AG/FDA Blog

FDA’s Proposed Guidance on Convening a GRAS Panel May Result in Higher Costs for GRAS Notifiers

Contributor: Mark L. Itzkoff Principal, The Law Office of Mark Itzkoff, mark@itzkofflaw.com On November 15, 2017, FDA released a proposed guidance document, Best Practices for Convening a GRAS Panel: Guidance for Industry.  The Guidance is, in part,… Read More
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FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules

On October 19, 2017, FDA announced the publication of two guidance documents to assist industry stakeholders in compliance with regulations promulgated pursuant to the Food Safety Modernization Act (FSMA): #235 – Current Good Manufacturing Practic… Read More
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Nutrition Facts Update: Compliance Date Expected to be Delayed 18 Months

Last Thursday, at the Politico Policy Summit, Commissioner Scott Gottlieb announced that the new Nutrition Facts requirements compliance date will be pushed back one-year and, subsequently, announced via Twitter that the compliance date extension wil… Read More
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FDA Adds New Chapter on Heat Treatment to its Preventive Controls Guidance under FSMA

Today, the Food and Drug Administration (FDA) announced the installment of Chapter Six to its “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food” (Draft Guidance). The Draft Guidance explains FDA’s c… Read More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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Biotech Regulations Must be Based on Facts, Not Fears

By Dr. Nina Fedoroff, as published in Agri-Pulse The Coordinated Framework (CF) for the Regulation of Biotechnology was first implemented 30 years ago. The CF was developed by the White House Office of Science and Technology Policy (OSTP). OSTP broug… Read More
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Priebus' January 20 Memorandum on Regulatory Freeze Pending Review

A memorandum from the President’s Chief of Staff, dated Friday, January 20, but released this afternoon via the Federal Register, directs all departmental and agency heads to forestall regulatory actions.  Previous administrations, including t… Read More
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2016 – Gone But Not Forgotten

Happy 2017, everyone!  2016 has come and gone.  Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!),… Read More
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What Is “Dietary Fiber”(for Purposes of Nutrition Labeling)?

FDA has issued two notices for publication in the Federal Register: A Request for Scientific Data, Information, and Comments (comments due within 45-days of publication); and A notice of availability about a draft guidance (comments due within 60-da… 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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