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5
Comparison and Analysis of Federal and State Food Labeling Requirements

The Committee collected information from the sources outlined in Chapters 2 and 4, first categorizing it according to the six provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) under study and then analyzing it. This chapter presents the analysis of those data with conclusions and recommendations related to the criteria outlined in Chapter 4. The discussion of the six provisions of FDCA Section 403 under study covers current Federal legal authority and regulations, the relationship of provisions to other FDCA misbranding sections and related Federal laws, a review of State and available local statutes, a summary of State, industry and consumer perspectives, and the Committee's conclusions.

COMPLEXITY OF THE ANALYSIS AND COVERAGE

The charge to the Committee was to study State and local food labeling requirements that were not identical to FDCA Sections 403(b), 403(d), 403(f), 403(h), 403(i)(1), and 403(k), as identified in Section 6 of the Nutrition Labeling and Education Act (NLEA). Although this mandate initially appeared straightforward, the nature of the laws and regulations involved and the ambiguities present in NLEA made the Committee's fulfillment of its mandate a complex task.

First, it was not possible in all cases to determine whether a particular State or local food labeling law and/or regulation was similar to one of the specific FDCA sections under study. In numerous instances, State laws and regulations did not address the specific misbranding issues dealt with in the six study provisions. In other cases, State requirements appeared both to require labeling ''of the type" regulated under one or more of the six



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Food Labeling: Toward National Uniformity 5 Comparison and Analysis of Federal and State Food Labeling Requirements The Committee collected information from the sources outlined in Chapters 2 and 4, first categorizing it according to the six provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) under study and then analyzing it. This chapter presents the analysis of those data with conclusions and recommendations related to the criteria outlined in Chapter 4. The discussion of the six provisions of FDCA Section 403 under study covers current Federal legal authority and regulations, the relationship of provisions to other FDCA misbranding sections and related Federal laws, a review of State and available local statutes, a summary of State, industry and consumer perspectives, and the Committee's conclusions. COMPLEXITY OF THE ANALYSIS AND COVERAGE The charge to the Committee was to study State and local food labeling requirements that were not identical to FDCA Sections 403(b), 403(d), 403(f), 403(h), 403(i)(1), and 403(k), as identified in Section 6 of the Nutrition Labeling and Education Act (NLEA). Although this mandate initially appeared straightforward, the nature of the laws and regulations involved and the ambiguities present in NLEA made the Committee's fulfillment of its mandate a complex task. First, it was not possible in all cases to determine whether a particular State or local food labeling law and/or regulation was similar to one of the specific FDCA sections under study. In numerous instances, State laws and regulations did not address the specific misbranding issues dealt with in the six study provisions. In other cases, State requirements appeared both to require labeling ''of the type" regulated under one or more of the six

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Food Labeling: Toward National Uniformity provisions of FDCA Section 403 under study and be either a standard of identity or analogous to other FDCA provisions (eg., imitation, ingredient labeling) for which automatic preemption applied. Finally, some State requirements appeared to be related to both FDCA misbranding provisions, subject to NLEA, and adulteration sections, which are excluded from consideration. Because many State requirements did not fall neatly into only one of the six study provisions, the Committee used its best judgment to classify and review State food labeling requirements under the provision it considered most appropriate. It did not review labeling issues that were clearly outside its charge (e.g., origin labeling, which is regulated by the U.S. Customs Service and the Federal Trade Commission). Based on the legislative history and text of NLEA, the Committee also excluded from its deliberations concerns related to food safety, grading, kosher, organic, natural, and open-date labeling. In addition, the Committee excluded any analysis of emerging State and local regulatory issues (e.g., environmental "green" labeling), although it believes some of these issues deserve consideration by the Food and Drug Administration (FDA; see Chapter 6). It was not surprising to the Committee that many State food labeling requirements fit into multiple provisions of FDCA Section 403 because provisions of the Act itself overlap considerably. For example, a requirement that a food bearing a certain name contain a prescribed amount of a particular food constituent may seem to prescribe a standard of identity at the same time that it constitutes a common or usual name requirement. If the Committee's charge had been only to classify a State food labeling requirement as parallel to one rather than another of the six provisions of FDCA Section 403 under study, which Section was chosen would be of little concern because the implications for preemption would be identical. The Committee recognized, however, that these FDCA provisions have developed over time, beginning with those whose forerunners were contained in the Pure Food and Drugs Act of 1906 [PFDA; i.e., Section 403(b)] and they have been modified by addition rather than by consolidation. Further, from a practical standpoint, it is common FDA enforcement practice to charge violators with violation of multiple FDCA sections. These factors made the Committee's review of FDA requirements and case histories more difficult. However, as discussed earlier, the Committee decided to view its own task broadly: for example, if it was reasonable to view a State regulation as a common or usual name requirement (even if a court might later determine it to be a standard of identity), it was treated as a matter for study by the Committee. Because it was to make recommendations to FDA about which State requirements it should consider adopting, the Committee felt that it would be entirely appropriate to take the broader rather than the

