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This article was originally published in The Tan Sheet

Executive Summary

USP FINAL VITAMIN-MINERAL MONOGRAPHS BECOME OFFICIAL NOV. 15 following publication in the U.S. Pharmacopeia's Supplement 9, which was released on Sept. 22. The final monographs for three remaining solid dosage classes -- oil- and water-soluble vitamins, oil- and water-soluble vitamins with minerals, and water-soluble vitamins with minerals -- complete the USP's standardization of six solid dose vitamin and mineral supplement categories comprising "75% of all multivitamins on the market," USP said in a Sept. 22 press release. Because vitamin-mineral supplements are regulated as foods under the present regulatory framework, the USP standard "will not currently be enforced by FDA," USP said. USP stressed that while these supplement monographs "bring to the field of vitamin and mineral supplements the same principles of product quality that are accepted as commonplace in areas of drug formulation," the supplement monographs are differentiated from "vitamin-mineral drugs" by their listing in a separate Nutritional Supplements section of the USP Official Compendium. In the USP system, most vitamins and mineral products list ingredients "by the applicable food name" instead of the "recognized drug name." However, USP stated that "mere use of a compendial name would not necessarily subject a vitamin or nutritional supplement to FDA enforcement of USP standards" or qualify the supplement as a drug. The completed standards for solid dosage form vitamin-minerals include such specifications as "potency ranges" for individual vitamins and minerals in tablet or capsule form; disintegration, dissolution, and weight variation requirements; microbial limits for various dosing forms; and packaging and labeling requirements. Monographs for two other vitamin-mineral classes -- minerals and oil-soluble vitamins -- became official on May 15, while the first monograph -- water-soluble vitamins -- became official in November 1992. In August, USP submitted comments to FDA regarding supplement ingredient labeling under the Nutrition Labeling & Education Act ("The Tan Sheet" Aug. 16, p. 7). "Beginning in late 1993, after all the USP standards for vitamins and mineral supplements have become official, consumers will begin to see an increasing number of products featuring 'USP' on the label adjacent to the product name," indicating that the product meets those standards, USP predicted. Paired with the release of the final monographs is a USP professional education program "to provide pharmacists and other health care providers with specific information about the new standards," USP said. In addition, USP will begin an independent consumer education effort by offering a new brochure explaining "issues related to the quality of vitamin and mineral supplement products" free-of-charge to consumers who contact the agency. The brochure will be made available in larger quantities for "a nominal charge," USP said. Beginning in early 1994, USP will begin working on its monographs for liquid dosage forms aimed at the pediatric and geriatric markets. And while USP has published monographs on single ingredient amino acids in the past, "discussions" on a monograph class for amino acids in combination with vitamins and minerals are now under way. USP monographs on enteral nutrition products and infant formula are also expected to be published in 1994. The nutritional supplements standards were drafted by the USP Subcommittee on Vitamins, Minerals and Enterals (VME), which was formed in July 1990 and began publishing monograph proposals in the fall of 1991. The VME subcommittee has worked with such industry groups as the Council for Responsible Nutrition, the Nonprescription Drug Manufacturers Association, and the National Nutritional Foods Association, as well as FDA's Center for Food Safety & Applied Nutrition, the Canadian Health Protection Branch, and health care professionals, in formulating the standards.

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