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VITAMIN/MINERAL BIOAVAILABILITY, PURITY AND IDENTITY STANDARDS

This article was originally published in The Tan Sheet

Executive Summary

VITAMIN/MINERAL BIOAVAILABILITY, PURITY AND IDENTITY STANDARDS should be adopted by FDA "to ensure the purity of vitamin and mineral supplements," the agency's Task Force on Dietary Supplements suggested in its final report publicly released on June 18. Standards for chemical identity also should be devised, and should include "specification of acceptable analytical methods for determining identity and quantity for each of the vitamins and minerals," the report says. In addition, the task force recommended that FDA "establish and implement disintegration standards" in order to "ensure that vitamin and mineral products are presented to the body in forms conducive for absorption and utilization." The report suggests that the agency "consider evidence other than disintegration and dissolution when such data are needed." The report points out that the U.S. Pharmacopeia is currently developing standards for vitamins, minerals and other nutritional supplements and recommends that FDA should incorporate the "best ideas from standards developed" by USP. Issues addressed by the USP standards, according to the report, include "analytical methodology, disintegration, dissolution, composition uniformity, weight variation, chemical interactions of components and content microbial limits." At a June 21 meeting of an FDA ad hoc advisory committee on stability testing of new drugs, USP official Tim Grady mentioned that, in devising standards for vitamins, USP discovered that "there are some really important stability problems," particularly with antioxidants. The task force emphasized that FDA should "establish a liaison . . . with nongovernmental agencies," such as USP, to "provide expert advice on the safety and standards, where necessary, and other scientific issues for the proper regulation of dietary supplements." In addition, the task force emphasized that good manufacturing practice regulations are needed for dietary supplements as well as a better adverse reaction reporting system. The task force also made recommendations on possible regulatory mechanisms for dietary supplements other than vitamins, minerals and amino acids. Called "category three" substances in the report, such supplements include black currant oil and evening primrose oil. The report urges that category three substances be regulated as food additives. A statement regarding the "nutritive value" of category three substances also should be provided on labeling, the task force suggested. "If the substance does not have known nutritive value, the statement would indicate that the nutritive value has not been established." FDA also was encouraged to "emphasize consumer education" for category three substances; to "continue to bring actions against category three substances that are represented for use as drugs," and to "maintain a regular inspection program to ensure that GMPs are being observed to gain additional information about category three substances, including ingredients and [the] nature and extent of contaminants," according to the report. The report advocated a broader public education campaign for all dietary supplements as well. FDA's "ultimate goal" for category three products should be to ensure their safe use, the task force said. "This may mean reviewing the safety of these ingredients before they are allowed on the market or engaging in active surveillance of those that are on the market," the report adds. However, the task force recommended that FDA also ensure "to the extent possible, freedom of choice for consumers by making a wide variety of products available." A "conscientious commitment to consumer education," the group reasoned, "should permit consumers to make more informed choices, and thereby reduce potential risk" of category three products. The task force also recommended that a safe upper intake limit should be established for vitamins and minerals ("category one" substances), and that amino acids ("category two" substances) be regulated as drugs ("The Tan Sheet" June 21, pp. 1 and 8). The task force also stated that FDA should "continue to regulate products that bear homeopathic claims as drug products" and that the Center for Drug Evaluation and Research "consider revising its present" compliance policy guide "to improve the agency's ability to deter manufacturers from" promoting products with homeopathic claims as nutritional supplements. Regarding herbs, the task force advised that the Center for Food Safety and Applied Nutrition and CDER work together "to resolve the safety and labeling issues related to the marketing of herbs in tablet, capsule, or other forms." The task force did not consider medical foods in the report because FDA regulation of these products "is currently being examined by a separate agency task force." Among other recommendations put forth by the task force was to "establish a mechanism to work closely with the Federal Trade Commission to coordinate actions regarding dietary supplements," work with appropriate state agencies to regulate supplements, and "share FDA's policies with the international community to foster good working relationships." Dietary supplements also should adhere to tamper-resistant packaging and child-proof caps requirements, the report states, and FDA should "act against misleading name claims, including brand names, on the labels of dietary supplements that imply therapeutic use, benefit and/or treatment."
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