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Food Labeling: Toward National Uniformity narrower approach. To illustrate this view, Appendix H contains a summary of State requirements for names of frequently cited food commodities. The issue is addressed further in the discussion of FDCA Section 403(i)(1) (common or usual names). Finally, the Committee reached all but a very few of its conclusions through consensus. There were several instances in which strongly held views of individual members kept the Committee from reaching complete agreement. When this occurred, the text expresses both views. The Committee's final conclusions on these matters reflect the view of a majority of its members. FOOD UNDER THE NAME OF ANOTHER FOOD-SECTION 403(B) FDCA Section 403(b) states that a food is misbranded "if it is offered for sale under the name of another food." Federal Requirements Section 403(b) is characterized as a general provision of FDCA Section 403, derived from the 1906 PFDA. Among other requirements, the 1906 Act provided that a food shall not be deemed to be misbranded in the case of mixtures or compounds which may be now or from time to time hereafter known as articles of food, under their own distinctive names, and not an imitation of or offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with a statement of the place where said article has been manufactured or produced. Section 403(b) was a noncontroversial holdover from the 1906 Act that represents a generalized statement of the type of requirement that has been expanded in more specific provisions of FDCA Sections 403(g) and (i)(1). The distinction between FDCA Section 403(i)(1) [common or usual names], and Section 403(b) is ambiguous. When FDA has charged manufacturers with violations of FDCA Section 403(b), it has usually done so together with other provisions of FDCA Section 403. The use of multiple sections of FDCA in bringing legal actions reflects, among other things, the duplication among the several misbranding provisions. Section 403(b) also protects against some of the same concerns as those addressed in FDCA Section 402, the economic adulteration provision. The intent of FDCA Section 403(b) is to prohibit the use of misleading names of foods when there is no common or usual name or definition and standard of identity for a food. (For

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Food Labeling: Toward National Uniformity example, a food cannot be labeled as crabmeat if it does not contain crabmeat or contains other fish meat without appropriate labeling.) The case most frequently cited as an example in which FDA relied exclusively on the prohibition basic to Section 403(b) involves apple cider vinegar, brought under the provisions of the 1906 Act. In this action, the government prevailed in its contention that vinegar produced from dehydrated apples and water was not "apple cider vinegar." The court ruled that cider is the expressed juice of apples, both popularly and generally known as such, and the product made from dehydrated apples and water did not represent "apple cider vinegar" U.S. v. 95 Barrels, 265 U.S. 438, 44 S.Ct. 529(1924). Hutt and Merrill (1991) point out the close relationship between FDCA Sections 403(b) and 402(b): Like the economic adulteration provisions, which am essentially designed to prevent the marketing of debased foods, section 403(b) requires a court to identify a standard against which to compare the product involved, i.e., the "other" food that the seized product is charged with imitating. The need for a standard of comparison is common to statutory as well as common law theories that are concerned primarily with "passing off" offenses (p. 53). The need for a standard of comparison was reinforced by the Bireley's orange beverage case [US. v. 88 Cases, 187 F.2d 967 (3d Cir. 1951)], an economic adulteration case. In that case, the government failed to prevail because the product could not be condemned unless there was a confusion with a defined superior product, it was not sufficient for consumers merely to consider that the drink contained more orange than it did. A violation of Section 403(b) could not be found "without a finding that a marketable inferior product is likely to be confused with a specified superior counterpart" (Hutt and Merrill, 1991). FDA has reiterated the language of FDCA Section 403(b) at 21 CFR §101.18(a), but it has not expanded or further elaborated on its meaning. FDA has also exempted selected foods from the general labeling requirements, including Section 403(b). Individually wrapped pieces of candy and other confectionery of less than 0.5 ounce per package are exempt from labeling requirements when the container in which they are shipped is in compliance [21 CFR §1.24(a)(4)]. In addition, eggs packaged in cartons of a dozen that can be divided into two six-egg containers are exempt if the original carton is adequately labeled, even though one of the resulting six-egg containers would not be in compliance [21 CFR 1.24(a)(9)(i)]. In the 1970s, FDA began formally to establish common or usual names for nonstandardized foods as an alternative to the procedurally burdensome process of establishing standards of identity for foods. The protection offered

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Food Labeling: Toward National Uniformity by this process overlaps considerably with FDCA Section 403(b). Today, for example, there is a common or usual name regulation for diluted orange juice beverage (21 CFR §102.32). Part 102 also establishes common or usual names for peanut spreads (21 CFR §102.23) and potato chips made from dried potatoes (21 CFR §102.41), as well as a variety of nonstandardized fish and other products. State Requirements Statements received by the Committee from States focused on enforcement of FDCA Section 403(b). For example, in his letter to the Committee, Ray Niles, Assistant Director of the Consumer Protection Division, Georgia Department of Agriculture, stated that: We fed that the FDCA, as well as title 21 CFR, adequately addresses misbranding of food (name of food under the name of the other), but we also feel there is no enforcement being taken in that area. As an example, soybean "cheese" is sold as cheese. The CFR's define cheese and exclude soybeans. More enforcement action would halt this practice. Another more glaring example of food sold under the name of another food is the failure of FDA to address well or municipal waters sold as "spring water" (Niles, 1991a). Industry Perspective Industry comments reflect the same concerns as those of the States regarding FDCA Section 403(b) and revolve around the use of misleading or fraudulent names for nonstandardized foods. It has been suggested that FDA recently has been less vigorous than in the past in addressing the naming of new foods and the agency should return to its policy of the 1970s by which it established such names. The Grocery Manufacturers of America (GMA) urged the Committee "to review this matter and to recommend that FDA reestablish the policy regarding common or usual names for nonstandardized food that the agency pursued at that time" (GMA, 1991). Consumer Perspective Consumer views of FDCA Section 403(b) coincide with those of the States and industry. Their concern is that the label properly identify the exact nature of the product sold (CSPI/CNI/CFA/NCL, 1991).

