural Chemists (which subsequently became the Association of Official Analytical Chemists) stated that the objectives of the organization were "to secure, as far as possible, uniformity in legislation ... and uniformity and accuracy in the methods and results" of analysis (Helrich, 1984). In 1897, representatives from 10 States met "for the purpose of forming a national Association ... with the end in view of producing, as nearly as conditions and laws would permit, uniformity of action in the enforcement of such food and drug laws" (Reindollar, 1951). The Constitution adopted by the resulting organization, the Association of Food and Drug Officials (AFDO), stated that the group's purpose was "to promote and foster such legislation as would tend to protect public health and prevent deception ... also to promote uniformity in legislation and rulings ..." (Jones, 1912). Since its inception, the AFDO slogan has been "uniformity through cooperation and communication,'' but the organization's

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Food Labeling: Toward National Uniformity goal has been uniformity without preemption (Burditt, 1990). This view reflects a desire to use the same legal requirements while maintaining authority to enforce local laws (Preemption results in uniformity, because there is only the Federal rule, but in that case there is also only Federal enforcement. The innovation of NLEA is that Congress provided for State enforcement of the Federal rules.) DEVELOPMENTS BETWEEN 1900 AND 1940 Food Production and Marketing Prior to the passage of FDCA, Americans generally preserved their own food through the traditional methods of cheesemaking, breadmaking, brewing, fomenting, pickling, salting, drying, and canning. "More was little needed in the way of packaging and labeling of foods produced by these methods. At that time marketers of food had little to use beyond graphics to differentiate their products. By the 1930s food products were being marketed in branded packaging, including Armour meat products and A&P coffee in bags (Walsh, 1986). In the same period, a number of new grocery items appeared, including bread sliced and wrapped prior to sale and frozen foods (Lund, 1989). Air conditioning of factories allowed dried products to be prepared, packaged, and distributed, leading to the development of such products as gelatin desserts, which were marketed for the first time. Up through the 1930s, the primary materials used for packaging were paper, paperboard, or tinplate, although glass was beginning to be an important packaging material. Early in the century, the use of corrugated paper containers to replace the wooden box became widespread (Downes, 1989). (Today, paper, paperboard, and corrugated paper are the leading U.S. packaging materials.) The designation of first self-serve grocery store has been attributed to Piggly-Wiggly, which opened in Memphis, Tennessee, in 1916 (Consumer Reports, 1986). This store was laid out with four aisles for shoppers to walk through to view and select from its 600 items. By the 1920s, the trend toward combination stores had begun, and grocers began stocking meats and perishables because shoppers preferred to make all their food purchases at a single location. By 1930, the national and regional chains were small stores, selling meats; canned goods; dairy products; bulk and packaged cookies, crackers, and bread; and a limited assortment of produce in season (FMI, 1986).

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Food Labeling: Toward National Uniformity Public Health At the beginning of the twentieth century, life expectancy was 49 years. It had increased to about 60 years by the 1930s and to more than 70 years by the 1960s. In 1990, life expectancy reached about 75 years (DHHS/PHS/CDC/NCHS, 1991). These changes were due in part to improvements in sanitation, control of infectious disease, and knowledge of nutrition (Meredith, 1932). It became more widely recognized that the food Americans were eating had an important effect on their health. One result of this awareness was that the Federal government took over control of the safety of the food supply by preventing the interstate transportation of unfit food. The States, for their part, continued to be responsible for food within their respective borders. During Congressional action on the legislation that subsequently became the 1906 Pure Food and Drugs Act, a witness representing a large food distributing company, who appeared before the House Committee on Interstate and Foreign Commerce to oppose passage of the pending food bill, declared that the food industry of the country rested on fraud and deception. "Make us leave preservatives and coloring matter out of our food," he declared, "and call our products by the right name and you will bankrupt every food industry in the country" (Wiley, 1914). Wiley suggested that manufacturers and dealers who would otherwise have made pure and properly branded goods were forced by unfair competition to practice the arts of adulteration and misbranding. During the same period, work of U.S. Public Health Service scientists an the dietary cause of pellagra—a disease resulting from a deficiency of niacin—brought into sharp focus the public health importance of good nutrition and added a new responsibility to the mission of public health officials, which earlier had been limited to sanitation and adulteration. The first 40 years of this century constituted the era of discovery of the nutrition deficiency diseases and isolation of the responsible nutrients (Erdman, 1989). A book published prior to the enactment of FDCA evaluated public health problems in terms of the debit and credit sides of the scientific ledger. It suggested that the problems that still remained on the debit side were polio, encephalitis, influenza, and cancer. On the credit side, it listed smallpox vaccination; antitoxin, toxin-antitoxin, and one-dose toxoid for diphtheria; typhoid and yellow fever vaccines; antilockjaw serum; vitamins for scurvy, rickets, and pellagra; and sanitary knowledge to keep foods and water supplies germ free (Davis, 1934). The author reported on a series of cases of "disease of bad plumbing" that occurred in Chicago in the early 1930s in which food handlers were contaminating food as a result of the use of contaminated water.

