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The U.S. Food and Drug Administration (“FDA”) recently released Chapter 14 of its Draft Guidance for Industry, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (“Draft Guidance”).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…

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:…

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…

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…

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 in more detail below, FDA’s “horizontal” approach to standards reform would look at amending wide groups of standards rather than evaluating standards…

The U.S. Food and Drug Administration (FDA) recently released an updated Fourth Edition of its Guidance for Industry entitled, “Fish and Fishery Products Hazards and Control Guidance, Fourth Edition – August 2019” (“the Seafood HACCP Guide”).1 The Seafood HACCP Guide is intended to assist processors of fish and fishery products in developing their Hazard Analysis…

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…

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…

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).…

Oatly, Inc. has chosen to discontinue its “no added sugars” advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD). Campbell argued that various claims found on Oatly oatmilk products, including “0 g added sugars” and “no added sugars,” were misleading because the products contain maltose, a sugar by-product…