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Food Labeling: Toward National Uniformity Conclusions The Committee perceived no major difference among the views of States, industry, and consumer groups on FDA implementation of FDCA Section 403(b), which was perceived as adequate. However, all parties were concerned with FDA's poor enforcement of current requirements or slow establishment of additional common or usual names [FDCA Section 403(i)(1)]. As discussed in Chapter 4, the Committee chose not to include enforcement as a measurement of adequate implementation but concurs with the concerns of these groups related to the establishment of common or usual names (see discussion later in this chapter). Based on its analysis and criteria, the Committee concludes that FDCA Section 403(b) has been adequately implemented. The Committee further concludes that State requirements related to FDCA Section 403(b) am candidates for preemption. To promote the development and Introduction of new foods, however, the Committee suggests that FDA pursue more aggressively the regulatory options that will allow the formal naming of new nonstandardized foods. Additionally, as part of its annual consideration of administrative revisions to FDCA, the Committee suggests that FDA consider consolidation of the objective of FDCA Section 403(b) with that of FDCA Section 403(i)(1). CONTAINER FILL AND DECEPTIVE PACKAGING-SECTION 403(D) FDCA Section 403(d) states that a food is misbranded "if its container is so made, formed, or filled as to be misleading." Federal Requirements From the beginning of deliberations to revise PFDA in 1933, a major legislative goal was to provide stronger regulation to prevent slack fill and deceptive packaging. Throughout the legislative consideration, the "so made, formed, or filled" language was understood to ban "deceptive or slack filled containers." The term "slack fill" refers to the partial filling of a package, even though the actual net quantity of the contents is accurately labeled. The term ''deceptive packaging" refers to the use of a container that is made to appear to have a larger amount of the product than is actually in the container, even though the part of the container designed to hold the product is completely filled and the net quantity of the contents is accurately

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Food Labeling: Toward National Uniformity stated. Deceptive packaging may occur by use of false bottoms, thick side walls, or other structural techniques. The "so made, formed, or filled" provisions of FDCA combined the specific concept of slack fill, which applies only to the level of fill in the immediate product container, and the general concept of deceptive packaging, which applies broadly to all aspects of product packaging. During the five years of Congressional debate on this issue, the language for this section remained unchanged: the term "filled" referred to the problem of slack fill, while the terms "made" and "formed" referred to other kinds of deceptive packaging (Hutt, 1987). Hutt (1987) also provides a description of the implementation of the slack fill and deceptive packaging provisions in FDCA Section 403(d). FDA has the authority under FDCA Section 401 to establish a specific standard for fill of container for particular food commodities and thus prohibit by regulation any nonfunctional slack fill. The agency, in its discretion, however, has determined that this is not a practical way to implement the Congressional policy embodied in FDCA Section 403(d) for all food (although it has done so in many standards of identity). FDA has also decided not to use its discretionary authority to promulgate general regulations governing slack fill under Section 403(d). The agency's argument in both instances is that it is not cost-effective to establish detailed regulations governing nonfunctional slack fill for all food products or specific food product classes; to make any such regulations realistic and supportable would require consideration of the specific characteristics of each of the individual food commodities and types of packaging involved. FDA considers the expenditure of agency resources that would be needed for such an extensive, complex effort highly disproportionate to the size of any problem being encountered in the marketplace. To combat misleading packaging, however, the agency has at its disposal the minimum basic label requirements, such as net weight of container, set forth under FDCA Section 403(e). To date, formal FDA implementation of FDCA Section 403(d) has been limited to a few court cases, all of which the agency lost. It may be that FDA has been successful in pursuing violations that have not resulted in reported decisions by courts; for example, violators may have become compliant before court action was necessary (Hutt, 1987). FDA Trade Correspondence (TC) offers historical evidence of agency rulings regarding specific concerns about slack fill. One such piece of correspondence, dated March 14, 1940, states that " gelatin dessert packages should be redesigned to avoid slack filling and consequent deception" (TC-161); correspondence dated August 20, 1940, notes that " [g]elatin dessert packages, to avoid charge of deception, should provide maximum fill with minimum of

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Food Labeling: Toward National Uniformity unavoidable unoccupied space" (TC-318). The standard adopted in the Arden Assorted Candy Drops case, U.S. v. 116 Boxes, 80 F.Supp. 911, 913 (D.Mass. 1948), was that the court should consider whether the container is "likely to mislead the ordinary purchaser of this type of merchandise, not one who was particularly attentive or prudent." In a case involving slack filled candy bars, U.S. v. Caraldo, 157 F.2d 802, 804 (1st Cir. 1946), the court held that there is no "hard and fast rule as to what would constitute slack-filling," and, therefore, it is a question of fact for the district court to decide. Further, as another court ruled, even if the container may deceive the purchaser into thinking it contains more than it does, the filling of the container may be "justified by considerations of safety" and reasonable in light of possible alternatives. However, the court noted as an example that although "some padding is obviously necessary in egg crates to safeguard the eggs, ... a 2-inch cotton cushion between each of the eggs would not be justified, even though such padding would serve fully the ends of safety,'' U.S. v. 174 Cases (Delson Thin Mints), 287 F.2d 246, 248 (3d. Cir. 1961). Related Sections of Law There is some degree of overlap between the wording of FDCA Sections 403(d) and 403(h), both of which address concerns related to fill of container. As a result, confusion can arise in the interpretation of Section 403(d) by the casual reader. Section 403(d) establishes the general provision that a food shall be deemed to be misbranded "if its container is so made, formed, or filled as to be misleading." On the other hand, FDCA Section 403(h)(2) must be read in context with FDCA Section 401, which authorizes FDA to establish by regulation specific criteria for evaluating the fill of container for certain food products. FDCA Section 403(h)(2) requires that a product be labeled as substandard if it fails to meet the FDCA Section 401 standard. This latter requirement is discussed more fully under FDCA Section 403(h)(2). In addition to the provisions of FDCA, the Federal Fair Packaging and Labeling Act of 1966 (FPLA) provided FDA with additional rulemaking authority [FPLA Section 5(c)(4)] to define nonfunctional slack fin on a commodity-by-commodity basis. To date, FDA has not chosen to promulgate regulations. It is important to note that California believed there is a need for additional consumer protection in this area and has adopted a nonfunctional slack fill provision identical to the language of FPLA (Cal. Bus. & Prof. Code §12606).

