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Food Labeling: Toward National Uniformity (1992)

Chapter: 5 Comparison and Analysis of Federal and State Food Labeling Requirements

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Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

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).

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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).

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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).

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

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.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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).

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

Consumer Perspective

Consumer groups stated that the absence of Federal regulations and very few Federal enforcement actions under FDCA Section 403(d) are evidence that Section 403(d) is not being adequately implemented by FDA. In fact, these groups believe that, taken together, this lack of FDA action is yet another example of the "federal government's failure to implement the law adequately" (CSPI/CNI/CFA/NCL, 1991).

One consumer group, the Center for Science in the Public Interest (CSPI) stated that

the language of the [FDCA] lacks specific guidance as to what constitutes a misleading container, making it extremely difficult to prosecute violations without adequate regulations. In fact, the FDA has not initiated a caw under this section of the [FDCA] in over 30 years (the last case initiated under Section 403(d) was brought in 1959) (Lindan, 1991, p. 3).

Further, CSPI and other consumer groups support legislative initiatives, similar to that proposed by New York, to prevent downsizing of packages by food manufacturers (CSPI/CNI/CFA/NCL, 1991).

Conclusions

The deliberations of the Committee regarding FDCA Section 403(d) were among its most extensive. The Committee found that notwithstanding FDW's decision to rely solely on the statutory provision of Section 403(d) and generally ignored the section, only a few States have taken independent action to establish their own requirements for slack fill and deceptive packaging. Yet, at the same time, a wide divergence of views exists among State officials, industry, and consumer groups regarding the adequacy of FDA's regulatory program. Consumer groups believe strongly that this provision of the law is not being adequately implemented whereas industry groups strongly believe that implementation of this Section is adequate. State officials provided the Committee with several examples of packages of food products that are currently being marketed, and represent, in their view, objectionable packaging practices that have occurred under FDA's current policies.

The Committee was impressed by the examples of packaging provided by State officials; such examples also lent support to the strong positions taken by consumer groups. The Committee recognized that FDA's lack of success in bringing actions (FDA has lost all court cases pertaining to slack fill) may have influenced the agency's efforts in this area. Moreover,

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

relatively few States have established more specific requirements related to slack fill and deceptive packaging, suggesting a satisfaction on their part with Federal requirements as established by Section 403(d).

Ultimately, two divergent views emerged within the Committee as well. One view was that, in the absence of evidence of a meaningful level of consumer deception, it is inappropriate to suggest that FDA expend limited resources to issue regulations to solve a problem that can be addressed adequately under present law. The examples of deceptive packaging presented to the Committee that had the most vivid impact could have been addressed quite readily under current law. Since the Committee concluded that enforcement would not be examined as an element of adequacy, new regulations should not be suggested on the basis of FDA's decision not to enforce present law more aggressively.

The alternative view was that deceptive or slack filled containers are to be considered a matter of national importance and the perception on the part of State officials and consumer groups that there is a problem supports that conclusion. It was the position of some Committee members that FDA might have been more successful in subsequent litigation had its policies and expectations of industry been adequately enunciated following the loss of the cases noted above. The matter was finally resolved by expressing the majority view of the Committee; the results are apparent in the following conclusions.

Based on its analysis and criteria, the Committee concludes that FDA implementation of FDCA Section 403(d) has not been adequate and that no single States requirement is adequate for adoption as a Federal requirement Given the California experience as an example, the Committee would argue that FPLA language provides FDA with a means to implement the intent of FDCA Section 403(d). Therefore, the Committee suggests that FDA consider using the FPLA definition for nonfunctional slack fill as a guide for interpreting and enforcing FDCA Section 403(d). The Committee further concluded that State requirements related to FDCA Section 403(d) be exempted from preemption until a formal FDA policy is in place.

PLACEMENT OF REQUIRED INFORMATION-SECTION 403(F)

FDCA Section 403(f) states that a food is misbranded

if any word, statement, or other information required by or under authority of this act to appear on the label or Labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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Federal Requirements

FDA's regulations implementing FDCA Section 403(f) are found at 21 CFR Part 101. Specific regulations include the placement of mandatory information (eg., product name, net weight, ingredients, name and address of manufacturer, etc.) and specifications for type size.

Section 101.1 — Principal Display Panel

The principal display panel "shall be large enough to accommodate all the mandatory label information required ... with clarity and conspicuousness and without obscuring design, vignettes, or crowding." This section also defines the location and size requirements for the PDP. A minimum type size of 1/16 inch is required for all information appearing on the principal display panel.

Section 101.2 — Information Panel

The information panel shall be "immediately contiguous and to the right of the principal display panel." A minimum type size of 1/16 inch is required for all information appearing on the information panel.

Section 101.3 — Identity Labeling of Food

The "statement of the identity of the commodity" shall be a primary feature on the principal display panel. This section defines prominence of the statement size and location on the panel.

Case Law

The Committee found only three Federal court cases that interpret FDCA Section 403(f). In U.S. v. 46 Cases, 204 F.Supp 321, 323 (D.R.I. 1962), the court held that a manufacturer would be in compliance with FDCA Section 403(f)

in a particular case if [its label] statements are prominent enough to be seen and understood by the ordinary individual who is interested in discovering and learning the information disclosed them-by, and who makes a minimum examination of the package to determine its net weight and the ingredients of the (food) contained in said package.

The required statements in this case were printed on the label in a distinctive color that was not used for any other statements appearing on the

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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package, and easily readable at a distance of approximately 29 inches by an average person. The manufacturer thus met the requirements of Section 403(f).

In contrast, when required information cannot be read without the aid of a magnifying glass, U.S. v. 70 Gross Bottles, Civ. No. 2365 (S.D. Ohio 1952), or it is printed in such small type on such a background as to be practically invisible, U.S. v. 274 Boxes, No. 14769 (D.N.J. 1950), the food is considered misbranded under FDCA Section 403(f).

State Requirements

At least 34 States have misbranding regulations that pertain to prominence, and the Committee identified a total of 96 State regulations and 2 pending bills. The great majority (78.1 percent) of State prominence regulations are targeted to specific foods, such as oleomargarine, and require that a product prominently and conspicuously place required information on the label. Most often, the required information specifies the exact nomenclature, such as "oleomargarine" or ice milk," to be placed on a product's label. Required type size and font are often specified in State regulations.

Dairy Products—Substitutes

Dairy product substitutes account for the largest group (a total of 48) of State regulations establishing prominence requirements. These regulations primarily establish specific product nomenclature that must appear on the product's label following specific criteria.

Eighteen States have regulations on oleomargarine/margarine.1 Many States require a minimum type size, and some even require a specific type font. In Indiana, for example, the name must be in plain Gothic letters of

1  

Ark. Stat. Ann. §20-59-201, §20-59-306; Cal. Food & Agric. Code §39471, §39501, §39521, §39382, §39411, §39432; Colo. Rev. Stat. §35-24-115; Conn. Gen. Stat. §21a-16; Del. Code Ann. Title 16, §3310; Iowa Code §191.2, Idaho Code §37-328, §37-331 to 37-332b, §37-333; Ind. Code §16-1-34-3; Kan. Stat. Ann. §65-639; Mass. Gen. Stat. Ann. §49; Mich. Comp. Laws §12,742; Minn. Stat. §33.06; Miss. Code Ann. §75-31-21; Nev. Rev. Stst. §584.165, §584.170, §584.175; N.Y. Agric. & Mkts. Law §62, Pa. Cons. Stat. Ann. Title 31, §800-4b; Vt. Stat. Ann. Title 6, §3441 and 3442; WiL Stat. §97.18.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

a type size not less than 20 points. An additional 12 State regulations focus on renovated or substitute butter, most often specifying type size and font.2

In Mississippi, as an example, renovated butter must be marked as such in plain Gothic letters at least 3/8 inch high on two sides of each container (Miss. Code Ann. §75-31-17, §75-31-423). Alabama requires substitutes for butter to declare ''substitute for butter" in black Gothic letters not less than I inch high and I inch wide (Ala. Code §2-13-17). There are 18 other State regulations that establish labeling requirements for reduced fat cheeses, ice milk, skim milk, nondairy products, or products in semblance of frozen desserts.3

Blended Products

Twenty State regulations have been issued pertaining to the nomenclature and labeling of blends or mixtures. Seven State have prominence regulations for honey products.4 Three States regulate oils that are mixtures or blends (Cal. Food & Agric. Code §28475 to 28478, §28480 to 28482, §28484 to 28486; Mass. Gen. Stat. Ann. §61; 7 Pa. Code §47.2 and 47.3). For example, California's olive oil regulation has specific requirements on the declaration required for any olive oil blended with other edible oils. Three States have prominence regulations on blended vinegars (Mass. Ann. Laws Ch. 94, §186 and 187; Minn R. 1550.0640; N.Y. Agric. & Mkts. Law §209).

