Feed

A Senate committee on Dec. 3 advanced President Donald Trump’s nomination of Dr. Stephen Hahn to be the next U.S. Food and Drug Administration (FDA) commissioner. The Senate Committee on Health, Education, Labor and Pensions approved Hahn’s nomination by an 18-5 vote, sending his nomination to the full Senate. Ranking Member Patty Murray, D-Wash., said she opposed Hahn’s nomination because he “refused to commit to implementing a strong policy to clear non-tobacco flavored e-cigarettes that have not undergone FDA review from the market – like the Trump administration promised to do before it ... Read More

By David Fairfield, Senior Vice President, Feed The U.S. Food and Drug Administration (FDA) announced Nov. 6 that it will continue its enforcement discretion policy for compliance with certain Food Safety Modernization Act (FSMA) supply-chain program requirements that may apply to receiving facilities that are co-manufacturers. FDA’s enforcement discretion potentially applies to entities that participate in certain “co-manufacturing” agreements in the production of human or animal food. By “co-manufacturing,” FDA means a contractual arrangement whereby one party (the brand owner) ... Read More

By David Fairfield, Senior Vice President, Feed The U.S. Food and Drug Administration (FDA) on Nov. 4 published a proposed rule that would establish a program for the testing of food by accredited laboratories as required by the Food Safety Modernization Act (FSMA). When finalized, the laboratory accreditation program will require testing of human and animal food in certain circumstances by accredited laboratories. Accredited laboratories would be required to follow model standards and would be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently ... Read More

The U.S. Food and Drug Administration (FDA) on Oct. 21 announced the availability of performance metrics that track the progress of the Center for Veterinary Medicine’s (CVM) Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings. The new CVM metrics are published within a section of FDA-TRACK, the agency’s performance management program that monitors and reports key data for certain FDA programs. CVM’s five-year plan for antimicrobial stewardship is organized under three goals: Align antimicrobial drug product use with the principles of antimicrobial ... Read More

Facilities that meet the definition of a “qualified facility” under the Preventive Controls for Animal Food rule issued under the Food Safety Modernization Act (FSMA) are required to submit an attestation form to the U.S. Food and Drug Administration (FDA) by Dec. 16, the agency said this week. In a reminder issued Oct. 10, FDA said qualified facilities are required to comply with the Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 507, subpart B (and related requirements in subparts A and F). However, qualified facilities are exempt from the preventive ... Read More

By David Fairfield, Senior Vice President of Feed The Food Safety Preventive Controls Alliance (FSPCA) on Oct. 1 announced the availability of an online training course that focuses specifically on the current good manufacturing practice (CGMP) requirements established by the U.S. Food and Drug Administration’s (FDA’s) final rule for Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The course is applicable to facilities required to comply with CGMP regulations for animal food, and provides a detailed review and explanation for ... Read More

By David Fairfield, Senior Vice President of Feed The U.S. Food and Drug Administration (FDA) on Sept. 30 launched a food safety dashboard designed to track the impact of the seven foundational rules established under the Food Safety Modernization Act (FSMA). For each of the major FSMA rules, FDA has identified measures intended to assist the agency in evaluating how well the rules are being implemented and identifying areas for improvement. FDA states this data will help the agency identify trends in food safety, implement a risk-informed planning and resource allocation framework, and ... Read More

By David Fairfield, Senior Vice President of Feed The U.S. Food and Drug Administration (FDA) on Sept. 19 released an updated version of its Food Defense Plan Builder (FDPB) to assist companies in complying with the requirements of the intentional adulteration (IA) rule established under the Food Safety Modernization Act (FSMA). FDA’s IA rule was published on May 27, 2016 and requires domestic and foreign food facilities that are required to register under the Bioterrorism Act to address hazards that may be introduced with the intention to cause wide-scale public health harm. ... Read More

By David Fairfield, Senior Vice President of Feed The U.S. Food and Drug Administration (FDA) on Sept. 23 issued draft guidance for industry (GFI) #263 to outline the agency’s recommended process for voluntarily bringing remaining approved animal drugs containing medically important antimicrobials under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription (Rx).  FDA’s action is part of the agency’s Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings and follows the agency’s ... Read More