FDA Reopens Food Facility Renewals for Certain Expired Registrations

Last night (12/21/2016) the U.S. Food and Drug Administration (FDA) provided a second chance at registration renewal for food facilities who failed to secure a confirmation from the U.S. agent listed on the registration.  The agency has not yet announced this publicly.  Tomorrow the agency will be releasing revised guidance on food facility registration but…

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FDA Publishes Final ACE Rule

On Friday, November 29, 2016, the U.S. Food and Drug Administration (FDA) published in the Federal Register a final rule entitled “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment”(“Final Rule”).  The Final Rule establishes requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE). …

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FDA Publishes Draft Guidance on Fiber Sources In Nutrition Facts

On November 23, 2016, the U.S. Food and Drug Administration (FDA) published a request for scientific data, information and comments that would help the agency evaluate the beneficial physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods.  FDA is requesting the information to help them determine whether a…

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FDA Releases Food Facility Registration Guidance

In November 2016, the U.S. Food and Drug Administration (FDA) published draft guidance for industry on Questions and Answers Regarding Food Facility Registration (Seventh Edition). Pursuant to section 415 of the Food, Drug and Cosmetic Act (FDCA), all U.S. and foreign facilities that process, pack and hold food for consumption in the U.S. must registered…

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FDA Publishes FSMA VQIP Guidance

On November 10, 2016, FDA published final guidance on the Food and Drug Administration’s (FDA) Voluntary Qualified Importer Program (VQIP).  The Food Safety Modernization Act (FSMA) required FDA to establish VQIP.  VQIP is a voluntary, fee-based program that provides for expedited review and importation of foods from importers who import food from facilities and farms…

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Webinar Replay: FSMA Final Food Facility Registration Rule and Proposed ACE Rule

On July 27, 2016, Erik Lieberman of U.S. Food Imports LLC held a webinar on FDA’s final FSMA rule on food facility registration.  The rule, published on July 14, 2016, makes major changes to the food facility registration process.  Lieberman also discussed FDA’s proposed ACE rule as it relates to food products.  A replay of…

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Webinar on FSMA Food Facility Registration Final Rule and ACE Rule 7/27

On July 14, 2016, the U.S. Food and Drug Administration published in the Federal Register the final rule on Amendments to Registration of Food Facilities (Final Rule).  The Final Rule was issued to implement section 102 of the Food Safety Modernization Act and makes many significant changes to the food facility registration process.  The Final…

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