The six remaining prominence regulations regarding blends or mixtures vary in scope and effect.5 In Massachusetts, for example, any maple product sold that consists of maple syrup in combination with other ingredients must be labeled with a statement in which all the ingredients appear in the same size type as the words "maple syrup" (Mass. Gen. Stat. Ann. §36C).

2  

Ala. Code §2-13-20; Conn. Gen. Stat. §21a-20; Idaho Code §37-328, §37-331 to 37-332b §37-333; Mass. Gen. Stat. Ann. §59; Miss. Code Ann. §75-31-17, §75-31-423; Mo. Rev. Stat. §196.775; N.H. Rev. Stat. Ann. §184.47; Utah Code Ann. §4-3-14.

3  

Ala. Code §2-13-17; Ark. Stat. Ann. §20-59-235; Ariz. Rev. Stat. Ann. §3-326, §36-906.14; Cal. Food & Agric. Code §39151, §39152, §39181, §39211, §39213; Fla. Stat. §503.011, §503.031, §503.062; Idaho Code §37-326; Minn. Stat. §32.62, §32.481, §32.5311; Minn. R. 1550.0620; N.D. Cent. Code §4-30-41.1 to 4-30-41.3; N.H. Rev. Stat. Ann. §184.52, Or. Rev. Stat. §621-425; Pa. Code §61.65; Vt. Stat. Ann. Title 6, §2811.

4  

Ala. Code §2-13-121, §1-13-122 Conn. Gen. Stat. §22-181a; Mont. Code. Ann. §50-31-204; N.Y. Agric. & Mkts. Law §205 and 206; 31 Pa. Stat. §382; Tex. Agric. Code §131.011, §131.081 to 131.084; Washington Rev. Code §69.28.400.

5  

Iowa Code §189.11; Mass. Gen. Stat. Ann. §36C; Minn. R. 1550.0600; S.D. Cod. Laws Ann. §39-4-15; Vt. Slat. Ann. Title 6, §493; W.Va. Code §16-7-2.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×
Disclosure of Colors, Flavors, and Preservatives

The Committee identified five States that have issued specific regulations on the prominent disclosure of any artificial colors, flavors, or chemical preservatives in food products.6 This area duplicates several Federal and State requirements related to FDCA Section 403(k). For example, Pennsylvania requires nonalcoholic beverages with artificial colors, flavors, or sweeteners to be conspicuously labeled as such (31 Pa. Code §790.7), and requires that added color in food be conspicuously declared on labels using such phrases as "artificially colored," "certified color added," "vegetable dye added," or "color added'' (7 Pa. Code §43.5).

Other Prominence Regulations

Thirteen other State regulations require the prominent labeling of various kinds of product information.7 Minnesota, for example, has regulations (Minn. R. 1550-0920) requiring products of substandard quality or below standard of fill to include statements to that effect in a prominent manner that parallels Federal requirements under FDCA Section 403(h) (see the later discussion).

Connecticut and Pennsylvania (Conn. Gen. Stat. §42-115j-6; Pa. Cons. Stat. Ann. Title 31, §4) set forth general requirements for placement and prominence of required information. All information required to appear on a package in Connecticut must be prominent, definite, and plain; the statute also requires that it be conspicuous as to size and style of letters and numbers, and the color of the letters and numbers contrast with the background color. In Pennsylvania, a wide variety of required messages must be located on the main label of each package, in type not smaller than 8-point Brevier capital letters.

6  

Ariz. Rev. Stat. Ann. §36-973; Minn. R. 1550-0870; 7 Pa. Code §43-5; 31 Pa. Stat. §790.7; S.D. Cod. Laws Ann. §39-4-5.

7  

Conn. Gen. Stat §42-115j-6; Haw. Rev. Stat. §328-41, §328-47, §328.62; Iowa Code §190.11; Mass. Ann. Laws Ch. 94, §117G; Mass. Gen. Stat. Ann. §154 and §155; Minn. R. 1550. 0920; Minn. Stat. §28.07; NJ. bill no. 4880 (pending); N.Y. Agric, & Mkts. Law §211; N.Y. Senate bill no. 5081 (pending), Assembly no. 7296 (pending); Pa. Com Stat. Ann. Title 31, §4; Tex health & Safety Code Ann. §436.08; Wash. Rev. Code §69.28.100; Wis. Stat. §97.57.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

Industry Perspective

Although numerous industry representatives stated their belief that FDA has adequately implemented the six provisions of FDCA Section 403 under study, only the NFPI specifically noted that FDA had more than adequately implemented FDCA Section 403(f). The Institute stated that the agency ''has established a regulation expressly governing minimum typesize for product label features. FDA also specifies throughout the regulation where certain information must appear and that information must appear together" (NFPI, 1991).

Consumer Perspective

The Center for Science in the Public Interest (CSPI) stated in a letter to the Committee that "[w]hile [Federal] regulations address many important issues, they are insufficient ... [T]he regulations do not address other problems with the format of required label information which make the label difficult to read. For example, the regulations do not address the problems of writing that is in all capital letters or that has a flush right margin" (Lindan, 1991).

Conclusions

In its analysis of this Section, the Committee concluded that FDA's regulations utilize a balance of location, continuity, size, and ink color to establish standard and predictable formats for food labeling.

Based on its analysis and criteria, the Committee believes that most of the State regulations related to FDCA Section 403(f) are designed to protect specific industries (see criterion 4, Chapter 4). Many of the products for which requirements exist we substitutes for products of special economic importance within a State. None appeared to meet a legitimate specific local consumer need, thereby qualifying them as candidates for exemption. As an example (although many of these requirements may now be preempted), some State prominence regulations require the use of pejorative terms (i.e., "imitation low-fat frozen desserts), which might deter consumers from purchasing the foods. This requirement conflicts with current public health efforts to encourage Americans to purchase and consume lower-fat products. Where not preempted, State requirements of this type should be discouraged by FDA. Based on its analysis and criteria, the Committee concludes that FDCA Section 403(f) Is adequately implemented. The Committee further

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

concludes that State requirements related to FDCA Section 403(f) are candidates for preemption.

One general principle that FDA should consider adopting relates to the specificity that often characterizes State prominence regulations, including specific requirements for minimum type size, font, and contrasting colors for background versus print of required material. These specifics eliminate ambiguity about possible violations of the prominence regulation and thus simplify compliance. FDA's current regulations do not provide as precise a definition for "conspicuous" and "prominent" as do some States. Therefore, this lack of definition may leave greater latitude for industry to interpret such regulations as broadly as it chooses and could place a greater enforcement burden on FDA. Although FDA should allow manufacturers a reasonable degree of flexibility, the Committee suggests that FDA review the results of recent studies on the readability of product information and consider whether the recommendations provided in these studies offer options to improve consumer use of product information (AARP, 1986; NDMA, 1990, 1991; Eskin, 1991).

STANDARDS OF QUALITY AND OF FILL OF CONTAINER-SECTION 403(H)

FDCA Section 403(h) provides that a food is misbranded

if it purports to be or is represented as—

  1. a food for which a standard of quality has been prescribed by regulations as provided by section 401, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

  2.  a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 401, and it falls below the standard of fill of container applicable thereto, unless its label beam, in such manner and form as regulations specify, a statement that it falls below such standard.

Federal Requirements

Section 403(h) must be read in conjunction with FDCA Section 401. Section 401 authorizes FDA to establish by regulation reasonable definitions and standards of identity, standards of quality, and/or standards of fin of container for any food. FDCA Section 403(h) protects consumers by requiring that when foods with established standards of quality and/or fill of container fail to meet those standards, they must be labeled as substandard.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

Regulations that provide general statements of substandard quality and fill of container, 21 CFR §130.14, have been promulgated under Section 403(h). Specifications include the exact wording of the required statements:

21 CFR § 130.14(a)

"Below Standard in Quality Good Food—Not High Grade"

21 CFR § 130.14(b)

"Below Standard in Fill."

Also specified are the size of the letters (which is dependent on the weight of the package), type style (Cheltenham Bold condensed capital letters), color of the lettering, and placement of the statements. Label statements must be enclosed within rectangles composed of lines not less than 6 points in width on a strongly contrasting, uniform background and placed where they can be easily seen near the food name or picture.

