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FDA issues draft guidance on remote regulatory assessments

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

FDA’s FY 2023 Budget Includes Several Proposals Significant to Food and Supplement Manufacturers

The U.S. Food and Drug Administration (FDA) recently released its Congressional Justification for the fiscal year (FY) 2023 budget. The agency is requesting $1.2 billion for its Foods Program to be allocated to initiatives...more

FDA Extends Enforcement Discretion for Several Requirements in FSMA Regulations

FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more

FDA Holds Summit on E-Commerce and Food Safety

The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more

FDA reviews New Era of Smarter Food Safety accomplishments

The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more

USDA to invest US$4 billion to strengthen food systems and improve supply chains

The U.S. Department of Agriculture (USDA or the department) recently announced plans to invest more than US$4 billion to strengthen critical supply chains under President Biden’s “Build Back Better” initiative....more

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more

FDA releases investigation report and plans additional steps to address safety of leafy greens

The U.S. Food and Drug Administration (FDA) has issued a report on its recent investigation into a Fall 2020 outbreak associated with leafy greens and announced its next steps to address the safety of leafy greens. ...more

New EU regulation defines “Food Safety Culture”

The European Union (EU) recently adopted a regulation requiring food business operators to establish and provide evidence of an appropriate food safety culture and detailing the steps they must take to satisfy this...more

FSMA update: FDA announces pilot program to evaluate third-party food safety standards

The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more

FDA Announces Inspections of Small Businesses under FSMA Intentional Adulteration Rule to Begin March 2021

The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more

FDA Releases Blueprint for the New Era of Smarter Food Safety

The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s...more

FDA Provides Update on Forthcoming New Era of Smarter Food Safety Blueprint

The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more

FDA Reopens Comments on Proposed Rule to Modernize Food Standards of Identity

The U.S. Food and Drug Administration (FDA) announced that it is reopening the comment period on a 2005 proposed rule to establish a set of general principles to use when considering whether to establish, revise, or eliminate...more

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

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 Adulteration (“IA rule”)....more

FSMA Update: FDA Announces Continuation of Enforcement Discretion for Co-Manufacturer Supplier Verification

On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

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 Act (FSMA)....more

FDA Holds Public Meeting on “A New Era of Smarter Food Safety” to Further FSMA Implementation

On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more

FDA Public Meeting: Horizontal Approaches to Food Standards of Identity Modernization

On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes...more

FSMA Update: FDA Launches “FDA-TRACK: Food Safety Dashboard” to Track FSMA Progress

The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of...more

FSMA Update: FDA Publishes List of Required Foreign Supplier Verification Program Records

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more

FDA Announces Public Meeting and Docket for Comments on “A New Era of Smarter Food Safety” to Facilitate FSMA Implementation

The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of...more

FDA Announces Public Meeting on Modernizing Food Standards of Identity

The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address “Horizontal Approaches to Food Standards of Identity Modernization.” As explained...more

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more

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