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8 Legislation and Regulation The Committee was specifically asked to consider the implications of its food labeling proposals for existing legislation governing nutrition and ingredient labeling and to propose policy options for modifying current statutory and regulatory directives. This language was interpreted by the Committee as a request to consider whether the laws under which the Food and Drug Administration ~DA) and the U.S. Department of Agnculture (USDA) now regulate food labels or the regulations they have issued should be changed to implement the recommendations set forth in earlier chapters. Chapters 5, 6, and 7 addressed the adequacy of current FDA and USDA regulations, and endorsed some changes and pointed out deficiencies in others. The changes in regulations required to implement the Committee's recommendations should be obvious from that discussion, and thus, they are not itemized here. This chapter deals with the other facet of the Committee's charge, that is, to assess the adequacy of existing statutes to support the changes in food labeling requirements that the Committee endorses. It examines the current statutory authorities of FDA and USDA and discusses the arguments for and against efforts to elicit new legislation. The Committee concludes that such legislation is desirable to foreclose disputes about existing authority and to ensure that FDA and USDA proceed in tandem to implement the needed changes in food labels. The enactment of appropriate legislation cannot be assumed, however, so the chapter concludes with a discussion of the desirability of administrative initiatives to improve nutrition labeling. The three statutes chiefly involved in nutrition labeling are the Federal Food, Drug and Cosmetic Act (FD&C Act), the Federal Meat Inspection Act SEMI 279

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280 NUTRITION LABELING Act), and He Poultry Products Inspection Act (PPI Act). The Committee rec- ommends that He U.S. Congress amend all three of these laws to eliminate doubt about the agencies' authority to expand He coverage and revise the content of current nutrition and ingredient labeling requirements. fine types of amend- ments that would be desirable are discussed below.) This key recommendation does not reflect the judgment that FDA or USDA would be held to lack the authority to adopt the reforms endorsed in this report Rather, it is a recognition that doubt about the existence of such authority may impede agency action and result in court challenges that could delay He implementation of need reforms. Furthermore, Be Committee recognizes that existing arrangements for internal executive branch review of agency rulemaking initiatives, whatever their gen- eral merit, will also cause delay. The enactment of legislation Hat directed both FDA and USDA to broaden the coverage and refonn the content of nutrition labeling and set a timetable for He adoption of implementing regulations would accelerate the administrative process and discourage court challenges. CURRENT LEGAL AUTHORITY TO EXPAND NUTRITION LABELING The difficult questions concerning the authority of FDA and USDA under existing laws to implement the Committee's recommendations relate to rec- ommendations to extend nutrition labeling to all packaged foods; foods sold in restaurants; and produce and fresh and frozen meats, poultry, and fish. A1- though the matter is not entirely free from controversy, discussions between the Committee and legal experts did not reveal serious doubt about either agency's authority to prescribe the content and format of nutrition information when such labeling can otherwise be required. With respect to the issue of coverage, it is not clear that FDA and USDA are in the same situation. The FD&C Act is perhaps less generous than either the FMI Act or the PPI Act, which give USDA the power to approve in advance all labels used on meat add poultry products. Therefore, this discussion begins with the question of whether FDA could, under current law, require that all packaged foods within its jurisdiction (subject to administratively determined exceptions) bear nutrition labeling. It then turns to the questions of FDA's authority to require nutrition labeling for foods sold in restaurants and its authority to require some point-of-sale nutrition information, that is, some form of nutrition labeling, for produce and seafood. An additional reason to begin this discussion with an examination of FDA's authority to broaden the coverage of mandatory nutrition labeling is that the products that fall within its jurisdiction comprise well over half of all foods purchased by Americans. In the Committee's view, a conclusion that FDA lacks, or might be held by a court to lack, such authority would alone be sufficient to

