OTC Inactive Ingredient Labeling Guidance To Be Issued By FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA plans to issue a guidance to industry on how to list inactive ingredients that may or may not be present in OTC drug labeling
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OTC labeling exemption
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)...
Inactive Ingredient "May Contain" Listing Sought By Perrigo
Perrigo is asking FDA to allow it to use the phrase "may contain" to list inactive ingredients on two of its over-the-counter cough/cold products.
CHPA petitions
OTC and supplement labels' use of the phrases "may contain," "may also contain" or "and/or" to list inactive and non-supplement ingredients is requested in two petitions submitted to FDA Sept. 8. CHPA's requests echo a petition submitted by Arnall Golden & Gregory June 2 (1"The Tan Sheet" June 5, p. 4). OTC drug and supplement labeling regs require all companies to list inactives on packaging, but the "specific makeup of composite inactive ingredients can vary slightly from supplier to supplier," CHPA notes, and multiple suppliers are necessary to ensure uninterrupted flow of products. Alerting consumers to potential allergens, a possible advantage to the requirements, is unjustified since consumers can self-select to their needs among the many competing products on the market, the association contends