Labeling requirements for foods that have established quality standards, but no standards of identity, are defined at 21 CFR Part 103. Currently, bottled water is the only such product. These regulations specify criteria for levels of microorganisms and physical factors such as turbidity, color, flavor, and odor as indicative of quality. The regulations also provide specific labeling language for foods with established quality standards that fail to meet the standard. The following are examples of these labeling requirements:

"Below Standard in Quality ...,"

  1. "Contains Excessive Bacteria"

  2. "Excessively Turbid"

  3. "Abnormal Color'' [21 CFR §103.5(b)].

The rarity with which any of the required statements now appear on labels is commonly attributed to their effectiveness as crepe labeling, which deters the marketing of products that do not meet the standards. Standards of quality and fill are frequently components of the more than 300 standards of identity for various foods (21 CFR §130 through §169.182).

Case Law

Only a few court cases have interpreted Section 403(h) directly. A number of other court cam have cited Section 403(h) to illustrate a contrast with Section 403(g), which imposes requirements on foods for which there are standards of identity. The paucity of interpretive case law suggests that most enforcement that has occurred has not resulted in reported decisions. The court has ruled that informative labeling can prevent violation of

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

Section 403(h) but not of Section 403(g); see, for example, U.S. v. 62 Cases, 183 F.2d. 1014, 1017 (10th Cir. 1950); and U.S. v. 30 Cases, 93 F.Supp. 764, 770 (S.D. Iowa 1950) reversed on other grounds , 340 U.S. 593 (1951).

State Requirements

A review of State labeling requirements in the area of standards of quality and fill of container raised an important question of interpretation of NLEA for the Committee. NLEA seems clear in regard to preemption of State labeling requirements "of the type" for which Federal standards of identity exist. If NLEA also calls for automatic preemption of State requirements for labeling products for which Federal standards of quality and fill of container exist, the question of whether there are State substandard labeling requirements related to FDCA Section 403(h) becomes moot. Further, it is reasonable to conclude that State substandard labeling requirements for foods that are not covered by FDA standards of fill or quality are also not covered by Section 403(h) and therefore not subject to study. The Committee decided to view its jurisdiction in this area broadly and review all State requirements regarding the labeling of products for which State standards of quality and fill of container have been established.

A number of States have regulations regarding standards of fill of container, but most do not establish labeling requirements for foods that do not meet these standards. For example, three States have set standards of fill of container for raw-shucked or canned oysters. Florida has established a maximum free liquor content (15 percent by volume) for containers of raw-shucked oysters [Fla. Admin. Code §5E-6.010(8)(d)]. In New York, a maximum of 10 percent free liquor (by volume) is allowed in containers of raw-shucked oysters (N.Y. Stat. §17-212). Maryland sets its standard at 5 percent (Md. COMAR 01.15.08.02). Minnesota regulation (Minn. R 1545.2670) requires drained weight of oysters to be no less that 59 percent.

Industry Perspective

No industry representative spoke directly to the adequacy of implementation of FDCA Section 403(h). However, GMA stated that the interrelationships of standards of identity and quality are complex and often impossible to separate. It pointed out that FDA has not attempted to designate which regulations in 21 CFR Parts 131 through 169 relate to quality and which relate to identity (Section 403(h) and Section 401, respectively). Instead, FDA has stated that most (if not all) of these

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

regulations apply to both the FDCA provisions on quality and identity. In GMA's Opinion, violations of food standards are undoubtedly concerned with food quality, except for provisions that relate solely to standard of fill of container. Furthermore, in the specific case of bottled water, it believes that no State may require any additional or different requirements for any such product that are not identical to requirements in 21 CFR §103.35 (GMA, 1991).

Consumer Perspective

No consumer group spoke directly to the adequacy of implementation of FDCA Section 403(h) but acknowledged that additional quality standards can be found interspersed with standards of identity and requirements for nonstandardized foods, although these standards only govern specific products. Further, they noted a similar situation for standards of fill. The only general Federal regulations relating to standards of fill pertain to the methodology for measuring the water capacity of containers and a statement of substandard fill. There may also be an occasional reference to a standard of fill interspersed with the regulations for standards of identity and common or usual name (CSPI/CNI/CFA/NCL, 1991).

Conclusions

FDA has regulations that establish adequate procedures for labeling products that fail to meet standards of quality and fin of container. Rarely are products found that contain the required statements set forth under FDCA Section 403(h), because of both the imparted inferior connotation of a product with "crepe labeling" and the link between standards of identity and fill for many products. Based on its analysis and criteria, the Committee concludes that FDCA Section 403(h) is adequately Implemented. The Committee further concludes that State requirements related to FDCA Section 403(h) are candidates for preemption.

Because of the ambiguities of NLEA regarding preemption of State standards of quality and of fill of container requirements for labeling "of the type," FDA should consult with Congress to clarify their status for the States and industry.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

COMMON OR USUAL NAME-SECTION 403(i)(1)

FDCA Section 403(i)(1) states that a food is misbranded "if it is not subject to the provisions of paragraph (g) of this section [which concerns standards of identity] unless its label bears (1) the common or usual name, if any there be."

A similar requirement is found in FPLA Section 4(a)(1), which specifies that each consumer commodity-packaged food, in this context-must "bear a label specifying the identity" of the product. The "common or usual name" required under FDCA constitutes the statement of identity required under FPLA [Sections 4(a)(1) and 5(c)(3)].

Federal Requirements

For more than 50 years, the regulation of food nomenclature has been a difficult and contentious issue for manufacturers and regulators (and the Committee found it no less so in its own deliberations). FDCA authorized the development of "standards of identity" that, in effect, are legally mandated recipes that standardize the composition and names of common products. Standards of identity were established for a large number of foods following passage of the 1938 Act. By the early 1950s, nearly half of foods purchased were "standardized" foods (i.e., those for which a standard of identity had been established; Lorman, 1990). Because of the cumbersome administrative process for creating and modifying standards of identity, however, in the mid-1970s, FDA began to address issues of nomenclature regulation primarily through the use of formalized 'common or usual names" (Hutt and Merrill, 1991).

Thus, FDA has published a definition of common or usual names and provided a mechanism by which such a name for a food can be established by regulation. Section 403(i)(1) is implemented mainly through regulations at 21 CFR §101.3, which deal with the identity of packaged food, and 21 CFR Part 102, which provide principles for the designation of common or usual names and contain the names of foods for which they have been established by regulation (Table 5-1). The general principles behind the use and development of common or usual names are delineated at 21 CFR §102.5. CFR §101.3(b)(3) specifies that a packaged food shall bear, in the absence of a common or usual name, "an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food." FDA essentially stopped adopting common or usual names for foods in the late 1970s.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

TABLE 5-1 Foods Listed in 21 CFR Part 102, Common or Usual Names for Nonstandardized Foods

Food Item

CFR Section

Peanut spreads

102.23

Frozen "heat and serve dinners

102.26

Foods packaged for use in the preparation of "main dishes" or "dinners"

102.28

Noncarbonated beverage products containing no fruit or vegetable juices

102.30

Diluted orange juice

102.32

Diluted fruit or vegetable juice beverages other than diluted orange juice

102.33

Mixtures of edible fat or oil and olive oil

102.37

Onion rings made from diced onions

102.39

Potato chips made from dried potatoes

102.41

Fish sticks or portions made from minced fish

102.45

Pacific whiting

102.46

Fried clams made from minced clams

102.49

Crabmeat

102.50

Seafood cocktail

102.54

Nonstandardized breaded composite shrimp units

102.55

Greenland turbot

102.57

NOTE: CFR = Code of Federal Regulations.

Petitions Regarding Common or Usual Names

As outlined in 21 CFR Part 102.19, FDA may issue, amend, or revoke regulations prescribing a common or usual name for a food. Any persons, such as manufacturers or State/local governments, may petition FDA to establish a common or usual name for new or substitute foods, as discussed below. Regardless of the extent of preemption of State/local laws and regulations, NLEA does not impair the ability of manufacturers or State/local governments to petition FDA for issuance or modification of a common or usual name.

FDA provided the Committee with examples of manufacturers' petitions and agency decisions with respect to establishing common or usual names. Denials of petitions by FDA have frequently been based on the potential for economic deception of consumers, if use of the requested common or usual name were to be allowed. Perhaps the most notable characteristic of these documents, however, is the rate at which the petitions were processed. Although FDA regulations ostensibly require a response in 180 days, and some were processed even faster, more than 6 and up to 24 months

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

frequently elapsed before a decision was issued. The limited data reviewed by the Committee also seem to show that petitions are denied more frequently by FDA than they are adopted.