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l~GISl~ION AND REGUI~ION 281 justify a recommendation that Congress should act, regardless of the conclusions that might be reached regarding USDA's current legal authority. FDA's Legal Authority To Mandate Nutrition Labeling on All Packaged Foods The term legal authority, rather than statutory authority, is used to draw a distinction between what might be termed the literal interpretation of statutory provisions and an assessment of the maximum scope of authority over food labels that courts would approve if FDA chose to exert that authority. (Lawyers would use the terms express and implicit legal authority to capture the same distinction.) This distinction may puzzle some readers, who might assume that such issues of agency power are clear-cut. They would be surprised by the vagueness of many laws, particularly older laws, as they apply to contemporary problems that very likely were not contemplated by the Congress that enacted them. In fact, important questions of administrative power are often not answered by the language or the history of statutes that support major regulatory programs. For a lawyer, however, such a concession does not end the analysis. Modern U.S. regulatory law has a dynamic character, both by legislative design and through judicial interpretation. In addition to conveying specific powers to an agency, Congress will often include a general grant of authority to an agency to adopt the regulations needed to implement a statute's general objectives. The Supreme Court has held that when Congress does so, an agency's exercise of this residual authority should be sustained unless it exceeds clear limits on its power (Chevron, U.SA. v. Natural Resources Defense Council, 467 U.S. 837 (1984~. The point of this abstract discussion is that FDA has the authority to do more than the specific language of the FD&C Act might at first appear to allow. Many of its current requirements for food labels represent the assertion of a general authority to adopt the regulations needed to implement the goals of the Act. For example, no provision of the FD&C Act states, in so many words, that FDA may prescribe the content of nutrition information provided voluntarily or require nutrition labeling on foods for which nutrition claims are made or to which one or more nutrients have been added. Yet, this is precisely the requirements of PDA's current regulations, and their validity has never been challenged (nor, in truth, has it been upheld) in any court Experienced legal experts believe that FDA's current regulations would be almost certainly sustained if they were now challenged. Accordingly, it is appropriate to begin this analysis with the legal theory on which FDA relied when it promulgated its original regulations in 1973. Section 403(a) of the ED&C Act provides that a food is misbranded (and subject to seizure or other enforcement proceedings) if "its labeling is false or misleading in any particular." The courts have read this language expansively to

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282 NUWTION LABEIING prohibit not only false or clearly deceptive statements but also statements that, although literally true, are misleading in context. This treatment of the language of section 403(a) is reinforced by another key provision, section 201(n), which reads as follows: If an article is alleged to be misbranded because the labeling . . . is misleading, then in determining whether the labeling . . . is misleading there shall be taken into account (among other things) not only representations made or suggested . . . but also the extent to which the labeling . . . fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling . . . relates under the conditions of use prescribed in the labeling . . . or under such conditions as are customary or usual. When it issued the regulations in 1973, FDA made essentially two argu- ments. First, it argued that a standardized format for nutrition labeling was required to prevent deception of consumers who would otherwise confront a bewildering array of statements about nutrient content on food labels. Second, relying on section 201(n), it argued that the making of a nutrition claim for a food or the addition of any nutrient (which would be disclosed on the label) would be misleading unless consumers were provided with more complete in- formation about the nutritional value of the food: Only by having available this full nutrition labeling for a food to which a nutrient is added or for which such claim or information is provided can such claim or information be evaluated and understood, and the food properly used in the diet. Without full nutrition labeling such claims or information would be confusing and misleading for lack of completeness, and could deceive consumers about the nutritional value of the food, its overall nutritional contribution to the daily diet, and its nutritional weaknesses as well as strengths (38 Fed. Reg. 2125, Jan. 19, 1973~. Some believe that this same theory could be extended to support the adoption of regulations mandating nutrition information on all packaged foods (or all except those that FDA chose to exempt) and perhaps others as well. In testimony made before the Committee in December 1989, a spokesman for the Grocery Manufacturers of America (GMA) articulated the argument FDA might make: The vast majority of the public is deeply interested in the nutritional composition of marketed food products. The nutritional composition of a food has come to be a material fact that is of inherent interest to the consumer . . . . Thus, the marketing of any food that makes a significant nutritional contribution to the daily diet is sufficient to digger nutritional labeling under section 201(n) of the FD&C Act. GMA does not believe that new legislation is needed in order to require nutrition labeling for all food Cat makes a significant contribution to the daily diet, and

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l~GISlAIlON AND REGUl~lON would support the promulgation of regulations by FDA to achieve this purpose (GMA, 1989). 233

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284 N~17tlTION LABELING these foods (DHEW/USDA/FrC, 1979). However, in congressional testimony in August 1989, then FDA Commissioner Funk Young suggested that agency officials believed that nutrition labeling could be required on all packaged foods under existing law (Young, 1989~. As this report was being completed, FDA proposed revisions of its nutrition labeling regulations that would, if adopted, apply to virtually all packaged foods within the agency's jurisdiction. This proposal asserts that the agency declined to mandate nutrition labeling of all foods in 1973 because knowledge of nutrient content was still incomplete and the methods of chemical analysis were inadequate in many cases. FDA now argues that these obstacles have since been removed. Furthermore, it stresses the growth in knowledge of the relationship between nutrition and long-term health, knowledge that makes choices among foods more important and justifies action to ensure that consumers can assess the consequences of the food selections they make. "[G]iven the history and use of nutrition labeling, the advances in nutrition science, and the public interest in healthful diets," the proposal concludes, "the nutritional content of a food is a material fact, and . . . a food label is misleading if it fails to bear the nutrition information that would be required . . ." (55 Fed. Reg. 29,47~29,533, July 19, 1990~. FDA's Authority To Prescribe the Content and Format of Nutrition Libeling The adoption of mandatory nutrition labeling for all packaged foods would probably present the most serious test of FDA's current legal authority. The Committee's recommendations, however, go further. They call for changes in the content and format of current nutrition labels and for the extension of nutrition labeling to classes of food that do not now bear labeling that meets FDA requirements: produce, seafood, and foods sold in most restaurants. They also call for labeling of fresh meat and poultry, but the power to accomplish this lies, if it exists at all, win USDA (see discussion of USDA legal authority, below). FDA's authority to prescribe the content and format of nutrition information in food labels, for whatever foods on which it may lawfully require such information, appears to be well established. The experts whom the Committee consulted generally concurred that the agency's authority to prevent misleading labeling and to force disclosure of the whole truth under section 201(n) would support any reasonable requirements for content and format, and the Committee agrees. Reasonable requirements are those requirements that are supported, on the one hand, by scientific evidence and, on the other, by studies of or reasoned judgments about consumer understanding and expectations, with appropriate consideration for simplicity, consistency, legibility, cost, and enforceability.

