OTC labeling rules may negatively affect ADA Seal of Acceptance program, assn. says.
This article was originally published in The Rose Sheet
Executive Summary
OTC LABELING RULES MAY AFFECT ADA SEAL OF ACCEPTANCE PROGRAM, the American Dental Association claims in Oct. 3 comments on FDA's proposed regulations for revised OTC drug labeling. While expressing support for the rulemaking in general, ADA notes it is "concerned...that the section of the rule establishing requirements for labeling content (201.66(c)) could have a negative effect on the ADA Seal of Acceptance program and the public and profession it serves." FDA published the proposed rule in the Feb. 27 Federal Register ("The Rose Sheet" March 3, pp. 11-13).