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FSMA and Dietary Supplements

By Charles Breen, EAS Senior Advisor for FSMA Consulting Services FSMA’s 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...

FSMA and Third-Party Auditing

A key piece of the regulatory jigsaw puzzle as FDA moves ahead with implementing the Food Safety Modernization Act (FSMA) is the voluntary, user-fee based program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food...

FDA Sends Revised FSVP Rule to OMB

  The Food and Drug Administration recently sent a revised rule to the White House Office of Management and Budget (OMB) that will be an important tool in FDA’s future oversight of foods and ingredients imported into the United States. Under FSMA, FDA has...