Click for next page ( 321


The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 320
D Food Standards and the Quest for Healthier Foods Alvm I. ~~* INTRODUCTION AND SUMMARY In 1938, in order to protect the American public from what it perceived to be increasing debasement of the traditional food supply, Congress enacted legislation that authorized the Food and Drug Administration (FDA) to create legally binding "standards of identity"or recipes for foods. FDA took up this challenge with enthusiasm, and by 1950 about half of the consumer food dollar was spent on foods that were governed by food standards (or standardized). But in dictating the level of "valuable" ingredients that should be in specific foods, FDA understandably reflected the thinking of the county at that time. Thus, whereas today many Americans seek to reduce their intake of fat, saturated fat, and cholesterol, 30 years ago PDA adopted food standards that assured that manufacturers did not cheat consumers by providing lower levels of those ingredients. In short, ingredients considered valuable in a food 30 years ago may be considered that food's nutritional liability today. With increased knowledge of He relationship between diet and health, it is fair to ask whether a government program originally adopted in 1938 to promote *Alvin J. Lonnan is a partner of the law firm Baker & Hostetler in Washington, D.C. 320

OCR for page 320
APPENDIX D 321 one set of nutritional values has successfully evolved so that it promotes the nutritional values of the 1990s. This paper first reviews the history of FDA's implementation of its food standards authority and then examines the impact of food standards on the availability and the consumer acceptance of new and "healthier" versions of standardized foods. For many decades, FDA enforced its food standards authority so as to impede the development of alternatives to standardized foods. At least since the 1970s, however, FDA has evidenced no hostility to the existence of modified standardized foods, but only to the use of the standardized name as part of the name of the substitute food. On the issue of nomenclature, however, FDA has tended to act in an ad hoc fashion and create confusion as to what the applicable rules are and has been unable to articulate a defensible rationale for whatever policy exists. Several alternatives can remedy the current situation. First, the procedures for adopting and amending food standards could be relaxed by Congress so that procedural requirements do not sense to discourage the modification of standards. Second, FDA could adopt procedural regulations to streamline the cumbersome statutory process, as it has done when faced with similar statutory mandates, such as for withdrawing approval of new drugs. Third, a general rule could be adopted to permit the accurate use of defined descriptors, such as low-fat, with any food name, whether standardized or nonstandardized. Fourth, if altered versions of standardized foods are to be treated differently than altered versions of nonstandardized foods, as appears to be the current rule, FDA should, through public rulemaking, articulate a coherent distinction (if one exists) for the disparate treatment. Finally, Congress could abolish food standards entirely (or EDA could revoke them) on the grounds that informative labeling and an educated public obviate the need for standards that, no matter how liberally applied, inevitably have anticompetitive impacts and costs. HISTORY OF FOOD STANDARDS The Legislative Mandate The Pure Food and Drug Act of 19061 was the first attempt at a compre- hensive federal statute governing both the safety and the quality of food. Under the Act, which prohibited the adulteration or misbranding of food products,2 the government had little trouble bringing adulteration cases against those who engaged in such traditional forms of economic cheating as diluting milk with wa- ter. More sophisticated forms of economic adulteration, however, often proved beyond the scope of the statute. Thus, when the government tried to condemn a product that was labeled as "Bred Spread," a fruit spread containing less fruit than jam would normally contain, the court held that the product was not adul-

OCR for page 320
322 J APPENDIX D terated jam, but a truthfully labeled unique product that contained less fruit than jam.3 Debasement of processed foods was sufficiently common that in 1930, at the behest of the canning industry, Congress authorized FDA to establish so- called standards of quality for canned foods.4 These standards established the minimum quality necessary to employ a particular name without declaring the product to be "substandard." Congress sought to comprehensively remedy the defects of the 1906 Act when it enacted the Federal Food, Drug, and Cosmetic Act of 1938.5 In a dramatic departure from the 1906 Act, section 401 of the 1938 Act authorized FDA to promulgate definitions and standards of identity for foods.6 The statutory mandate provides that: Whenever in the judgment of [FDA] such action will promote honesty and a fair dealing in the interest of consumers, [itJ shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity . . . . In prescribing a definition and standard of identity for any food or class of food In which optional ingredients are permitted, [FDA] shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label ....7 Having thus concluded that FDA should be empowered to establish stan- dards for foods, Congress also gave it the authority to enforce any standards it adopted Congress provided that a food would be deemed to be misbranded: If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 401, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard ....8 A food that is not subject to a standard of identity is required to disclose its common or usual name, if there is one, and its ingredients, if it contains more than one.9 Congress also continued the ban, found in the 1906 Act, against imitation foods, declaring a food misbranded "tiff it is an imitation of another food, unless its label bears . . . the word 'imitation' and, immediately Hereafter, the name of the food imitated.'' l Procedural Requirements Although Congress empowered EDA to issue food standards whenever in its "judgment" to do so would promote "honesty and fair dealing in the interest of consumers," it afforded FDA little leeway in the procedures to be followed to adopt a s~ndard.l1 Congress enacted the Federal Food, Drug, and Cosmetic Act 8 years before the Administrative Procedure Act was adopted Thus, the concept of notice and comment nulemaking was essentially alien to Congress

OCR for page 320
APPENDIX D 323 in 1938. Accordingly, Congress mandated, in section 701 (e3 of the Act, that food standards be adopted by formal rulemaking on a record, a process that combines elements of both rulemaking and adjudication.l3 The first step in this process is a proposal to create a standard, issued either by FDA on its initiative or by petition of any interested ~ to FDA. Interested parties may comment on the proposal orally or in writing. After receiving comments, FDA issues an order establishing the standard. Any person who disagrees with the standard may, within 30 days after entry of the order, file objections, stating the grounds therefore, and request a public hearing. The filing of the objections automatically stays the operation of the standard. At a public hearing, both FDA and those opposed to the standard introduce evidence and testimony and witnesses are subject to cross-examination. At the conclusion of the hearing, FDA must issue an order, "based only on substantial evidence of record at such hearing ...." A person who disagrees with this final order can challenge it in the court of appeals. Even setting aside cases of notorious food standard proceedings, such as the one to define peanut butter,l4 the standard-setting process has proved more and more bothersome to FDA over time. FDA IMPLEMENTATION OF FOOD STANDARDS The Traditional Approach Mod standards are a potent force in the marketplace. The 1989 edition of Title 21 of the Code of Federal Regulations contains 257 discrete food standards regulations, some of which cover many foods. (For example, 21 CFR 155.200 establishes a definition and standard of identity for "certain other canned vegetables." In fact, it is a generic standard covering 34 named canned vegetables.) At one time it was estimated that standardized foods account for approximately half of the supermarket bill of the American consumer.l5 There are 19 categories of food standards, although two categories alonemilk and cream, and cheese and cheese products- account for 104 discrete standards. The largest single category of food standards is cheese and cheese products, totaling 73 discrete foods. The large number of standards in this category is probably a reflection of both the dally industry's traditional belief in the use of standards to prevent imitations and competition as well as the facility with which large cheese companies managed to create new standards for their new products in We past. For most of the past 52 years, FDA has enforced the food standards provision of the 1938 Act so as to serve as a disincentive, or at least a discouragement, to product innovation. For much of this period, it has probably done so intentionally, for the "innovation" of 30 years ago was often considered debasement rather than improvement. New products have evolved, however, sometimes by creating new standards and sometimes by adopting new common

