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DSHEA labeling regs

This article was originally published in The Tan Sheet

Executive Summary

Amway's Nutrilite division estimates the cost of label changes to comply with FDA's 1997 dietary supplement regulations totals roughly $3,000 per label, Quality Control, Technical & Regulatory Affairs Senior Manager James Lassiter tells a Drug Information Association meeting in Arlington, Va. March 9. The estimate includes "review time, marketing time, layout [and] printing," but not "scrap" costs. The costs also take into account a change in "presentation" in terms of marketing claims and a change in labeling "orientation" on containers. The rules are effective March 23 for products labeled after that date. The regulations, published Sept. 23, 1997, include the requirement that labels bear a "Supplements Facts" box ("The Tan Sheet" Sept. 19, 1997, pp. 1-7)

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