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Food Labeling: Toward National Uniformity An early home health book of the period suggested that: The addition of any substance to an article of food may constitute a fraud an our pockets without causing us other injury, but in many cases adulteration of food and drugs is hurtful to the health. Milk, for example, may be the sole food of infants or invalids and these will run the risk of malnutrition if, as is sometimes done, some of the cream is removed and water added to bring down the specific gravity of the milk to that of milk which retains the whole cream. Milk containing preservatives must not be sold (Robinson, 1939, p. 20). At that time, books and magazines on health frequently provided information on food adulteration and the problems that consumers should look for (Barkan, 1985). One volume on health and diet described food adulteration as being of two kinds: injurious and noninjurious. The noninjurious type of adulteration was classified as conventional—to suit the taste and demands of the public, usually done by use of coloring or bleaching, which could be harmful. accidental or incidental—arising from the environment, carelessness, or incompetency on the part of the manufacturer and usually consisting of an admixture of some foreign substance, such as husks, stems, or leaves.  intentional—for purposes of gain and competition (Friedenwald & Ruhrah, 1913, p. 222). Food Regulation In the early 1900s, the food industry strongly supported national food legislation in order to obtain national uniformity in regulatory requirements to build credibility for the food supply. After considerable debate on the constitutionality question surrounding States' rights, Congress enacted the Pure Food and Drugs Act of 1906. This law was the first national effort to regulate food and drugs by prohibiting the adulteration or misbranding of these products. The Act defined food as including wall articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound." One of the goals of the law was to establish national uniformity to reduce confusion in the marketplace. Consistent with the food industry's support for passage of the legislation, the House report stated that the laws and regulations of the different States are diverse, confusing, and often contradictory. What one State now requires the adjoining State may forbid. Our food products are not raised principally in the States of their consumption. State boundary lines are unknown in our commerce, except by reason of local regulation and laws, such as State pure-food laws. It is desirable, as far as possible,

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Food Labeling: Toward National Uniformity that the commerce between the States be unhindered, One of the hoped-for good results of a national law on the subject of pure foods is the bringing about of a uniformity of laws and regulations on the part of the States within their own several borders (U.S. Congress, 1906). In spite of these intentions, passage of the 1906 Act did not secure national uniformity in food regulation. The Act did not establish the basis for a comprehensive national regulatory scheme bemuse it applied only to regulation of foods in unbroken packages in interstate commerce—and then only to the actual label of the product. Once the food package was broken, and many packages continued to be in large bulk containers, the States had authority over the sale of the product. In a number of cases, the courts upheld State regulations that imposed requirements different from or in addition to those imposed by the Federal government. By contrast, early statutes to regulate meat and poultry products dealt with the issue of uniformity. The 1907 Meat Inspection Act required postmortem inspection of all animals and meat prepared for human consumption and transported in interstate commerce (Olsson and Johnson, 1984). The legislation also gave USDA the authority to supervise both processing and labeling of all meat products, and preempted State requirements for those products when moved in interstate commerce. Prior label approval was required for the marketing of meat products. In the mid-1920s, USDA established a voluntary poultry inspection program. The 1921 Annual Report of the USDA Bureau of Chemistry pointed out that both officials and manufacturers complained of the lack of uniformity in the exercise of food control by Federal and State governments: Lack of uniformity increases the costs of doing business, and the increased cost is usually passed on to the consumer. It arises not merely from differences in the various laws but also from differences in the interpretation of the laws by the officials in the application by them of different standards to the same product in different jurisdictions (USDA, 1921, p. 7). Concerns about the problem of nonuniform food requirements have, however, persisted to the present, as indicated by an average of one speech on the subject given annually at the AFDO conference (Burditt, 1990). During consideration of the legislation that was to become FDCA, a 1935 Senate report, in recognizing the "problem of uniformity," noted that the States had unanimously urged the Federal government to assume leadership in modernizing existing law (U.S. Congress, 1935). FDCA continued the authority of Federal officials over foods that traveled in interstate commerce. The Act defined the term food in Section 201(f) as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." In structure,

