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Regulatory News In Brief

This article was originally published in The Tan Sheet

Executive Summary

Ortho Molecular supplement claims draw warning letter; FDA flags Global Source Management violations; Zi Xiu Tang bee pollen capsules recall follows FDA buzz; Wal-Born users eligible for refunds, FTC says; GAO endorses FDA comparability approach to food import safety.

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FSMA Supplier Verification Rule Close, But Third-Party Accreditation Stalls

FDA Center for Food Safety and Applied Nutrition Director Michael Landa says rules for preventive controls for human food and the foreign supplier verification program are “in the final stages of review.” However, the rule for accreditation of third-party inspectors is stalled.

Global Source Management Supplements Seized As Unapproved New Drugs

U.S. Marshals seized several products marketed as dietary supplements from Sunrise, Fla.-based Global Source Management and Consulting's offices during a Feb. 13 raid, according to FDA





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