Statute
FSMA
302 published works
A Seat at the Table
FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA
By Joe Levitt, Maile Hermida, Elizabeth Fawell, Leigh Barcham
The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities…
A Seat at the Table
FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule
By Joe Levitt, Elizabeth Fawell, Maile Hermida, Leigh Barcham
The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration…
Global Regulation Tomorrow
FCA consults on optimising the SM&CR
By Charlotte Henry, Imogen Garner (UK), Hannah Meakin (UK), Jonathan Herbst (UK)
On 23 January 2019, the FCA published Consultation Paper 19/4 (CP19/4), ‘Optimising the Senior Managers & Certification Regime (SM&CR) and feedback to DP16/4 – Overall responsibility and the legal function’.…
A Seat at the Table
Intentional Adulteration Rule under FSMA Training Requirements and Course Availability
By Joe Levitt, Elizabeth Fawell, Maile Hermida
This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the…
Global Insurance Blog
“No deal” Brexit: UK Government publishes details on draft regulations amending FSMA
On 22 November 2018, HM Treasury published Explanatory Information on the draft Financial Services and Markets Act 2000 (Amendment) (EU Exit) Regulations 2019 (the "Draft FSMA Regulations"). The Draft FSMA…
A Seat at the Table
FDA Issues Final Guidance on Mandatory Recall Authority under FSMA
By Joe Levitt, Elizabeth Fawell, Maile Hermida, Christine Forgues
The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the…
A Seat at the Table
FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors
By Joe Levitt, Maile Hermida, Elizabeth Fawell, Leigh Barcham
The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce.…
The Daily Intake
FDA Issues Draft Guidance on Produce Safety Requirements under FSMA
FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current…
A Seat at the Table
Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions
By Joe Levitt, Maile Hermida, Elizabeth Fawell, Leigh Barcham
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically,…
The Daily Intake
FDA Sued for Failure to Implement “High-Risk” FSMA Provisions by the Statutory Deadlines
The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA on October 15 for failure to implement provisions of the Food Safety…