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  1. The Committee limited its study of the six FDCA Sections to any implementing regulations for which rulemaking had been completed and advisory opinions had been published, as defined in 21 CFR §10.85.

  2. In reviewing State and local requirements and their relationship to the six provisions of FDCA Section 403 under study, the Committee viewed its own jurisdiction broadly to ensure a fair, balanced review of the materials provided by State and local officials and other interested persons.

Once the principles for evaluating adequacy were established, the Committee interpreted adequacy of implementation in the following manner. In some circumstances where only a law existed, the law alone could be judged to adequately implement the provision. In other circumstances, the existence of implementing regulations for a given section of the law could be judged to represent adequate implementation of the statute. In other situations, consideration could be given to other types of evidence to assist in judging adequate implementation of a provision of the law; i.e., an FDA advisory opinion.

Two additional concepts that could be used to define adequate implementation are compliance and enforcement. Compliance would address the extent to which manufacturers have met the provisions of laws and regulations; i.e., the degree to which food labels in the marketplace comply with Federal labeling requirements. An evaluation of enforcement would address the extent to which FDA has pursued manufacturers that market products with labels that do not meet Federal requirements. With regard to compliance as a measure of adequate implementation, this criterion was considered to be important because it represents the effectiveness of existing requirements to fulfill the Congressional mandate on the six FDCA misbranding provisions under study. However, the Committee received no information on compliance from its requests to FDA and the States. Anecdotal cases of noncompliance were cited in discussions with State officials, but no comprehensive record of noncompliance problems 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.

The Committee considered the question of whether FDA's enforcement of existing laws and regulations should be a criterion for evaluating the adequacy of implementation of the six provisions of FDCA Section 403. To determine the intention of Congress on whether enforcement was an issue for the Committee's consideration, it reviewed the provisions of NLEA and



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