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 Additionally, on September 27, 2018, FDA published a Federal Register Notice announcing availability of a draft guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls. Publication of the Draft Guidance is the second of a series of policy steps the agency is taking as part of a broader plan to improve oversight of food safety and the recall process.
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.
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.
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.
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
• Trade dress
• Unfair competition
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.
The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier verification requirements under FSMA. A new section of the FDA’s Data Dashboard will help companies that perform supplier verification under FSMA by functioning as a “one stop shop” for identifying compliance and enforcement information related to specific suppliers. Second, FDA announced that the Voluntary Qualified Importer Program (VQIP) will not launch until the Fiscal Year (FY) 2020 benefit year—i.e., October 1, 2019. VQIP is a voluntary, fee-based program that offers expedited review and entry of food into the United States.
The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, which outlines the rulemaking actions currently under development in each federal agency. This post 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 Administration (FDA), Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans.
Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs). Demands for more information, as well as changes to or prohibitions on labels’ use of certain terminology, are on the rise. But do label-reform advocates fully appreciate the legal and regulatory complexities and burdens food-labeling revisions impose on the industry, especially when those changes involve state-specific rules? Martin Hahn and Samantha Dietle discuss in the Washington Legal Foundation’s Legal Backgrounder.
On March 29, 2018, Food and Drug Administration (FDA or the agency) Commissioner Scott Gottlieb, M.D., delivered a nutrition-related policy address. The Commissioner emphasized FDA’s role in helping Americans improve their nutrition as a step towards reducing chronic disease, with a particular focus on sodium reduction. The Commissioner’s address provides important insight into the shape that FDA nutrition and health policy can be expected to take in the next few years.