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State standards of identity that are different from Federal standards of identity were preempted on the date NLEA was enacted (November 8, 1990). However, a State statute or regulation setting forth a common or usual name for a food that is not identical to the requirements of FDCA Section 403(i)(1) is not immediately preempted but subject to review after the conclusion of this study. If preemption occurs, it will become effective November 8, 1992. However, regulatory areas of concern to the States cannot easily be categorized. Therefore, it is difficult to determine from a legal point of view whether State requirements are (1) "standards of identity" that are different from Federal standard, and thus already preempted by NLEA; (2) "standards of identity" in cases in which no Federal standards exist and therefore may not be preempted; or (3) "common or usual names'' that are different from Federal standards, not yet preempted, and thus subject to the Committee's review for determination of the adequacy of Federal requirements.

The Committee decided that it could not distinguish in any principled way among these three categories of misbranding and therefore it would view its own jurisdiction broadly. If it was reasonable to consider that the State regulation fell within the purview of the Committee's jurisdiction, it was treated as a matter for study. 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 NLEA.

DEVELOPING THE COMMITTEE'S CRITERIA

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. The definition of adequate as "equal to, proportionate to, or fully sufficient for a specified or implied requirement" was used as a foundation for decisions.

  2. The intent of any section and any regulation, as interpreted by the Committee, was a consideration, including, as appropriate, a consideration of the impact of Sections 403(a)(1), 403(e), and 403(i)(2) when used in conjunction with the six provisions that are the subject of the Study.



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