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in the marketplace comply with the 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 the 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 of FDCA. However, this issue was not mentioned as a criterion in either the provisions of NLEA, or the Congressional debate on the subject. In addition, the Committee received no information on compliance from its requests to FDA and the States. 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.

The Committee also 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 intent of Congress on whether enforcement was an issue for the Committee's consideration, it reviewed the provisions of NLEA and the Congressional record debate on the issue and discussed the question with a number of individuals familiar with the course of the Act's development. No evidence was presented to the Committee which would indicate that enforcement was an anticipated criterion for determining adequacy of implementation. While the Committee believed that the issue of enforcement was important in terms of evaluating the agency's implementation record, it also recognized that FDA's enforcement record is significantly influenced by resources available (adequate manpower and funding) and the political will at given points in time. Therefore, the Committee chose not to include enforcement as a criterion for adequate implementation. However, because enforcement was considered to be an important issue for the future, the issue is addressed at considerable length later in the report.

State Regulations as an Indicator of Adequacy of FDA Implementation

The two most frequently cited justifications for State regulation were that (1) States provide an avenue by which new and innovative regulatory



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