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This article was originally published in The Tan Sheet

Executive Summary

Development of Hazard Analysis and Critical Control Points for dietary supplement companies urged by clients of D.C.-based law firm Emord & Associates, who say FDA's proposed GMP standards for supplements would economically harm small businesses by substantially raising production costs without increasing safety and quality. The plaintiffs in the Pearson v. Shalala case say the agency lacks a sufficient scientific basis upon which to ground GMPs for the entire industry and supplement companies are in the best position to identify their own production risks and appropriate countermeasures

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