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Food Labeling: Toward National Uniformity State Requirements Several State Attorneys General (1991) have suggested that States often take the lead in responding to the public's needs locally in advance of any Federal response. They cited the example of regulation of misleading package containers as an instance in which they believed States were providing such leadership. Some States have enacted laws or promulgated regulations that indicate a different resolution of container fill and deceptive packaging policy issues from that of FDA. Representatives from the Florida Department of Agriculture and Consumer Services (FDACS) cited several examples of commercially available food products that in their opinion are deceptively packaged (Woodward, 1991). In one case, a manufacturer made two varieties of single serving packets of powdered hot beverage mix. The variety that was called "light" contained 40 percent less product by weight, but the size of the envelopes and external package for both varieties were the same. FDACS considers Federal action on deceptive packaging inadequate, especially for products in opaque containers. Likewise, Michigan expressed a need for greater clarity of FDA policies relative to container fill and deceptive packaging. Some State and local jurisdictions have also addressed the matter of "downsizing" of products or "package shorting," the practice of reducing the amount of product in a package while maintaining the same size container. Downsizing is considered an issue of deceptive packaging rather than slack fill. Examples of foods that have been alleged to be downsized by manufacturers include canned tuna fish, coffee, tea, cereals, spaghetti sauce, and soup mixes. New York recently introduced legislation that would require notice of the package change to appear clearly and conspicuously on the principal display panel for at least 6 months from the date the downsizing occurs (AFDO, 1991; Lindan, 1991). In contrast, no Federal regulations deal with the practice of downsizing. The following list outlines State labeling requirements "of the W represented by FDCA Section 403(d): Alabama has enacted specific rules for "fill" of food packages (Ala. Ag. Rule no. 80-1-22-.10). Alaska requires that "a fisheries product is misbranded if ... its container is made, formed, or filled in a manner that is misleading ..." (Alaska Stat. §18-34.160).

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Food Labeling: Toward National Uniformity California prohibits nonfunctional slack fill of containers unless it is (a) necessary to protect the contents of the package or (b) required by the machines used to pack the contents in such packages (Cal. Health & Safety Code §26437). A second California requirement for deceptive packaging which prohibits all nonfunctional slack fill packaging is discussed below (Cal. Bus. & Prof. Code §12606). Connecticut requirements prohibit deceptive packaging or filling of the container by requiring that no commodity in package form shall be wrapped or in a container that is formed or filled to mislead the purchaser as to the quantity or the quality of the contents of the package (Conn. Gen. Stat. §42-115m). Furthermore, the contents of a container shall not fall below such reasonable standard of fill as may have been prescribed for the commodity in question by the Commissioner of Consumer Affairs. Minnesota has established tolerances and variations from the quantity of contents marked on packages. The only allowable discrepancies are those owing to (1) unavoidable errors when weighing the product in compliance with good commercial practices, (2) differences in capacities of bottles and similar containers resulting from unavoidable manufacturing difficulties, or (3) atmospheric conditions (Minn. R. §1550.0480). New Jersey has introduced a State bill which requires that consumers must receive clear and conspicuous label notice for at least six months in instances in which the net weight, measure, or quantity of food in a package has been reduced without a substantial change in packaging (N.J. Bill 4880, pending). Washington requires that any slack filled container shall be conspicuously marked "slack filled" (Wash. Rev. Code §69.28.100). The activities in California to regulate misleading packaging deserve further discussion because the State has chosen to implement FPLA requirements that go beyond FDA requirements. The California Attorney General interpreted the State's slack fill provision as not requiring proof that the slack fill is misleading or deceptive and prohibiting any unoccupied space in cases in which the immediate container is enclosed within an outer retail package (eg., a bottle in a cardboard carton). In Hobby Industry Association of America, Inc. v. Younger , 101 Cal. App. 3d 358,161 Cal. Rptr. 601 (1980), the court upheld the position of the California Attorney General.