Imitation, Alternative, and Substitute Food Products

Since passage of the 1938 Act, any food product that was similar to but did not meet a standard of identity was required by FDCA Section 403(c) to be termed "imitation," regardless of the relative food values of the standard and nonstandard product. Because the term "imitation" was generally viewed by consumers as negative and perceived as inferior, many substitute products that might have been marketed were abandoned by food manufacturers. Following recommendations made at the 1969 White House Conference on Food, Nutrition, and Health during revision of FDA's labeling policies in the early 1970s, a change in emphasis occurred, and the word imitation was required only to reflect nutritional inferiority of the substitute product (FDA, 1973b). The agency reaffirmed its position a decade later, rejecting alternative approaches (FDA, 1983). FDA's purpose in using "imitation'' in this way was to provide a means by which new products could be given an appropriate descriptive name rather than bearing the demeaning term "imitation" (Hutt, 1989). By the early 1980s, however, FDA was imposing descriptors such as "alternative'' and "substitute" on the labeling for products that simulated standardized foods and were nutritionally equivalent but did not meet the standard. This change was a significant departure from the policies adopted in the early 1970s, immediately following the definition of "imitation" to mean nutritional inferiority. Hutt and Merrill offer an interpretation of this change in FDA's policy:

In the early 1970s, FDA made the decision to apply the same policy on common or usual names to standardized and nonstandardized foods. Previously the agency had taken the 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. Under its new policy FDA took the position that the common or usual name for a nonstandardized food could include the name of a 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 macronutrient composition modified to meet national nutrition goals. Food producers responded by developing dozens of new products with a reduced content of calories, sodium, cholesterol, and fat.

A decade later, however, FDA reverted to the pre-1970 approach. Modified versions of standardized foods were required to be designated as "alternative or "substitute" products. If a modified product had its own standard of identity, however, the "alternative or "substitute language could be omitted. In substance, the agency

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

substituted the terms "alternative" or "substitute for the older "imitation" as a way of differentiating between standardized and nonstandardized versions of the same product (Hutt and Merrill, 1991, pp. 156–157).

Although the agency may not agree entirely with the position quoted above, FDA leadership has recognized the possibility that consumers may be misled and confused as a result of the labeling policies of the past 20 years. However, as FDA Commissioner David Kessler recently commented, "There must be an incentive for industry to develop new food products" (Van Wagner, 1991).

State Requirements

Many State statutes or regulations establish or have bearing on the common or usual names of foods, as revealed by the materials provided to the Committee. The discussion below illustrates State requirements currently in effect and outlines the concerns expressed by States regarding FDA implementation.

A number of State agencies expressed concern about the responsiveness of FDA in addressing local nomenclature problems. Many regulators feared that even with the petition process, their ability to deal with certain regulatory problems might be diminished following preemption. One key issue is the overlap among standards of quality, standards of identity, and common or usual names.

In this regard, the Arizona Department of Health Services specifically cited its rule for labeling of bottled water, which is more restrictive than Federal regulations (Ariz. Rev. Stat. Ann. §9R-8-204). The State has rules providing that defined common names be used for bottled water products in addition to quality standards and prefers that these requirements not be preempted (Englender, 1991).

The California Department of Health Services stated that its Health & Safety Code (§26594) establishes definitions and standards for bottled water products that have no similar Federal definitions. In addition, the California Code of Regulations (§15825) provides that shrimp, crab, and seafood cocktails must have at least 30 percent of the defining item and a pH of 3.70 (Sheneman, 1991).

The Connecticut Department of Consumer Protection reported several areas of common or usual name regulation that were of concern relative to preemption, including (1) names for certain meats (Conn. St. Regs. §21a-102-1 to §21a-102-6), (2) definitions for bottled water products (Conn. St. Regs. §21a-150a to §21a-150j), and (3) labeling of juices and ciders (CoraL St. Regs. §21a-146 to §21a-148). Connecticut recommended that FDA adopt

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

standards either equal to or more stringent than those currently in effect in the State (Schaffer, 1991).

Florida's Department of Agriculture and Consumer Services (FDACS) stated that:

There is a great deal of abuse in the market place with respect to common or usual name declaration.... Frequently rather than develop a fanciful name or unique identifier for a new food, the food is identified in relation to a standardized or commonly recognized food. Examples are designer foods which are formulated to meet a specific health issue and diluted juice beverages or fruit flavored beverages ... the regulations with respect to common or usual names are inadequate and currently provide for consumer confusion, misrepresentation and fraud" (Crawford, 1991).

FDACS identified several areas in which preemption could occur and questions might be raised about the level of protection offered by the Federal statutes: whether (1) regulations for unenriched bakery, cereal grain, and pasta products would be permitted; (2) the quality standards of Florida's Bottled Water Law would be enforceable (the law provides both standards of identity and quality that exceed Federal standards); and (3) FDA through its rulemaking process would follow the FDACS recommendation to adopt portions of the Florida Citrus Code to provide what Florida views as greater consumer protection than Federal statutes (Crawford, 1991; FDACS, 1991).

The Georgia Department of Agriculture (GDA) considered FDCA and its implementing regulations generally adequate but expressed concern that "there is no enforcement being taken in this area" (Niles, 1991a). It provided examples that included the marketing of "soybean cheese products" that are specifically excluded under Federal standards of identity and the failure of FDA to address deception in the area of bottled water. GDA argued further that

the common or usual name of the food has become unenforceable; dairy products with standards of identity are being manipulated and no longer meet standards of identity, nonstandardized foods are out of control, and in many cases, are meaningless. Ibis is an area which seems impossible to regulate, and is creating chaos in the food business (Niles, 1991a).

Thus, adequacy and uniformity of enforcement at the Federal level seem to be the key to the acceptance of preemption on the part of the States with respect to common or usual names. In another communication, GDA discussed issues and concerns regarding the labeling of bottled water (Niles, 1991b). Ray Niles, Assistant Director of GDA, indicated that the issues with respect to the labeling of spring versus well water were mainly economic and did not pertain to public health. He indicated that Georgia, along with other

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

States, would not be in favor of preemption of its regulations regarding the labeling of spring water.

As an expression of concern over preemption, the Hawaii Department of Health has submitted a request for exemption of its standards pertaining to bottled water, milk poi, oriental noodles, and frozen desserts (Tamura, 1991). Each of these matters pertains to food standards and, potentially, common or usual names.

The Maine Department of Agriculture reported two areas of its regulations that concern nomenclature (Davis, 1991). Its cider labeling law would be preempted unless a waiver is requested. In addition, Maine's common or usual names for surimi products would be preempted.

The Michigan Department of Agriculture indicated that FDCA is "adequate in concept although [it] lacks clarity" with respect to several areas including common or usual names (Heffron, 1991). The agency indicated that labeling of diluted fruit beverages is an example of lack of uniformity "that could easily be from vagueness in requirements (and also from a lack of enforcement efforts of any kind)." As Frank (1991) suggests, conflicts exist between Michigan's Regulation No. 549, which defines a variety of juice-based beverages, and the common or usual names proposed by FDA.

The Nevada Department of Human Resources Health Division stated that the impact of preemption would be minimal in that State because it considers the Federal statutes adequate (Nebe, 1991).

The South Dakota Department of Health and Department of Commerce and Regulation reported that existing State food and beverage statutes would be preempted. These agencies felt that Federal food and beverage requirements would be more stringent than those currently in effect and thus would provide better protection (Senger, 1991).

The Utah Department of Agriculture identified problems related to deceptive brand names, trade names, and trademarks. The Department argued that these issues provide an "opportunity for consumer confusion" (McClellan, 1991). The Vermont Department of Agriculture stated concerns related mainly to the naming of maple syrup products (Dunsmore, 1991).

Appendix H provides additional information on selected commodities and details about State/local versus Federal common or usual name requirements.

Industry Perspective

Representatives of the food industry have indicated that "the regulations in Section 101.3 and Part 102 (of the CFR) provide an entirely adequate federal system for regulating common or usual names," with the exception

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

of cases that involve modification of standardized foods (GMA, 1991). GMA also stated that "any state requirement relating to a common or usual name for a food product that is not identical with the Federal requirement [will] be preempted [by NLEA]."

A similar opinion was voiced by Kraft General Foods; that is, after the date of preemption under NLEA,

if a state considers it necessary to create a regulation which parallels or is identical to the FDA's section 102.5 governing common or usual names (or any other FDA regulation applicable to statements of identity), that State regulation will be required to specify that such product names may be established either through common usage by industry, or through resort to a Federal regulation as prescribed by section 102.5(d). We submit that there can be no other interpretation of the section 6 admonition that no state may directly or indirectly establish or continue in effect any type of product name requirement that is not identical to the FDA's requirement (KGF, 1991).