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Food Labeling: Toward National Uniformity FDCA was a series of definitions elaborating the two basic concepts, adulteration and misbranding. Under the statute, FDA was empowered to regulate all labeling of food shipped in interstate commerce and deal with other matters relating to the safety and wholesomeness of food. FDCA also contained the enforcement remedies available to FDA. The sanctions it authorized include criminal prosecution of individuals and firms responsible for prohibited acts, injunction against such acts, and seizure of adulterated or misbranded goods; the latter sanction is the one most commonly used. FDA has also used several informal remedies such as publicity and regulatory letters, under the provisions of the Act, and recalls through negotiations with industry, which are not explicitly provided for in the Act. DEVELOPMENTS BETWEEN 1940 AND 1970 Food Production and Marketing With the advent of World War II came the compelling need for mass production and transportation of food to the troops. In the 1940s, mass production allowed the movement of large quantities of raw materials through production plants, and improvements in conveying led to the use of automation to facilitate production and packaging. Along with the increased need for foods for the military came the development of many substitute foods. At the same time, frozen foods were introduced on a large scale (frozen concentrated citrus juices were developed by USDA researchers in the mid-1940s), and vending machines became a new means to sell foods (IFT, 1989). Supermarkets quickly adjusted to post-World War 11 prosperity, each decade, store inventories grew by 2,000 to 3,000 additional items. By the 1950s, introduction of the freestanding home freezer provided convenient storage for consumers who selected the newly developed frozen dinners and frozen, ready-to-eat bakery goods (Lund, 1989). Foreign foods became widely accepted. Increased prosperity led to targeted markets and allowed the food industry to introduce a large number of new products. One such product was instant milk powder, which led to dried milk powders, whey products, cocoa-and strawberry-milk beverages, and spray-dried coffee and tea (Goldblith, 1989). Late in the decade, the perceived need for food in bomb shelters resulted in technological advances that spurred the production of new foods with a long shelf-life. During the 1960s, advances in equipment technology led to a high-quality freeze-dried coffee that quickly became popular (Lund, 1989). New ingredients, such as off blends and flavoring agents, were also entering the market at this time. Foam-mat drying and related techniques improved the

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Food Labeling: Toward National Uniformity taste of dried milk. Enzyme technology began to be applied in food processing to develop unique products. By the 1970s, health and organic foods were becoming regular items on the grocery shelf. This decade also saw the introduction of membrane-processing systems, which changed the characteristics of food fluids; commercial use of these systems focused on industry by-products (Lund, 1989). Extrusion of carbohydrate and protein foods was another innovation that led to a new generation of precooked, ready-to-eat cereals, snack foods, candy bar fillings, breading for fish sticks (that did not require baking), and dried vegetable and animal protein products (e.g., textured vegetable protein; Goldblith, 1989). A major advance for the food industry came with the more widespread use of aseptic processing. Originally developed in the 1940s, it is defined as separate high-temperature, short-time sterilization (HTST) of a food product and its packaging material (or container), and the filling of the product in a sterile atmosphere (IFT, 1989). The major advantages of such processing are improved shelf life, food quality, and nutrient retention; reduced energy use in processing and distribution; reduced storage required for packaging materials; the ability to combine paper, plastic, and metal foils in packaging; and potential expansion of sales into new markets. A more recent development introduced in the 1960s is the retort pouch, which is constructed of a combination of polyester, aluminum foil, and a heat-sealing polyolefin. Although applications of this kind of packaging in the United States, which were intended to allow thermal processing and shelf-stable distribution, have been limited to date, the pouch offers the advantages of light weight, compact size, easy disposal, convenient reheating, and energy savings in terms of processing and distribution. A significant disadvantage is the lack of a practical method for recycling such materials. More recent canning developments have included the two-piece can using draw-redraw techniques, welded cans, and lighter-weight tinplate (Goldblith, 1989). As a packaging material, plastics were virtually unknown before the 1930s. The discovery of polyethylene and the applications developed for polyvinyl chloride during that decade marked the beginning of a revolution in food packaging. The need for and resulting shortage of all materials created by World War II led to major advances in the development of plastics and their applications. Plastic packaging offered the advantages of being lightweight, durable, and unbreakable. Added to the use attributes of plastic were the engineering advantages of mechanical performance equal to metal, ease of design, flexibility, endless moulding and functional possibilities, dispensing capabilities, barrier properties, and controlled permeation

