Food Labeling Toward National Uniformity (1992) / Chapter Skim
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4 Criteria for Determining Adequate Implementation of the Federal Statute
4 Criteria for Determining Adequate Implementation of the Federal Statute
Pages 63-84
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From page 63... ...
is preempted a year after enactment. State labeling requirements "of the type" required by FDCA Sections 403(b)
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From page 64... ...
This language emphasized in particular that Congress expected the Committee to go beyond merely determining the existence of a Federal regulation. Rather, it was to decide, once State requirements were preempted, whether the remaining Federal statutes and regulations were adequate for the protection of the public.
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From page 65... ...
FDA continues to believe that successful civil and criminal actions establish valuable precedent for future conduct by the regulated industry. When appropriate, the agent y has relied on the established body of case law in the area of food labeling, especially that created during the first two decades following passage of the 1938 Act (Huts and Merrill, 1991~.
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From page 66... ...
Regulations are now used to set standards for or otherwise define products, require specific labeling, establish procedures or define good manufacturing practices for the industry, or establish administrative processes for use by the public or the agency itself (Pfeifer, 1984~. FDA's rationale in part is that by publicly establishing rules, responsible firms will comply, thus contributing to efficient enforcement of FDCA (Huts and Merrill, 1991~.
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From page 67... ...
The first advisory opinions were issued during the early 194Os as excerpts from trade correspondence, generally known as TCs. However, after passage of the Administrative Procedure Act in 1946, such policy statements were required to be published in the Federal Register, and the TC system was discontinued Davidson, c.
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From page 68... ...
Several examples of the types of State requirements that would not be subject to the preemption provisions of the 1990 amendments were given in the Congressional Record of July 30, 1990 (H5842~. The examples included State laws pertaining to issues for which there is no national framework, such as open date labeling, unit price labeling, container deposit labeling, religious dietary labeling, and previously frozen labeling ADA, 1991, p.
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From page 69... ...
AFDO believes that Florida officials have more experience than officials from other States in dealing with misbranding of fruit juices and, therefore the State requirements are beneficial both to consumers as well as industry (AFDO, 1991~. The Attorneys General of seven States (California, Iowa, Minnesota, Missouri, New York, Texas, and Wisconsin)
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From page 70... ...
In these instances, the States urged the Committee to recommend that such State requirements be candidates for adoption as Federal requirements. The example most frequently cited was, again, the regulation of bottled water labeling (see Appendix I)
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From page 71... ...
SUMMARY OF INDUSTRY COMMENTS The comments provided by industry generally took the position that FDA has adequately implemented by setting requirements and monitoring compliance of the six provisions of FDCA Section 403 under study. In comments on behalf of Kraft General Foods, Inc., Merrill Thompson suggested that it should be presumed that the FDCA Sections under study
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From page 72... ...
, Inc., made two specific points regarding adequate implementation: We have no objection to learning from the states, where they have clearhy and significant improved upon the Federal law and regulations. Where a state cannot demonstrate a unique local condition that requires a unique local solution, but rather has identified a local approach that is superior to the national approach, that approach should indeed be adopted for the entire country.
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From page 73... ...
The first such view was that it should be presumed that the existing FDCA Sections and any associated FDA regulations adequately implement the purpose of such
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From page 74... ...
It concluded that the existence of Section 6(by(1) is evidence of the conclusion of Congress that it cannot be presumed that the six FDCA Sections to be studied are being adequately implemented.
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In considering this question, the Committee was confronted with the problem of defining success. In many cases, the differences between Federal and State requirements were small, and their relative significance was not readily apparent.
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From page 76... ...
These documents include proposed regulations, preambles to proposed and final regulations, Compliance Polipy Guides, guidelines, advisory opinions, letters to the regulated industry, Regulatory and Notice of Adverse Findings letters (both now called Warning Letters) , records of court actions, speeches, press releases, and speeches given by FDA officials.
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From page 77... ...
, or the product will be considered misbranded. These three sections affected the Committee's review of the adequacy of implementation of FDCA Sections 403(b)
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From page 78... ...
Anecdotal cases of violations were cited in discussions with State officials, but no comprehensive record of noncompliance was available for the Committee's use. Although the Committee recognized the critical importance of compliance to an evaluation of adequate implementation, the absence of compliance data required the Committee to omit inclusion of compliance as a criteria for determining adequacy of implementation of the six provisions of FDCA Section 403 under study.
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From page 79... ...
Identify existing State/local laws with provisions applicable to food labeling reform efforts currently being undertaken by FDA as related to FDCA Sections 403(b)
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From page 80... ...
Because the conclusions of the Committee are only recommendations to FDA about which State requirements it should consider embracing, the Committee felt that it would be appropriate in its categorization of State requirements to take the broader rather than the narrower approach to the interpretation of NLEN DEVELOPING THE COMMI11EE'S CRITERL4 In carrying out its charge, the Committee evaluated the adequacy of FDA's implementation of the six provisions of FDCA Section 403 in the following manner. First, it applied the principles developed through its own deliberative process: 1.
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From page 81... ...
In reviewing State and local requirements and their relationship to the six provisions of FDCA under study, the Committee viewed its OWE jurisdiction broadly to ensure a fair, balanced review of the materials provided by State and local officials and other interested persons. Second, the Committee reviewed and evaluated all State requirements it had assembled against the tasks defined in the IOM Proposed Plan of Action described earlier in this chapter.
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From page 82... ...
1991. Statement of Sharon Lindan, Assistant Director for Legal Affairs, CSPI, on behalf of CSPVCNVCFA/NCL 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 83... ...
1991. Presentation by Bruce Silverglade, Director of Legal Affairs, Center for Science in the Public Interest, before the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C.
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