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This article was originally published in The Tan Sheet

Executive Summary

VITAMIN/MINERAL QUANTITATIVE AMOUNTS SHOULD BE INCLUDED ON NUTRITION LABEL, FDA determined in a proposed rule implementing the nutrition labeling provisions of the Nutrition Labeling & Education Act for dietary supplements. The nutrition labeling proposal was published in the June 18 Federal Register along with NLEA regs for health claims and nutrient content claims ("The Tan Sheet" June 21, pp. 4 and 9). Although FDA is not requiring that information on the quantitative amounts of vitamins and minerals be included on the labels of conventional foods, the proposal states that "this information is necessary and useful on the labels of dietary supplements . . . by virtue of the way that such products are formulated, marketed and used." In explaining why the agency feels that dietary supplement labeling should include information on quantitative amounts, the proposal points out that supplements "are often formulated and marketed on the basis of offering specific amounts of certain vitamins and minerals to consumers." In addition, FDA noted that consumers often "try to maintain a certain quantitative intake of specific nutrients in their diets." FDA added that most dietary supplement labels currently include quantitative information, and continuing to provide such information "will help ensure that consumers are fully informed about the content of these products." Quantitative amounts for vitamins and minerals may be stated "in terms of the absolute amount by weight of the nutrient or the percent of Daily Value that the amount represents," FDA said. FDA received several comments opposing quantitative amount information for supplements on the basis that "only percent of Daily Value should be mandatory, consistent with the labeling of vitamins and minerals on the labels" of conventional foods, the agency said. One comment maintained that "a requirement for too much information is discriminatory against products with larger numbers of nutrients and might discourage the use of smaller packages that are less expensive to consumers." FDA added, however, that "about half of the comments supported FDA's position on declaring amounts." "To reduce consumer confusion and to ensure that it is readily observable and comprehensible to consumers, the agency is proposing that nutrition labeling on vitamin or mineral supplements be presented in a manner that is as similar as possible to the nutrition labeling of other foods," FDA said. FDA issued regs implementing NLEA for conventional foods on Jan. 6. The agency explained that the heading on the nutrition label should read "Nutrition Facts" and the label should be boxed off with one color type on a neutral contrasting background. Declaration of nutrition information should be "on a 'per serving' basis" (as opposed to a "per unit" or "per day" basis) and should specify whether the serving is a tablet, capsule, packet or teaspoonful. Servings per container also must be specified, FDA said, unless the identical information is stated in the net quantity of contents declaration. "Dietary supplements in liquid or powdered form will always have to declare 'servings per container,'" FDA stated. The agency emphasized that supplement firms must declare every nutrient that is present in a product at more than insignificant amounts, which are defined as the "amount that allows the declaration of 'less than one gram.'" In terms of nutrient order, the agency proposed that all vitamins be listed first, followed by minerals in the following order: calcium, iron, phosphorus, iodine, magnesium, zinc and copper. Like foods, dietary supplement labels must also bear a complete list of ingredients including "fillers, artificial colors, flavors, binders and excipients." The agency also is allowing vitamin synonyms in supplement labeling such as ascorbic acid for vitamin C, thiamin for vitamin B[1], riboflavin for vitamin B[2] and folacin for folate. The FDA proposal also asks for comments on a requirement for dietary supplements that "percent Daily Values for all nutrients be expressed to the nearest whole percent," which is different from what FDA requires for conventional foods. "Greater precision is possible with formulated supplements as opposed to what is possible for naturally occurring nutrients in foods in conventional food form," FDA explained. The agency added that it believes that "consumers will be interested in this precision on dietary supplements of vitamins or minerals." Many dietary supplements "are currently labeled in this manner," the proposal points out. FDA also suggested that the percentages of RDIs be based on RDI values for adults and children four or more years of age. "FDA intends to revisit the issue of whether to establish RDIs for infants, children under four years of age, or pregnant or lactating women at the time it considers the broader question of the appropriate values for RDIs," according to the proposal.

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