OCR for page 320
324 APPENDIX D or unusual names acceptable to FDA. But, there is general agreement (if not evidence) that, until the 197Qs, EDA stood in the way of product innovation. More recent standards have tended to be more broadly drawn, characterizing many ingredients as "optional," thus affording some flexibility in formulation and invoking the statutory requirement that optional ingredients be listed on the .l6 In examining the history of FDA implementation of food shards and related provisions, it is important to remember that the outcome was not mandated by statute nor was it necessarily suggested by public policy. Much of the history of food standards is guided by a narrow enforcement philosophy and by untested assumptions about how consumers will react to product labels. PDA's traditional protectiveness of the use of a s~i~d name as ~ of the name of a Unstandardized food seems to be based, in part, on the theory that the latter would be confused with the former, when it is the very difference between the two that industry is trying to promote. Yet, the early rigidity of food standards was amply supported by the congressional intent. The failure of the 1906 Act to effectively prevent the adulteration of food for economic reasons led to the passage of the food standards provisions in the 1938 Act. According to Congress, the evil to be remedied was that under the 1906 Act, "[tithe Government has had difficulty in holding such articles as commercial jams and preserves and many other foods to the time-honored standards employed by housewives and reputable manufacturers.''l7 Accordingly, the early standards of identity adopted a "recipe" approach. The term "recipe" is used here in a very formal way: the right of a person to vary a recipe to either decrease the quantity of one ingredient and increase the quantity of another, or to substitute for an ingredient temporarily absent from the cupboard, was not provided to food manufacturers. Two objectives explain He FDA's prolonged adherence to its original recipe fonnat (1) a desire to preclude any modifications of basic food formulas that could contribute to consumer deception, and (2) a concern to restrain the growing use in food production of chemical additives if safety had not been demons~ated.l8 The importance of food standards in the marketplace went far beyond the food being sla~i~ FDA broadly interpreted the prohibition against "pur- porting to be" a standardized food. Although a literal reading of "purports to be" might imply an attempt to 'pass off" the substitute as the real thing, FDA took the position that any food, no matter how truthfully labeled, which looked like or tasted like a standardized food 'purported to be" that food. Thus, establishment of a standard essentially outlawed foods similar to the product defined in the standard. In 1941, when FDA established standards for farina products and enriched farina products,l9 it outlawed the sale of a product that had been on the market for over 20 years: farina win vitamin D.20 Since

OCR for page 320
APPENDIX D 325 the product did not contain all of the vitamins specified in the enriched farina standard and the plain farina standard did not permit the addition of any vitamins, FDA argued that the product could not be sold at all. Because avoidance of consumer confusion is one of the goals of the food shards program, the court upheld this claim, stating that "the statutory purpose to fix a definition of identity of an article of food sold under its common or usual name would be defeated if producers were free to add ingredients, however wholesome, which are not within the definition.''21 This extraordinarily strict reading of the statutory provisions can most likely be explained by an inherent distrust on the part of FDA of the ability of consumers to detect differences in food products based on their labeling and by the agency's desire to have a simple black and white test for whether or not a product "purported to be" a standardized food. The statutory ban against imitating another food product without disclosing that fact prominently was another tactic FDA used to protect the traditional ingredients of foods. Interestingly, because the penalty for purporting to be a standardized food is that the food cannot be marketed at all, the first litigated case Involving the imitation prohibition involved an attempt to use it as a sword rather than as a shield. In 62 Cases of Jam v. United States,22 FDA argued that a product labeled as "imitation jam" could not be sold because it "purported" to be jam, a standardized food. "Delicious Brand Imitation Jam" contained only 25 percent fruit, rather than the 45 percent required by the applicable standard of identity.23 The product was sold principally to institutional buyers rather than to consumers. FDA argued that the product "purported to be" ~am, and was not, and thus could not be sold. Although the appellate court age, the Supreme Court did not. The court declined FDA's invitation to read 'purports to be" and "imitation" as coextensive. Section 403(g) [which bans foods that purport to be standardized foods] was designed to protect the public from inferior foods resembling standard products but marketed under distinctive names .... Congress may well have supposed Mat similar confusion would not result from the marketing of a product candidly and flagrantly labeled as an "imitation" food.24 The imitation jam case thus permitted manufacturers to label a food as "imita- tion" and thus deviate from an applicable standard of identity while still using, in part, the standardized name. Because it has been generally believed by in- dustry that the word "imitation" would be the kiss of death in the marketplace, imitation foods have succeeded, if at all, only in institutional settings where consumers do not make the purchase choice and do not see the product label.25 Although FDA "lost" the imitation jam case, it was a Pyrrhic victory for in- dusby. A conjunction of the readings of 'purports to be" and "imitation" led to the following situation: A food that resembled a standardized food could not be sold, regardless of how informative its labeling, unless it called itself

