Food Labeling Toward National Uniformity (1992) / Chapter Skim
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5 Comparison and Analysis of Federal and State Food Labeling Requirements
5 Comparison and Analysis of Federal and State Food Labeling Requirements
Pages 85-140
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From page 85... ...
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(~)
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From page 86... ...
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.
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From page 87... ...
~1) [common or usual names]
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~. 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.
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From page 89... ...
The Grocery Manufacturers of America (GALA) 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~.
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From page 90... ...
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)
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From page 92... ...
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.
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From page 93... ...
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.
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A second California requirement for deceptive packaging which prohibits all nonfunctional slack fill packaging is discussed below (Cal.
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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.
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The Committee found that notwithstanding FDA'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.
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From page 97... ...
. Therefore, the Committee suggests that FDA consider using the FPIA definition for nonfunctional slack fill as a guide for interpreting and enforcing FDCA Section 403(d)
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From page 98... ...
Section 101.2—Infor~nation Panel The information panel shall be Immediately contiguous and to the right of the principal display panel." A minimum type size of I/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.
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From page 99... ...
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 masons (78.1 percent)
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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 Bleruled Products Twenty State regulations have been issued pertaining to the nomenclature and labeling of blends or mixtures.
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From page 101... ...
Code §43.5~. Other Prominence Regulations Thirteen other State regulations require the prominent labeling of venous kinds of product informat~on.7 Minnesota, for example, has regulations (Minn.
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From page 102... ...
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 cnteria, the Committee believes that most of the State regulations related to FDCA Section 403(f)
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From page 103... ...
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.
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From page 104... ...
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.
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From page 105... ...
NLEA seems clear in regard to preemption of State labeling requirements "of the type" for which Federal standards of identity Bust. 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)
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From page 106... ...
is adequately implemented. The Committee further concludes that State requirements related to Fl)
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From page 107... ...
~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.
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From page 108... ...
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.
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From page 109... ...
This change was a significant departure from the policies adopted in the early 1970s, immediately following the definition of "imitations to mean nutritional infenontr. 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.
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From page 110... ...
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.
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. 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.
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From page 112... ...
suggests, conflicts exist between Michigan's Regulation No. 549, which defines a variety of juicebased 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~.
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From page 113... ...
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)
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From page 114... ...
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)
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From page 115... ...
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.
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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 FDC~ 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.
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From page 117... ...
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 andIor standardize the names of the venous 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.
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From page 118... ...
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.
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From page 119... ...
. Therefore, the Committee suggests that Florida andior 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.
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Seafood Finfish and Shellfish There are a number of State requirements dealing with common or usual names of seafood (see Appendix H)
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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.
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In addition, a well-regulated system of common or usual names is essential to prevent economic deception of consumers. Therefore, the Committee suggests that: .
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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.
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FDA Compliance Policy Guide 7102.02 (Chow Mein Noodles, Chinese Noodles and Other Onental Noodles; Labelings, addresses similar issues as the Hawaii rule. Conclusions Because of national marketing and acceptance of onentaltype 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.
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From page 125... ...
consider submitting a petition to FDA to establish a common or usual name for the Vidalia onion based on measurable geographical, botanical, andIor quality criteria that justifiably differentiate it from other varieties or species of onion. Gild Rice Specific regulations concerning unsold rice exist in only Ho States Minnesota and Wisconsin (Minn.
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From page 126... ...
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.
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From page 127... ...
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)
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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~.
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State Requirements lithe 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)
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. Label Requirements for Specific Foods Containing Artificial Colorings, Flavorings;, and Chemical Preservatives l~wenty-two States do not exempt butter and other dairy products from labeling requirements, in contrast to FDCA Section 403(k)
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From page 131... ...
§25-4-1302~. Likewise, Arizona statutes require that bulk foods offered self-se~v~ce style to consumers include a declaration of artificial color or flavor and any chemical preservatives contained in the product (Ariz.
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. 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~.
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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~.
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From page 134... ...
As a result, for many State labeling requirements for additives, colors, and chemical preservatives, there are not clear delineations among economic adulteration, health and safeW 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 NLEN This lack of preemption of adulteration provisions iNLEA Section 6(a)
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From page 135... ...
. Further, the proposed regulations make clear that hypoallergenic foods and infant foods are subject to the labeling requirements of 21 CF~ §105.62 and §105.65, which require the declaration by common or usual name of all ingredients including flavorings, colors, and spices.
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From page 136... ...
1991. Statement of Sharon Lindan, Assistant Director for Legal Affairs, CSPI, on behalf of CSPVCNVCFAlNCL at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C May 30.
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From page 137... ...
1991. Statement of Shetwin Gardner, Vice President, Science and Technology, GMA, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.G May 30.
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From page 138... ...
1991. Statement of Eugene Wellca, President, NFPI, at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C.
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From page 139... ...
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.
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