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Food Labeling: Toward National Uniformity poultry products (USDA, 1989). By 1990, more than half of all packaged foods sold in the United States bore some type of nutrition labeling (IOM, 1990). These changes in food labels that were begun in the 1970s represented a fundamental shift in regulatory philosophy and a major advance in consumer information. From the perspective of the 1990s, however, the adequacy of nutrition information on food labels was questionable, and indeed, during this period, some consumer and professional organizations began to press their concerns regarding nutrition labeling. Several changes were made to the labeling provisions of FDCA during the 1970s and early 1980s. The 1976 amendment to the Health Research and Health Services Act (P.L. 94–278), known as the Proxmire Amendment, was aimed at the labeling regulations for dietary supplements. In 1981, the Infant Formula Act (P.L. 96–359) authorized FDA to adopt regulations requiring that certain nutrient content, labeling, and good manufacturing practices be met in the preparation of these products. In 1978 and 1979, several Federal agencies decided to review existing food labeling regulations in the United States to determine whether these provisions were still appropriate. FDA, USDA's Food Safety and Quality Service, and the Federal Trade Commission held public meetings on a variety of labeling issues and subsequently published a notice in the Federal Register that set out their tentative position on the changes that were needed (DHEW/USDA/FTC, 1979). The document addressed changes in ingredient labeling, nutrition labeling, label format, open dating, standards of identity, disease prevention claims, imitation and substitute foods, food fortification, and the procedures required for implementing the changes. However, for a number of reasons, including limited scientific consensus and a political climate favoring deregulation, no changes were made at that time. The only regulatory change actually implemented following the late-1970s reform effort concerned sodium content and sodium descriptors (FDA, 1982). Although several major legislative proposals to reform food labeling were introduced during this period, no bill was enacted by Congress. An additional concern was the proliferation of health messages (disease prevention claims) appearing in conjunction with the sale of food, which needed more vigorous regulation than was being provided under existing policy. FDA's traditional position on health messages, which had been developed to combat health fraud, was that a food for which a health claim was made was an unapproved drug. This classification required that the product be shown to be both safe and effective for use prior to marketing. By the mid-1980s, however, food manufacturers generally had begun to use nutrient content and disease prevention claims to promote products. In instances in which claims were made without supporting data, the agency could have taken rapid action based on its view that the food was an

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Food Labeling: Toward National Uniformity unapproved new drug. However, the gathering evidence of the relationship between diet and long-term chronic disease led the agency to reconsider its position and announce plans to revise its policy (Hile, 1986; FDA, 1987). Yet in the process of developing a policy to use food packages to provide nutrition information on the role of dietary changes in reducing the risk of chronic disease, FDA was faced with a conflict: the desire to provide more information but not compromise its ability to combat health fraud. The Federal government's slow pace in developing a contemporary policy on health messages because of this conflict—while such messages proliferated in the marketplace—led to the involvement of State Attorneys General in attempts to fill the regulatory gap that they perceived existed in preventing consumer fraud in product labeling and advertising claims. The State Attorneys General pursued a regulatory course parallel to FDA's traditional policy; that is, such claims required that the products be considered unapproved new drugs and removed from the marketplace (Cooper et al., 1990). By the late 1980s, efforts to reform the current policy on food labeling, especially in regard to nutrition information, were proceeding in several arenas. Improved food label information was more universally viewed as a way to assist consumers in making food choices that would be more healthful. In the spring of 1989, major new legislation was introduced in Congress to mandate nutrition labeling for food products under FDA jurisdiction (Porter, 1991). By August, FDA, in cooperation with USDA, announced plans to reform nutrition information and other aspects of food labeling (FDA, 1989). In an Advance Notice of Proposed Rulemaking, the agency outlined a plan to elicit input from interested parties about proposed changes in the nutrition label by requesting written comments, holding public hearings across the country, and contracting for a study to address potential label changes. In the fall of 1989, the U.S. Department of Health and Human Services (DHHS) and USDA contracted with the Institute of Medicine's Food and Nutrition Board to conduct a study on various aspects of existing nutrition labeling practices. On February 13, 1990, FDA reproposed rules for allowing health messages to appear in conjunction with the sale of foods (FDA, 1990b). The agency proposed to allow the use of six specific statements of the relationship between diet and disease and establish a mechanism by which other relationships might be approved for label use. In July 1990, FDA proposed regulations for mandatory nutrition labeling of foods under its jurisdiction as the first phase of its food labeling reform initiative (FDA, 1990a,c). These proposals also focused on reference values, nutrient content, serving size, and cholesterol labeling terminology. Subsequent proposals were to include proposed reform of ingredient labeling, standards of identity, label format,

