OTC labeling exemption
This article was originally published in The Tan Sheet
Executive Summary
Zee Medical should implement asterisk notations for over-inclusive inactive ingredient listing for company's PainAid Pain Relief Tablets, FDA tells firm in Dec. 10 letter. In November 1999, Zee was granted FDA permission to use phrase "may contain" to list inactive ingredients. However, in November 2001 responses to citizen petitions filed by an Atlanta law firm and CHPA, agency said manufacturers should, instead, use phrase "contains one or more of these ingredients" and place asterisks next to inactives that may or may not appear in the product (1"The Tan Sheet" Nov. 12, 2001, p. 4)...