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DIETARY SUPPLEMENT EXEMPTION FROM FDA "NONFUNCTIONAL SLACK- FILL" REGS

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT EXEMPTION FROM FDA "NONFUNCTIONAL SLACK- FILL" REGS should be granted "when a minimum package size is needed to accommodate a label bearing information required by FDA, by other state or federal laws, or by commercial necessity," Perrigo urged in March 4 comments to FDA. Perrigo -- whose subsidiary, Perrigo of South Carolina, produces and distributes private label dietary supplement products -- was responding to the agency's proposed rule defining the circumstances under which nonfunctional slack-fill within a food package would be considered misleading. Perrigo argued that it is appropriate to exempt dietary supplement packages from the "nonfunctional slack-fill" definition in FDA's proposal because "many supplement products meet the criteria . . . for a minimum package size requirement" in that they are packaged in small quantities and are subject to FDA food labeling requirements. Dietary supplement firms must provide "adequate and appropriate cautionary information and/or directions for use on their products," the company said, and are required, "for reasons of commercial necessity, to include a UPC code on every product label." To be effective, UPC codes "must be a specified minimum size," Perrigo added. The company also pointed out that many manufacturers are trying to reduce the amount of packaging for their products for environmental reasons. Perrigo noted that some companies have eliminated the outer carton for some of their products, "which means they do not always have the option of using the additional space on the carton for all of this required labeling information." Most companies have tried to improve the readability of supplement labels through "more liberal spacing, greater print clarity and more distinct contrast," Perrigo maintained. "These measures ultimately require somewhat more label space . . . and further demonstrate the need for a minimum package size to accommodate a larger label," the company suggested. To encourage label readability initiatives, "particularly for elderly consumers of dietary supplements," Perrigo maintained that "supplement manufacturers need some assurance that the minimum package size necessary to accommodate all required labeling information in a more readable format will not be considered misleading." Perrigo also argued that dietary supplement packaging is less likely to deceive consumers than packaging for conventional food products. "The value of dietary supplements to consumers lies not in the overall weight or volume of the tablet, but in the quantities of the nutrients each tablet provides and the number of tablets in the package," Perrigo told the agency. Therefore, a supplement's package size "is far less important and far less likely to mislead a supplement consumer than the package of a conventional food product for which weight and volume are the keys to product value," the company maintained.

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