Cover Image


View/Hide Left Panel
  1. The absence of an FDA implementing regulation would not lead to an automatic conclusion that implementation was inadequate.

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

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

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

  5.  In reviewing State and local requirements and their relationship to the six provisions of FDCA 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.

Second, the Committee reviewed and evaluated all State requirements it had assembled against the tasks defined in the IOM Proposed Plan of Action described earlier in this chapter.

Third, the Committee categorized the State requirements according to the following criteria:

  1. An adequate Federal requirement exists on the issue (the field is thus occupied).

  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.

As part of its consideration of adequacy, the Committee has suggested the adoption of State requirements by FDA that might otherwise be preempted if, in its judgment, those requirements clearly provide special benefit to the consumer. To the extent possible, it has also established priorities among the candidates under criteria 2 and 3 above. Under this approach, the Committee left to FDA the legal determination of whether certain State requirements (statutes and/or regulations) were "definitions and standards" or "common or usual names," and the steps necessary under NLEA regarding their preemption. The results of the review and evaluation

The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001

Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement