The U.S. Food and Drug Administration (FDA) has released a blueprint of plans to implement the Food Safety Modernization Act and a hub for the New Era of Smarter Food Safety. The blueprint focuses on four elements: (i) tech-enabled traceability; (ii) smarter tools and approaches for prevention and outbreak response; (iii) new business models and retail modernization; and (iv) food safety culture. "This document represents the thinking of FDA food safety experts, consumers, the food industry, technology firms, federal and state regulatory partners, our regulatory counterparts in other nations, and academia," the blueprint states. "Together, we envision a framework that will enable food to be traced to its source in seconds and will utilize new data analytical techniques to strengthen prevention of foodborne illnesses, alerting consumers in real time before contaminated or misbranded foods are consumed. We envision a framework in which education, communication, and democratization of data will enable…
Tag Archives FDA
The U.S. Food and Drug Administration (FDA) has entered a new phase of enforcement for the Foreign Supplier Verification Program (FSVP) regulation, the legally required due diligence program to review and approve foreign suppliers of imported food. In May 2020, FDA placed two companies on Import Alert 99-41, which is essentially an import ban where an importer cannot import the food until they implement an appropriate FSVP to FDA’s satisfaction. This is not the first time FDA placed a company on Import Alert 99-41. However, the previous import alert listing concerned a company that imported food associated with a recall and foodborne illnesses. In this instance, there is no indication that the food caused any food illnesses or was otherwise non-compliant; rather, it appears that the only issue was the importers failed to comply with the FSVP requirement. This inherently changes the tenor of an FSVP inspection because they now…
The U.S. Food and Drug Administration (FDA) has published the results of its investigation into an outbreak of E. coli in November and December 2019 caused by romaine lettuce and other leafy greens from the Salinas Valley area of California. FDA found that nearby land used for cattle grazing was the most likely contributing factor associated with three outbreaks that stemmed from three distinctly different strains of E. coli.
The U.S. Food and Drug Administration (FDA) has published a food-safety checklist for retail food establishments that have been closed or operating in a limited capacity during shelter-in-place orders. The list covers issues that may arise if a facility has been closed, such as ensuring water and sewage lines or coolers and freezers are working, and approaches to slowing the spread of COVID-19, such as social distancing measures and increased outdoor air circulation. Checklist sections include facility operations; water, plumbing and ice; cleaning, disinfecting and sanitizing for food contact and non-food contact surfaces; food temperature control; product inspection and rotation; warewashing equipment; handwashing stations; employee health; and social distancing.
The U.S. Government Accountability Office (GAO) has publicly released its April 2020 report on the partnership between the Food and Drug Administration (FDA) and Department of Agriculture (USDA) on the development of cell-cultured meat. GAO indicated that it began the inquiry after some stakeholders “expressed concern about the agencies' oversight of cell-cultured meat amidst a fragmented federal food safety oversight system.” GAO recommended that “FDA and USDA more fully incorporate leading practices for effective collaboration in the agencies' interagency agreement,” and the agencies “partially concurred and indicated a willingness to incorporate these practices in a more detailed agreement, which would also meet the intent of the recommendations.”
By Shook Of Counsel John Johnson The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged during the COVID-19 outbreak. However, COVID-19 is disrupting plant operations and supply-chains, which companies must be mindful of as they continue to function within the regulatory requirements: Food safety remains FDA’s top priority. The agency is continuing to work with companies to implement food recalls, and FDA will conduct mission critical, for-cause inspections when necessary. Monitor email inboxes for a message from an FDA investigator indicating that the agency is requesting records to conduct a remote inspection. FDA has indicated that these remote inspections will start for food importers to determine their compliance with the Foreign Supplier Verification Program (FSVP). Current Good Manufacturing Practices (cGMPs), Food Safety Plans, Hazard Analysis Critical Control Points (HACCP) Plans and FSVP must continue to be implemented. In doing so,…
The U.S. Food and Drug Administration has urged several sellers of products with cannabidiol (CBD) to stop marketing their products as able to treat or prevent COVID-19. The letters, sent by the Center for Drug Evaluation and Research (CDER), emphasize that “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” The targeted CBD Sellers—including Indigo Naturals, Native Roots Hemp, CBD Online Store and Nova Botanix LTD—market their products with claims ranging from “boosting the immune system” to providing stress relief “when everyone else is panicking.” The letters urge the companies to respond within 48 hours to a CDER COVID-19 Task Force email address.
By Partner Lindsey Heinz and Associate Zac Parker The U.S. Food and Drug Administration (FDA) sent warning letters to Jimmy John’s Franchise, LLC and its supplier Sprouts Unlimited Inc. regarding food safety practices after the agency traced an outbreak of E. coli to Jimmy John’s produce, which had previously caused outbreaks of foodborne illnesses. In the letter to Jimmy John’s, FDA focused on the company's prior sales of adulterated products, its misrepresentations to FDA regarding the sourcing of its sprouts, and the need for Jimmy John’s to demonstrate “long-term, sustainable corrections” that would prevent these outbreaks in the future. It comes as no surprise that letters like these make headlines and risk hurting a food supplier’s reputation. In light of these warning letters and the concerns raised by potential outbreaks of the new coronavirus COVID-19, food manufacturers must be vigilant about supply chain management, whether at the growing, transporting, processing or…
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional adulteration of food under the Food Safety Modernization Act. The guidance focuses on food defense corrective actions, food defense verification, reanalysis and recordkeeping. The rule applies to domestic and foreign companies required to register with FDA as food facilities.
A U.S. federal court entered a consent decree of permanent injunction prohibiting Home Style Foods, Inc., and its owner and quality manager from selling food products until the company complies with federal regulations. U.S. Food and Drug Administration (FDA) inspections reportedly found Listeria monocytogenes in the company's food preparation area and documented violations of seafood safety regulations. “After repeated food safety violations, the FDA worked with the U.S. Department of Justice to obtain this injunction in order to prevent potentially contaminated food from reaching consumers. The company failed to take the appropriate corrective actions resulting in this action,” an FDA official said in a press release. “When a company fails to follow the law, the government will take action to protect the food supply."