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Food Labeling: Toward National Uniformity As so interpreted, this California provision (Cal. Bus. & Prof. Code §12606) is clearly "of the type" covered by Section 403(d), because both address slack fill. The interpretation of Section 12606 appears not to be identical to the Federal interpretation, however, because it prohibits all "nonfunctional slack fill packaging whether or not there is other proof of deception or fraud." The language of FPLA was adopted as the standard by California in developing its State statute. By prohibiting what it considers to be inherently misleading slack fill, California has been particularly aggressive in adopting a unique approach that differs from that of FDA and other States. It may be that other States have not identified this issue as a problem worthy of independent legislative action (GMA, 1991). As the Assistant Director of the Consumer Protection Division of the Georgia Department of Agriculture stated, "We have not encountered problems with container fill and deceptive packaging. If we do, we feel the FDCA is more than adequate if enforced. Sections 101.18 and 101.105 of Title 21 CFR adequately deal with this, but again, lack enforcement" (Niles, 1991a). However, in the view of the State Attorneys General and many other State officials, until such time as FDA promulgates regulations to interpret this section of FDCA, statutes such as California Business and Professions Code Section 12606 and any State statutes dealing with downsizing should prevail (State Attorneys General, 1991). Industry Perspective GMA supports the decision of FDA not to promulgate regulations pertaining to FDCA Section 403(d). The Association's comment to the Committee was that "that determination should stand as the national approach to the matter" (GMA, 1991). A representative of the National Frozen Pizza Institute (NFPI) indicated that, despite FDA's failure to establish violations of FDCA Section 403(d) through litigation, the Institute also believes that FDA has adequately implemented this provision. Support for this argument comes from the fact that the Act requires the net weight statement to appear on every package and, in many cases, FDA has established specific product standards of fin (NFPI, 1991). This same view was held by a representative speaking on behalf of the Quaker Oats Company and Schreiber Foods, Inc. (Quaker Oats and Schreiber Foods, 1991).

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Food Labeling: Toward National Uniformity Prohibitions on Colors, Flavors, and Chemical Preservatives in Specific Foods Minnesota regulations (Minn. Reg. §1550.0620) require that any "salad oil be free of artificial coloration or added ingredients that cause it to appear "a shade of yellow"; the regulations also require that catsup and tomato sauces be free of added artificial color (Minn. Reg. §1550.0850). California prohibits the use of artificial colors or flavors in olive oil (Cal. Health & Safety Code §28481). A prohibition against artificial colors in vinegar exists in Rhode Island (R.I. Gen. Laws §21-22-1 and §21-22-3) and West Virginia (W.Va. Code §19-22-1, §19-22-5 and §19-22-6). Washington prohibits the use of yellow coloring in macaroni (Wash. Rev. Code §69.08.045). The Pennsylvania State Code's Chapter 43, which governs food flavoring materials, states that it is unlawful to add color to vanilla or vanillin flavor and prohibits cider vinegar from containing artificial color (§9921–924). Federal regulations require that artificial flavors, colors, or chemical preservatives be approved by FDA and declared on the label. FDCA Section 403(k) does not specifically prohibit the use of approved colors, flavors, or chemical preservatives in particular foods. It is not clear whether the State regulations noted above are "standards of identity or States are attempting to prevent "economic adulteration." In any case, these statutes appear to require labeling "of the type" addressed by Section 403(k). Label Requirements for Specific Foods Containing Artificial Colorings, Flavorings, and Chemical Preservatives Twenty-two States do not exempt butter and other dairy products from labeling requirements, in contrast to FDCA Section 403(k), which exempts butter, ice cream, and cheese from the required label declaration of colors, flavors, and chemical preservatives.12 12   Alaska Stat. §17.20.04; Ariz. Rev. Stat. Ann. §36-906; Ark. Stat. Ann. §82-1111; Cal. Health & Safety Code §26559; Conn. Gen. Stat. §21a-102; Fla. Stat. §500.11; Ga. Code Ann. §26-2-28-11; Idaho Code §37–123; Kan. Stat. Ann. §28-21-11; Ky. Rev. Stat. Ann. §217.095; La. Rev. Stat. Ann. §608, Mass. 105 CMR §520.118; Mich. Comp. Laws §289.717; Minn. Stat. §33.03; N.H. Rev. Stat. Ann. §146.5; N.M. Stat. Ann. §25-2-11; N.D. Cent. Code §19-02.1-10; Ohio Rev. Code Ann. §3715.60; Okla. Stat. §63-1-1110; R.I. Gen. Laws §21-31-11; Vt. Stat. Ann. §4060; Wis. Stat §97.03.

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Food Labeling: Toward National Uniformity Label Requirements Regarding Quantities of Artificial Colorings, Flavorings, and Chemical Preservatives Minnesota's regulations (Minn. Reg. §1550.0410) require that when two or more mixtures of preservatives are used, the names and percentages of each ingredient must be clearly printed in the order of predominance. They also require that the name and percentage of each ingredient used in oleomargarine be listed and its source revealed (Minn. Reg. §1550.0860). Ohio law requires that soft drink labels specify the name and amount of any preservative used (Ohio Rev. Code Ann. §913.24). Pennsylvania has a similar soft drink requirement (Pa. Stat. §790.7; §790.8). South Dakota requires that "[a]ll foods which contain any preservative, other than those substances specifically mentioned in §39-4-4, ... shall be plainly and conspicuously labeled to show the presence and amount of such preservative" (S.D. Codified Laws Ann. §39-4-5). In contrast, Federal regulations currently do not require that the amount of the preservative used be specified on the label; however, they do require that the common name and function be listed. Label Requirements for Colors, Flavors, or Preservatives in Bulk Foods Several States require that individual "bulk" foods be labeled regarding the use of a food coloring. Minnesota Regulation 1550.0870 requires that the color added to oranges not exceed the average representative natural color that the varietal oranges would have when naturally colored. Each orange and its container must be labeled "color added. California also requires that oranges sprayed with artificial coloring be labeled "color added" (Cal. Admin. Code Title 3, R. 365.3A). Texas requires all citrus fruits treated with "coloring matter" to be marked with the words "color added'' (Tex Agric. Code §95.011 and §95.012; §95.016 through §95.018). FDA only requires that a container or placard disclose the use of artificial coloring [21 CFR §101.22(e)]. Colorado requires the manufacturer of bulk foods sold at the retail level to label products as to the presence of any artificial color, flavor, or chemical preservative (Co. Stat. §25-4-1302). Likewise, Arizona statutes require that bulk foods offered self-service style to consumers include a declaration of artificial color or flavor and any chemical preservatives contained in the product (Ariz. Rev. Stat. Ann. §36-973).

