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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).…

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”…

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting, conditioning, and holding of seed for sprouting.

The Draft Guidance notes that the FDA has reported 50 outbreaks of foodborne illness associated with sprouts in…

The Office of Management and Budget (OMB) recently released the Spring 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug…

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). The consent order, which was approved by the district court judge on June 11, 2019, establishes…

On May 31, Hogan Lovells will offer an important training program on conducting a vulnerability assessment under the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule), which is part of the FDA Food Safety Modernization Act (FSMA). This 1-day workshop will deliver the standardized “Conducting Vulnerability Assessments” training curriculum developed by…

U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era of smarter food safety (the Statement). The Statement reflects on the evolution of our food system from an “around…

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 growing, harvesting, packing, and holding almonds, pulse crops, wine grapes, and hops. FDA received feedback from these entities that they should be exempt after it…

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand food safety monitoring. The statement details how FDA would use requested funds, if provided by Congress, to build a “smarter, more technologically advanced…