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I~GISl'ION AND REGUI~ION 285 Similarly, EDA's decisions to exempt certain categories of packaged food from some or all nutrition information requirements, if supported by evidence and reasoning, would very likely be upheld. Thus, the agency could, under current law, properly decide to exempt foods sold in packages that are too small to bear full nutrition information or foods that make no significant nutritional contribution, such as condiments, chewing gum, and coffee and tea. By mentioning these examples, the Committee does not mean to imply that they should be exempted either by FDA or by Congress. The Committee does agree, however, that the authority to exempt foods from some or all nutrition labeling requirements is essential; furthermore, it believes that decisions about which foods to exempt should be made by FDA or USDA and not specified by statute. Requests for exemption from, or modification of, the standard requirements are likely to be numerous. The merit of such a request for any food, or any category of foods, should require an examination of nutrient content (to assess the need for nutrition information) and the feasibility of alternative means of conveying desired information. These Apes of issues are better resolved at the agency level than by Congress. FDA's Authority To Require Nutrition labeling of Produce, Seafood, and Foods Sold in Restaurants The Committee's recommendations that some form of nutrition labeling should be required for fruits and vegetables, seafood, and foods sold in limited- menu restaurants raises other serious issues. However, the experts whom the Committee consulted were in general agreement that if FDA could establish its authority to mandate nutrition labeling on all packaged foods, its extension of these requirements to produce, seafood, and foods sold in restaurants would likely be upheld. Nothing in the FD&C Act purports to exempt any of these categories of foods from its basic labeling requirements, although EDA, for prac- tical reasons, has by tradition effectively, although never expressly, exempted all three areas. Significant practical problems would accompany efforts to require nutrition information for any of these categories of food, whether authorized by new legislation or undertaken under existing law. In the case of produce and most seafood, FDA would have to devise, or require sellers to devise, a substitute for the conventional package label, presumably some form of above-bin sign or placard perhaps supplemented by information on the display carton, and would have to take account of such problems as seasonal changes, relocations of displays, and damage by customers. In the case of foods sold in restaurants, FDA would have to be able to demonstrate that the foods it required to be labeled were sufficiently well standardized in the restaurants covered that nutrition statements were reliable and were sold in a setting where labeling was practicable. It is

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286 NU7mTIoN LAsELlNG worth reiterating that labeling need not be affixed to the product; any information displayed in conjunction with the foods described would qualify and would, in principle, be subject to regulation by FDA. The general law governing U.S. administrative bodies requires that their requirements, even when authorized by legislation, be supported by facts and reasoning. The usual formulation of this principle is that agency regulations must not be arbitrary or capricious, and although this test accords agencies consid- erable deference, courts apply it senously. Moreover, courts have been willing to overturn agency regulations that appear to require substantial expenditures in return for modest benefits (National Tire Dealers and Retreaders Association v. Brinegar, 491 F.2d 31 (1974~. Thus, FDA's efforts to extend nutrition labeling to produce, seafood, and some foods sold in restaurants would probably face the sternest test if they were challenged as impractical rather than as unauthorized. FDA's few statements on the issue of its authority to regulate the labeling of produce, seafood, and foods sold in restaurants have betrayed some ambivalence. The problems of enforcement in these contexts, coupled with the judgment that food labeling violations generally rank low in pnority, have made FDA reluctant to exert jurisdiction over such foods. Yet, when squarely confronted, EDA has generally claimed that it has the authority to regulate the labeling of produce (and, by implication, seafood) and foods sold in restaurants (Huts and Merrill, 1990~. When it adopted the current nutrition labeling regulations, FDA at first decided that they should apply to fresh fruits and vegetables. The agency ultimately retreated from this position, but the reasons it offered had nothing to do with legal authority. In the mid-1970s the agency was urged to require ingredient labeling for foods sold in limited-menu restaurants. Again, its decision not to proceed chiefly reflected concern for the practical obstacles to federal enforcement, which overrode any doubts about statutory authority. FDA revisited these issues in 1979 during the joint DHEW/USDA'/~C review of federal regulation of food labeling and advertising. For restaurants, the immediate issue was again the labeling of ingredients, which some pardes had urged the agencies to require. The agency's entire discussion of the legal aspects of this possibility reads as follows: [P]resent legal authority would be adequate to extend ingredient labeling to those restaurant foods that come in "containers', or that have "wrappers," but it is questionable whether this authority could be applied to other kinds of restaurant foods. A change in the law may be needed in order to require ingredient listings of food served in traditional restaurants (DHEW/USDA/PTC, 1979, p. 14~. The July 1990 FDA proposal would extend nutrition labeling to produce, but the preamble does not address the specific issue of authority. The agency explicitly does not propose to require nutrition labeling for foods sold in