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Food Labeling: Toward National Uniformity health claims, and label descriptors. By the summer of 1990, the agency also had initiated several label format studies (FDA, 1991a). In September 1990, the Institute of Medicine's Committee on the Nutrition Components of Food Labeling released its report, Nutrition Labeling: Issues and Directions for the 1990s, which addressed the issues that had prompted FDA's proposed revision of its regulations, as well as other issues such as expansion of coverage of mandatory nutrition labeling to most food products regulated by FDA and USDA, presentation of label information, and legal authority for implementing label changes (IOM, 1990). The Committee explored a number of issues: the extent to which foods should be covered by nutrition labeling, specific nutrient information that should be provided on packages, presentation aspects of nutrition information, and the appropriate legal and regulatory configurations by which labeling reform might be implemented. The study did not include a consideration of the implications of changes in Federal labeling policy on State and local statutes and regulations. On November 8, 1990, President Bush signed NLEA, which had been introduced in Congress 18 months earlier. The new law was concerned specifically with FDA's food labeling authority, addressing issues similar to those already under review by the agency. It required mandatory nutrition labeling on most packaged foods and voluntary nutrition information for produce and seafood; specified the nutrient content information that must appear on the label; provided for certain descriptive terms to be defined and claims to be allowed; established a petition mechanism for additional nutrient and health-related claims; required that consumer education be undertaken; provided for State enforcement of Federal requirements in instances in which the Federal government had not acted; revised certain requirements for ingredient listings and standards of identity; provided for national uniform nutrition labeling; and specified the effective dates for implementation of various provisions of the Act. Successful passage of the legislation required the support of industry, which had, from the beginning of the debate, favored Federal preemption of all State food safety and labeling requirements. As passed, NLEA provided for Federal preemption of State food labeling requirements and specifically exempted State food safety requirements from preemption. CURRENT FEDERAL AND STATE ROLES IN FOOD REGULATION Today, meat and poultry inspection programs are essentially federalized. In the past decade, as a result of technological changes, the amount of meat and poultry inspected has increased markedly while the number of staff has

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Food Labeling: Toward National Uniformity remained essentially the same. States that have continued to operate their own programs must annually review whether paying half the costs of running a State inspection program makes sense when the Federal government is willing to take over the program and pay all of the costs. Many States have opted for Federal inspection for budgetary reasons. In cases in which a State fails to meet Federal requirements, the Federal government assumes responsibility for the inspection of its intrastate plants. Currently, 28 States continue to operate their own meat inspection programs, and 24 still operate poultry inspection programs (Thrasher, 1991). The current USDA meat and poultry inspection budget is about $500 million, about the same as FDA's entire budget (U.S. Congress, 1991). State and local regulatory officials have long been concerned about the lack of uniformity among food and drug laws. In response to this concern, AFDO developed and has used as its major uniformity tool the Uniform State Food, Drug, and Cosmetic Bill as a model law for all States (AFDO, 1984). Since 1938, AFDO has continued to amend the model bill to keep it current with changes made to FDCA. One major step to assist that effort was the addition of several provisions providing for automatic adoption of Federal statutes and regulations. The result has been substantial uniformity written into law by State legislatures and implemented by State enforcement officials in their regulations. If enacted by every State, the Uniform Bill is seen by AFDO as providing a sound basis for national uniformity in the regulation of food labeling. Currently, 45 States have adopted the model law; 23 States have adopted all or parts of Federal regulations by reference (FDA, 1990d). Unfortunately, the adoption of uniform laws, codes, and some implementing regulations, and their interpretation have not resulted in uniform enforcement procedures by all State agencies with jurisdiction over food products. It often remains unclear why State regulation arises. One possible explanation may be that States see practices that FDA could address under the law but does not—or at least not to States' satisfaction. In other words, States would favor a different Federal policy. Another possibility is that States see practices that Federal requirements simply do not address or would be unlikely to address because of their local character. The extent to which State requirements can be categorized as representing distinctive, genuine local needs or reflecting different judgments on how food products ought to be labeled has a bearing on the assessment of the adequacy of Federal implementation. However, such information is not readily available. There are more than 380 State agencies that carry responsibilities similar to those of FDA, which results in understandable differences in regulatory philosophy and enforcement procedures (DHHS, 1990). Since AFDO's membership is drawn from regulatory officials in Federal, State, county, and

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Food Labeling: Toward National Uniformity local governments, the organization has continued to encourage and support uniformity of food laws and regulations among these various jurisdictions. Current State activities that complement the Federal government's activities in food control are embodied in a number of programs and services. Most States have differing organizational structures, methods of program administration, and arrangements with FDA for the various food enforcement activities performed in their jurisdictions. Some States have two departments involved in these activities, but most have three. In the annual report FDA prepares on these State efforts, the food program is divided into the following 13 areas (DHHS, 1990, p. 3): Aquatic products Bakeries Candy manufacturers and repackers Canneries Food service Food storage Grade A milk processors Grains Manufactured milk products Retail level establishments Shellfish Soft drink bottlers Other food activities Reports indicate that in fiscal year 1989, a total of $145.53 million was spent on all these food activities by 46 States and Puerto Rico; this figure represents 74 percent of the total $196.06 million spent for all food and drug control activities by the States. The food categories listed above are not subdivided to permit an assessment of actual food labeling activities performed by State agencies. Table 3-1 provides a review of total food expenditures by program category. Federal and State regulators have worked together in a number of ways to promote uniform enforcement procedures. The FDA publication State Programs and Service in Food and Drug Control noted the following initiatives: joint FDA/State inspection of specific establishments or industries to effect both interstate and intrastate correction of violative practices, and for training purposes; FDA field office conferences with State counterpart officials to promote mutual understanding and agreement on current consumer protection priorities and planning compliance activities; formal training courses for State and local regulatory officials, held annually across the country in up to 50 locations, which cover food and drug issues to promote state-of-the-art knowledge and uniform inspection/analytic procedures patterned after FDA practices;

