AG/FDA Blog

I’m a FSVP Importer: How Do I Know When I Need To Comply?

That is one of the most common – and difficult – questions to answer when OFW Law teaches a Food Safety Modernization Act Foreign Supplier Verification Programs (FSMA FSVP) course.  Determining the compliance dates is typically more chal… Read More
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The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

FSMA – The D.C. acronym for the Food Safety Modernization Act.  When I am working with clients or speaking with industry, everyone is familiar with FSMA.  But they think of FSMA as the Preventive Controls or Produce Safety Rules.  Some are also… Read More
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FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulga… Read More
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FDA Issues Final Guidance on VQIP

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Imp… Read More
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Food Regulation: A Changing of the Guard

Irrespective of whether you voted for or against Donald Trump, last night’s election results will lead to a significant changing of the guard in how food is regulated by FDA and USDA.  In his Contract with America, soon-to-be-President Trump promi… Read More
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An Early Look at Some Congressional Changes Impacting Agriculture

With the House and Senate remaining under Republican majorities, it is very unclear what matters may be handled in the lame duck session, and which ones will be pushed into the 115th Congress.  Some will want to extend the Continuing Resolution fro… Read More
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CFSAN Issues Updated Guidance on Food Facility Registration

FDA today published notification of the availability of an updated, draft guidance on food facility registration, Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (Nov. 2016). Publication of this dra… Read More
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Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act.   See generally Foo… Read More
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Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents ac… Read More
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FDA Revises Food Product Categories for Food Facility Registrations

FDA has issued a revised guidance that explains the necessity of having food product categories in food facility registrations submitted to FDA under section 415 of the FD&C Act (21 U.S.C. 350d), and that updates the food product categories to be… Read More
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