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In Brief: FDA "imminent hazard" criteria

This article was originally published in The Tan Sheet

Executive Summary

FDA "imminent hazard" criteria: Agency determines in final rule published July 23 to retain Sec. 25 in the Code of Federal Regulations describing the criteria FDA would use in determining whether an imminent hazard exists. The agency proposed revoking the section in an Aug. 21, 1979 notice, withdrew the proposed rule on Jan. 20, 1994, then reproposed it in 1996. FDA is retaining the section because the term "imminent hazard" appears in several provisions of the FD&C Act and its implementing regs, including provisions on adulterated dietary supplements, and continued guidance in interpreting the provisions is thought necessary...
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