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The U.S. Food and Drug Administration (FDA) has issued a draft Guidance on how the agency interprets its rules related to the refusal of operators of foreign food establishments to allow inspection by FDA officials.
Under the U.S. Food Safety Modernization Act (FSMA) of 2011, the FDA can refuse entry into the U.S. of any imported food product from a foreign factory or warehouse that has denied access to U.S. officials and representatives seeking to inspect that facility. Published in early December, the FDA’s draft Guidance is intended to provide more detailed information for operators of foreign food establishments on the rights and responsibilities of the FDA under the FSMA, and how the agency defines “refuses to permit entry…to inspect.”
Guidance documents issued by the FDA and other U.S. government agencies are intended to present the current thinking of a regulatory agency on specific topics, do not establish legally enforceable responsibilities, and are not binding on either the FDA or the public. Nonetheless, they can be helpful in developing policies and procedures that support compliance with FDA regulations and requirements.
Public comments on the draft Guidance are due by not later than February 26, 2018, and may be submitted electronically here (reference Docket No. FDA-2017-D-6528). The complete text of the FDA’s draft Guidance on the inspection of foreign food establishments is available here.