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Food Labeling: Toward National Uniformity technical and consultative assistance provided by FDA to States that have primary responsibilities in milk safety, retail food protection, and shellfish sanitation; development of communication networks among the cooperating State agencies and FDA headquarters/field offices; distribution to State officials of various FDA technical and procedural manuals and information; voluntary worksharing agreements under which FDA field offices and State agency managers delineate establishment and/or industry coverage to avoid duplicative or unplanned concurrent inspections; coordinated response plans for emergencies including agreements with cooperating State agencies to facilitate communications and decisionmaking in emergency situations related to food industries or products; and the State contract program, in effect for 14 years, which has had a significant impact on improved uniformity in State inspectional procedures (DHHS, 1990). TABLE 3-1 Total Food Expenditures by Program Category Program Category Expenditures (millions of dollars) Percentage of Total Frequencya Food service 31.20 28.32 38 Grade A milk 21.43 19.45 38 Retail establishments 16.10 14.61 42 Shellfish 7.50 6.91 25 Manufactured milk 6.95 6.31 32 Canneries 5.36 4.86 25 Warehouses 3.58 3.25 40 Aquatic products 3.03 2.75 29 Bakeries 2.92 2.65 40 Bottling plants 1.35 1.23 38 Candy 0.80 0.73 36 Grain 0.69 0.63 17 Miscellaneous 9.27 8.41 33 TOTAL 110.18     NOTE: Because some States do not report their expenditures by program category, them is a discrepancy between the total food expenditures noted in Table 3-1 and the total in the text. a Frequency refers to the number of States with inspectional activities in a given program category. SOURCE: DHHS, 1990, p. 7.

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Food Labeling: Toward National Uniformity The current regulations governing the labeling of food are located principally in the following sections of the Code of Federal Regulations (CFR): 21 CFR 1.20 Presence of mandatory label information   1.21 Failure to reveal material facts 21 CFR 101.1 Principal display panel of package form food   101.2 Information panel of package form food   101.3 Identity labeling of food in package form   101.4 Food; designation of ingredients   101.5 Food; name and place of business of manufacturer, packer, or distributor   101.15 Food; prominence of required statements   101.18 Misbranding of food   101.22 Food; labeling of spices, flavorings, colorings, and chemical preservatives   101.105 Declaration of net quantity of contents when exempt 21 CFR 102 Common or usual name of nonstandardized foods 21 CFR 103.14 General statements of substandard quality and sub-standard fill of container IMPLICATIONS FOR FDCA SECTION 403 Throughout most of the twentieth century, the increasing amount of food products in interstate commerce has led to persistent problems for State regulators. More recently, the increasing complexity that exists at all levels of government has expanded the areas of overlap between Federal and State activities. In some cases, the enactment of local statutes has further added to the practical difficulties of determining the actual or appropriate relationships among agencies. For decades, obsolete State provisions have not been repealed, despite enactment of the AFDO Uniform Bill. In addition, individual States have frequently modified the Uniform Bill prior to enactment or instituted their own interpretation of similar language, thus creating local exemptions to the general rule of uniformity. Finally, a number of State agencies have adopted additional regulatory requirements on an ad hoc basis to protect local interests (e.g., for indigenous agricultural products or to obtain local political support). These diverse sources of State requirements have been viewed by industry to interfere with interstate

