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determine whether those provisions were still appropriate. Although the agencies prepared detailed recommendations for implementing changes in many aspects of food labeling, a lack of scientific consensus and the prevailing deregulatory environment would not support comprehensive reform at that time.

Criticism of the type of information on food labels escalated in the 1980s as scientific investigations convincingly demonstrated the relationship between dietary habits and the prevalence of chronic diseases. American consumers became increasingly attentive to choices among foods and sought improved information on the products that they were selecting. In addition, the proliferation of health claims being made for foods created a demand for more consistent and scientifically sound messages on labels. By 1990, efforts to reform the current policy on food labeling, especially in regard to nutrition information, were being pursued by the Federal agencies and Congress. The food industry was particularly concerned about national uniformity in food regulation. All of these efforts culminated in the passage of NLEA.

CRITERIA FOR DETERMINING ADEQUATE IMPLEMENTATION OF THE FEDERAL STATUTE

In carrying out its charge, the Committee evaluated the adequacy of FDA's implementation of the six provisions of FDCA Section 403 by first applying principles developed during its 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 FDCA Sections 403(a)(1), 403(e), and 403(i)(2) when used in conjunction with the six provisions that were the subject of the study.

  3. The absence of an FDA implementing regulation would not lead to an automatic conclusion that implementation was inadequate.

  4. The level of enforcement would not be a consideration in determining adequacy of implementation.

  5. The strictest requirement, whether Federal, State, or local, would not always be recommended for adoption as the national standard.



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