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FSMA and Dietary Supplements By Charles Breen, EAS Senior Advisor for FSMA Consulting Services FSMAs preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements (DS) from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR

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The opponents warn that prohibition would have a negative financial impact on small businesses operating on tight margins