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GISl'ION AND REGUI~ION 237 restaurants, but it implies that this decision represents a pragmatic judgment, not a concession that it lacks legal authority. FDA's authority under current law to require nutrition information, in some form, for produce, fresh and frozen seafood, and foods sold in restaurants therefore remains unresolved. No court decision squarely addresses the issue, but neither does any court decision cast doubt on FDA's power. The FD&C Act's labeling requirements extend to foods "held for sale after shipment in interstate commerce" (21 USC 301~. The agency's failure historically to attempt to control the information that restaurants provide about the foods they serve and its extremely modest efforts to influence the information that sellers of produce and seafood provide to consumers could undermine any effort now to exert long-dormant and, perhaps, debatable statutory authority. It remains the judgment of many experienced lawyers, however, that if FDA could devise nutrition labeling requirements for these foods that could be implemented economically and enforced without huge expenditures, courts probably would uphold its regulations against the outright claim that the FD&C Act does not provide the authority for their adoption. USDA's Authority To Expand Nutrition Labeling of Meat and Poultry Products The issues surrounding USDA's existing authority to expand the coverage of nutrition labeling parallel those discussed in connection with FDA, although the analysis does not. Unprocessed meat and poultry are usually sold fresh and frozen in wrappers that bear very simple labels. Processed meat and poultry products appear in a wide variety of forms in supermarkets, and many of the dishes featured by restaurants include meat or poultry. Perhaps the chief significant difference between the FDA and USDA sectors of the retail food business is that meat and poultry products, unlike produce, are almost never sold without any packaging whatsoever. With respect to the authority to extend nutrition labeling to all packaged meat and poultry products, USDA appears to stand on firmer ground than does FDA, although as noted above, FDA's claim is quite plausible. Under the FMI Act, a label must be affixed, under the supervision of a USDA inspector, to any meat product that is placed or packed "in any can, pot, tin, canvas, or other receptacle or covering." In addition to confirming that the contents have passed inspection, the label must include, at a minimum, the name of the food, a statement of the quantity of the contents (typically net weight), a list of ingredients (unless it is subject to a standard of identity), and the name and place of business of the producer. Furthermore, the label may not be "false or misleading in any particular' (FMI Act 607~. The FMI Act does not, however, contain an explicit general grant of authority to require affirmative disclosures of information. Nor is its prohibition of misleading labeling accompanied by an

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288 NUTRITION LABEllNG

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GISl'70N AND REGUl'ION 289 to mandate nutrition information on labeling of fresh and frozen unprocessed meats and poultry if it chose to assert it. i' Whether USDA could assert the same authority over off-package labeling s less clear. The agency has previously said it has jurisdiction over point- of-purchase printed materials as "labeling," but it has never attempted to require prior approval of such materials (Kushner et al., 19901. On at least one occasion it took the position that placards posted beside meat product displays in supermarkets were not "labeling" (American Meat Institute Y. Pndgeon, 74 F.2d 45 (1984~. The Committee is less confident that USDA would be successful if, without change in the existing law, it attempted to prescribe labeling, including nutrition information, for meat- and poultry-containing foods sold by restaurants. The Committee found no evidence that USDA has ever sought to claim such jurisdiction over foods sold by restaurants. For the purposes of this report, however, it suffices to state that USDA's authority to prescribe nutrition labeling for foods sold by limited-menu restau- rants is by no means clear. This is of concern to the Committee, which rec- ommends that nutrition information be required for foods provided in limited- menu establishments. Putting aside the practical problems of implementation, the Committee's recommendation requires that some federal agency have clear legal authority to act in this area. FDA's claim to such power may be stronger than USDA's but it may lack jurisdiction over those restaurant foods that con- t~n substantial amounts of meat and poultry. A labeling scheme that omitted these products would be inadequate. Meat or poultry dishes provide most of the protein offered by limited-menu restaurants; the principal share of vitamins and minerals; and most significantly, most of the calones, fat, cholesterol, and sodium. It is their exclusion from current labeling requirements that prompts the Committee's recommendation that nutrition labeling be required for such foods. DESIRABILITY OF SEEKING NEW LEGISLATIVE AUTHORITY FOR NUTRITION LABELING The foregoing discussion of FDA and USDA legal authority to mandate nutrition labeling for all packaged foods and extend the requirement, or some variant, to produce, seafood, fresh and frozen meats and poultry, and foods sold in restaurants at least suggests the desirability of new legislation that would lay continuing doubts to rest. And for this reason the Committee, in principle, recommends that Congress amend the FD&C, FIJI, and PPI Acts to enlarge and clarify the authority of the two agencies. However, the pursuit of new legislation could have disadvantages that should be acknowledged.