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Food Labeling: Toward National Uniformity commerce and create a seeming disparity between Federal and State laws and regulations. As a result, food manufacturers that wish to market a new food product complain that they must attempt to achieve compliance with Federal requirements and then wait to see if any State challenges the product for noncompliance with its requirements. The dramatic changes and advances over the past 50 years in the manufacturing, packaging, and marketing of foods have presented regulatory concerns for FDA and the States. For example, texturized vegetable protein products that were introduced in the 1970s mimicked tuna, chicken, pepperoni, and cheddar cheese in their appearance, taste, smell, and mouth feel. Federal regulators were justifiably concerned about the potential labeling of these products under FDCA Sections 403(b) and 403(i)(1) with the potential for nomenclature issues that these developments might represent. In response to new technologies, common or usual names were established for onion rings made from dried onions, potato chips from dried potatoes, and fish sticks or portions from minced fish (21 CFR Part 102 Subpart B). The use of new and innovative packaging materials has increased the potential for the marketing of misleading containers under FDCA Section 403(d) and abuse of the prominence of information provisions under FDCA Section 403(f). Similarly, the use of artificial flavors and colors and chemical preservatives in the preparation of new and unique substitute foods, specialty foods, and snack foods has emphasized the importance of the Section 403(k) labeling requirements. Hutt and Merrill (1991) have pointed out that in recent years the ingredient statement has allowed consumers to identify and avoid specific ingredients, in contrast to the view in 1938 that ingredient labeling was strictly an economic issue. The very fact that the supermarket of today carries from 9,000 to 12,000 items and a new item can be introduced and withdrawn in a period as short as 3 months highlights the importance of minimizing the burden of all food labeling requirements. For many years, Federal, State, and local food regulators have supported the goal of uniformity through means other than preemption. Although much has been accomplished, many regulators and the food industry remain concerned that the goal has not been achieved to the extent desired. For those holding this view, NLEA is seen as an opportunity to accelerate the process of achieving national uniformity in food labeling while continuing to provide for joint Federal/State initiatives and a meaningful role for States in food labeling policy development and implementation.

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Food Labeling: Toward National Uniformity REFERENCES AFDO (Association of Food and Drug Officials). 1984. Uniform State Food, Drug, and Cosmetic Bill, 1984 Revision. Laws and Regulations Committee Accepted and Endorsed. Annual Meeting, Seattle, Washington, June 19. Barkan, I.D. 1985. Industry invites regulation: The passage of the Pure Food & Drugs Act of 1906. Amer. J. Public Health 75:18–26. Boyle, K. 1987. Diverting product: A way of life or just a temporary glitch. Food Broker Quarterly 3:36. Summer Burditt, G. 1990. Uniformity through cooperation and communication. Food Drug Cosmetic Law J. 45:319–325. Buzzell, R.D., J.A. Quelch, and W.J. Salmon. 1990. The costly bargain of trade promotion. Harvard Business Review.90(2):141–149. Consumer Reports. 1986. I'll Buy That! 50 Small Wonders and Big Deals that Revolutionized the Lives of Consumers: A 50 year Retrospective. Mt. Vernon, N.Y.: Consumers Union. Cooper, R.M., R.L. Frank, and M.J. O'Flaherty. 1990. History of health claims. Food Drug Cosmetic Law J. 45:655–691. Davis, W. 1934. The Advance of Science. Garden City, N.Y.: Doubleday, Doran and Company, Inc. DHEW/USDA/FTC (U.S. Department of Health, Education, and Welfare; U.S. Department of Agriculture; and Federal Trade Commission). 1979. Advance Notice of Rulemaking. Tentative Position of Agencies. Fed. Reg. 44:75990–76020, Dec. 21. DHHS (U.S. Department of Health and Human Services). 1988. The Surgeon General's Report on Nutrition and Health. Washington, D.C.: Government Printing Office. DHHS (Department of Health and Human Services). 1990. State Programs and Services in Food and Drug Control. Food and Drug Administration. Washington, D.C.: Government Printing Office. DHHS/PHS/CDC/NCHS. 1991. Vital Statistics of the United States. 1988, Vol. 11 sec. 6. Downes, T.W. 1989. Food packaging in the IFT era: Five decades of unprecedented growth and change. Food Technol. 9:228-240. Erdman, J.W. 1989. Nutrition: Past, present and future. Food Technol. 9:220–227. FDA (Food and Drug Administration). 1973. Regulations for the Enforcement of the Federal Food, Drug and Cosmetic Act and the Fair Packaging and Labeling Act; Nutrition Labeling. Fed. Reg. 38:2125–2132; Jan. 19. FDA (Food and Drug Administration). 1974. Annual Reports 1950–1974 on the Administration of the Federal Food, Drug, and Cosmetic Act and Related Laws . U.S. Department of Health, Education, and Welfare. Washington, D.C.: Government Printing Office. FDA (Food and Drug Administration). 1982. Food Labeling; Declaration of Sodium Content of Foods and Label Claims for Foods on the Basis of Sodium Content. Final Regulations. Fed. Reg. 49:15510–15535; April 18. FDA (Food and Drug Administration). 1987. Food Labeling; Public Health Messages on Food Labels and Labeling. Fed. Reg. 52:28843–28849; Aug. 4. FDA (Food and Drug Administration). 1989. Food Labeling; Advance Notice of Proposed Rulemaking. Fed. Reg. 54:32610–32615; Aug. 8. FDA (Food and Drug Administration). 1990a. Food Labeling; Definition of the Terms Cholesterol Free, Low Cholesterol, and Reduced Cholesterol; Tentative Final Rule. Fed. Reg. 55:29455–29473; July 19. FDA (Food and Drug Administration). 1990b. Food Labeling; Health Messages and Label Statements; Reproposed Rule. Fed. Reg. 55:5175-5192; Feb. 13.