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Food Labeling: Toward National Uniformity Label Requirements for Foods Prepared and/or Served on Premises Chapter 62, Section 23-62-1 of the Rhode Island Truth in Food Disclosure Law requires that a list of all preservatives and artificial ingredients added to food prepared on the premises of all retail preparers of food, including bakeries and restaurants, be available to consumers on request. Section 21a–104a of the Connecticut General Statutes applies to any bulk display of unpackaged foods, including those in a salad bar, offered for sale at any retail or wholesale establishment. The establishment is required to prominently display a sign warning that a particular product contains a sulfiting agent that may cause allergic reactions in some persons. Tennessee requires that food service establishments that treat produce with sulfiting agents post a sign stating that sulfites are used and list the items that are treated (Tenn. Code Ann. §53-8-116). West Virginia requires that hotels and restaurants that use sulfites on salad bars post a sign (W.Va. Code §16-6-22a.11). Maine requires that food prepared at the retail level containing a crystalline form of MSG be labeled as such with the label either next to the nonpackaged food or the food as listed on the menu. Alternatively, the establishment can display a directory referring customers to information about the MSG content of unpackaged foods (Me. Rev. Stat. Ann. Title 22, §2157.13). Other State Labeling Requirements Two States require the labeling of chemicals used in seafood. For example, Maryland requires that each container of crabmeat contain information that a chemical is added (Md. Health-Gen. Code Ann. §21–339). Texas regulations an labeling crabmeat require a designation on the container if a chemical has been added (Texas Health & Safety Code –436.08). Implementation California claims that it has used its State labeling provisions with respect to artificial colors, flavors, and chemical preservatives in ''repeated" and "successful" prosecution of violations to protect consumers from misbranded products (Sheneman, 1991). In general, however, States expressed concern with respect to their continuing ability to enforce existing

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Food Labeling: Toward National Uniformity State regulations and uncertainty regarding their role in enforcement of Federal regulations. Despite the differences between the Minnesota law cited above and Federal provisions, a letter to the Committee from that State expressed no concern about the loss of State laws to Federal preemption (Masso, 1991). Michigan expressed concern about a lack of clarity with respect to labeling of artificial colorings, flavorings, and chemical preservatives (Heffron, 1991). Generally, States with different or more stringent regulations for flavors, colors, and chemical preservatives believe that preemption under NLEA will reduce consumer protection in areas not now addressed by Federal statutes, regulations, or other implementing policies. Industry Perspective Industry comments indicate that most manufacturers consider FDA has adequately implemented the provisions of FDCA Section 403(k) for labeling artificial flavors, colors, and chemical preservatives (GMA, 1991). Given the complexity and detail of the implementing regulations that have evolved over 40 years, industry expressed the view that there is no reason for change. Consumer Perspective CSPI and other consumer groups represented at the Committee's public meeting stated that Federal regulation under FDCA Section 403(k) has been insufficient, citing Connecticut's sulfite labeling requirement as providing greater consumer and health protection than federal requirements (CSPI/CNI/CFA/NCI, 1991). Connecticut requires that a sign be posted on bulk displays of unpackaged foods, such as salad bars, to indicate the presence of sulfites (Conn. Gen. Stat. §21a–1041). Such signs would inform consumers about foods that contain sulfiting agents, which can cause significant health effects in those sensitive to these chemicals. Some citizen petitions also indicated their belief that individual preservatives in foods should be declared on food labels (i.e., Clay, 1981). The consumer representatives cited another example of State regulation related to FDCA Section 403(k) in which the Federal requirement is less stringent: the labeling of MSG when added to foods as an artificial flavor enhancer. While 21 CFR §101.22(h)(5) requires that MSG be identified by its common or usual name, other provisions of the Federal regulations create exceptions to this rule. Section §101.22(h)(1) permits the term "natural flavor" to be used for foods that contain up to 20 percent added

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Food Labeling: Toward National Uniformity MSG. While such practices do not violate Federal regulations, consumers argue that those sensitive to MSG do not have the information they need to make informed purchasing decisions. Conclusions FDA regulations do not require that many added colors, flavors, and chemical preservatives be listed by their specific names on the ingredient listing but rather by generic names established for particular categories of ingredients. Thus, most flavors, colors, and spices need not necessarily be listed individually, which has been a long-standing source of debate between consumers and industry. Consumer groups argue that this type of generic labeling does not provide them with the information necessary to determine precisely the ingredients contained in a given product. On the other hand, more extensive labeling might crowd out other important information on the label. In addition, industry is reluctant to provide such information because it could reveal trade secrets. These arguments are now moot in regard to certified colors because NLEA requires that they be individually listed in the ingredient statement [NLEA Section 7(3)]. It appears that State requirements with respect to flavorings, colorings, and spices are frequently written in a way that combines the concepts of misbranding under FDCA Section 403(b) and economic adulteration under FDCA Section 402(b)(4). The latter section states that a food is adulterated if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. As a result, for many State labeling requirements for additives, colors, and chemical preservatives, there are not clear delineations among economic adulteration, health and safety issues, and misbranding requirements. It is clear, however, that State statutes and regulations that specifically address issues of adulteration, in contrast to misbranding, are not preempted under NLEA. This lack of preemption of adulteration provisions [NLEA Section 6(a)] would apply especially to any requirement respecting a warning statement in the labeling of food concerning the safety of the food or component of the food. Before passage of NLEA, FDCA provided that colorings need not be declared by their common or usual name but could be designated by the collective term "colorings" [FDCA Sections 403(g) and (i)]. NLEA amended FDCA Section 403(g) with respect to colorings, so that after May 8, 1993, only colorings for which FDA does not require certification under FDCA Section 706(c) will be exempt from label declaration by their common or usual name. Although NLEA did not change the requirements for spices and

