Dietary Supplement Ingredient Alphabetical Listing Sought In Citizen Petition
This article was originally published in The Tan Sheet
Executive Summary
Listing supplement non-dietary "ingredients" or "other ingredients" alphabetically would be consistent with regs requiring that OTC drug inactive ingredients be declared in alphabetical order on labeling, an Atlanta law firm tells FDA.
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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
Dietary supplement inactive listing
Supplement makers' use of the phrase "may contain" or "may also contain" to list ingredients that may or may not appear in the product when manufactured by multiple suppliers is requested in a citizen petition submitted to FDA June 2 by law firm Arnall Golden & Gregory on behalf of an unnamed client. The client, a supplement manufacturer, also packages "thousands" of supplements for "hundreds" of retailers, and is likely the same company that recently made an identical request for varying inactive ingredient listing on OTC labeling of drugs sourced by different suppliers (1"The Tan Sheet" June 5, p. 4). The supplement petition does not apply to dietary ingredients, which must be listed precisely under the FD&C Act
Varying Inactive Ingredient Listing On OTC Labeling Requested
An across-the-board variance allowing listing possible inactive ingredients on labeling of OTC drugs manufactured by multiple suppliers is requested in a citizen petition filed with FDA May 16. A slightly revised petition followed on May 23.