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298 Nl=tlTlON LABEl]NG Dietary Allowances have been established by the Food and Nutrition Board of the National Research Council or that sellers of food may desire to list. A label that included all of the mandated components and dozens of others added to or present in a food would often be difficult to read or understand. The question arises, therefore, whether FDA and USDA should be empowered to prohibit the listing of any components on the grounds that (1) they are not useful in human nutrition or are inevitably consumed in adequate quantities or (2) that their appearance crowds the label and risks confusion. Although sympathetic with He concerns reflected in this reasoning, the Committee is reluctant to endorse any categorical ban on the truthful listing of nutrition components, absent a convincing showing that this is the only means of preventing consumer confusion. The Committee does, however, believe that FDA and USDA should be able to restrict the nutrition panel to specific components and to require that any other components that the seller chooses to include appear elsewhere on the label. Current law appears to provide FDA and USDA with this authority. Exceptions from Mandatory l~eling FDA and USDA already possess, and sometimes exercise, the authority to modify their general labeling requirements for specific foods. This authority to modify or, in appropriate cases, even to waive requirements is essential to the practicability of any comprehensive system of nutrition labeling. Explicit confirmation of this authority would be desirable, but it should be general rather than itemized It would be appropriate for new legislation to describe, in general terms, the kinds of justifications that might support modifications of or exemptions from standard labeling requirements (e.g., small size of the package, lack of nutritional contribution, and perhaps even the modest resources of the manufacturer), but it should not codify exemptions. Final decisions about which foods or firms should be exempted from requirements or eligible for reduced requirements should remain with FDA and USDA. Label Format Issues Basic Label Design Chapter 7 discussed the factors Nat should be weighed in prescribing a standard format for nutrition labeling. The Committee does not endorse a single format, and legislation should not do so either. Legislation should direct FDA and USDA to develop and then test different formats and ultimately specify, by regulation, a uniform format that must be followed by all sellers of food. Me issue of FDA-USDA uniformity is addressed in more detail below.)

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l~GISl'ION AND REGUl'ION Modifications of Starboard Format 299 The two agencies should be empowered to approve modifications of the standard format in appropriate cases. For example, it may be appropriate to allow foods that contain very few of the mandatory components of nutrition labeling to use an abbreviated version of the standard format, although the Committee does not endorse such modifications for foods that are lacking in desirable components. It also appears clear that some changes, modifications, or alternative modes of presentation will be required for foods in very small packages. There is an obvious tension between the goal of label uniformity, which will facilitate consumer use of nutrition labeling, and the possible need for modi- fication for specific foods or markets. The Committee believes that uniformity should be a very high priority and that the burden of justifying adjustments of the uniform nutrition labeling format should rest on those who seek them. Legislation should not attempt, however, to determine whether that burden has been met; FDA and USDA are better equipped to resolve such claims on a case-by-case basis. Process for Adopting a Starboard Format A single format should apply to all packaged foods, and for the purposes of this discussion, it is assumed that a uniform format will be agreed to by FDA and USDA. The Committee is not convinced that there is one best procedure for deciding on the appropriate format for nutrition labeling. FDA and USDA should participate jointly in the effort, and their implementing regulations should be issued contemporaneously. The importance of interagency consistency is such that the Committee favors a statutory requirement that obliges either agency to justify publicly why it declines to subscribe to a common resolution of any format issue. In the Committee's judgment, the process for selecting the standard label format should allow comment from members of the public, and it should accord substantial weight to the views of individuals in three sectors in particular: (1) the professional nutrition community, (2) experts in consumer understanding and behavior, and (3) state and local health and regulatory authorities. A statutory advisory committee might be a useful vehicle for ensuring that the views of individuals in these sectors are adequately considered. It seems likely that the standard label format will require periodic revision as understanding of nutrition and health is improved by science, as food con- sumption patterns change, and as merchandising practices evolve. Accordingly, the Committee believes that a mechanism should be put in place for considering

