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Shelf life requirement in supplement labeling regs problematic for mfrs. -- packager.

This article was originally published in The Tan Sheet

Executive Summary

SUPPLEMENT SHELF LIFE REQUIREMENT PLACES STRAIN ON MANUFACTURERS because of potential misbranding concerns, Merical President Dean Baltzell said at a recent dietary supplement packaging conference. The Dietary Supplement Health & Education Act implementing regs' requirement that products contain 100% of all added nutrients for the full length of their shelf life "is going to put a huge burden on the industry," Baltzell maintained. FDA published the final regs, which will take effect March 23, 1999, in the Sept. 23, 1997 Federal Register ("The Tan Sheet" Sept. 29, 1997, pp. 1-7). Baltzell, whose Anaheim, Calif.-based packaging company did $25 mil. in Rx, OTC and supplement packaging in 1997, made his remarks at the NutraPack '98 conference in Anaheim Jan. 21-22.

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