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In Brief: OTC sodium/cation labeling

This article was originally published in The Tan Sheet

Executive Summary

OTC sodium/cation labeling: Nonprescription Drug Manufacturers Association recommends "paragraph listing, in alphabetical order, of cation contents with no special heading" (e.g., "Each tablet contains: calcium (x mg); magnesium (x mg); potassium (x mg); sodium (x mg)") in Feb. 25 comments to FDA. The comments respond to the final rule on sodium content labeling requirements published in the April 22 Federal Register ("The Tan Sheet" April 29, 1996, p. 8). The "logical placement" of the statement in labeling, NDMA says, is "after the `Warnings' section, immediately following a listing of inactive ingredients when one is present." The sodium rule, as well as the Feb. 27 proposed OTC labeling regs, request suggestions for placement of cation warnings in labeling. The trade group also reiterates its opinion that FDA has expressed threshold levels of cation contents ambiguously in terms of both "single recommended dose" and "maximum recommended daily dose"...
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