U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow more time for farmers and state regulators to receive training on the rule. Routine inspections for large farms (i.e., farms with more than an average $500,000 in produce sales during the previous 3-year period) were delayed until spring 2019, and routine inspections for small farms, other than sprouts operations, were delayed until spring 2020. In his statement, Commissioner Gottlieb confirmed that routine inspections for large domestic and foreign farms will commence this spring, as planned.

FDA also has established a Produce Inspections webpage to serve as a central location for farms and state partners to find resources related to inspections. The webpage includes a new Fact Sheet with information on what farms should expect of their first inspection. It also includes new documents to be used during Produce Safety inspections, including the recently developed inspectional observation form and a procedure for dispute mitigation and resolution.

This blog briefly summarizes the fact sheet and new inspection documents, including FDA Form 4056 and Produce Safety Dispute Mitigation and Resolution Procedures. Click here to read more.

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The document’s recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers foods and dietary supplements (as well as all other FDA-regulated products).

This blog provides background for FDA’s development of the Guidance, as well as a high-level summary of the Guidance’s recommendations. Click here to read more.

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first document is for farms covered by the Produce Safety Rule (PSR). The second document is for facilities subject to FDA’s Preventive Controls for Human Food (PCHF) rule and that manufacture, process, pack, or hold fresh-cut produce. The deadline for comments on both guidance documents is April 22, 2019.

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Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish and publish a list of high-risk foods and engage in rulemaking setting forth additional traceability record keeping requirements for facilities that manufacture, process, pack, or hold those foods. The lawsuit was brought in the U.S. District Court for the Northern District of California by the Center for  Food Safety (CFS) and Center for Environmental Health (CEH).

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On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety. Additionally, on September 27, 2018, FDA published a Federal Register Notice announcing availability of a draft guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls. Publication of the Draft Guidance is the second of a series of policy steps the agency is taking as part of a broader plan to improve oversight of food safety and the recall process.

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The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule under the FDA Food Safety Modernization Act (FSMA). Through a Notice to Industry, FDA is inviting food companies with multiple facilities that implement centrally developed supply-chain programs and recall plans to apply to participate in two-tier inspections. FDA plans to limit initial participation in the program to five businesses. FDA will consider the results of the two-tier inspections pilot to determine the feasibility of employing the two-tier approach to inspections on a broader scale. This post summarizes the program and FDA’s criteria for participation. Interested companies must notify FDA of their desire to participate no later than October 31, 2018.

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On August 1, 2018, two consumer groups sued the U.S. Department of Agriculture (USDA), USDA Secretary Sonny Perdue, and Agricultural Marketing Service (AMS) Administrator Bruce Summers for failing to meet the statutory rulemaking deadlines for the National Bioengineered Food Disclosure Standard (NBFDS). The suit was filed by the Center for Food Safety (CFS) and Center for Environmental Health in the United States District Court for the Northern District of California. 1/ On September 6, 2018, the plaintiffs filed a motion for summary judgment requesting that the court order USDA to issue the rule within 60 days.

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The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an obligation to register as a food facility. The first document is the finalized seventh edition of FDA’s Questions and Answers Regarding Food Facility Registration (Final Guidance). The second document is a supplemental draft guidance to the seventh edition (Supplemental Draft Guidance), which addresses which parties must register in situations where multiple entities share a physical space (e.g., a food manufacturer leases a building). The Supplemental Draft Guidance is open for comments through October 19, 2018. This memorandum summarizes the changes made in the Final Guidance since it was originally proposed in draft form in December 2016 and the new content in the Supplemental Draft Guidance.

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Key considerations for food companies considering a package refresh or new product launch – an integrated legal team approach

Launching a new food product? Revising your label? On September 13, the Hogan Lovells Food and Beverage team will offer a free webinar on key considerations for food and beverage packaging and labeling.  Food regulatory partners Maile Hermida and Elizabeth Fawell will be joined by trademark partner Julia Matheson to discuss what you need to know if you are refreshing your product’s packaging and labels – either on your own initiative or to comply with new labeling requirements – or launching a new product.

Maile and Elizabeth will discuss key labeling considerations facing food companies, including new nutrition labeling requirements, GMO disclosures, and class action litigation.  Julia will provide an overview on trademark, trade dress, and unfair competition claims.

Topics for this one hour webinar include:
•           Labeling hot issues
•           False advertising claims
•           Trademark
•           Trade dress
•           Unfair competition

Click here to register.

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and they must take steps to ensure those mitigation strategies are working. This first installment includes the first four chapters of the Draft Guidance, which provide FDA’s recommendations on how to develop a food defense plan, including one particular method for conducting a vulnerability assessment to identify significant vulnerabilities and actionable process steps, developing mitigation strategies for actionable process steps, and monitoring mitigation strategies. It also contains templates for various components of a food defense plan.

Click here to read more.