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NDMA VOLUNTARY IRON SUPPLEMENT GUIDELINES INCLUDE WARNING LABELS

This article was originally published in The Tan Sheet

Executive Summary

NDMA VOLUNTARY IRON SUPPLEMENT GUIDELINES INCLUDE WARNING LABELS that caution consumers to keep the products out of reach of children, the Nonprescription Drug Manufacturers Association announced in a Sept. 27 press release. The industry program stipulates that all iron supplements containing less than 30 mg of iron per solid dosage unit should carry warning labels "as soon as possible" but no later than Dec. 31, 1994. Products containing greater than or equal to 30 mg of elemental iron per unit dose need to include the warning by Sept. 30, 1994 under the industry program. The new voluntary warning labels on iron supplements will read: "Warning: Close tightly and keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center Immediately." Under another part of the NDMA program, participating iron supplement manufacturers have agreed to package all iron- containing supplements with more than 30 mg of elemental iron per solid dose in child-resistant packaging by March 1, 1994. Current Consumer Product Safety Commission mandatory regulations require that packages with more than 250 mg of iron be packaged with CRPS. "All of our members already comply with the current [CPSC] CRP requirements for iron products," NDMA President James Cope said. He said the program is being launched to "provide an additional margin of safety." NDMA members also agreed that iron-containing products with 30 mg or more of elemental iron per dose will be formulated without the sweet outer coating usually accompanying these products by Sept. 30, 1994. NDMA also announced that it has teamed up with CPSC on a publicity campaign to urge adults to "protect young children from accidental ingestion of iron supplements." NDMA is fully funding the campaign that will reach consumers through public service announcements in newspapers, magazines, television and radio. As part of the campaign, the Commission will be making a video news release and a radio news feed available on Sept. 27, which will feature CPSC Chairman Jacqueline Jones-Smith. Radio advertising is primarily targeted toward Hispanics, NDMA noted. The announcement comes just before CPSC's Sept. 28 meeting to discuss pediatric iron poisonings ("The Tan Sheet" July 26, p. 11). FDA Center for Food Safety & Applied Nutrition Office of Special Nutritionals Director Elizabeth Yetley, PhD, and NDMA Senior VP-Science & Technology Willian Soller, PhD, are scheduled to speak at the meeting, which will begin at 9 a.m. at the International Trade Commission offices in Washington, D.C.
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