OCR for page 320
326 APPENDIX D "imitation," a form of labeling that told the consumer only what the product was not, and which largely guaranteed that the product would not reach supermarket shelves. FDA's war against "imitation" foods continued to erupt episodically. In 1953, FDA sought to brand as "imitation ice cream" a nondairy product that resembled ice cream in taste, color, texture, and melting properties.26 The product, called Chil-Zert, was conspicuously labeled "not an ice cream" on all four sides of the carton, immediately below the product name. On two sides there appeared the disclaimer "contains no mile or mink fat!" The court agreed with FDA's assertion that Chil-Zert was an imitation ice cream, even though there was no evidence whatsoever that any misleading statements about the product had been made or that consumers would in any way be misled. Incubi, at the time, ice cream was not a standardized food.27 In 1966, FDA sought unsuccessfully to condemn a product labeled as "imitation margarine" which contained less fat than the level required for standardized margarine.28 FDA's argument' that all products made in semblance of butter must be called margarine, was rejected by the court. At the same time Hat the agency was enforcing its expansive view against using standardized names for substitute foods, it was also enshrining substitutes in standards of their own. Perhaps the best-known example of a standardized substitute food is margarine. In the cheese area, for example, there is pasteurized blended cheese, pasteurized processed cheese, pasteurized processed cheese food, pasteurized cheese spread, pasteurized processed cheese spread, and a host of similar products. Presumably, the same agency that believes that consumers would be confused by "nonfat" versions of standardized cheeses expects consumers to know the subtle distinctions between cheese and cheese food or between blended cheese and processed cheese. More obviously FDA has defined ice cream, ice mild (ice cream with less mile fat), and mellorine (the ice cream-like product that may legally contain nondairy fats). FDA's Policy Evolves Two separate developments helped push FDA into resolving the conflicts created by its interpretation of food standards and substitutes for standardized foods. First, improvements in technology and an increased reliance upon pros cessed foods by consumers made possible the development of a gamer variety of foods which had not been traditionally part of the American diet. Second, stardng in the late 1950s and accelerating through the 1960s, there was an in- creasing recognition of the role played by diet in development of certain chronic diseases, especially heart disease.29 The 1970 report of the White House Con- ference on Food, Nutrition, and Health, which summarized the new learning and which criticized FDA's efforts to stigmatize as imitation many new and

OCR for page 320
APPENDIX D 327 healthful substitute foods, helped push PDA to attempt to resolve the simmer- ing conflict.30 In the 1970s, FDA began a concerted effort to ensure that foods were informatively labeled, rather than labeled with terms that revealed what the food was not. In a regulation announcing the agency's policy on common or usual names, FDA both announced the principles it would use in establishing common or usual names for food products (and which industry could use for the same putpose) and sought a way to impose regulatory standards on food products without the elaborate procedures and the commitment of agency resources required in a section 701(e) rulemaking.31 Similarly, in a regulation adopted in 1973, FDA for the first time defined the term "imitation" so that alternative or substitute foods could be formulated in such a way as to avoid the use of that stigmatized term.32 The regulation provides that a food that is a substitute for and resembles another food would be considered an imitation only if it is nutritionally inferior to the food for which it substitutes and resembles. Nutritional inferiority was defined as a reduction in the content of an essential nutrient present at a level of 2 percent or more. Reflecting current thinking, however, a reduction in the caloric or fat content of the food did not signify nutritional inferiority. This regulation permitted manufacturers to produce variants of standardized foods and know that they could do so without running the risk of being branded an imitation. The regulation was upheld against challenge by consumers.33 Having defined objective criteria for avoidance of the term imitation, the agency attempted to apply nomenclature standards evenhandedly to substitutes for both standardized and nonstandardized foods. As one of the participants has described the change: In the early 1970's, FDA made the-decision to apply the same policy in common and usual names to standardized and nonstandardized foods. Previously the Agency had taken a position that any new substitute for a standardized food was required to be labeled as an imitation but a new substitute for a nonstandardized food was not required to be so labeled. Dressings for salad illustrate the impact of this policy. FDA had promulgated a standard for French dressing, 21 C.F.R. 169.115, but not for Italian or Russian dressing. Under its traditional policy a reduced calorie version of French dressing had to be labeled as imitation French dressing, but a reduced calorie version of Italian or Russian dressing could be described as "reduced calorie" Italian or Russian dressing. Under its new policy FDA took the position that the common or usual name for a nonstandardized food could include the name of the standardized food, as long as the difference between the products was made clear .... This new policy was intended to prevent standards of identity from operating as barriers to the development of new food products, especially new versions of traditional [foods] with micronutrient composition modified to meet national nutritional goals. Food

OCR for page 320
328 APPENDIX D producers responded by developing dozens of new products wide a reduced content of calones, sodium, cholesterol and fat.34 By the mid-1970s, FDA's policy had changed so dramatically it was affirmatively stating that "tomato juice enriched with vitamin C" does not purport to be standardized tomato juice,35 that enriched macaroni fortified with protein does not purport to be standardized enriched macaroni36 and that raisin bread, a standardized food, made with appropriately fortified flour could be sold as nonstandardized "enriched raisin bread."37 FDA's Current Policy Many individuals thought that with the decisions and regulations cited above, the then40-year-old dispute on naming nonstandardized versions of standardized foods had ended, but that assumption was wrong. Whether as a result of a conscious change in policy or simply regulation on an ad hoc basis without a written or explicit policy, FDA has once again asserted that the name of a new or modified food depends upon whether it is intended to substitute for a standardized or a nonstandardized food. Ondeed, the current director of the Center for Food Safety and Applied Nutrition said he is not aware that the unified naming policy had ever been FDA policy.38) For example, in a regulatory letter issued on May 1, 1986, FDA argued that a low-fat yogurt sweetened with concentrated fruit juice could not be called "yogurt" because fruit juice was not an acceptable sweetener under the standard of identity.39 Other than the use of a nonrecognized sweetener, the product complied with the standard for low-fat yogurt. FDA recommended that the product be called "low fat yogurt substitute" or "flavor-cultured dairy dessert." To confuse the issue, on November 23, 1988, the agency stated in a letter that it was acceptable to call a food "lowfat yogurt with aspar~ne sweetener."40 While inconsistent with its position 2 years earlier, this opinion appears to be consistent with FDA's current position (see p. 331~. The principal disputes today and in the near future over the use of standard- ized names in nonstandardized food products will involve reduced-calorie and reduced-fat versions of standardized foods. With over 100 food standards gov- erning products with milk fat as a mandatory ingredient and at mandatory levels, "reduced-fat" labeling of standardized foods will continue to occupy a major portion of industry's efforts and FDA's objections. It is important to note that FDA does not object philosophically to all low-fat versions or reduced-fat ver- sions of standardized foods that use the standardized name. Ink, the agency has standardized many such foods itself. One of the more recent standards of identity is that for yogurt, low-fat yogurt, and nonfat yogurt. Most consumers are familiar with nonfat milk, low-fat milk, and milk, each a standardized food. It is only when a manufacturer on his attempts to apply the "low-fat" or "non- fat" terminology to a nonstandardized version of a standardized food and use