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Food Labeling: Toward National Uniformity flavoring or noncertified colors, FDA is encouraging firms to voluntarily declare spices by name when they are added to food. With respect to flavorings, the agency is continuing to support the exemption from required declaration, but voluntary declaration of noncertified coloring has been proposed (FDA, 1991a). In the proposed 21 CFR §101.22(k) of June 21, 1991, the agency also recommended that manufacturers voluntarily declare all colorings in butter, cheese, and ice cream to provide consumers with more consistent information (FDA, 1991a). Further, the proposed regulations make clear that hypoallergenic foods and infant foods are subject to the labeling requirements of 21 CFR §105.62 and §105.65, which require the declaration by common or usual name of all ingredients including flavorings, colors, and spices. The proposed 21 CFR §101.22(k) also deals with the labeling of protein hydrolysates used for flavor-related purposes. FDA's current regulations state that when the specified hydrolyzed vegetable proteins are used as ingredients in a fabricated food, they may be declared as "salt and hydrolyzed vegetable protein" (21 CFR §101.35). Moreover, the agency has stated that because protein hydrolysates are considered flavor enhancers and not flavorings, they must be declared by their common or usual name in the ingredient list when used in foods. Despite the existence of 21 CFR §101.35 and the agency's stated position, some manufacturers have taken the view that when protein hydrolysates are added to food as flavorings, they need not be declared by name in the ingredient list. Instead, these ingredients may be listed as flavor or natural flavor. The agency has proposed to add a new Section (h)(7) to 21 CFR §101.22 to require that any protein hydrolysate used for flavor-related purposes in food be specifically declared in the ingredient list, because these ingredients function in foods both as flavors and flavor enhancers. In addition, because the source of a protein hydrolysate has a significant effect on its properties, inclusion of the source in the name is essential to meet the requirements of 21 CFR §102.5(a). The agency also considered the potential for adverse reactions to glutamates and MSG, which are components of protein hydrolysates. Because MSG, as it occurs in protein hydrolysates, is a component of these ingredients and not itself an ingredient, it is not subject to the ingredient declaration requirement of FDCA. The agency does not believe that scientific evidence exists to establish that MSG causes particularly severe adverse reactions or support the claim that reactions that occur at low doses are life-threatening. Therefore, FDA has proposed—as a tentative decision-that it will not require the declaration of MSG in protein hydrolysates

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Food Labeling: Toward National Uniformity (FDA, 1991). The Committee is aware that the labeling of glutamate is a safety issue and not preempted under NLEA. The requirements of Section 6(a)(2) and Section 7 of NLEA will have a direct impact on the requirements of FDCA Section 403(k) and parallel State requirements. However, in light of the proposed regulatory changes to 21 CFR §101.22, and FDCA Section 402(c) on adulteration is not preempted by NLEA (health-related warnings are exempt from preemption), many issues addressed by specific State regulations will either be covered by the proposed implementing rules or not be subject to preemption under NLEA. The concerns of the consumer representatives reflect a mixture of safe and misbranding issues and may represent a need for additional statutory authority and enforcement (Chapter 6). To the extent possible, FDA should provide guidance to States and industry in determining whether a State requirement is related to FDCA Section 403(k) or a requirement under the State adulteration provisions, with respect to "health-related" warnings. Based on its analysis, criteria, and current FDA regulatory activity, the Committee concludes that FDCA Section 403(k) is adequately implemented. The Committee further concludes that State labeling requirements related to FDCA Section 403(k) are candidates for preemption. REFERENCES AARP (American Association of Retired Persons). 1986. Truth About Aging: Guidelines for Accurate Communications. Washington, D.C.: AARP. AFDO (Association of Food and Drug Officials). 1984. Uniform State Bottled Water Code. York, Pa.: AFDO. AFDO (Association of Food and Drug Officials). 1991. Statement of R.D. Sowards, Jr., AFDO, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Clay, N. 1981. Citizen petition to the Food and Drug Administration, no. 81P-0330. October 12, 1981. Rockville, Md.: Dockets Management Branch, FDA. Crawford, B., Florida Department of Agriculture and Consumer Services. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 5. CSPI/CNI/CFA/NCL (Center for Science in the Public Interest, Community Nutrition Institute, Consumer Federation of America, and the National Consumers League). 1991. Statement of Sharon Lindan, Assistant Director for Legal Affairs, CSPI, on behalf of CSPI/CNI/CFA/NCL at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Davis, C.F., Maine Department of Agriculture. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. Sept. 3. Dunsmore, G.M., Vermont Department of Agriculture. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 15.

