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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SAFETY REVIEW PROPOSED BY REP. CARDISS COLLINS (D-Ill.) in the Dietary Supplement Consumer Protection Act of 1993 (HR 2923), introduced on Aug. 6. The legislation dictates that FDA begin a safety review of all dietary supplement ingredients on the market prior to Aug. 5, 1993 within 60 days of enactment of HR 2923. The review can draw evidence of an ingredient's safety "through either scientific procedures or experience based on common use in a dietary supplement," the bill states. Dietary supplement ingredients are defined by the bill as "a vitamin, mineral, or herb or other similar nutritional substance the intended use of which results, or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any dietary supplement." A comprehensive safety review of all currently sold dietary supplements was characterized by House Energy & Commerce Committee/health subcommittee Counsel William Schultz as a key component of any dietary supplement legislation ("The Tan Sheet" July 5, p. 10). The idea also has been embraced by the Center for Science in the Public Interest, which proposed an FDA dietary supplement safety evaluation as part of legislation it floated on Capitol Hill in the spring ("The Tan Sheet" April 26, p. 12). Unlike dietary supplement bills introduced by Rep. Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah) in April ("The Tan Sheet" April 12, p. 6), HR 2923 attempts to create a regulatory framework for supplements within the Nutrition Labeling & Education Act, Rep. Collins indicated in an Aug. 6 statement introducing the legislation. "Unless supplement manufacturers are brought under the rubric of the NLEA, as Congress originally intended, consumers will not be able to tell fact from fiction," Rep. Collins declared. Calling the current exemption of dietary supplements from NLEA "unwarranted," Collins said her bill would "clear up . . . confusion and provide FDA with express authority to keep unsafe dietary supplements off the market." Under a 1992 law prompted by Sen. Hatch, regulations implementing NLEA for dietary supplements cannot go into effect until December. Proposed NLEA implementing regs were published in June ("The Tan Sheet" June 21, pp. 1-11). Collins explained that the legislation grew out of "continuing concerns about the health of older Americans." To that end, the congresswoman noted that HR 2329 "requires label statements regarding possible adverse effects of any supplement on particularly vulnerable segments of the population, such as the elderly." The bill also directs manufacturers to state on the label "the level, if any, at which a dietary supplement can cause adverse effects and the specific nature of any adverse effects and shall identify segments of the population, including the elderly and children, that may be affected." Under the Collins bill, manufacturers introducing a dietary supplement into interstate commerce must notify FDA "at least 90 days before making such introduction or delivery" in a manner prescribed by the agency. The Hatch and Richardson bills do not require an FDA prenotification mechanism for supplements. New dietary supplement products will be deemed unsafe, the bill says, unless: a regulation exists "prescribing the conditions under which such dietary ingredient may be safely used"; or the ingredient is "generally recognized, among experts . . . as having been adequately shown through scientific procedures to be safe under the conditions of its intended use." Manufacturers whose products do not adhere to those criteria have the option of filing a petition with FDA requesting the "issuance of a regulation prescribing the conditions under which such ingredient may be safely used," the legislation says. If FDA decides to deny a petition, it must notify the petitioner of the reasons, HR 2393 stipulates. In establishing regulations on the safety of a dietary ingredient, the bill directs FDA to specify: "the classes of dietary supplements in which the ingredient may be used"; "the maximum quantity which may be used or permitted in the dietary supplement"; "the manner in which such ingredients may be added to or used in the supplement"; and "any directions or other labeling or packaging requirements for such ingredient deemed necessary . . . to assure the safety of its use." To ensure that a supplement "provides the vitamin, mineral or herb or other nutritional substance that it claims to provide, and is manufactured in a manner designed to prevent adulteration," the legislation requires FDA to establish good manufacturing practices for dietary supplements, including process and quality control procedures. Manufacturers, distributors and retailers are obligated to report "knowledge which reasonably supports the conclusion that a dietary supplement or ingredient may be adulterated or misbranded" under the bill. A supplement can be considered misbranded if its label does not contain an expiration date or the statement on potential adverse effects, according to HR 2923. Under the Hatch and Richardson bills, dietary supplements are considered adulterated if they contain ingredients that present a "substantial and unreasonable risk of illness or injury" or if the manufacturer has not provided a "history of safe use" for the product. Among other provisions, the Collins bill mandates that FDA establish an advisory committee "to assist in the implementation of the amendments made by this act." In her statement on the bill, Collins suggested that one function of the committee could be to help FDA with "the approval of new health claims" for dietary supplements. The bill also requires the National Institutes of Health to "expand and intensify programs with respect to research and related activities regarding dietary supplements." HR 2923 appropriates $ 10 mil. to NIH for fiscal year 1994 "and such sums as may be necessary for each of the fiscal years 1995 through 1997" to carry out the research initiatives. Rep. Collins asserted in her statement on HR 2923 that the legislation is the "only dietary supplement bill pending in this Congress that is supported by a broad spectrum of consumer and public health groups not associated with the dietary supplement industry." Groups that have endorsed the legislation include CSPI, the American College of Physicians, the American Cancer Society, the American College of Preventive Medicine, the National Council on Aging, the Society for Nutrition Education, the Association of Schools of Public Health, the Consumer Federation of America, and Public Voice for Food and Health Policy. In an Aug. 12 statement, the Nutritional Health Alliance condemned the Collins bill, asserting that the legislation "would delay the approval of most health claims for years to come" by forcing dietary supplements into the "presently unworkable NLEA formula." NHA, along with industry groups such as the Council for Responsible Nutrition and the National Nutritional Foods Association, support the Hatch and Richardson bills and have planned a Capitol Hill lobbying day for the bills in September ("The Tan Sheet" Aug. 9, p. 5).

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