OCR for page 320
APPENDIX D 329 the standardized name that FDA objects. FDA's position seems to be that con- sumers would be misled by a nonstandardized, low-fat version of a standardized daily product such as sour cream, but that they are not misled when FDA itself determines the identity of yogurt and low-fat yogurt, for example. The assump- tion implicit in this distinction seems to be that consumers know which foods are s~ardized and which are not, and that that somehow makes a difference. Industry's Views The recent round of FDA hearings on food labeling issues demonstrated that there is no unified industry view on the role of food standards in today's marketplace. Understandably, attitudes appear to reflect the competitive position of the commentator as much as any deep philosophical position. For example, the dairy industry, whose products appear to be most under attack today because of the fat content of those products, takes the most inflexible approach. The recently completed Report and Recommendations of the National Commission on Dairy Policy, an organization of dairy producers created by Congress, proposed that FDA enforce existing food standards "to protect the consumer from fraud and deception" and more strictly enforce the misbranding provisions of the Act, 'particularly with regard to non-standardized foods which purport to resemble foods for which standards of identity or common or usual names have been established.''41 The Commission took issue with FDA's definition of "imitation" as being based solely on nutritional inferiority and asked Congress to define the term imitation "to be applied to any food product that simulates a standardized food.' Cheese makers are bearing the brunt of the consumer's changing attitude toward the value of fat in foods. Unlike the National Commission on Dany Policy, however, the United States Cheese Makers Association has supported the adoption of a system to name fat-modified cheeses by using qualified versions of the standardized name.43 Using a Wisconsin regulation as a model, the Association urged the creation of a general standard for versions of standardized cheeses with reduced mink fat content. That standard would require that the reduced-fat version of the standardized cheese have '1he same or substantially same flavor, texture, and body characteristics" as the standardized product, limit the increase in moisture content to 25 percent above that allowed in the standardized cheese, and require a one-third reduction in milk fat content. The cheese makers also noted: If it is to be the Govemment's policy to encourage Americans to consume less fat, edible products containing less fat must be available to them. A 50 percent or more mills fat reduction requirement makes that virtually impossible in the cheese industry and denies consumers the ability to reduce fat intake and still enjoy and get the nutrition cheese provides.44

OCR for page 320
330 APPENDIX D Without specifying the reduction that should be required, others age with the suggestion that "low-fat" or "reduced-fat" cheeses should be available. For example, Quaker Oats Company noted that FDA should countenance formulation and labeling, for example, of "low-fat cheddar cheese'' with a reduced mink fat content, but with the organoleptic properties of "cheddar cheese." Standards of identity should not stand as a disincentive to production of more healthful foods and ingredients (e.g., soy-based daby alternatives). Moreover, these new innovative products should not be saddled with pejorative names such as "substitute." so long as they are nutridonallv equivalent to the products which they resemble. - _ A C - - --I - 'J ~ The Quaker Oats comment is interesting because it, in some ways, reflects some of the confusion surrounding this issue. Regardless of its past attitudes, FDA has, for at least 15 years, "countenanced" formulation of low-fat cheeses and has not used standards as a disincentive to production of, for example, soy-based dairy alternatives. It is only the last sentence of the quoted comment that addresses the real issue: What are these modified or substitute foods to be called, and what impact will these names have on their acceptability to the consumers the companies are trying to seine? Kraft General Foods (KGF) also endorsed the use of appropriate modifiers with standardized names to describe altered versions of s~ardized foods. KGF asked: "What clearer or more concise method could be used to describe a 'low fat cheddar cheese' except by those very terms? It describes a product with the physical and organoleptic characteristics of cheddar cheese except that it is low in fat."46 The company stated that it supported the existence of food standards, which serve as a benchmark upon which to build modified products, but urged FDA to use sufficient regulatory flexibility to use those standards in a manner that encouraged the development of new, healthier modified products "marketed in terms which will clearly describe the new products in relation to the familiar existing benchmarks."47 Consumer groups, as well, supported those segments of industry that charge that the current system discourages the development of more healthful foods. The Center for Science in the Public Interest (CSPI) charged both that a standardized food name was misleading and that modified products should not be required to bear "unfamiliar or pejorative names."48 CSPI stated that "the current law poses obstacles to updating nutntionally-obsolete standards and to marketing new, more healthful products. I;DA should take steps to encourage the food industry to reformulate and name foods more consistently with current nutritional goals, without violating consumers' expectations about the quality of such foods."49 CSPI also urged FDA to first review the names of standardized foods that include nutritional terms and revise those that no longer reflect contemporary thinking. For example, CSPI objected to the standardized name "low-fat milk," which allows for 2 percent fat, a 50 percent reduction from that

OCR for page 320
332 APPENDIX D Safety and Applied Nutrition, Fred R. Shank, laid out the agency's views on the use of standardized names. FDA has allowed the name of a standardized food in the name of a nonstandardized food when ingredients have been added to the standardized food to make a new food. For example, FDA has countenanced the marketing of '~yogurt sweetened with aspartame," "calcium fortified orange juice," and "tomato juice with added vitamin C." In each instance, the standardized portion of the new food (e.g., the tomato juice "tomato juice with addled vitamin C',) has complied with the applicable standard.55 When a manufacturer chooses to subtract ingredients from the standardized food, thus no longer meeting the standard, FDA's position is that the standard- ized name cannot be used with the simple n~lalificatinn of "nonfat" or "God fat.~,s6 Shank also stated that the existence of standards for yogurt, low-fat yogurt, and nonfat yogurt do not support KGF's position. The use of those modifiers, he noted, is a direct crossover from the standards for milk. Thus, low-fat yogurt is made with low-fat milk. In addition, Shank noted that in standardizing the three yogurts, the agency was simply standardizing the names industry itself had been calling various foods prior to the standard's enactment. Although FDA's position does not seem to satisfy industry today because of the desire to delete or reduce ingredients such as fat from s~ardized foods, it must be recognized that it in fact represents a substantial departure from the agency's traditional interpretation. There is little question that a court following the Quaker Oats precedent would hold calcium-fortified or vitamin C-fortified tomato juice or enriched raisin bread to be illegal as foods that purport to be the standardized food but that do not meet the standard. Similarly, FDA has not mceded at all, despite considerable pressure from some quarters, from its position that nutritional inferiority, and nutritional inferiority alone, is the standard to determine whether a food is an "imitation." Thus, for all practical purposes the issue of imitation foods has been buried and not revisited. It is, as suggested earlier and as recognized by the agency, only in the nomenclature of foods that disputes still exist. Interviews with FDA officials responsible for food labeling decisions reveal that the public confusion and dispute are mirrored by internal disagreement. Just as some daily producers believe that the standards of identity should be enforced as they were in the 1940s, some agency officials believe that any use of the standardized name in a food from which standardized ingredients have been removed is both illegal and wrong. Others recognize that, by and large, the issue is really one of the removal of fat from daily products and are genuinely struggling to reach an agreement as to how modified products should be named. One FDA official, for example, stated that it would be a "violation of the English language" to permit the sale of a product called "nonfat ice ~ ~ ~ , ^~ ,,