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300 NUTRITION LABELING and recommending desired changes, including revisions in the content of the standard label. Legislation should not describe in detail the process for establishing the standard label format. It should merely (1) direct that the job be done, (2) prescribe a deadline for its completion, and (3) mandate consideration of the views of the public and those in the three sectors mentioned above. Institutional Issues The Committee considered a cluster of issues surrounding allocation of responsibility for regulating food labeling, including the wisdom of the current bifurcation of federal authority between FDA and USDA, the occasions and justifications for discrepancies between FDA and USDA labeling requirements, the impact of the distinction between USDA's system of advance label approval and FDA's system of post hoc enforcement, and the sensitive issue of the power of the states to regulate the labels of foods sold within their borders. Although some of these topics were not directly relevant to the Committee's charge, it was quickly apparent that judgments on the central issues of content and format required a thorough understanding of the institutional setting of federal label regulation. Furthermore, the achievement of some of the Committee's goals, such as broadened coverage and uniformity of nutrition labeling, may depend on which agency exercises authority in this field. FDA and USDA Uniformity The Committee believes that different approaches to providing nutrition information on food labels diminish the utility of labels to consumers and impede efforts to increase nutritional literacy. Although no single label format is perfect and debate over the components that should be required (or allowed) in nutrition labeling is to be expected, it is essential that one format be established and that a single list of mandatory components be prescribed by federal law. Therefore, the Committee was concerned about reports that FDA and USDA often differ in what Hey require or allow on food labels and that they have sometimes embraced conflicting positions on identical issues, such as the criteria for approving reduced-fat claims on food labels. A detailed comparison of FDA and USDA labeling requirements was not undertaken, but it was the Committee's impression that the charges of inconsistency are exaggerated. They are not, however, groundless. Federal requirements for food labels should be uniform, and the Committee recommends that legislation should mandate uniformity, subject to narrow exceptions. There may be instances in which the marketing context, the character of a food, or the use of a food may justify different approaches even on common questions. Thus, legislation should not demand uniformity without exception;

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l~GlSl~70N AND REGULATION 301 it should require that either agency provide for the record justifications for distinctive approaches for labeling specific foods, justification couched in terms that are relevant to the goals of nutrition labeling (e.g., consumer health and understanding). The Committee also believes that requirements for nutrition labeling should be spelled out in regulations and not left to case-by-case decisionmaking. Leg- islation should require both FDA and USDA to adopt implementing regulations by a fixed date. Consoli~tzon of W,eling Authority Prom time to time, individuals familiar with federal food labeling control have suggested that He authority to regulate labeling for all foods should be placed in a single federal agency, either FDA or USDA. The Committee did not closely study the implications of placing federal labeling authority exclusively in FDA or USDA, although the case for doing so is not obvious. The Committee also concluded that any recommendation made on this subject would entirely obscure the central objective: to improve nutrition labeling expeditiously. Choice of Regulatory Mode The Committee gave greater attention to the different modes of implement- ing labeling requirements by FDA and USDA. USDA requires approval in ad- vance for all labels of meat and poultry products. FDA, by contrast, establishes labeling requirements by regulation and attempts to secure compliance through a combination of advice giving, publicity, and periodic enforcement proceedings. The latter type of system is obviously more vulnerable to budgetary constraints and personnel cutbacks, which slow the issuance of new regulations and dimin- ish private expectations of enforcement. In the USDA context, resource cutbacks chiefly produce delays in label approval. In the USDA system, since no label may be used until it has been approved, marketplace behavior and official pre- scnption, at least in theory, always coincide. These significant differences prompted the Committee to reflect on whether FDA should be empowered to require advance approval of all labels used on foods within its jurisdiction. (It would seem imprudent for USDA to relinquish the kind of control it is able to exert over the labels of foods within its jurisdiction.) Practicality, however, prompted the Committee to refrain from recommending such a scheme. Its implications for EDA's budget would be dramatic arm, thus, would surely be unsustainable as a political matter. The Committee therefore assumed Hat FDA will continue to regulate nutrition labeling in the mode it now employs, a mode that almost inevitably results in some gap between the requirements of the law and regulations and He labeling

