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GMP Cost Impact, Ephedra Suits Loom Over Supplement Industry – Israelsen

This article was originally published in The Tan Sheet

Executive Summary

The Office of Management & Budget likely is delayed in releasing GMPs because it is grappling with issues surrounding the economic impact of the rule on small businesses, according to UNPA head Loren Israelsen

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Dietary Supplement GMP Spin-Off Reg May Address Small Business Impact

The Office of Management and Budget on May 23 completed reviewing an interim final rule related to dietary supplement good manufacturing practices FDA is expected to publish within six weeks, according to OMB.

FDA courtesy letters

The agency recently sent courtesy letters to several firms concerning the mislabeling of products as dietary supplements when, in fact, they are conventional foods. The companies that received letters for mislabeled products include KSERO Corp., Enzymatic Therapy, Alpine Confections and Tronex. The agency requests that Enzymatic Therapy change the labels for Liquid Calcium Magnesium with Botanicals, ITI Mega Multi Vitamin Drink Mix and LeveLife Synergy Drink Mix to comply with labeling for conventional foods; currently, the products are labeled as dietary supplements. United Natural Products Association head Loren Israelsen previously identified FDA's growing interest in defining the distinctions between conventional foods and dietary supplements as an issue of increasing importance to the industry (1"The Tan Sheet" Aug. 3, 2006, p. 6)...

Supplement Groups Cheer As Hatch Seeks Sixth Senate Term

Dietary supplement trade associations are welcoming Senator Orrin Hatch's (R-Utah) decision to add six more years to his 30-year tenure

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