OCR for page 320
APPENDIX D 333 cream" because fat is the component that makes milk cream and to produce a "dreamless" ice cream was perceived by this official as not only violating the English language but also debasing the Act. Another senior official, however, said that he had no problem with redefining the English language so long as the result yielded a level playing field. He noted that simply permitting the use of the term "reduced fat" with a name of a standardized food set no standards as to how that reduction in fat could be achieved. When fat is removed from many dairy products, something must be put in its place. The ingredients used to replace the fat can have a substantial impact on the nutritional and organoleptic characteristics of the resulting product. When asked whether the use of defined descriptors such as reduced-fat or low-fat would make it easier to use standardized names, there was again disagreement. Shard stated that since the agency would probably require a 50 percent induction in fat to qualify for Me reduced-fat modifier, he did not believe that that would be a practical alternative for most dairy products. (bile cheese makers agreed with him on this point. See the discussion on p. 329.) On the other hand, when asked whether he would object to the sale of a product called reduced-fat cheddar cheese if that product shared the organoleptic properties of standardized cheddar cheese and achieved the agency's expected 50 percent reduction in fat, he said he would be hard-pressed not to accept it. Another FDA official, however, flatly refused to countenance the use of such a name, although he could provide no reasoned explanation for his position. The agency officials interviewed were unable to articulate a principled distinction between applying descriptors to nonstandardized names and applying them to standardized names. It may be that there are some products, such as ice cream, for which the public perception is so inextricably tied up with the traditional ingredients that descriptive distinctions ultimately fail. Yet, whether or not consumers would be misled by a product called "nonfat ice cream" may depend in part on consumers' expectations when they buy ice cream. If consumers in fact expect to receive flavored cream that is frozen while stirring, "nonfat ice cream" probably would be misleading. If, on the other hand, consumers expect to receive a frozen daily dessert with the organoleptic properties of ice cream, then they may not be disappointed by a product with those properties but with no fat. Similarly, one would probably get different results if one asked consumers whether they would buy ice cream without any cream in it, or ice cream without any fat in it. It is also important to consider whether use of the standardized name as part of a modified food has policy implications or is merely an attempt to "pass off" an inferior product by using the name of a superior product. After all, some venerable substitute products, such as margarine, have developed an identity of their own and are now the object of modified versions themselves. If one believes that consumers will fry more readily a modified standardized food that promises heals benefits if it looks like, tastes like, and is named after that food,

OCR for page 320
334 APPENDIX D then requiring cumbersome names probably does have a marketplace and health impact. (The marketplace impact may simply be the added costs of advertising and promotion to establish the franchise for the food; see p. 335.) Despite the agency's firmly entrenched attitude against sanctioning the use of reduced-fat or nonfat as part of the name of a nonstandardized version of a standardized food, it has, in fact, not always taken vigorous action to prohibit that use. The agency has stated that it does not like the name "reduced-calorie mayonnaise," but that product remains on the market. One company is selling a "Hench nonfat dressing," a name that appears to violate current agency policy, and another company is selling cheddar reduced-fat cheese. Finally, the state of flux in which the agency finds itself on this issue is perhaps best reflected by the fact that it is apparently quite willing to issue temporary marketing permits for the manufacture and sale of altered versions of standardized foods. The agency has issued three temporary marketing permits for "light ice cream," a product whose label declares it to contain "reduced calories" and "reduced fat."S7 Similarly, in 1989 the agency issued six temporary marketing permits for "light" sour cream. The Director of the Center for Food Safety and Applied Nutrition said that the agency is perfectly willing to use temporary marketing permits as a method to bring altered products to the market using the standardized name until such time as a new policy is developed How the existence of a temporary marketing permit means that "light sour cream" is not confusing to consumers when that same name would be, in FDA's view, in the absence of the permit is not apparent. Shank also staled that the agency is seriously considering asking Congress to amend the Federal Food, Drug, and Cosmetic Act to abolish the requirement that food standards be adopted and amended by using section 701(e3 formal rulemaking procedures. He said the agency would be willing to make more changes to food standards if it could do so using notice and comment rulemaking. THE MARKET IMPACT OF FOOD STANDARDS In view of the vast array of foods available in the supermarket today, it is fair to ask whether FDA's attitudes and enforcement priorities have, in fact, hindered the development of new and potentially more healthful food products. Industry observers suggest that in the 1960s, the trade literature contained numerous articles concerning the hindrance to new product development caused by FDA's enforcement attitudes. There is no real evidence that these products could not actually be sold, yet He strongly held belief that a conservative FDA stifled innovation may, in fact, have contributed to stifling innovation. With the changes in the available products brought about by changes in FDA's attitudes in the 1970s, it is clear that companies felt that the law provided more leeway for product innovation and that innovation took place. Promulgation in 197B of FDA's rule on labeling of induced-calorie and low-calorie foods established