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Food Labeling: Toward National Uniformity FDA (Food and Drug Administration). 1990c. Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrient Content Revision; Serving Size; Proposed Rules. Fed. Reg. 55:29475–29533; July 10. FDA (Food and Drug Administration). 1990d. State Law Data: 1990. Rockville, Md.: FDA. FDA (Food and Drug Administration). 1991a. FDA Report of Consumer Research on Alternative Nutrition Label Formats; Availability. Fed. Reg. 56:23072–23083; May 20. FMI (Food Marketing Institute). 1986. America the Bountiful. How the Supermarket Came to Main Street. In cooperation with Beatrice Companies, Inc. Washington, D.C.: FMI. Friedenwald, J., and J. Ruhrah. 1913. Diet and Health in Disease, 4th ed. Philadelphia, Pa.: W. B. Saunders Co. Friedman, M., ed. 1991. Gorman's New Product News. 26:1. Jan. 6. Chicago. Gorman Publishing Co. Goldblith, S.A. 1989. 50 years of progress in food science and technology. From art based on experience to technology based on science. Food Technol. 9:88–286. Helrich, K. 1984. The Great Collaboration: The First 100 Years of the Association of Official Analytical Chemists (AOAC). Arlington, Va.: AOAC. Hile, J.P. 1984. Remarks before the Food and Drug Law Institute Seminar on State and Federal Roles in Food Regulations. Washington, D.C. Sept. 26. Hile, J.P. 1986. Understanding the Food and Drug Administration's position on health claims. Food Drug Cosmetic Law J. 41:101–104. Hutt, P.B., and S.A. Brown. 1985. Hillsborough Co. FL et al. v. Automated Medical Laboratories. Brief for Grocery Manufacturers of America, Inc. as amicus curiae in support of appellee. Before the Supreme Court. March 29. Hutt, P.B., and R.A. Merrill. 1991. Food and Drug Law: Cases and Materials. 2nd ed. Westbury, N.Y.: Foundation Press. IFT (Institute of Food Technologists). 1989. Top 10 food science innovations. 1939–1989. Staff report. Food Technol. 9:309. IOM (Institute of Medicine). 1990. Nutrition Labeling: Issues and Directions for the 1990s. Report of the Committee on the Nutrition Components of Food Labeling, Food and Nutrition Board. Washington, D.C.: National Academy Press. Jones, A. 1912. The Object of the Association (AFDO) as Defined by the New Constitution. American Food J. July 15. Lund, D. 1999. Food processing: From art to engineering. Food Technol. 9:242–247. NRC (National Research Council). 1989. Diet and Health: Implications for Reducing Chronic Disease Risk. Report of the Committee on Diet and Health, Food and Nutrition Board, Commission on Life Sciences. Washington, D.C.: National Academy Press. Olsson, P.C., and D.R. Johnson. 1984. Meat and Poultry Inspection: Wholesomeness, Integrity and Productivity. pp 220–241 In Seventy-fifth Anniversary Commemorative Volume of Food and Drug Law. Washington, D.C.: Food and Drug Law Institute. Porter, D.V. 1989. Preservation of Food by Irradiation. Congressional Research Service, Library of Congress. CRS 89–491. SPR: Washington, D.C. Porter, D.V. 1991. Nutrition Labeling and Education Act of 1990: P.L. 101–535. Congressional Research Service, Library of Congress. CRS 91–146. SPR.: Washington, D.C. Reindollar, B. 1951. The Association of Food and Drug Officials. Food Drug Cosmetic Law J. 6:52–54. Robinson, V. 1939. The Modern Home Physician. New York: W.M. Wise & Co. Shattuck, L. 1850. Report of the Sanitary Commission of Massachusetts. Boston, Ma. Sim, M.B. 1951. Commercial Canning in New Jersey: History and Early Development. Trenton, NJ.: New Jersey Agricultural Society. Smithwick, P.J. 1988. Diverting: Deals of Wheels. Pp. 19–20, 43–44 in Management Challenges, 1988. Progressive Grocer Executive Report. January.

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