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the Congressional 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 that 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 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 clearly a concern to States and consumer groups, and was considered to be an important issue for the future, the issue is addressed at considerable length later in the report.

Second, the Committee reviewed all of the State requirements it had assembled and evaluated them in terms of the tasks defined in the IOM's Proposed Plan of Action for the study. Third, the Committee categorized the State requirements according to the following criteria:

  1. An adequate Federal requirement exists on the issue.

  2. The agency has not adequately implemented the Act in the area of concern represented by the State requirement. Such a conclusion would be based on the requirement's national importance, its national prominence as indicated by the frequency of attention to the issue by the States, and/or the lack of an existing Federal regulation.

  3. The State requirement meets a demonstrated local need.

  4. The State requirement provides only economic protection to the industry, is without consumer benefit, and/or has no other redeeming virtue.

Beyond Federal laws and regulations, there is a tremendous variety of less formal written materials that analyze, interpret, and discuss FDA's view on its statutory mandate. These documents include preambles of proposed and final regulations, compliance policy guides, guidelines, advisory opinions, letters to the food industry, Regulatory Letters and Notice of Adverse Findings letters (now both called Warning Letters), speeches, press releases, and talk papers. The Committee concluded that although many informal mechanisms are used to implement the law, it would not be possible or appropriate to examine all such materials in determining the adequacy of implementation. However, the Committee did view advisory opinions (as defined in 21 CFR §10.85) as representing the formal position of FDA on a matter and, except in unusual situations, as obligating the agency to follow that position until it was amended or revoked. Therefore, the Committee



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