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FDA ALLIANCE-BUILDING ON DIETARY SUPPLEMENT REGULATION

This article was originally published in The Tan Sheet

Executive Summary

FDA ALLIANCE-BUILDING ON DIETARY SUPPLEMENT REGULATION includes meetings with 12 medical professional, industry and patient groups from May 14 to June 2 in preparation for the agency's upcoming proposal on the regulation of dietary supplements, which will appear in the Federal Register by June 15. Initiated by FDA, the "informational" sessions apprised invited organizations on the agency's position on dietary supplement regulation and on what will be proposed in the upcoming notice. In addition to offering general regulatory proposals for supplements, the notice will solicit comments on the safety of amino acid supplements in light of a July 1992 report by the Federation of American Societies for Experimental Biology (FASEB) concluding that "there is insufficient scientific evidence to establish safe upper levels of intake for any of the amino acid supplements on the market today." The document also will announce the availability of a report on regulatory problems associated with dietary supplements. Compiled by a special FDA task force on supplements, the so-called "Dykstra" report "recommended certain changes in FDA's approach" in regulating nutritional products, according to a question-and- answer document provided to groups meeting with FDA. The agency will ask for comments on the task force report in the notice. The regulatory notice is expected to be published about the same time as a set of three FDA proposals for implementing the Nutrition Labeling & Education Act in regard to dietary supplements. By statute, FDA is required to issue proposed NLEA regs for dietary supplements by June 15. The agency believes it is on track to meet that deadline. Organizations invited to the meetings included the American Pharmaceutical Association, the American College of Physicians, Association of State and Territorial Health Associations, American Nurses Association, FASEB, the American Frozen Food Institute, the Grocery Manufacturers Association, the National Organization for Rare Diseases and the American Diabetes Association ("The Tan Sheet" May 31, In Brief). FDAers who met with the groups included Mitchell Zeller, who recently left the House Government Operations/human resources and intergovernmental relations subcommittee to become special assistant to Deputy Commissioner for Policy Michael Taylor ("The Tan Sheet" April 19, p. 15), and FDA Office of Special Nutritionals Acting Director Elizabeth Yetley, PhD. Apart from informing the groups of the upcoming documents, FDA provided the organizations with an "information packet" containing an agency position paper on dietary supplements. In the paper, FDA argued that while most vitamins and minerals "do not ordinarily pose a safety problem," other products "may be promising more than they can deliver and often lack scientific proof for their claims. The level may not even identify the actual contents." Alluding to dietary supplement bills introduced by Sen. Orrin Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.) that would decrease FDA regulation of supplements, FDA noted that "some people have urged Congress to take away FDA's authority to conduct premarketing safety reviews [for supplements(BRACKET). This would be a major legal and philosophical change from the current system, putting the burden of proof regarding safety onto FDA rather than the manufacturers, and making it difficult for FDA to take any actions until actual harm to users has occurred." "Ongoing, informed public debate about dietary supplements will help everyone involved," the agency said. FDA asserts that "freedom of choice is not really free if it is based on false assumptions of safety or unproven label claims." FDA concluded its position paper by underscoring that it is "always interested in seeing new products on the market that will benefit the health and well-being of American consumers" and will continue to "work with anyone who is interested in bringing such products to market." In a Q&A document provided in the packet, FDA noted that dietary supplement products that "are of concern to FDA" and may be harmful to human health include "high potency vitamins, minerals and amino acids; and some substances sold as herbs, enzymes, bioflavanoids, inert glandulars, evening primrose oil, or other substances such as RNA, DNA, PABA or rutin." These products may be proposed as candidates for heightened regulatory attention by FDA in the upcoming proposal. FDA also cautioned in the Q&A document that the term "natural" on dietary supplement labeling and advertising does not "necessarily mean 'safe.'" In an accompanying "fact sheet on dietary supplements" provided in the packet, FDA distinguished between "vitamins and minerals that comprise more than 80% of the dietary supplement market" and products that "have no recognized role in nutrition." Understanding this distinction was called the "critical first step" in the ongoing dietary supplement debate by FDA's Taylor at a FASEB meeting in March ("The Tan Sheet" April 5, p. 1). The fact sheet also pointed to several cases in which products other than mainstream vitamins and minerals have caused death and injury, such as the amino acid L-trypotophan and herbal ingredients such as germander, comfrey and chaparral. Adverse incidents associated with chaparral are part of an ongoing FDA investigation ("The Tan Sheet" May 31, p. 5). The information packet provided to the groups also contained a copy of Taylor's speech at the FASEB meeting and a comparative analysis of the Hatch and Richardson bills. FDA also has put together a similar packet for those consumers who request information on dietary supplements. Released in May, the packet contains a position paper, a Q&A document, a list of consumer organizations involved with supplement issues, a comparison of dietary supplement legislation and a copy of Taylor's FASEB speech. A "Dear Consumer" cover letter signed by FDA Associate Commissioner for Consumer Affairs Alexander Grant asserts that dietary supplements are a "topic of high consumer and congressional interest and potential confusion due to misleading messages from certain nongovernmental groups that do not accurately portray FDA's position."

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