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This article was originally published in The Tan Sheet

Executive Summary

NDMA PROPOSES FIVE INTERCHANGEABLE TERMS FOR USE IN OTC LABELING in June 4 comments to FDA. The Nonprescription Drug Manufacturers Association letter responds to an April 5 agency solicitation for "terms included in various OTC drug monographs [that] may be used interchangeably," such as "doctor" and "physician," and "consult" and "ask" ("The Tan Sheet" April 5, p. 9). The terms suggested by NDMA for interchangeable use include "clean" and "cleanse"; "persist" and "continue"; "chronic" and "persistent"; "assistance" and "help"; and "pulmonary" and "lung." The association suggested that "in at least two cases . . . the alternative terms may be better understood by consumers: 'Lung' disease may be better understood than the more technical 'pulmonary' disease, and 'persistent' may be better understood than 'chronic.'" NDMA said it arrived at the five paired terms through a survey of its members. In general, NDMA said it supports "the agency's efforts to enlarge the range of terms available for use in OTC required labeling. Permitting labeling to use different words that mean the same thing advances the goal of effective consumer communication." "To avoid possible confusion," NDMA also asked FDA to confirm in the preamble to the final rule that the interchangeability proposal would apply only to OTC monograph language "otherwise required to be declared verbatim on OTC labeling" and "should not apply to or otherwise affect labeling subject to the agency's flexibility policy, which permits use of truthful and nonmisleading terminology about indications as an alternative to nonmonograph language." Regarding FDA's proposed interchangeability of doctor/physician and consult/ask, NDMA said it "agrees it is appropriate and efficient to include these and other sets of alternative terms in the OTC regulation covering general conditions for labeling all OTC drugs." However, the association noted that it would not be appropriate to use the term "health professional" interchangeably with doctor/physician, because the term health professional "may include pharmacists, nurses, midwives and others who are not licensed to practice medicine." NDMA asked FDA to clarify this in the preamble to the final rule.

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