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FSMA

302 published works

  1. Marler Blog

    FDA Announces FSMA Food Traceability Proposed Rule, A Major Milestone in the New Era of Smarter Food Safety

    By Bill Marler

    From FDA Press Release from yesterday: Today, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published…

  2. The Daily Intake

    FDA Requests Information That Could Result in Expanding the Rarely Consumed Raw (RCR) List of Produce Commodities Exempt From the Produce Safety Rule

    By Keller and Heckman LLP

      FDA’s Food Safety Modernization Act (FSMA) Final Rule establishing “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (see our detailed summary here) includes an…

  3. Food Poison Journal

    Limes, Red Potatoes, Lemons, Valencia Oranges recalled due to positive Listeria test

    By Patti Waller

    Freshouse II, LLC of Salisbury, NC is recalling the following specific production lots, brands and weights of Valencia Oranges, Lemons, Limes, Organic Limes, and Red B Potatoes because they have…

  4. The Daily Intake

    FDA Temporarily Relaxes Requirements for Qualified Exemption Under the Produce Safety Rule 

    By Keller and Heckman LLP

    Under the Food Safety Modernization Act (FSMA) Produce Safety Rule, a farm is eligible for a qualified exemption and associated modified requirements (described in 21 CFR 112.6) if (1) the farm’s…

  5. The Daily Intake

    FDA Resumes Records Review Under the FSVP Rule by Remote Inspections Instead of Onsite Visits to Importers

    By Keller and Heckman LLP

    The Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) requires importers to perform certain risk-based activities to verify that their foreign supplier is producing food in accordance with…

  6. A Seat at the Table

    COVID-19 Update: FDA Announces Plans to Conduct Remote FSVP Inspections

    By Maile Hermida, Elizabeth Fawell, Leigh Barcham

    In response to the COVID-19 outbreak, the U.S. Food and Drug Administration (FDA) has announced it will begin requesting that importers send the agency records required under the Foreign Supplier…

  7. The Daily Intake

    FDA Issues Guidance on Temporary Policy Regarding FSMA and FSVP Onsite Audit Requirements Due to COVID-19

    By Keller and Heckman LLP

    On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued its “Temporary Policy Regarding Preventive Controls and FSVP [Foreign Supplier Verification Food Program] Food Supplier Verification Onsite Audit…

  8. A Seat at the Table

    FDA Releases Third and Final Installment of Draft Guidance for FSMA Intentional Adulteration Rule

    By Joe Levitt, Elizabeth Fawell, Maile Hermida

    The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional…

  9. A Seat at the Table

    FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

    By Joe Levitt, Maile Hermida, Elizabeth Fawell, Mary Lancaster

    The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization…

  10. The Daily Intake

    FDA Will Extend Enforcement Policy Allowing Some “Co-Manufacturers” Additional Time to Implement Certain FSMA Supply-Chain Program Requirements

    By Keller and Heckman LLP

      We reported on the Food and Drug Administration’s (FDA) November 2017 guidance giving certain co-manufacturers two more years to comply with requirements for a supply-chain program for certain raw…