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SUPPLEMENT INDUSTRY COOPERATES WITH FDA ON NEW LABELING REGULATIONS

 WASHINGTON, Dec. 30 /PRNewswire/ -- In response to detailed comments by the Council for Responsible Nutrition (CRN), FDA has agreed to extend until July 1, 1995, the effective date for implementing label changes based on "undue economic hardship."
 The Council for Responsible Nutrition, which strongly supports a consumer-oriented label format, met with agency officials in December to petition FDA for the deadline extension and for labeling revisions. CRN told FDA that an extensive economic analysis revealed an industry impact of $109 million, representing almost 3 percent of total dietary supplement sales, if manufacturers were forced to make labeling changes by June 1994.
 "The Council for Responsible Nutrition is pleased that FDA has been responsive to the dietary supplement industry's request to grant a one- year extension for the effective date for label changes required by the Nutrition Labeling and Education Act (NLEA) of 1990," said CRN President J.B. Cordaro.
 Meeting the Dec. 31 statutory deadline, FDA's final rules for dietary supplement labeling under NLEA were issued on Dec. 29 as part of a seven-part, 450-page document. The regulations, slated for publication in the Jan. 4 Federal Register, address labeling for dietary supplements and standards and procedures for making health claims.
 In its December meeting with FDA officials, CRN also suggested changes in label formats to make dietary supplements labels more understandable. FDA has determined that it lacks sufficient consumer research information to make additional changes requested by CRN. However, the agency indicated at the meeting that it would be receptive to CRN's petition if supported by new consumer research data on label format changes that CRN believes will make labels more user-friendly for the 100 million consumers of dietary supplements.
 "CRN took FDA's encouragement very seriously and immediately formed a Working Group on Nutrition Labeling designed to work on a cooperative basis with FDA to develop consumer research data as quickly as possible," said Cordaro.
 Based on a preliminary analysis of the final rules for health claims for dietary supplements, Cordaro said that FDA still interprets "significant scientific agreement" too narrowly. "FDA's restrictive final rules for health claims underscore the need for congressional action to direct FDA to allow consumers access to more scientific information about the value of dietary supplements," Cordaro said. "CRN will continue to work to seek passage of legislation introduced by Sen. Orrin Hatch (R-Utah) and Congressman Bill Richardson (D-NM) to legislate a standard and establish a process that can provide a freer flow of information in a more timely and useful manner," he concluded.
 -0- 12/30/93
 /CONTACT: Moira Saucer of the Council for Responsible Nutrition, 202-872-1488/


CO: Council for Responsible Nutrition; Food and Drug Administration ST: District of Columbia IN: HEA SU: EXE

KD-PB -- DC017 -- 8181 12/30/93 18:05 EST
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Date:Dec 30, 1993
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