OCR for page 320
APPEPIDIX D 335 rules that could help support the naming of altered versions of standardized foods. The availability of products such as low-sugar apricot preserves, low- sugar orange marmalade, and reduced-calorie salad dressing are ample testimony to the perceived consumer market for such products. There is, however, a persistent belief that FDA policy stifles innovation. The clear message of many companies during the food labeling hearings was that FDA's attitude toward the naming of nonstandardized versions of standardized foods was hindering innovation. FDA's Shank believes that "standards have not kept manufacturers from developing more healthful foods. If they can achieve the organoleptic properties [that consumers want], they've been able to come up with names that adequately position the products."58 Shank believes that technological problems in making modified foods are the primary forces that either drive or hinder new foods. 'problems of formulating an acceptable food are a bigger issue than what you call it." Shank's assessment is supported by the development of products such as Simplesse@, a new substitute for dairy fat. Within weeks after its approval, it appealed on the market, replacing the fat in a fat-free ice-cream-like frozen dessert product which reportedly looks and tastes like premium ice cream. Its manufacturer is promoting it by its brand name, Simple Pleasures), and has satisfied the statutory requirement that it bear a common or usual name by calling it "frozen dairy dessert" Of course, with a large enough advertising budget for the first product of its type, it may be that the product would sell, regardless of its name. One of the consequences of limiting the use of standardized names in modified standardized products is that trademarks assume a greater role and enhanced advertising budgets are required. If the common or usual name of the food cannot easily disclose to consumers the alteration that has been accomplished to the standardized food and do so in a manner that is not thought to be counterproductive from a commercial standpoint, it is necessary to create or use trademarks and to advertise them heavily to create a market for the product. The expenditure necessary to create brand recognition means that smaller companies with smaller advertising budgets are less likely to be able to introduce innovative products and that lower-cost generic products are not likely to be created at all. For example, many supermarket chains sell house- brand cream cheese. If such a chain wanted to sell a reduced-fat version of cream cheese in response to perceived consumer demand for lower-fat food, it could not legaRy call the product House-Brand Reduced-Fat Cream Cheese, although that is a name that provides a good idea of what the food is and is not. Without a large advertising budget, it is unlikely that this supermarket chain would try to market the same product as House-Brand Reduced-Fat Spreadable Cheese Product. The use of trademarks and money to circumvent common or usual name requirements can create new problems. Philadelphia brand cream cheese is

OCR for page 320
336 APPENDIX D probably one of the best-known trademarks in the marketplace. Capitalizing upon that franchise, there are now two Philadelphia Light products in He marketplace. One Philadelphia Light is a foil-wrapped cheese packaged to resemble Philadelphia brand cream cheese. Upon superficial examination, most consumers will probably assume that Philadelphia Light is a low-fat or low- calorie version of Philadelphia brand cream cheese. In fact, it is and it is not. Upon closer examination, one can see that Philadelphia Light bears the common or usual name of neutchatel cheese, a standardized cheese whose principal difference from cream cheese is its fat content 59 Once popular in the United States, it has fallen into disfavor in recent years. But the manufacturer, by being able to trade on its well-known Philadelphia trademark, is awe to convey He accurate message that this is a reduced-calorie or reduced-fat version of cream cheese without Funning afoul of He Act. (Generic neutchatel cheese, however, would not have that advantage, and most consumers would not recognize Hat neutchatel cheese is, in fact, a standardized version of reduced-fat cream cheese.) Ocher shopping in He supermarket cheese department would reveal another Philadelphia Light cheese, this one resembling whipped cream cheese in a plastic tub. This Philadelphia Light, however, is called pasteurized process cheese food product and contains cream cheese and low-fat cottage cheese. Where, as here, the brand name intentionally overpowers the common or usual name of the food, one might question whether the need to avoid He use of standardized names in nonstandardized products serves to protect or to mislead consumers. USING FOOD STANDARDS TO IMPROVE THE NUTRITIONAL QUALITY OF FOOD A reduction in the levels of ingredients that are thought to be undesirable is only one way of adapting foods, including standardized foods, to promote a healthier population. Food standards can also be used to encourage the consumption of more healthful ingredients, either by mandating their presence or by providing labeling rules that permit the use of the standardized name in an altered version. In fact, the earliest food standards were emphatically used to help promote nutrition of Americans by encouraging and requiring the addition of vitamins and minerals. In 1940, FDA proposed to establish a standard of identity for flour. Partly in response to the American Medical Association's 1938 recommendation encouraging the fortification of milk, butter, and grain products, FDA developed an enriched-flour standard. Indust~y's voluntary use of enriched flour became widespread, and during World War II it was required. Although these changes sought to correct diseases due to deficiencies, not diseases of affluence, they provide ample precedent of He use of standards of identity to attempt to improve the health of Americans.

OCR for page 320
APPENDIX D 337 Assuming the existence of widespread agreement that fortification with a particular nutrient is desirable, one is still faced with the question of how to achieve it in a standardized food Taking fiber as an example and macaroni and noodle products as the vehicle, one could encourage the consumption of more fiber by amending the standards of identity for various noodle products to require the addition of a specified level of an identified fiber. Alternatively, one could determine that a specified percentage increase in the fiber content of macaroni would entitle that standardized food to be called "high-fiber macaroni" or, perhaps less attractively, "macaroni with X percent added fiber." Since FDA's current policy permits the use of standardized names in nonstandardized foods if one is adding something to a food that otherwise meets the standard, the addition to standardized foods of nutritional components such as fiber is presumably permitted without Fiber regulatory action (assuming, of course, that the fortification did not displace a required level of a mandatory nutrient, such as protein). Food standards could also be used to promote the public health by reducing or eliminating the intake of ingredients thought to be unhealthful. Salt, for example, is an optional ingredient in many canned vegetables and a risk factor for hypertension. As an optional ingredient, its presence is declared (in small typed in the ingredient statement. A strongly proactive health policy might prohibit the addition of salt to standardized foods on the (untested) assumption that, left to their own choosing, consumers would use less salt. Similarly, the minimum fat levels of cheeses could be reduced to the lowest level capable of maintaining the general characteristics of the product. Prohibiting or reducing ingredient levels in standardized foods is likely to arouse considerably more opposition than permitting or encouraging fortification would. And, as discussed below, until procedures to adopt or amend food standards are changed, the commitment of resources that such an approach would require make it unlikely that it will be attempted. ONIONS FOR CHANGE The inconsistencies of FDA's behavior in recent years demonstrate that it has not articulated a coherent and principled body of rules to determine when the name of a standardized food may or may not be used in the name of an altered version of that food. Until such rules exist, it seems likely that decisionmaking will continue to be varied and ad hoc. Also, the agency's apparent abandonment of the view in the 1970s that the rules for naming foods should be the same whether those foods were standardized or nonstandardized should once again be enforced. It is not apparent why the names "low-sodium cheddar cheese" (a standardized food) and "low-sodium havarti" (a nonstandardized food) are nonmisleading to consumers, while "low-sodium Swiss cheese" (a modified version of a standardized food) is misleading.