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302 NUT~lTlON LABELING practices that actually occur. It is critical, however, that FDA have the resources it needs to effect a high level of compliance with its labeling requirements. National Uniformity National uniformity of food labeling is a controversial issue, one on which views are strongly held and fiercely defended. Resolution of the issue will affect the achievement of the Committee's goals of improved nutrition labeling and increased nutrition literacy. The Committee believes that uniform federal requirements for nutrition la- beling should apply nationwide and that state and local governments presumably should not be able to require different or additional nutrition information on food labels or in nutrition labeling. Legislation should include language that would accomplish this goal. The Committee's position does not include or imply support for, or for that matter opposition to, proposals to preempt labeling requirements by states whose purpose is to warn consumers about the health risks thought to be associated with individual foods. It does mean that no state should ordinarily be able to require that food labels include nutrient information that is not mandated by FDA or USDA regulations. Nor should a state be able to adopt a different definition of any descriptor whose meaning has been established by federal statute regulation. In principle, the Committee believes that any food that bears nutrition labeling meeting federal requirements should be marketable in every state. The Committee acknowledges, however, that there may conceivably be circumstances in which local needs might justify some compromise of this principle. To allow for that possibility, legislation could permit a state to seek FDA approval for requiring specific additional nutrition information on specific foods sold within its borders. The sort of provision visualized by the Committee is similar to one that Congress included in the 1976 Medical Devices Amendments to the FD&C Act, and could direct FDA to consider both the scientific basis of a state's claim and the impact of its recognition on the interstate movement and cost of food. No proposal that would prevent the sale of complying foods in other states would be approvable; a state should not be allowed to require label information that another state forbids, thereby forcing sellers to adopt two different labels. This recommendation is made with the awareness that two of the three key federal food labeling statutes the ~II Act and the PPI Actcurrently provide, without qualification, for preemption of state and local labeling requirements. By contrast, the FD&C Act does not displace state labeling requirements; only if there is a clear conflict with federal requirements or if FDA determines that a specific requirement should be exclusive are state regulations displaced. The Committee could discern no sound justification for this disparity. However,

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I~GISl~lON AND REGUl'ION 303 pragmatism leads the Committee to refrain from recommending any change in the USDA-administered statutes. State Participation in Setting Federal Obeying Standards The recommendation described above reflects a judgment that national label uniformity and easy movement of foods throughout the United States are important goals. The Committee also recognizes, however, the strong interests of state and local public health officials in ensuring that their citizens are well informed about the nutrient content of foods. Furthermore, the Committee recognizes that federal agencies must often depend on the assistance of state officials to enforce federal requirements. Two steps would strengthen state- federal cooperation in this area. A formal mechanism such as a national food labeling committee that would include representatives of state governments that would advise FDA and USDA on the design of nutrition labeling requirements could increase the willingness of states to collaborate in enforcement and, perhaps, persuade federal authorities to fashion their requirements to reflect states' interests. Such a committee could be established without new legislation, but a legislative mandate to FDA and USDA to form such a committee would ensure implementation of this inexpensive proposal. The second step would be more controversial because it would have financial resource implications. If state and local regulatory officials are going to be needed as parmers in enforcing requirements to improve the content and broaden the coverage of nutrition labeling, as would surely be true if the Committee's recommendations for labeling produce, fresh and frozen meats, poultry, and seafood, and some foods sold in restaurants were implemented, federal financial assistance to states and localities may be essential. Congress should consider this suggestion either as part of new labeling legislation or in conjunction with other proposals for federal aid to local public health programs. Timing of Implementation Several current bills to expand federal authority to regulate food labeling provide for a specific date by which, except for administrative approval of exceptions, new labeling regulations must be complied with. The Committee is eager to see its recommendations or other sound recommendations for improving the nutrition information on food labels implemented quickly. It is more important, however, to set deadlines for the administrative development of new labeling regulations than to fix the date by which all foods must be in compliance. It would be appropriate for new legislation to fix dates for action by the two agencies. The Committee is less confident that a statutory schedule

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304 NUTRITION LABELING for private-sector compliance that allows for administrative exceptions would expedite implementation of new labeling rules. Other Legislative Changes Ingredient labeling The Committee recommends two changes in the current rules governing ingredient labeling for foods. First, all sugars in a food should be aggregated and named individually, albeit perhaps in the alternativefor purposes of listing in order of predominance. Implementation of this recommendation would not require legislation. Second, manufacturers of all foods covered by FDA standards of identity should be required to list ingredients in the same manner as other FDA-regulated foods. This will require Congress to amend sections 403(g) and 403(i) of the FD&C Act to eliminate the current language, which indicates that only those optional ingredients specified by the standard need to be listed. Ingredients of meat and poultry products for which USDA has adopted shards of identity are generally already required to be listed. Procedure for Adiopting and Amending FDA Starboards of Identity A more careful study of He nutrition implications of FDA standards of identity might lead to the conclusion that the current system of standards should be substantially revised or even abandoned. One need not have arrived at firm judgments about the current appropriateness of food standards, however, to be confident that the current procedures for adopting and amending standards should be changed. The arguments for such change were presented above. Accordingly, the Committee recommends that Congress repeal section 701(e) of the ED&C Act (and other requirements for formal rulemaking). Alternatively, it should amend this provision to exclude the reference to standards of identity adopted pursuant to section 401 of the Act. Either form of amendment would leave FDA, in adopting, amending, or repealing standards of identity, subject to the conventional rulemaking procedures of the Administrative Procedure Act (5 USC 553~. Implementing Reform if Congress Fails To Act The Committee believes that the advantages of new legislation outweigh the disadvantages, which are not negligible. It is possible, however, that Congress may fail to act in the near future to clarify the authority of FDA and USDA to refonn and broaden their nutrition labeling requirements. It is also possible that one or both agencies may decide to proceed with reforms without, or while