Consumer Perspective

Consumer groups have raised a number of issues regarding the adequacy of FDA's common or usual name provisions. In a joint statement to the Committee, four consumer groups indicated that

improperly identifying food poses a health hazard to consumers with allergies, high cholesterol or other health conditions for which accurate identification of the product is essential. In addition, improper implementation of these sections [of FDCA labeling provisions] permits economic deception by allowing companies to misname inferior, less expensive products in the hope that they will be mistaken for those of higher quality (CSPI/CNI/CFA/NCL, 1991).

With respect to common or usual names, consumer groups have pointed out that regulations are sporadic and insufficient to address all concerns in this area. As shown in Table 5-1, there are only 17 regulations for nonstandardized foods (in 21 CFR Part 102), eight of which deal with fish and seafood (CSPI/CNI/CFA/NCL, 1991).

In contrast, the Arizona Consumers Council (Rudd, 1991) indicated that Federal regulation of common or usual names appeared adequate.

General Conclusions

Based on its analysis and criteria, the Committee concludes that an adequate procedure currently exists in 21 CFR Part 102 for the development and application of common or usual names under FDCA Section 403(i)(1).

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

The Committee further concludes that State requirements for the process of establishing and defining a common or usual name are candidates for preemption. However, to promote the development and Introduction of new foods, the Committee suggests that FDA should more aggressively pursue regulatory options that will allow the formal naming of new, nonstandardized foods.

Discussion of Common and Usual Names for Specific Foods

Having reached the general conclusions detailed above, the Committee discussed whether it had an obligation to review and comment on State requirements for specific foods. Here, as in its discussions of FDCA Section 403(d), the Committee failed to reach unanimity. One position put forth was that although it would be appropriate to examine specific foods to determine whether FDA is adequately implementing FDCA Section 403(i)(1), the conclusion that adequate implementation has occurred should then end the inquiry. Further, the Committee, having concluded that the general principles concerning common or usual names serve to adequately implement the statutory goal of Section 403(i)(1), suggests that it will be FDA's prerogative, under NLEA, to conclude whether all State common or usual name requirements are preempted. These members also felt that a discussion of specific State food requirements by the Committee would only serve to cause confusion because after first concluding that FDA had adequately implemented Section 403(i)(1), the Committee would then specify ways in which it allegedly had not.

The issue as to whether the Committee would continue its study of Section 403(i)(1) by including State requirements for specific foods was a matter of considerable debate. The majority of the Committee concluded that it should view its jurisdiction broadly and review State requirements that establish specific names for foods. The Committee conceded that the results of such a review might further exacerbate concerns expressed over the differences between standards of identity and common or usual names. However, because of the frequency with which these foods were mentioned by States, industry, and consumer groups as having requirements that differed from Federal standards (if any exist), the Committee elected to summarize these issues in the following discussion and provide suggestions to FDA based on its review.

The Committee selected the following food categories for review related to State requirements for common or usual names because of their economic or public health importance, prominence by virtue of the number of State

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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requirements that address them, regional significance, or fulfillment in some other fashion of the criteria established by the Committee.

Bottled Water

The regulation of bottled water requires consideration of two provisions of FDCA that Congress has directed should be studied: the requirement that a food not subject to a standard of identity bear a common or usual name (if any there be) [FDCA Section 403(i)(1)], and the requirement that a food meet any applicable standard of quality or disclose on its label that it does not [FDCA Section 403(h)(1)]. This discussion examines whether FDA has adequately implemented the statutory provisions of FDCA Section 403(i)(1) (for additional information on bottled water requirements, see Appendix I).

In 1973, FDA exercised its authority under FDCA Section 401 and established quality standards for bottled water. In proposing the standards, FDA explained that "bottled water is increasingly being used as a source of drinking water.... The consumer expects bottled water to meet the minimum criteria established for public drinking water supplies" (FDA, 1973a). The agency based the quality standards on the 1962 Public Health Service standards for public drinking water supplies. It noted that the recently created Environmental Protection Agency (EPA) had assumed the responsibility for establishing drinking water standards and FDA intended to revise the bottled water standards to keep them compatible with the EPA standards.

When FDA first proposed a standard of quality for bottled water, the agency departed from its usual procedures of proposing a standard of identity at the same time. (The bottled water quality standard is the only quality standard FDA ever adopted without at the same time adopting a standard of identity.) The agency's initial Federal Register notice did not explain its rationale for this decision, but several commentors urged FDA to regulate the use of identifying terms such as "spring," "well," and "distilled water." FDA declined, stating that

there is no need for a requirement that the source of treatment of the water be declared on the label of bottled water. Bottled drinking water can be produced from various sources of water, and various types of treatment of the water can be used in manufacturing bottled water of an acceptable quality. If the manufacturer decides to provide information in the labeling or in advertising relating to bottled water, stating or implying that it is the product of a specific source of water or that the water has been treated in a specific manner, such information must be truthful, tactual, and not misleading in any respect. Section 403(a) of the act provides that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular. The Commissioner concludes that this statutory authority is sufficient to provide for

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

regulatory action in instances where false or misleading statements concerning the source or treatment of bottled water are made and that specific statements to this effect in the standard are unnecessary (FDA. 1973a, p. 32561).

Although several parties filed objections to the final rule, FDA concluded that they did not justify changing the regulation or conducting a hearing, and the quality standard became effective on June 19, 1975 (FDA, 1975).

In 1974, passage of the Safe Drinking Water Act codified the division of labor between FDA and EPA for regulating water. In addition to directing EPA to promulgate National Primary Drinking Water Standards, the Safe Drinking Water Act also added Section 410 to FDCA. Section 410 directs FDA to consult with EPA whenever the latter issues interim or revised national primary drinking water standards and, within 180 days of EPA's promulgations, to either amend the bottled water standard or explain in the Federal Register why it was not doing so. In 1975, FDA adopted Good Manufacturing Practice (GMP) regulations for bottled water, including bottled mineral water (21 CFR §129.1 et seq.). Among other things, these regulations specify the kinds of facilities that must be used and process controls that are required to ensure a safe product. Recently, as part of hearings before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, FDA indicated that it was reconsidering the coverage of the bottled water standards to include mineral water and the water component in flavored beverage products fabricated from bottled water ingredients. The agency further noted that it was considering a new quality standard to require the water component of such products as seltzer, tonic water, and colas to meet quality standards based on EPA's primary drinking water standards (Shank, 1991).

A total of 16 States have expressed their dissatisfaction with FDA's regulation of bottled water by adopting laws or regulations to provide additional controls. These laws vary, but in general they address two basic issues: the nomenclature of various types of bottled waters and the purity of these products.8 Many States have adopted the model bottled water regulation of the Association of Food and Drug Officials (AFDO) or some variation of it. This regulation contains definitions for artesian well, bottled, demineralized, drinking, light mineral, mineral, mineralized, natural, purified, spring, and well water. It requires that all bottled waters bear one of the

8  

Ariz. Ag. Rule 290.063 R9-8-20.4; Cal. Health & Safety Code §26591 to §26594; Conn. Gen. Stat Ann. §21a-150; Del. Code Ann. §4315; Fla. Admin. Rule 500.455; Haw. Rev. Stat. §328D-6; La. Rev. Stat. Ann. §608(12) and reg. 49:2.1110; Me. Rev. Stat. Ann. Title 36, §1572; Md. Code Ann. §21-336; Miss. reg. §15.18; Mont. Code Ann. §50-31-236; NJ. Stat. Ann. §24.12-9; N.D. Cent. Code §19-08-02; Ohio Rev. Code Ann. Title 9, §913.24; Okla. Stat. Ann. §1-917; Tex. Rule §229.81 to §229.88.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

defined names and that artificially carbonated waters disclose the addition of carbonation. The model rule also requires compliance with the FDA standard of quality and the bottled water GMPs. In addition, it requires source water and finished product sampling (AFDO, 1984).

In communications to the Committee, a number of States and representatives of consumer groups expressed discontent with FDA's inaction in the face of false and misleading labeling claims for bottled water products. Further, the Committee found that even a cursory examination of supermarket shelves confirmed that a number of products might be the subject of FDA enforcement action. Much of the concern being expressed stems from the recent growth of the bottled water industry, which has made the public and regulators more aware of potentially false and misleading labeling for bottled water products (Prakash, 1991; Weisenberger, 1991).

Conclusions FDA's original decision not to define the various kinds of bottled water may have been correct when it was adopted in 1973, but the market for, and the public perception of, bottled water have changed substantially since then. The proliferation of products in the marketplace and the increasingly aggressive claims made for those products have magnified the opportunity for public confusion, indicating that the existing policy is not adequate. Therefore, the Committee suggests that FDA establish common or usual names or standards of identity for bottled water and concludes that State laws and regulations that define and/or standardize the names of the various kinds of bottled water be considered candidates for preemption after a Federal requirement is established. The Committee further suggests that AFDO's model bill be examined as a unifying basis for Federal regulation of bottled water.

