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CONGRESS IMPOSES MORATORIUM ON SUPPLEMENT REGULATIONS

 CONGRESS IMPOSES MORATORIUM ON SUPPLEMENT REGULATIONS
 WASHINGTON, Oct. 7 /PRNewswire/ -- Congress has imposed a one-


year moratorium on the Food and Drug Administration's (FDA) mandate to implement the Nutrition Labeling and Education Act (NLEA) of 1990 for nutritional supplements. The legislation, sponsored by Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was included in the "Prescription Drug User Fee Act of 1992" as Title II, "The Dietary Supplement Act of 1992."
 The legislation includes a one-year moratorium on FDA's proposal to replace the existing U.S. Recommended Daily Allowance (U.S. RDA) label standard for vitamins and minerals with the Reference Daily Intake (RDI). The RDI was not mandated in NLEA but was added to proposed labeling regulations by FDA.
 Throughout the moratorium, FDA's current enforcement powers remain, and the American consumer continues to be protected from fraudulent claims and unsafe products. Hatch underscored this point in a floor statement supporting the moratorium on implementing the NLEA for dietary supplements.
 "I reiterate that the FDA will continue to retain its existing authority to pull any product whatsoever off the market if it is toxic, deleterious, poisonous or otherwise injurious to people," he said.
 The moratorium allows FDA to approve health claims for dietary supplements of vitamins, minerals, herbs or other nutritional substances that are supported by significant scientific agreement. In addition, the legislation requires three reports on: 1) FDA's regulatory enforcement priorities regarding food additives; 2) FDA's overall efficiencies in allocating regulatory resources to priority risk areas; and 3) the relationship between safety regulations for dietary supplements and their health effects in the United States and other industrialized countries.
 The bill resulted from the bipartisan recognition that Congress, FDA and the Department of Health and Human Services (HHS) need to more fully examine issues related to the regulation of dietary supplements. Following the introduction of the Health Freedom Act of 1992 by Hatch and the Health Choices Act of 1992 by Rep. Bill Richardson (D-N.M.), other key health legislators, including Sen. Edward Kennedy (D-Mass.), Rep. John Dingell (D-Mich.), Waxman and Rep. Norman Lent (R-N.Y.), supported the moratorium concept.
 The Dietary Supplement Act of 1992 provides additional time to assess the rapidly emerging scientific evidence supporting the role of dietary supplements in enhancing the health and well-being of the American public. "Congress should be applauded since this moratorium creates a magnificent opportunity for our industry to work in a spirit of cooperation with Congress, HHS and FDA to develop a more appropriate regulatory framework for dietary supplements that reflects the consumer's interests," said J.B. Cordaro, president of the Council for Responsible Nutrition.
 The Dietary Supplement Act of 1992 also places a one-year moratorium on FDA changing the current U.S. RDA label standard for vitamins and minerals. Ninety-five percent of the comments FDA received earlier this year opposed the agency's proposal to adopt the RDI as a new label standard. The scientific community indicated that large segments of the U.S. population could be placed at nutritional risk if the RDI standard was adopted. The moratorium allows additional time for obtaining a thorough assessment of the scientific rationale for any proposed changes from the existing U.S. RDA.
 "We believe the rationale for the Recommended Dietary Allowance (RDA), upon which label standards are based, should be re-focused toward health promotion and disease prevention," Cordaro said. "Dietary advice should reflect current scientific findings for more generous consumption of vitamins and minerals which help protect against chronic diseases."
 Under the act, new regulations to implement NLEA for supplements will be proposed in June 1993 and issued in December 1993. However, this moratorium does not affect FDA's final rules for conventional foods.
 CRN is an association of the nutritional supplements, ingredients and other nutritional products industry.
 -0- 10/7/92
 /NOTE: Cordaro is available for interviews by calling the contact below./
 /CONTACT: Susan Fitzgerald of the Council for Responsible Nutrition, 202-872-1488/ CO: Council for Responsible Nutrition ST: District of Columbia IN: HEA SU: LEG


KD -- DC032 -- 7624 10/07/92 17:35 EDT
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