As seen in news reports, two recent Department of Justice (DOJ or Department) memoranda address the role of guidance documents in civil enforcement actions. Taken together, the two memoranda greatly limit the Department’s use of DOJ and other agencies’ guidance documents to support civil enforcement actions, as guidance documents do not impose binding standards on private parties. However, for the reasons set forth below, the memoranda are not expected to have a significant impact on enforcement actions initiated by the Food and Drug Administration (FDA) in food-related matters.
On February 9, 2018, the U.S. Cattlemen’s Association (USCA) submitted a petition requesting the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) to establish labeling requirements that would exclude synthetic products made from alternative proteins and lab-grown meat from animal cells from being marketed as “beef” and/or “meat.” The petition requests that new regulations be adopted limiting the term “beef” to describe the tissue or flesh from animals born raised, harvested, and processed in the “traditional” way, and limiting the term “meat” to the tissue or flesh of animals that have been harvested in the “traditional” manner.
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.
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.
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.
The U.S. Food and Drug Administration (FDA) has issued Draft Guidance on public warning and notification of recalls under 21 C.F.R. Part 7, and has announced steps to release recall information more quickly. The Draft Guidance provides recommendations to industry and FDA staff regarding the use, content, and circumstances for issuing public warnings and public notifications, and also discusses the parties responsible for issuing public warnings. The document’s recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers food, dietary supplements, and cosmetics (and other FDA-regulated products). Importantly, the Draft Guidance discusses the release of retail consignee information as a part of public warnings of recalls and signals that there may be more to come from FDA in this area. In addition, FDA issued a blog post, reflecting the Draft Guidance, announcing that the agency has adopted a new policy to release recall information in FDA’s weekly Enforcement Report, even when the recall has not yet been classified.
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
In response to a recent report by the Department of Health and Human Services (HHS) Office of Inspector General (OIG), Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that FDA will be issuing guidance on recall communications within the next six months. Commissioner Gottlieb’s announcement followed an OIG report that identified several shortcomings in FDA’s initiation and oversight of food recalls. OIG had issued an “early alert” in June 2016 notifying FDA of its preliminary finding that FDA lacks policies and procedures to ensure that firms or responsible parties initiate food recalls promptly. The complete report issued in December includes additional findings concerning issues such as the timeliness of FDA’s evaluation of health hazards and audit checks, as well as actions FDA has taken in response to the early alert. We summarize the report’s findings and the policy initiatives Commissioner Gottlieb has announced in response to it in the post below.
The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections. In particular, FDA describes refusal to permit photography during an inspection as a refusal of inspection. We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign governments refuse inspection. FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.
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.