As one of the most highly regulated food industries in the United States, dairy must comply with regulations issued by multiple federal agencies, including the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the U.S. Environmental Protection Agency, the U.S. Department of Homeland Security and the U.S. Department of Commerce, among other state and local regulatory bodies. IDFA’s Regulatory RoundUP transitioned to an online format in 2020, connecting dairy professionals virtually with regulatory officials who have direct responsibility for the rules affecting dairy plants, products, and personnel.
Resigstrants of Regulatory RoundUP can find the sessions and presentations from the webinar series below. If you registered for the series and can not see the videos and slides below, please refresh your session by logging out and logging back in to the IDFA website via the red button in the top right corner of your screen.
Attendee List
View the 2020 Regulatory RoundUP attendee list here.
Presentations
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Following the FDA’s earlier announcement of the New Era of Smarter Food Safety initiative, the FDA released its Blueprint for the Future on July 13, 2020. The Blueprint outlines how the agency plans to leverage technologies to enable a more digital, traceable, and safer food supply. While this initiative and the specific goals of the Blueprint will rely on technology, it must be people-led and utilize public-private-partnerships. The FDA has determined several priority areas for focus: tech-enabled traceability, use of advanced tools and predictive analytics for prevention and response, addressing new business models and the modernization of retail sales, and food safety culture. Dr. Mark Moorman, FDA Director of the Office of Food Safety will share his insights on the Blueprint and will be available to answer questions.
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In March 2019, the FDA and USDA announced a basic framework for jointly regulating human food products from cultured animal cells. According to the framework, FDA will oversee the initial aspects of the production process and regulate the collection and growth of the cultured cells. Once the cells mature enough to become “meat”, USDA then will take over and regulate the production including the labelling of the products. Presumably, if the product is not labeled as “meat” by USDA, then the FDA would solely regulate the product. The regulation of acellular agriculture products like dairy and egg white proteins that are sourced from cell cultures would be entirely regulated by FDA. Many questions remain about how the FDA will regulate these products, such as key aspects necessary to deem it as GRAS, and labeling of the ingredients as well as finished products containing the products (including compliance with FALCPA).
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In 2020, litigation often drives food labeling decisions, not FDA regulations. In the last decade, lawsuits over food labeling focused mainly on the use of claims such as “natural” and “healthy.” More recently, plaintiffs have scrutinized and courts have considered a multitude of other labeling claims, as well as the labeling of plant-based foods and flavor labeling. In this session, Veronica Colas will share her expertise advising food companies on the current state of food labeling litigation, lessons your company can learn from these lawsuits, and how we might forecast the future of this area of litigation.
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FDA’s “Mitigation Strategies to Protect Food Against Intentional Adulteration” rule requires companies to determine vulnerabilities and implement protections against potential major attacks on the food supply. IDFA’s goal is to make certain that the dairy industry can continue to implement food defense practices in a way that is tailored to their operations and that FDA investigators provide reasonable flexibility in interpreting and enforcing the regulation. Though FDA has published guidance, questions still remain. This session will offer insights on how to prepare and not be caught off guard when FDA begins compliance inspections in earnest.
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The market for food, cosmetic and dietary supplements with Cannabidiol (CBD) continues to explode. Nonetheless, FDA’s position thus far is a firm “No”, preventing dairy and other manufacturers from using CBD as an ingredient in food due to its use as an active ingredient in the drug Epidiolex. This presentation will evaluate the regulatory basis for the FDA position and explore a strategy for the dairy industry to help FDA affirm the safe and lawful use of CBD in dairy products.
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In today’s world, there is increasing pressure from customers, consumers, lawmakers and regulators to ensure greater visibility and traceability throughout the supply and value chains. Interests range from calling out bioengineered or rainforest-friendly ingredients to protecting consumers during a foodborne outbreak by ensuring fast and complete removal of implicated products from the market. But in many cases, full traceability from farm to fork is impossible. Understanding and delineating what is possible and reasonable will help the dairy industry ensure mandatory requirements don’t go too far, too fast.
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Methods of analysis for detection and quantification of chemical contaminants that might end up in finished products are becoming more powerful and able to detect smaller and smaller concentrations, well below levels considered hazardous. For Grade “A” milk, antibiotic residues have been an important area of focus over recent years, but incidental environmental contaminants such as per- and polyfluoroalkyl substances (PFAS) and others have also caught the attention of industry and regulators alike. This presentation outlined FDA’s thinking and approaches to assessing and managing chemical residue risks in dairy foods.
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While many nutrition-related policies, such as nutrition standards for school meals, are set at the federal level, cities and states also set nutrition policy that may work its way up to federal action. What local policies have advanced to the federal level and what other local policies could make the jump?
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COVID-19 was and continues to be a cataclysmic event that profoundly affected the relationship between the food industry and the FDA and how we work together. This session analyzed industry’s working relationship with FDA during the COVID-19 pandemic with the intent of identifying lessons learned and areas for future enhanced collaborative efforts. COVID-19 lessons can provide a guidepost for creating a strengthened partnership with FDA that can lead the way for improvements in the safety, continuity, and robustness of the food supply, ultimately resulting in advancements in public health. Key questions addressed by the panel were:
- What were the COVID-19 key drivers that helped foster a change in the relationship between the FDA and the food industry?
- How can these key drivers be captured and used to implement changes in policies, approaches, and procedures going forward?
- What else needs to occur to build upon the lessons learned and work more effectively and efficiently with FDA?
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