On January 11, 2018, the Food and Drug Administration issued its 2018 Strategic Policy Roadmap (the Roadmap) in an effort to provide transparency about the FDA’s policy undertakings. The Roadmap outlines key priorities that the Agency will pursue in 2018 to advance its public health mission. The Roadmap covers all FDA-regulated product areas and includes the following priorities related to food:

  • Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease
  • Strengthen FDA’s scientific workforce and its tools for efficient risk management

FDA notes that there are areas of overlap both between all priorities mentioned as well as with other aspects of work at FDA. Importantly, for food regulation, FDA outlined how it will continue to focus on implementing the new Nutrition Facts Panel and menu labeling regulations and associated guidance, as well as continuing to implement FSMA and the associated field realignment that now
has a dedicated cadre of food (and feed) inspectors. Other noteworthy inclusions on the nutrition and labeling side are revisions to the “healthy” claims regulations, updating food standards to promote public health, providing new opportunities to make ingredient information more helpful to consumers, and advancing guidance on dietary sodium reduction. On the food safety side, FDA will
continue to build its pathogen database networks and, under FSMA, implement preventive controls rules and pay particular attention to implementing the produce safety rule through increased training and collaboration with the states.

We provide an overview of FDA’s priority areas, and the corresponding goals and action items, most relevant to food policy.

Click here to read our overview.

The U.S. Food and Drug Administration (FDA) has taken two important steps to launch the Voluntary Qualified Importer Program (VQIP) under the FDA Food Safety Modernization Act (FSMA). First, FDA has started accepting applications for participation in VQIP, a voluntary, fee-based program which offers expedited review and entry of human and animal food into the United States. Second, FDA has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by FSMA, a step needed to implement VQIP. This post discusses both developments.

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U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., and U.S. Department of Agriculture (USDA) Secretary Sonny Perdue announced a formal agreement on January 30, 2018, intended to increase coordination and collaboration between the two agencies. The high-level agreement is limited on details, but includes commitments to developing interagency working groups for the following three “issues of shared concern.”

  • Dual-Jurisdiction Food Facilities: The agreement states that FDA and USDA share the goal of streamlining oversight of dual-jurisdiction facilities by identifying and potentially reducing the number dual-jurisdiction facilities. The agencies also aim to bring greater clarity and consistency to jurisdictional decisions under USDA and FDA’s respective authorities and decrease unnecessary regulatory burdens.
  • Produce Safety: FDA and USDA express their commitment to enhancing their collaboration and cooperation on produce safety activities, including the implementation of FDA’s Produce Safety regulation under the FDA Food Safety Modernization Act (FSMA).
  • Federal Regulation of Biotechnology Products: The agreement states that the agencies are committed to modernizing the Coordinated Framework for the Regulation of Biotechnology, as well as the U.S. agricultural biotechnology regulatory system to develop efficient, science-based regulatory practice by working in partnership with other federal agencies. Both agencies have commitments for improving the regulation of biotechnology that are outlined in the September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products and a recent Task Force on Agriculture and Rural Prosperity Report.

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The U.S. Food and Drug Administration (FDA) has issued five FDA Food Safety Modernization Act (FSMA) final and draft guidance documents relating to supplier verification under both the Foreign Supplier Verification Program (FSVP) and the Preventive Controls for Human Food (PCHF) rules, as well as draft guidance regarding the Preventive Controls for Animal Food (PCAF) rule.
We briefly summarize the issues addressed in each of the following documents:

  • FSVP Draft Guidance;
  • Chapter 15 (Supply-Chain Program) of the Hazard Analysis and Risk-Based Preventive Controls for Human Food Draft Guidance;
  • Guidance on the Application of FSVP Regulation to Importers of Grain Raw Agricultural Commodities;
  • Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 Draft Guidance;
  • FSVP Small Entity Compliance Guide (SECG); and,
  • Hazard Analysis and Risk-Based Preventive Controls for Animal Food Draft Guidance.

We encourage a close review of each of the documents, as they address important issues affecting compliance with the major FSMA regulations. Note that comments can be submitted at any time on guidance documents. FDA has established dates by when comments are requested to be submitted on the draft guidance document

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On January 4, 2018, the Food and Drug Administration (FDA) announced through Guidance that it does not intend to enforce particular provisions of the Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), Produce Safety, and Foreign Supplier Verification Programs (FSVP) regulations issued under the FDA Food Safety Modernization Act (FSMA). This post provides an overview of the situations in which FDA will exercise enforcement discretion, specifically:

  • Written assurance provisions in all four rules related to the downstream control of identified hazards or microorganisms that are a potential risk to public health;
  • FSVP requirements for importers of food contact substances (FCS);
  • PCAF requirements for certain manufacturing/processing activities performed on human food by-products for use as animal food; and
  • Certain facilities that are similar to farms, but that do not meet the “farm” definition.

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FDA recently shared information regarding a number of ongoing FDA Food Safety Modernization Act (FSMA) implementation issues. This post summarizes updates and developments regarding the following matters:

1. The written assurance requirements under several FSMA regulations;
2. Industry concerns regarding the Intentional Adulteration regulation;
3. Regulation of human food by-products for use as animal food when these materials are further processed to facilitate storage and distribution;
4. Various initiatives regarding implementation of the Produce Safety rule; and
5. Compliance with the Sanitary Food Transportation rule.

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On December 1, 2017, the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS or the agency) issued its Fiscal Year 2018 Annual Plan.  The Annual Plan, which is directly aligned with the agency’s 2017 – 2021 Strategic Plan, outlines the ways FSIS plans to achieve its strategic goals over the next fiscal year. It serves as an operational guide for FSIS, where the agency explains the progression of activities from the key milestones the agency achieved in FY 2017, outlines what it plans to achieve in FY 2018 and why, and describes how it will assess progress by using Strategic and Annual Plan measures and targets.

Overall, the agency anticipates focusing on prevention of product contamination and foodborne illness, modernizing systems and approaches, and streamlining to enhance business. Continuing priorities for FY 2018 include further implementation of the New Poultry Inspection System (NPIS) and Siluriformes fish inspection, effectively using Public Health Risk Evaluations (PHREs) and pathogen reduction performance standards for Salmonella and Campylobacter in poultry, and modernizing swine and egg products inspection systems. The agency plans to continue increasing use of whole genome sequencing, further develop key informational tools and resources for inspection personnel, and work with public health partners to prevent Listeria monocytogenes in retail  delicatessens. The agency will also encourage industry continued adoption of food defense and humane handling practices, and consumer adoption of safe food-handling practices.

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On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”

The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.

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The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food on its behalf and, as explained below, will affect contracts between brand owners and co-manufacturers, and brand owners and suppliers.

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The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

The FSA is developing an innovative “whole system strategy” to feed law control and enforcement. The proposed amendments to the Code and Guidance aim to improve consistency of enforcement and reduce the regulatory burden for feed businesses, while maintaining a high level of public and animal protection.

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