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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT "OTHER INGREDIENT" LABEL LISTING PROPOSED BY USP in July 28 comments on FDA's June 18 proposed rule implementing the nutrition labeling provisions of the Nutrition Labeling & Education Act for dietary supplements. The U.S. Pharmacopeia recommended that FDA allow on dietary supplement nutrition labels a separate listing of "other ingredients" -- or "nutrients that are [not] the sources of vitamins and minerals." The "other ingredients" listing could be placed under the "Nutrition Facts" box and could be "followed by a listing of all other substances incorporated as excipients," USP suggested. Vitamins that would not fall into the "other ingredient" category include beta carotene, biotin, folic acid, niacin, pantothenic acid, panthenol or dexpanthenol, "vitamin A and its esters," and vitamins B[1], B[2], B[6], B[12], C, D, E and K, according to USP. Elements that are not considered "other ingredients" by USP standards are calcium, chromium, copper, iodine, iron, fluoride, magnesium, manganese, molybdenum, phosphorus, potassium, selenium and zinc. USP explained that its rationale for devising "a policy of inclusion of other ingredients" ranging "alphabetically from acerola to watercress," was to "cover as many nutritional supplements marketed nationally as possible." USP stressed that, in order to be included in a USP-approved product, "other ingredients" must "not interfere with the test procedures specified in the pharmacopeia for determination of compliance" and adhere to "applicable regulatory requirements." In its June 18 nutrition labeling proposal, FDA did not provide for the inclusion of "other ingredients" in dietary supplement labeling. The agency proposed only that ingredients existing in a dietary supplement in higher than "insignificant amounts" (more than 1 gram) be included in the "Nutrition Facts" box on the label ("The Tan Sheet" June 28, p. 9). USP also suggested that FDA consider incorporating USP standards for dietary supplements into the agency's regulatory framework for the products. For example, USP said it developed a "labeling scheme by which nutritional supplement preparations which purport to conform to USP standards can differentiate themselves." Under the USP system, supplements complying with USP manufacturing standards can place the letters "USP" after the name of the product, provided that: "USP-recognized nutrients present in the dosage forms are listed separately from other ingredients including excipients"; and the "source of recognized nutrients, such as salt form of mineral used, shall be indicated parenthetically for each nutrient where applicable," the comments explain. If FDA decides not to incorporate the USP labeling scheme into its regulatory framework, USP urged that the agency alternatively allow exemptions to its regulations for companies wishing to instead adhere to the USP labeling system. USP emphasized that USP standards are "recognized de jure in Canada and other countries." To date, USP has completed monographs for three of six dietary supplement (tablet and capsule) classes: water-soluble vitamins, oil-soluble vitamins, and minerals. Monographs for the remaining three classes -- water-soluble vitamins with minerals, oil- and water-soluble vitamins, and oil- and water-soluble vitamins with minerals -- are slated for publication in USP's Pharmacopeial Forum on Sept. 15, with a finalization date of Nov. 15. Once a USP supplement monograph for a given class has been finalized, manufacturers whose products comply with the document may place the acronym "USP" beside the product name, USP said. Dietary supplement ingredients adhering to USP standards may also bear the "USP" logo beside the ingredient listing, but manufacturers must include a caveat that the entire "dosage form does not meet USP standards." In addition to the remaining three classes of dietary supplement monographs, USP is working on a "consumer dietary supplement handbook" as well as a chart of "unconventional products (bee pollen, bioflavonoids, ginseng, etc.)." The chart will address "claims being made and toxicities that have been reported" for those products, USP told FDA. USP monographs on enteral nutrition products and infant formulas also are expected to be published by 1994. Both documents will include "a chart of all products on the market," USP noted. In May, USP finalized guidance documents on standards for the disintegration and dissolution of supplements, and on general manufacturing standards.

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