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FDA Issues Draft Guidance for Importer Program Under FSMA

Jun 10, 2015

The Food Safety Modernization Act requires the Food and Drug Administration to establish a voluntary, fee-based program that will expedite the review of imported foods for importing companies that maintain a high level of control over their supply chains. Last week, FDA issued draft guidance for industry on the Voluntary Qualified Importer Program for importers of human or animal food and is seeking comments before finalizing the guidance.

The draft guidance describes the program and outlines the eligibility criteria for participation. It also explains the application process, the steps for obtaining a facility certification for the foreign supplier of a food imported under the program, the user fee, conditions that might result in the revocation of eligibility and criteria for reinstatement of eligibility.

IDFA is discussing the draft guidance with members of its regulatory committees and plans to submit comments, if necessary, before the August 4 deadline.

Read “FDA’s Voluntary Qualified Importer Program Guidance for Industry.”

For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at

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