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 FDA-TRACK, an agency-wide performance management program. There are separate dashboards for: (1) Preventive Controls and Current Good Manufacturing Practice (CGMP) Measures,
FSMA
FSMA Update: FDA Issues Draft Guidance on Recall Plans Under the Preventive Controls for Human Food Rule
The U.S. Food and Drug Administration (“FDA”) recently released Chapter 14 of its Draft Guidance for Industry, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (“Draft Guidance”). Entitled “Recall Plans,” the chapter explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (“PCHF…
FSMA Update: FDA Publishes List of Required Foreign Supplier Verification Program Records
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
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. [1] The thirteen-page document contains detailed checklists of the required records,, though not every record on the list will be applicable to every importer. These…
A Seat at the Table – What’s new in food law
Please join us on Wednesday, November 6 for the launch of a new webinar series featuring updates on the latest news and trends in the food and beverage industry. Our first webinar will focus on updates regarding CBD, FSMA, and the FTC. Please see below for the program agenda:
Navigating the regulatory landscape for CBD:…
FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0
The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Rule) under the FDA Food Safety Modernization Act (FSMA). The FDPB is a…
FDA Announces Public Meeting and Docket for Comments on “A New Era of Smarter Food Safety” to Facilitate FSMA Implementation
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
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 FDA’s ongoing implementation of the FDA Food Safety Modernization Act (FSMA), the agency is exploring new and…
Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
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 plaintiffs want FDA to meet its obligation under FSMA to establish a program for the recognition of accreditation bodies and accreditation of laboratories…
FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act (FSMA) regulations. Under the FSVP rule, importers must take steps to verify that their foreign suppliers produce food that satisfies U.S. food…
FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020
The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program (VQIP). These fees were authorized by the FDA Food Safety Modernization Act (FSMA) and were first implemented in October 2011 (for FY 2012).…
FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive Controls Regulations
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive Controls Regulations for Human and Animal Food).” The Guidance is intended to help facilities determine whether they qualify as a “small business”…