Cider, Cider Vinegar, and Other Vinegar Products

A number of States have established requirements for cider, cider vinegar, and other vinegar products. These requirements fall generally into several categories: definitions of the quality and type of raw materials allowed in the production of apple cider products, standards for method of processing and acetic acid concentration for vinegar, the methods of heat treatment of cider, and common or usual names for cider.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

The Committee identified 11 States that regulate cider and vinegar products.9 Maine prohibits the labeling of a product as "cider" if it has been heated at 155°F or higher during production (Me. Rev. Stat. Ann. Title 7, §543-A), and it anticipates preemption unless it petitions for exemption (Davis, 1991). Michigan defines, sets compositional standards and processing and labeling standards for vinegars (Mich. Comp. Laws §289.552 to §289.558).

Conclusions In applying its criteria, the Committee concluded that none of the State requirements it had identified met the threshold for consideration for adoption as a Federal requirement, nor did there appear to be a compelling reason for additional Federal regulation. Therefore, the Committee concludes that State requirements for cider products am candidates for preemption.

Citrus Products

There are four primary citrus-producing States (Arizona, California, Florida, and Texas). Florida produces approximately 90 percent of all juice products marketed in the United States. The Florida Department of Agriculture and Consumer Services (FDACS) and the Department of Citrus (FDC) provided the Committee with an extensive analysis of the impact they perceived from the application of NLEA national uniformity provisions to the Florida Citrus Code (FDACS/FDC, 1991). Their analysis identified the central difference between Federal and State regulations to be in grading (not subject of this study) and standards of identity (preempted upon enactment). The responses of the remaining States did not indicate any provisions above and beyond standard labeling requirements or grading standards similar to those of the U.S. Department of Agriculture (USDA).

Conclusions After reviewing Florida's analysis and its current requirements and the provisions of the remaining three citrus-producing States, the Committee concludes that the issues raised by this review fall outside its charge and the State requirements are either already preempted (juice standards of identity) or would not be affected by preemption (grading). The

9  

Conn. Gen. Stat. §21a-146 to §21a-148; Iowa Code §190.8, §191.8; Me. Rev. Stat. Ann. §543-A; Mass. Gen. Stat. Ann. §170 and §171; Mich. Comp. Law §289.552 to §289.558; N.H. Rev. Stat. Ann. §146:14; N.Y. Agric. & Mkts. Law §207 and §208; Ohio Rev. Code Ann. §3715.28 to §3715.33; Pa. Code §921 to §924; R.I. Gen. Laws §21-22-1 to §21-22-3; W.Va. Code §19-22-1, §19-22-5 and §19-22-6.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

Committee, however, found merit in Florida's position that its standards of identity may provide additional consumer protection (i.e., specific production criteria beyond FDA's standard of good manufacturing practice). Therefore, the Committee suggests that Florida and/or other citrus-producing States consider petitioning FDA to amend the Federal standards of identity for citrus products, and existing State requirements be exempt from preemption until the petition process is complete.

Honey

With the exception of dairy products, more States have regulations for honey than for any other single food.10 A review of these requirements reveals that a number of States have established grade standards similar to those established by USDA (7 CFR Part 52), microbiological standards, and adulteration regulations. However, most appear to provide economic protection for local industry.

Conclusions Notwithstanding the above evaluation of State requirements for honey, the fact that 23 States decided to specifically regulate this food suggested to the Committee the potential benefit of some Federal unifying regulatory requirement. The promulgation of a Federal standard of identity and quality under FDCA Section 401 would establish national uniformity through clear preemptive action. If appropriate, concerns over the possible microbiological contamination of honey, especially with Botulinum spores, might be addressed in a standard of quality established not only under the misbranding provisions but also under the adulteration provisions of FDCA. Such an initiative, however, is not viewed as a high priority among the numerous activities associated with implementation of NLEA. State requirements that establish grades or define adulteration are not subject to study.

10  

Ala. Code §2-11-121 and §2-11-122; Ark. Stat. Ann. §20-57-402; Cal. Food & Agric. Code §29401 to §29421, §29448, §29471 to §29474, §29501 to §29504, §29531, §29581 to §29587, §29611 to §29620, §29641 to §29644, §29671 to §29675, §29677; Col. Rev. Stat. §35-25-102 and §35-25-109; Conn. Gen. Stat. §22-181a; Fla. Stat. §582.02, §586.03, §586.051; Ga. Code Ann. §26-2-233; Iowa Code §190.1 and §198.14; Kan. Stat. Ann. §65-681; La. Rev. Stat. §608.1; Minn. Stat. §31.74; Miss. Code Ann. §75-29-601; Nev. Rev. Stat. §583.355; N.H. Rev. Stat. Ann. §429.23; N.M. Stat. Ann. §25-9-263; NJ. Stat. Ann. §205 and §206; N.Y. Agric. & Mktg. Law §206; Ohio Rev. Code Ann. §3715.01, §5715.38; Okla. Stat. Title 78, §81 to 83; Wash. Rev. Code §69.28.020 to 390, §69.28.030, §69.28.400; W.Va. Code §19-20-1 and §19-20-2; Wyo. Stat. §11-8-102.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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Therefore, the Committee suggests that FDA consider the need for a single unifying Federal requirement for honey. The Committee further suggests that State requirements for honey be exempted from preemption until a Federal requirement is established.

Milk, milk Products, and Other Dairy Products

This category of products represented by far the largest number of State requirements. A careful review and evaluation of these requirements, however, led the Committee to the conclusion that all were standards of identity and thus regulated by FDA under FDCA Section 401. The Committee concludes that the State dairy requirements were preempted upon the date of enactment of NLEA and are not subject to study. (Appendix G illustrates the abundance of such requirements.)

Seafood

Finfish and Shellfish There are a number of State requirements dealing with common or usual names of seafood (see Appendix H). As noted earlier, of the 17 regulations specified in 21 CFR Part 102 that deal with common or usual names, eight involve seafood (Table 5-1). In an effort to promote uniformity and standardize the confusing and potentially misleading nomenclature of seafood, FDA has issued The Fish List — FDA Guide to Acceptable Market Names for Food Fish Sold in Interstate Commerce as a formal advisory opinion (FDA, 1988). This list provides the allowed market name and the scientific and common names for a wide range of common species.11 Although some criticism has been directed toward the categorization in this list because of the wide range of species within each class, the Committee viewed it as a positive step in providing order in the marketplace.

11  

Specific item include capelin/smelt; crabmeat (common or usual name of species defined); kippers; red snapper, lobster, langostino, and crawfish; imitation breaded shrimp, caviar, canned shrimp (size designations); crabmeat products with added fish or other seafood ingredients (e.g., ''deviled crabs''); minced fish; Pacific whiting; Greenland turbot and halibut; seafood cocktails; nonstandardized breaded composite shrimp units ("made from minced shrimp" products); fried clams made from minced clams; shellfish, crustaceans, and other aquatic animals (mainly quantity guidelines); imitation crab, processed and/or blended seafood products, including surimi; pollock (cannot be called "snow cod"); Chilean Centolla crab (cannot be called "king crab"); Pacific snapper; golden snapper; tilapia; and calamari/squid.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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Particular controversy has developed with respect to nomenclature of red snapper (Lutjanus campechanus) owing to the sale of Pacific coast rockfish under the name of red snapper (Otwell, 1985). In response, FDA developed Compliance Policy Guide No. 7108.04, which states:

BACKGROUND—The name "red snapper" has been preempted by many years of consistent consumer usage as meaning only the fish Lutjanus campechanus. Because of the high esteem in which this fob is held by consumers, and the relatively limited catch, there have been numerous attempts to substitute other, less expensive fishes for this species. Substitutes of less desirable species have included members of the family Lutjanidae, groupers, a number of West Coast rockfishes of the genus Sebastes, and other species. The West Coast rockfishes have, until relatively recently, been distributed mostly locally, and thus have been beyond the reach of the Federal Food, Drug, and Cosmetic Act. Some of the states an the West Coast have officially sanctioned "red snapper" as an alternative name for such members of the Sebastes genus, although these fishes am quite different in appearance, flavor, and texture, and are generally regarded by consumers familiar with Lutjanus campechanus as inferior.

POLICY—The labeling or sale of any fish other than Lutjanus campechanus as "red snapper" constitutes a misbranding in violation of the Federal Food, Drug, and Cosmetic Act.

Notwithstanding the formal FDA guideline, California still allows the sale of rockfish species under the name of "red snapper" in intrastate commerce.

