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Fixed-Combination OTCs Derived From Botanicals Due For Rulemaking

This article was originally published in The Tan Sheet

Executive Summary

A proposed rule on fixed-combination OTC products derived from natural sources, including animal and botanical raw materials, could be issued by FDA as early as July, according to the agency's "unified agenda" published in the Federal Register April 24.

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A scant 37 (16% of 238) dietary supplement establishments that responded to an FDA manufacturing practices survey said they report consumer complaints of adverse events to FDA.

Only 16% Of Supplement Makers Surveyed Report AEs To FDA - GMP Study

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