As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding the scope of FDA food facility inspections during the government shutdown, which is summarized in this memorandum. We will continue to monitor major developments related to the scope of FDA’s food safety activities during the government shutdown; food companies may also wish to follow Commissioner Gottlieb’s Twitter account for the most recent developments on this issue. In a related update, we understand that FSIS is now in the process of reviewing label submissions in a limited capacity.

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On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS), and the Consumer Product Safety Commission (CPSC). These agencies will be operating under significantly reduced functions until the shutdown ends, i.e., until Congress passes a new appropriations bill providing funding for these agencies. This post provides a summary of the scope of each of these agencies’ operations during the shutdown, as well as the implications for the food and other consumer product industries.

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The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when the new regulations were published, correct errors in FDA’s sample Nutrition Facts Panel (NFP) and Supplement Facts Panel (SFP) formats, and update cross references that were not updated when the new rules were issued. This post highlights the key changes affected by the technical amendments.

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Yesterday the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) released its final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016. In this post we summarize the top ten key highlights of the final rule.

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The California legislature has passed a law amending the state’s slack-fill statute for food containers subject to the Federal Food, Drug and Cosmetic Act (FFDCA). Assembly Bill 2632 (AB 2632), which Governor Jerry Brown signed into effect on September 19, 2018, revises the slack-fill statute by creating four new so-called “safe harbor” provisions, under which empty space in a container is not considered nonfunctional slack-fill. These new safe harbor provisions provide additional clarity on the types of food packages that will not be considered to contain nonfunctional slack-fill and may provide some relief to the food industry from the recent surge in purported class law suits seeking damages for allegedly slack-filled packaging. This memorandum summarizes the changes to the state slack-fill statute.

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The U.S. Food and Drug Administration (FDA) last month announced it would exercise enforcement discretion over two qualified health claims characterizing the relationship between the reduced risk of coronary heart disease (CHD) and the consumption of oleic acid in edible oils (containing at least 70 percent of oleic acid per serving) when consumed in place of saturated fats (SFA). Oleic acid is the most common monounsaturated fatty acid (MUFA) and can be found naturally in numerous food sources, including edible oils, meat, cheese, nuts, seeds, eggs, pasta, milk, olives, and avocados. Oleic acid has been used as food or as components of food, such as olive oil, by man for many years, and has been approved as a direct additive to foods.

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This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule) to conduct a vulnerability assessment if using the Key Activity Types method. Below, we review the requirements for “qualified individuals” in the IA rule and provide additional details on the training courses available now and forthcoming from FSPCA.

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The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through 2020 to support innovation in plant and animal biotechnology. As highlighted in FDA Commissioner Gottlieb’s statement, the agency is committed to fostering innovative advances in the field while ensuring the safety of plant and animal biotechnology products used by consumers. The Action Plan identifies three concepts as critical to FDA’s success in fulfilling its goal: 1) advancing public health by promoting innovation; 2) strengthening public outreach and communication; and 3) increasing engagement with domestic and international partners.

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On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured products. Under the proposed framework, FDA plans to oversee cell collection, cell banks, cell growth, and cell differentiation. USDA will oversee cell harvest, production, and labeling of food products derived from the cells of livestock and poultry. While the technical details of the framework remain undefined, the agencies have expressed their view that no legislation on the topic is necessary because the agencies have statutory authority to regulate cell cultured food products derived from livestock and poultry.

This announcement comes three weeks after USDA and FDA hosted a joint public meeting on the topic, and before comments on the meeting are due. The agencies also announced they continue to seek public comment on the issue and will extend the deadline to submit comments until December 26, 2018.

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The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum 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) and the United States Department of Agriculture’s (USDA’s) 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. More information can be found by clicking on the blue link next to each item, which will take you to a specific page about each agenda item on OMB’s website.

We want to caution that the dates included in the Unified Agenda are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations. Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.

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