Several matters of seafood nomenclature have also been addressed by States, which have developed (1) common or usual name regulations for halibut that are identical to the Federal regulations (Alaska Stat. §17.20.045; Mass. Gen. Stat. Ann. §194B; Or. Rev. Stat. §616.217; Wash. Rev. Code §69.04-315); and (2) labeling requirements with respect to the source of catfish (i.e., "farm-raised catfish," "river or lake catfish," "imported catfish," or ''ocean catfish") (Ark. Stat. Ann. §20-61-202 and §20-61-206; Miss. Code Ann. §69-7-605 to 69-7-609). FDA's list of acceptable market names further distinguishes between marine species identified as either "ocean catfish'' or "sea catfish" (FDA, 1988; NFERF, 1991b). It should be noted that regulatory and promotional aspects of aquaculture per se are under USDA jurisdiction, whereas regulation of harvested catfish and derived food products (including labeling aspects) is handled by FDA.

Surimi-based Imitation Crab and Other Fish Substitutes Various substitute seafood products pose a labeling problem because of the need to accurately identify products for possible public health reasons (e.g., allergy) and prevent economic deception. With respect to imitation crab products (i.e., products that are defined as not 100 percent crabmeat and often contain surimi manufactured from the processed flesh of pollock or similar fish), such products must be labeled "imitation crabmeat" and bear an

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

appropriately descriptive common or usual name because they are not nutritionally equivalent. In addition, the term "crab legs" has been declared false and misleading when applied to products that contain no crabmeat (NFERF, 1991a).

The NFERF position is based on a guideline issued by FDA with respect to seafood products containing surimi:

POLICY

  1. If the surimi-based product purports to be or is represented as a specific type of natural seafood, including shape or form representations, but is nutritionally inferior to that seafood, it must be labeled as imitation. To date FDA has not encountered any surimi-based products in which nutritional equivalency has been achieved.

  2. An additional statement of product identity must appear on the principal display panel such as "A blend of fish with ____." The blank is to be filled with the common or usual name of the ingredient or component, such as "snow crab." Because the fish used in the surimi base has been decharacterized, the word ''fish" is adequate for the statement of product identity. If an artificial flavor or color is added, the label must so state.

  3. The specific names of all seafood used in the product shall appear in the ingredient statement in descending order of predominance ("pollock" must be used as opposed to "white fish"; "snow crab" rather than ''crab"). All other ingredients must also be declared in descending order of predominance.

  4. Note: The intermediate surimi product usually contains sugar and/or sorbitol and phosphate compounds as cryoprotectants. These should be listed in the ingredient statement unless removed during the manufacturing process.

  5. Products that am not purported or represented to be a specific type of seafood or seafood body part, need not be labeled imitation, but may be marketed if the label property reflects their composition.

  6. Labeling of surimi-based products may suggest use in recipes in place of the natural seafood products by a generalized statement such as, "use like crabmeat, lobster, or shrimp in all seafood recipes," or a similar statement (FDA Compliance Policy Guide No. 7108.16).

Several States have regulations that define various aspects of these issues, including definitions of "crabmeat," and address matters pertaining to "imitation" (Me. Rev. Stat. Ann. Title 12, §6111 and §6112; Md. Health-Gen. Code Ann. §21-340 and §21-341; Tex. Health & Safety Code §436.041, §436.047, §436.048).

Conclusion Nomenclature of seafood is an issue of both public health and economic concern. Identification of species is essential in cases of certain forms of food allergy. In addition, a well-regulated system of common or usual names is essential to prevent economic deception of consumers.

Therefore, the Committee suggests that:

  • The Fish List should be continued as a formal FDA advisory opinion to industry.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×
  • the designations of origin (farm, river, lake) for catfish, which provide potentially useful information to consumers, should be considered by FDA as a candidate for an advisory opinion or incorporated into Federal regulations.

  • because FDA policies for labeling surimi-based products appear to provide adequate regulation, State requirements are candidates for preemption.

Miscellaneous State Food Labeling Requirements

The foods listed below are subject to State labeling requirements. Each represents a unique food or a food of special commercial interest and is subject to regulation by only one or two States. They have been grouped in this section for convenience in presenting the Committee's conclusions and recommendations.

Maple Syrup

Two States (N.Y. Agric. & Mkts. Law §203 and §204; Vt. Stat. Ann. Title 6, §492, §493) cited varying requirements related to standards of identity, quality, grading, and common name of origin for maple syrup and related products. In particular, Vermont argued that its standard of identity and grading system for maple syrup and related products were superior to FDA's standard of identity and USDA's grading standards. Both of these issues fall outside of the charge to the Committee.

Conclusions The Committee concludes that the State maple syrup requirements reviewed are either standards of identity and preempted under NLEA Section 6, or grade standards and not subject to NLEA preemption; and therefore, are not subject to study.

Olive and Vegetable Oils

California law requires that products presented as olive oil may be only the oil of the olive tree, in the absence of added color or flavor. The oil may be blended with other oils only if it is clearly labeled (Cal. Health & Safety Code §28475 to §28478, §28480 to §28482, §28454 to §28486). Rhode Island has a similar law that requires identification of blends containing olive oil (R.I. Gen. Laws §21-21-1, §21-21-2, §21-21-6). New York law further

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

requires that oil blends that contain olive oil must be labeled with the percentage of each ingredient (N.Y. Agric. & Mkts. Law §204-a).

Conclusions Federal regulations concerning ingredient labeling and nomenclature of blended oils appear adequate. Therefore, the Committee concludes that State requirements related to olive oil and oil mixtures are candidates for preemption.

Oriental Noodles

Hawaiian Administrative Rule §11-29-7 exempts certain oriental noodle products made without egg from Federal standards of identity for macaroni and noodle products (21 CFR Part 139). FDA Compliance Policy Guide 7102.02 (Chow Mein Noodles, Chinese Noodles and Other Oriental Noodles; Labeling), addresses similar issues as the Hawaii rule.

Conclusions Because of national marketing and acceptance of oriental-type noodles, the Committee suggests that the existing FDA compliance policy guide serve as the national standard for oriental-type noodles and individual State requirements be considered candidates for preemption.

Pine Nuts

The New Mexico Pinon Nut Act limits the labeling of pinon (or pine) nuts to those from the native pinon tree, Pinus edulis and Pinus monophylla (N.M. Stat. Ann. §25-10-1 to 3). The Act not only limits labeling to the above species but also provides for a program to promote native pinon nut harvesting and marketing and the future cultivation of local pinon tree varieties.

Conclusions The Committee concludes that although this State provision meets a particular need, it appears to serve only the economic interest of a limited commodity industry. Therefore, the Committee suggests that New Mexico petition FDA to exempt its pine nut provision from preemption or create a national common or usual name for pinon (pine) nuts.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×
Poi

Hawaiian Administrative Rule §11-29-6 defines poi (a paste made from taro root tubers) and provides standards for the percentage of solids in poi and in ready-mixed poi. Hawaii believes that this rule contributes to consumer protection through prevention of economic fraud and adulteration of this unique product.

Conclusions In view of the highly localized and culturally specific nature of poi, the Committee suggests that Hawaii petition FDA to exempt its poi provision from preemption.

Vidalia Onions

The State of Georgia has a regulation providing a common or usual name for the Vidalia onion in terms of its botanical identity and locality of production (Ga. Code Ann. §2-14-131 to 2-14-134). Its unique flavor has been credited to the low sulfur soil in the area in which it is grown (Harris, 1983).

Conclusions This State requirement appears to be predominantly protectionist in that no specific justification is provided for limiting the source to the defined producing locality. However, because of the widespread recognition of the Vidalia onion name, the Committee suggests that Georgia (or any other group or industry) consider submitting a petition to FDA to establish a common or usual name for the Vidalia onion based on measurable geographical, botanical, and/or quality criteria that justifiably differentiate it from other varieties or species of onion.

Wild Rice

Specific regulations concerning wild rice exist in only two States—Minnesota and Wisconsin (Minn. Stat. §30.49; Wis. Stat. §97.57). These requirements specify the nature of the product and the mode of harvest. Wild rice (botanically a grass) constitutes a minor part of the overall rice market, compared with polished rice, brown rice, and their derived products and is only a minor part of the American diet. The Minnesota and Wisconsin wild rice regulations may be viewed as mainly protecting State industry economic concerns. However, the high price of wild rice makes the possibility of consumer fraud an issue.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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Conclusions The high cost of wild rice makes this product prone to consumer deception through substitution and blending regardless of its relative market position compared with other rice products. Therefore, the Committee suggests that FDA issue a formal advisory opinion or establish a common or usual name regulation defining wild rice in terms of its botanical name(s). Current State requirements should not be candidates for exemption from preemption until a formal FDA requirement is in place.