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Food Labeling: Toward National Uniformity Englender, S.J., Arizona Department of Health Services. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 9. Eakin, S.B., Public Policy Consultant. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. Dec. 5. FDACS (Florida Department of Agriculture and Consumer Services). 1991. Statement of Bob Crawford, Commissioner, FDACS, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. FDACS/FDC (Florida Department of Agriculture and Consumer Services and Florida Department of Citrus). 1991. Memoranda outlining the impact of national uniform food labeling on the Florida Citrus Code. March 25 and Oct. 15. FDA (Food and Drug Administration). 1973a. Bottled Water, Proposed Quality Standards. Fed. Reg 38:1019–1020; Jan. 8. FDA (Food and Drug Administration). 1973b. Food Labeling; Imitation; Proposed Rule. Fed. Reg. 38:2138–2139; Jan. 19. FDA (Food and Dmg Administration). 1975. Quality Standards for Bottled Water; Final Rule. Fed. Reg. 40:21932–21934, May 20. FDA (Food and Drug Administration). 1993. Food Labeling; Use of the Term Imitation; Proposed Rule Related. Fed. Reg. 48:37665–37666; Aug. 19. FDA (Food and Drug Administration). 1988. The Fish List—FDA Guide to Acceptable Market Names for Food Fish Sold in Interstate Commerce. Washington, D.C.: Government Printing Office. FDA (Food and Drug Administration). 1991a. Food Labeling; Declaration of Ingredients; Proposed Rule. Fed. Reg. 56:28591–28636; June 21. FDA (Food and Drug Administration). 1991b. Food Labeling; Declaration of Ingredients; Common or Usual Name for Nonstandardized Foods; Diluted Juice Beverages; Proposed Rule. Fed. Reg. 56:30452–30466; July 2. Frank, R.L., Olsson, Frank and Weeda, P.C. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. Oct. 16. GMA (Grocery Manufacturers of America). 1991. Statement of Sherwin Gardner, Vice President, Science and Technology, GMA, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Harris, A. 1983. Growers in Valdalia savor the sweet success of their onions. Washington Post p. a16. July 3. Heffron, E.C., Michigan State Department of Agriculture. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 11. Hutt, P.B. 1987. Development of Federal law regulating slack fill and deceptive packaging of food, drugs, and cosmetics. Food Drug Cosmetic Law J. 42:1–37. Hutt, P.B. 1989. Regulating the misbranding of food. Food Technol. 43(9):288–295. Hutt P.B., and Merrill, R.A. 1991. Food and Drug Law: Cases and Materials. 2nd ed. Westbury, N.Y.: Foundation Press. KGF (Kraft General Foods). 1991. Statement of Merrill S. Thompson, Special Counsel, Arnold & Porter, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Lindan, S., Assistant Director for Legal Affairs, Center for Science in the Public Interest. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 5. Lorman, A.J. 1990. Food standards and the quest for healthier foods. Pp. 320–342 in Nutrition Labeling: Issues and Directions for the 1990s. Report of the Committee on the Nutrition

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Food Labeling: Toward National Uniformity Components of Food Labeling, Food and Nutrition Board, Institute of Medicine. Washington, D.C.: National Academy Press. Masso, T.W., Minnesota Department of Agriculture. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. Sept. 10. McClellan, D., Utah State Department of Agriculture. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 8. Nebe, J.L., Nevada State Department of Human Resources. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 3. NFERF (National Fisheries Education and Research Foundation). 1991a. Position on Use of FDA Compliance Policy for Naming Seafood Products. Washington, D.C.: NFERF. NFERF (National Fisheries Education and Research Foundation). 1991b. The Retail Seafood Identity System. Washington, D.C.: Government Printing Office. NFPI (National Frozen Pizza Institute). 1991. Statement of Eugene Welka, President, NFPI, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Niles, R., Georgia Department of Agriculture. 1991a. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. June 17. Niles, R., Georgia Department of Agriculture. 1991b. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. Sept. 24. NDMA (Nonprescription Drug Manufacturers Association). 1990. Voluntary Codes and Guidelines of the OTC [Over the Counter] Medicines Industry. Washington, D.C.: NDMA. NDMA (Nonprescription Drug Manufacturers Association). 1991. Label Readability Guidelines. Washington, D.C.: NDMA. Otwell, W.S. 1985. Florida Seafood Regulations and Regulators. Florida Seagrant College Program, Report No. 72. Gainesville, Fla. University of Florida. Prakash, S. 1991. Looking to ride a bottled water wave. Washington Post Business, March 16. p. 3. Quaker Oats and Schreiber Foods. 1991. Statement of Richard L. Frank, Partner, Olsson, Frank and Weeda, P.C., on behalf of the Quaker Oats Company and Schreiber Foods, Inc., at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 30. Rudd, J., Arizona Consumers Council. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 15. Schaffer, G., Connecticut State Department of Consumer Protection. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. May 28. Senger, K., South Dakota Department of Health. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 8. Shank, F.R. Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration. 1991. Testimony of Fred R. Shank before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce, U.S. Congress. April 10. Sheneman, J.M., California Department of Health Services. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 12. State Attorneys General. 1991. Statement of Attorneys General of the States of California, Iowa, Minnesota, Missouri, New York, Texes, and Wisconsin to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine , Washington, D.C. May 30.

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Food Labeling: Toward National Uniformity Tamura, M, Hawaii State Department of Health. 1991. Letter to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. June 27. Van Wagner, L.R. 1991. Crackdown on misleading labels. Food Processing 52(3):8–12. Wiesenberga, A. 1991. The pocket guide to bottled water. Contemporary Books, Chicago, III. Woodward, B. 1991. Presentation by Betsy Woodward, Chief, Food Laboratory, Division of Chemistry, Florida Department of Agriculture and Consumer Services, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C. July 30.

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