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I~GlSlAICION AND REGULATION 305 awaiting, new legislation. These interrelated scenarios raise several questions, two of which the Committee addressed. FDA Action in the Absence of New Legislation The nutrition labeling legislation currently pending in Congress addresses the authority and obligations of FDA. There are probably greater uncertainties about FDA's than USDA's authority to implement the Committee's recommen- dations for reform. Nonetheless, FDA and DHHS have already initiated rule- making to revise and expand current nutrition labeling requirements for foods within FDA's jurisdiction. FDA's notice of proposed rulemaking asserts that the proposed reforms can all be supported by its current statutory authority. Although the Committee is not as confident as FDA that its assertions of authority will be sustained, the chances are likely enough that the agency should proceed with its rulemaking even in the absence of confirmatory or clarifying legislation. This statement should not be understood to mean that the Committee endorses all substantive features of FDA's proposals. Some are essentially congruent with the Committee's recommendations; some are compatible with the Committee's views. Others, however, reflect different judgments about the information to be included, how information should be expressed, and the foods to be covered. With respect to these differences the Committee stands by the conclusions and recommendations set forth in this report USDA Action in the Absence of New Legislation USDA does not appear to confront the same uncertainties about either legal authority or likely congressional action that FDA currently faces. Nor has USDA yet shown the same interest in broadening the coverage or reforming the content of its requirements for nutrition labeling of meat and poultry products. The Committee believes that, whether or not Congress acts to clarify and direct FDA,s authority to reform nutrition labeling, USDA should promptly initiate administrative proceedings to implement the recommendations set forth in this report. The Committee is satisfied that USDA currently has adequate legal authority to adopt all, or surely most, of these recommendations. Moreover, the Committee regards USDA action in this arena as essential for accomplishment of the desired long-term nutrition goals set forth in the reports of the Surgeon General (DHHS, 1988) and NRC (1989~. Indeed, the most serious common deficiency of the bills pending in Congress for broadening nutrition labeling is their failure to cover the foods regulated by USDA. The reasons for this omission may be understandable in political terms, but it remains a deficiency nonetheless. The Committee urges USDA to join with FDA in leading the overdue effort to

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306 Nlm~lTION LABFl1NG enhance and expand the information Cat U.S. consumers are provided about the nutritional quality of the foods they consume. REFERENCES DHEW/USDA/FTC (U.S. Deparunent of Health, Education, and Welfare, U.S. Depart- ment of Agriculture, and Federal Trade Commission). 1979. Food Labeling Back- ground Papers. Government Printing Office, Washington, D.C. 124 pp. DHHS (U.S. Depar~nent of Health and Human Services). 1988. The Surgeon General's Report on Nutrition and Health. Government Printing Office, Washington, D.C. 727 PP GMA (Grocery Manufacturers of America). 1989. Statement by Sherwin Gardner, Vice President, Science and Technology, Grocery Manufacturers of America' Inc., to the Committee on the Nutrition Components of Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C., December 4, 1989. Hutt, Phi. 1989. Regulating the misbranding of food. Food Technol. 43~9~:288. Hutt, P.B., and R. A. Merrill. 1990. Food and Drug Law: Cases and Materials. The Foundation Press, Mineola, N.Y. In press. Kushner, GJ., R.S. Silverman, S.B. Steinborn, and R.A. Johnson. 1990. A Guide To Federal Food Labeling Requirements. Prepared for the U.S. Department of Health and Human Services and the U.S. Department of Agriculture. Government Printing Office, Washington, D.C. 37 pp. Merrill, RENA., and Pie. Hutt. 1980. Food and Drug Law: Cases and Matenals. The Foundation Press, Mineola, N.Y. 959 pp. NRC (National Research Council). 1989. Diet and Health: Implications for Reducing Chronic Disease Risk. Report of the Committee on Diet and Health, Food and Nu- ~ition Board, Commission on Life Sciences. National Academy Press, Washington, D.C. 750 pp. Young, F. 1989. Testimony before the Subcommittee on Health and the Environment, Committee on Energy and Commerce, U.S. House of Representatives, Washington, D.C., August 3, 1989.

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APPENDIXES

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