LABELING OF ARTIFICIAL COLORINGS, FLAVORINGS, AND CHEMICAL PRESERVATIVES-SECTION 403(k)

FDCA Section 403(k) provides that a food is misbranded

if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulation promulgated by the Secretary. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the caw of butter, cheese, or ice cream. The provisions of this paragraph with respect to chemical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.

Federal Requirements

The Pure Food and Drugs Act of 1906 first laid the statutory framework for regulation of artificial colorings, flavorings, and chemical preservatives. Section 7(4) of the 1906 Act declared that food was adulterated *if it be mixed, colored, powdered, coated, or stained in a manner whereby damage or inferiority is concealed." Section 7(5) deemed adulteration to include "any added poisonous or added deleterious ingredient which may render such article injurious to health." Preservatives were allowed as long as they could be removed prior to consumption. The 1906 Act did not require labeling of artificial coloring, flavorings, and chemical preservatives in foods.

FDCA, however, declared a food misbranded if its label did not declare the presence of artificial flavors, colors, and chemical preservatives. Congress acted further in this regard by twice amending the 1938 Act: in 1958, with the Food Additives Amendment (P.L. 85–929), and in 1960, with the Color Additive Amendments (P.L. 86–618). The former prohibited approval of any food additive if "the proposed use of the additive would promote deception of the consumer in violation of this chapter or would otherwise result in adulteration or in misbranding of food within the

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

meaning of this chapter." Parallel language was contained in the Color Additive Amendments.

Current Requirements

FDA has established regulations that set out the rules on declaration of flavors, colorings, and preservatives (21 CFR §101.22). These regulations govern every aspect of the requirements established under FDCA Section 403(k), including applicable exemptions found at 21 CFR §101.100.

The definitions related to FDCA Section 403(k) are contained in 21 CFR §101.22(a)(1) and (2) through 21 CFR §101.22(a)(4). Artificial flavors include substances listed in 21 CFR §172.515(b) and §182.60, with spices listed in 21 CFR §182.10 and Part 184. Natural flavors include the natural essence or extractives obtained from plants listed in 21 CFR §172.510 and Part 184. The term "artificial color" means any color additive as defined in 21 CFR §70.3(f). A definition of chemical preservative is contained within 21 CFR §101.22(a)(5). A product's label must state that artificial colors, flavors, or chemical preservatives are present [21 CFR §101.22(a)(1)], and this message must be presented in a manner that can be understood by the consumer [21 CFR 101.22(a)(2)].

According to 21 CFR §101.22(b), foods subject to FDCA Section 403(k) require labeling "even though such food is not in package form." However, foods are exempt from compliance with Section 403(k) requirements when they are unpackaged and sold in small units [21 CFR §101.22(d)] whose labeling is not likely to be read "by the ordinary individual under customary conditions of purchase and use." Further, food sold in bulk is also exempt if the label for the bulk container is plainly in view or a counter sign is displayed that bears ''prominently and conspicuously" the required information [21 CFR §101.22(e)]. Consistent with the language of Section 403(k), chemical preservatives applied to fruits and vegetables prior to harvest are also exempt from compliance [21 CFR §101.22(f)].

Foods that contain spices or natural and/or artificial flavors may declare those ingredients using generic terms rather than by their individual names. However, substances commonly understood to be foods (e.g., garlic powder, dehydrated onions, celery powder) must be declared by their common or usual name, as must salt (sodium chloride) and monosodium glutamate (MSG) [21 CFR §101.22(h)(3), (4)]. The use of words, pictures, or colors to indicate that a food contains a recognizable, characterizing flavor requires that the manufacturer declare such a flavor on the principal display panel in one of several means specified by the regulation [21 CFR §101.22(i)].

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

Chemical preservatives not exempted by 21 CFR §101.100 must be labeled with both the common or usual name of the ingredient and a separate identification of the function of the preservative [21 CFR §101.22(j)]. Certain color additives that are of health significance (e.g., that may cause allergic reactions) must be identified by their specific names [21 CPR Part 74 and 21 CFR §101.22(c)].

In 1986, FDA adopted a regulation limiting the use of sulfiting agents (21 CFR §182.3739 through §3862) but did not declare a preemptive policy. The agency stated that it would not preempt in the absence of a "genuine need to stop the proliferation of inconsistent requirements" (FDA, 1986). The existing FDA regulation states that sulfites must be declared on food labels if they are present above a given level. Below that level, they are considered an incidental additive and not required to be listed in the ingredient statement [21 CFR §101.100(a)(4)].

The Committee examined TC and administrative information letters regarding implementation, including specific interpretations of FDCA Section 403(k). There are several TC letters dating from 1940 that deal specifically with the determination that vanillin is an artificial flavoring and products (chocolate, in this case) containing it should be so labeled (TC-176, 1940). Likewise, caramel was determined to be an artificial color. Another TC letter details the methods of label declaration of its content (TC-203, 1940). During this period, nitrogen and carbon dioxide in canned foods were not considered chemical preservatives (TC-198, 1940).

In an information letter, the use of the words "color added" or "certified color added" was determined by FDA to be in compliance with FDCA Section 403(k) (Administrative Information Letter No. 87, 1949). With respect to label declarations of preservatives, the agency took the position in a 1963 Bureau of Enforcement Guideline that for finished foods in which flavorings such as spices have been treated with a chemical preservative, no label designating this practice is required if that chemical preservative was not intended to nor did it have any preservative effect on the finished food (BE-145, 1963). Active enforcement has occurred on labeling requirements for FD&C Yellow Dye No. 5 in foods has been active, due to the allergic reaction experienced by some consumers (21 CFR §74.705).

In a related section, FDCA Section 402(c) provides that a food is adulterated "if it is, or it bears or contains, a color additive which is unsafe" within the meaning of FDCA Section 706(a) dealing with certified or coal-tar colors.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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Case Law

Two Federal court cases interpreting FDCA Section 403(k) in conjunction with other provisions of FDCA Section 403 were identified and reviewed. Neither provided extensive discussions of how the courts interpreted Section 403(k) and were valuable only as historical references. The Supreme Court concluded in U.S. v. Sullivan, 332 U.S. 689,68 S.Ct. 331 (1948), that if a "violation ... [is] a 'technical, innocent' one ... for which the Administrator should have made an exemption," the criminal prosecution should be dropped. The United States District Court held that a taste test used to determine if squalene was added to a blend of olive and other vegetable oils was insufficient proof of misbranding under Section 403(k). The Second Circuit Court of Appeals reversed the decision on an adulteration charge but apparently supported the misbranding standard, U.S. v. Antonio Corrao Corp., 185 F.2d 372, 375 (2d Cir. 1950) (quoting district court opinion).

State Requirements

The statutes of 21 States are identical to Federal FDCA provisions but lack the exemption of butter, cheese, and ice cream from the required labeling of artificial coloring under FDCA Section 403(k). Other States differ from Federal law with respect to the labeling of flavorings, colorings, and preservatives in specific foods; they also differ in their labeling requirements for specific substances and the degree to which nonpackaged, bulk, and prepared foods should be labeled. These specific differences in State regulations, discovered in the materials made available to the Committee, are discussed below.

Label Requirements for Specific Colors, Flavors, or Preservatives

Connecticut requires that food to which a sulfiting agent has been added must be labeled with the name of the agent and its function [Conn. Stat. §21a-104(a)(2)]. Federal regulations implementing FDCA Section 403(k) require that sulfites be listed when present above the level of 10 parts per million [21 CFR §101.10(a)(4)].

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×
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.

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×
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).

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×
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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
×

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

Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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(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.

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Suggested Citation:"5 Comparison and Analysis of Federal and State Food Labeling Requirements." Institute of Medicine. 1992. Food Labeling: Toward National Uniformity. Washington, DC: The National Academies Press. doi: 10.17226/2001.
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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.


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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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×

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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The Nutrition Labeling and Education Act of 1990 (NLEA) changed the existing regulatory framework for food labeling requirements that was shared among federal, state, and local levels of government. In addition to creating a system of mandatory nutrition labeling for foods, NLEA provided a schedule for the preemption of state and local labeling requirements that were not identical to federal provisions. Six provisions were not to be preempted until a study on the adequacy of the federal implementation of those provisions was completed.

Food Labeling is the result of that study. It presents recommendations concerning the Food and Drug Administration's implementation of the six provisions that were studied, suggestions for the future disposition of relevant state and local food labeling requirements, and views on the continuing importance of the working relationship among the various levels of government in assuring that consumers are protected from misleading label information.

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