OCR for page 320
338 APPENDIX D Yet, FDA's concern for the consumers' expectations for a standardized food can be appropriately recognized as well. A regulation to define reduced- fat and low-fat products would go a long way toward making the use of the descriptor appropriate in connection with the name of the standardized food. For example, if reduced-fat always means a one-third reduction in fat, it seems entirely appropriate and nonmisleading to suggest that ice cream made with one-third less fat than that called for in the standard could reasonably be called "reduced-fat ice cream," so long as its organoleptic properties and nutritional content were essentially the same as that of standardized ice cream. (If they were not, the product could be called reduced-fat frozen dessert ~ Similarly, a standardized product such as jam that contains one-third less sugar could appropriately be called reduced-sugar jam without being mislead- ing to the concept of jam. As consumers become more sophisticated and as the agency looks to appropriate descriptors, it may be that the current regulation permitting the use of "reduced-calorie" in connection with the names of nonstan- dardized foods and, perhaps, some standardized foods should be reexamined. A reduction in calories can be accomplished in a number of ways, usually by reducing fat or carbohydrates, and it may be that the price that industry will have to pay for using standardized names should be disclosure of how the reduction in caloric content took place. One alternative would be to permit the use of the descriptors "low" and "non" in connection with a standardized name only when fat, for example, has been removed but not replaced with other ingredients. This is how the various forms of mink are named. Similarly, there seems to be little chance of consumer deception when a totally different characterizing ingredient is used and disclosed- to make an otherwise complying version of a standardized food. For example, the nonstandardized food "goat's milk yogurt" is unlikely to be confused with regular yogurt, which is made with cow's milk. (On the other hand, there is a standard for goat's mild ice cream.) The most difficult problem to resolve is the nomenclature of foods from which both some ingredient has been removed and another has been added to replace it. Also needed are changes in the procedures used to adopt and amend standards. The formal adjudicatory hearing represents what Congress thought was necessary in 1938 to protect the rights of interested parties. For better or worse, today Congress routinely grants regulatory agencies the power to adopt equally important regulations by the less formal notice and comment procedure. It is difficult to explain why adopting and amending food standards should require a more formal and legalistic procedure than, for example, setting the mortgage interest rate on government-insured loans.60 Although formal adjudication is a useful tool to test the validity of rules based on determinable and contested fact, the findings involved in setting food standards are more like policy decisions than objectively verifiable facts. The procedures used to establish and amend food standards should assure

OCR for page 320
APPENDIX D 339 that all policy and factual predicates are recognized, all differing views are acknowledged and responded to, and all decisions are explained adequately. This approach, plus meaningful judicial review, should more than adequately protect the public and private interests at stake. Absent congressional revision of the food standards procedures, FDA could adopt regulations that have the effect of sharply limiting an objector's right to a hearing and thus streamline the procedure administratively. Similar regulations have been issued, and upheld, in the drug withdrawal area,61 and other agencies as well have successfully adopted regulations limiting what otherwise appeared to be an absolute right to a heanng.62 Lest adopting and amending food standards by informal rulemaking be considered a panacea, it should be remembered that recent regulatory reform initiatives and declining budgets have made the issuance of any kind of rule difficult and time-consuming. If informal rulemaking is not the answer, then Congress should consider simply abolishing the food standards provisions of the Act and rely instead upon fully informative labeling and a better educated public to achieve the same consumer protection goals Congress had in mind in 1938. Whatever policy its internal debates ultimately yield, FDA must resolve this issue and test its conclusion in a public forum. Ad hoc decisionmaking is as dangerous to progress as an intentionally negative rule is. The issues raised by to question of the use of standardized names in nonstandardized foods create enough controversy and implicate enough different values that fairness dictates that it be adopted in a public setting conducive to aping and responding to all conflicting views. Finally, FDA needs sufficient resources to enforce whatever naming scheme is ultimately adopted. Consumers are probably most frequently confused when an absence of FDA rules and I;DA enforcement leaves manufacturers to Heir own devices.63 NOTES Act of June 30, 19(16, ch. 3915, 34 Stat. 768, repealed by 52 Smt 1059 (1938~. 2. Id. 7 & 8, 34 Stat. 769. 3. See United States v. Ten Cases Bred Spred, 49 F.2d 87 (8th Cir. 1931~. See generally R. Merrill & E. Collier, "'Like Mother Used to Make': An Analysis of FDA Food Standards of Identity," 74 Colum. L. Rev. 561, 565 (1974) (hereinafter cited as "Merrill & Collier"~. 4. Act of July 8, 1930, ch. 874, 46 Stat 1019. See H.T. Austem, '~he F~-R-M- U-L-A-T-I~-N of Mandatory Food Standards," Food Drug Cosm. L.Q. 559 (December 1947). 5. Act of June 25, 1938, ch. 675, 52 Stat. 1040. It is customary to refer to provisions of the Act by their original section number with a parallel citation to Title 21 of the United States Cod/e, and that practice will be followed here.

