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CRN WILL NOT BREAK RANKS ON BROAD DEFINITION OF DIETARY SUPPLEMENTS

This article was originally published in The Tan Sheet

Executive Summary

CRN WILL NOT BREAK RANKS ON BROAD DEFINITION OF DIETARY SUPPLEMENTS and will continue to support the inclusion of herbals and amino acids in the definition, Council for Responsible Nutrition President J.B. Cordaro told the group's annual meeting on Sept. 20. "CRN endorses and will maintain its support for a broad definition of dietary supplements that includes herbs, amino acids and other similar substances as well as vitamins and minerals," Cordaro stated in his "State of the Industry" address. CRN, he declared, "will not sacrifice any one supplement or product category to enhance another." FDA has indicated an interest in streamlining the definition of dietary supplements to primarily include just vitamins and essential minerals. In recent speeches, FDA Deputy Commissioner for Policy Michael Taylor has maintained that the term "dietary supplement" is "unfortunately" being used to "refer to a very diverse spectrum of products that pose widely varying concerns" and that may require different regulatory approaches. Similarly, in FDA's June 18 advance notice of proposed rulemaking on dietary supplements, the agency dealt with amino acids, herbs and "other components of dietary supplements" in sections separate from vitamins and minerals ("The Tan Sheet" June 21, p. 1). In defining the term "dietary supplements" in the ANPR, however, FDA included vitamins, essential minerals, protein, amino acids, herbs, animal and plant extracts, fats and lipid substances, dietary fibers and other compounds. A broad definition for dietary supplements is included in supplement legislation introduced by Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.) in April ("The Tan Sheet" April 12, p. 6). The Hatch and Richardson bills, which are endorsed by CRN and other industry groups, define supplements as vitamins, minerals, herbs, amino acids and any other "concentrate or extract" used to supplement the diet. However, a bill introduced in August by Rep. Cardiss Collins (D-Ill.) eliminates amino acids from the definition and defines supplements as vitamins, minerals, herbs or similar nutritional substances intended to supplement the diet. Cordaro underscored that passing legislation "that you can live with for many years to come" is the association's "number one priority," and urged the industry to "collectively direct our competitive energies to passing legislation and shaping regulation." Cordaro acknowledged that the dietary supplement industry "encompasses a diverse mix of associations, companies and individuals," with each having "its own view and unique role to play." But in lobbying for the Hatch and Richardson bills and commenting on FDA's ANPR, Cordaro emphasized that "no segment of the supplement industry can go it alone. We are all in this together." Art Ulene, MD, chairman of the Feeling Fine Program and a former correspondent for the "Today" show, however, encouraged CRN to distance itself from "fringe" elements of the industry. "I urge you to do something to stop the irresponsible members of your industry" who "do a great disservice to the general public and they do great damage to your industry," Ulene declared. Referring to a statement made by Cordaro that CRN supports the sale and use of "all safe dietary supplements made to quality standards," Ulene asked the meeting attendees how they plan to deal with companies that are "passive with respect to products that do not meet the standard" for safety. "Are you prepared to do something about those supplements that cannot be proven safe?" Ulene asked. "Are you prepared to do something about those claims, wild claims sometimes," that are made by some dietary supplement firms? Ulene, who revealed that he is "in the process of adopting an active role personally in the dietary supplement business," also recommended that CRN members target non-users of dietary supplements in their promotions. He noted that "approximately 65% of the people of this country remain non-users" and that "studies show that huge segments of this country are not even consuming" the Recommended Dietary Allowance of most nutrients. "These numbers represent a huge opportunity lost" for the supplement industry, Ulene concluded, adding that dietary supplement firms should work with physicians to get the word out to consumers about the beneficial health effects of supplements.
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