OCR for page 320
340 APPENDIX D 6. The Federal Food, Drug, and Cosmetic Act actually authorizes '.the Secretary" to enforce its provisions. Since 1938, "the Secretary" has been, variously, the Secretary of Agriculture, the Federal Security Administrator, the Secretary of Health, Education and Welfare, and the Secretary of Health and Human Services. FDA is a nonstatutory agency, a part of the U.S. Department of Agriculture first, then the Federal Security Administration, then the U.S. Department of Health, Education, and Welfare, and now the U.S. Department of Health and Human Services. For simplicity, this paper uses the term '6FDA" in place of '4the Secretary" and as if it had existed since 1938. 7. Section 401, 21 USC 341. Section 401 also authorized FDA to continue to adopt standards of quality and empowered it to adopt standards of fill of container as well. 8. Section 402(g), 21 USC 342(g). 9. Section 403(1), 21 USC 343(i). 10. Section 402(c), 21 USC 342(c). 11. Section 701(e), 21 USC 371(e). 12. Codified at 5 USC 551 et seq. 13. FDA also received from Congress the authority to adopt rules by a different, less onerous process. Contained in section 701 (a) of the Act, this authority was originally thought to permit the agency simply to issue the kinds of housekeeping rules required to operate any organization, such as the hours it would be open for business, the number of copies of documents to be submitted, and similar matters. With the passage of time, this general grant of housekeeping rulemaking has in fact been interpreted by the agency, with the support of the courts, to be a general grant of notice and comment rulemaking authority. 14. FDA and the food industry argued for 11 years to adopt a standard of identity for peanut butter, with much of that time devoted to the question of whether the food should contain 87 or 90 percent peanuts. FDA prevailed, and peanut butter contains 90 percent peanuts. See generally Merrill ~ Collier, 74 Colum. L. Rev. at 585-591. 15. IdatS61. 16. Section 401, 21 USC 341, authorizes FDA to "designate the optional ingre- dient which shall be named on the label." This has been read to mean that mandatory ingredients need not be listed on the label. 17. H.R. Rep. No. 2139, 75th Cong. ad Sess. 5 (1938~. 18. Merrill ~ Collier, 74 Colum. ~ Rev. at 568. 19. Now codified at 21 CFR 139.110 and 139.115 (1989), respectively. 20. Federal Security Administrator v. Quaker Oats Co., 318 U.S. 218 (1943~. 21. Id. at 232. 22. 340 U.S.593~1951~. 23. Now codified at 21 CFR 150.160 (1989~. 24. 340 U.S. at 600. 25. It is interesting to speculate whether the fact that consumers never saw the imitation jam label was part of PDA's motivation in attempting to outlaw the product. 26. United States v. 651 Cases . . . Chocolate Chd-Zert, 114 F. Supp. 430 (N.D.N.Y. 1953~. 27. The prohibition against imitating a food without prominently labeling it as imitation applies to all foods, not just standardized foods.

OCR for page 320
APPENDIX D 341 28. Unded States v. 856 Cases . . . "Demi," 254 F. Supp 57 (N.D.N.Y. 1966~. 29. See, e.g., National Academy of Sciences, The Role of Dietary Fat in Human Health (1958~; Amencan Heart Association, Dietary Fat and Its Relation to Heart Attacks and Spokes, 23 Circulation 133 January 1961~; American Medical Association, The Regulation of Dietary Fat, 181 JAM4 411 (Aug. 4, 1962~. 30. White House Conference on Food, Nutrition, and Health, Final Report, Report of Panel m-2 at 120 (1970~. 31. Now codified at 21 CFR 102.5 (1989~. 32. Now codified at 21 CFR 101.3(e) (1989~. 33. Federation of Homemakers v. Schmidt, 539 F.2d 740 (D.C. Cir. 1976~. 34. R. Merrill ~ P. Hutt, Cases and Materials on Food and Drug Law at 126 (2d ea.) (in press). Peter Barton Hutt served as Chief Counsel of FDA from 1971 to 1975. 35. 39 Fed. Reg. 31,898 (Sept. 3, 1974~. 36. 43 Fed. Reg. 11,695 (Mar. 21, 1978~. 37. 43 Fed. Reg. 43,456 (Sept. 26, 1978~. 38. Interview with Fred R. Shank, Director, Center for Food Safety end applied Nutrition, Food and Drug Administration (Mar. 23, 1990~. 39. FDA Regulatory Letter No. SEA-86-11, to Parker Hentage (May 1, 1986~. 40. Letter from L. Robert Lake, Director, Office of Compliance, Center for Food Safety and Applied Nutrition, PDA, to Stuart Pape (Nov. 23, 1988~. The author of this letter conceded in a telephone interview that when he wrote the second letter, he recognized that the underlying product yogurtconformed to the standard of identity. 41. National Commission on Dairy Policy, Report and Recon~nendations at 88 (1989~. 42. Id. 43. Comments of the United States Cheese Makers Association, FDA Docket No. 89N-0226 (Dec. 13, 1989). 44. Id. at 5. 45. Comments of the Quaker Oats Company at 12, FDA Docket No. 89N-0226 pan. 5, 1990~. 46. Comments of Kraft General Foods at D-2, FDA Docket No. 89N~226 (Jan. 5, 1990~. 47. Id. 48. Comments of the Center for Science in the Public Interest at 39, FDA Docket No. 89N-0026 (Jan. 5, 1990~. 49. Id at 38. 50. Id. at 39. 51. Comments of the American Public Health Association at 6, FDA Docket No. 89N-0026 Jan. 5, 1990~. 52. Comments of the Chocolate Manufacturers Association and the National Con- fectioners Association at 16, FDA Docket No. 89N-0026 Dan. 5, 1990~. 53. Comments of the Milk Industry Foundation and the International Ice Cream Association at 3, FDA Docket No. 89N-0026 (Nov. 1, 1990~. 54. Letter from Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, to Merrill S. Thompson (Mar. 13, 1990~. 55. Id

OCR for page 320
342 APPENDIX D 56. KGF changed the name of the food in question after receiving this letter. 57. The most recent temporary market permit was noticed at 55 Fed. Reg. 12,736 (Apr. 5, 1990~. See also 55 Fed. Reg. 3772 (Pete. 5, 1990~. 58. Interview with Fred R. Shank, Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration (Mar. 23, 1990~. 59. Now codified at 21 CFR 133.162 (1989~. 60. See, e.g., 38 USC 1803 (setting of interest rates for Veterans Administration loans). 61. The regulations themselves were upheld in Ph~naceutical Manufacturers Ass'n v. Finch, 318 F. Supp. 301 (D. Del. 1970), and their application in a series of Supreme Court cases, USV Pharmaceutical Corp. v. Weinberger, 412 U.S. 655 (1973~; Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973~; Ciba Corp. v. Weu'- berger, 412 U.S. 640 (1973~; and Weinberger v. Hynson, Westcott & Dunning, Irlc., 412 U.S. 609 (1973~. 62. See, e.g., United States v. Florida East Coast R. Co., 410 U.S. 224 (1973~. 63. One author has suggested that FDA use its "enforcement discretion" and establish "action levels" for "selected 'lite' standardized foods." J. Agar, '~Generally Recognized as Sour Cream: Treating Standards of Food Identity as a Success," 44 Food Drug Cosm. L. Rev. 237, 248 (1989~. He argues that the Act contains sufficient discretion that the agency can permit the sale of modified standardized foods that are somehow not legal: '7he analysis suggested in this article does not suggest that honesdy labeled modifications of standardized foods must in all cases be within the law." It is hard to imagine how the statute could be interpreted in such a way that a truthful and nonmisleading food name would be unexceptional from an enforcement standpoint but illegal nonetheless. A policy that cannot be articulated in the Federal Register and defended successfully in court should not govern the future of modified standardized foods.