FDA’s New Era: A Continued Evolution – at Full Throttle
Updated: May 31, 2019
We’ve been keeping a close eye on the new leadership at FDA and an ear to the ground to determine the direction the agency will be taking. From what we’ve seen and heard, former Commissioner Scott Gottlieb set the pace, and it seems it will be a continued evolution of the course taken in recent years – at a brisker, modernized pace.
Two key statements from Acting Commissioner Ned Sharpless, who took office in April, and Deputy Commissioner of Food Policy and Response, Frank Yiannas, who took office in November, led to this expectation: Sharpless’ comment at his First All-Hands Meeting: “I plan to maintain FDA’s current course of action in every area and proceed full speed ahead,” and their co-statement description of the "New Era of Smarter Food Safety" as being “people-led, FSMA-based and technology-enabled.”
The background of the two leaders also should provide a good balance for the agency. As former director of the National Cancer Institute at NIH, cancer researcher and cancer doctor, Sharpless would seem to have a stronger bent toward the drug side of FDA, while Yiannas’ food safety leadership at Walmart and Disney brings the other side of FDA to the front lines. That’s not to say the Sharpless isn’t focused on food. Addressing what he saw as some of the key challenges in food safety, he discussed a number of areas that seem reflective of the thinking of Yiannas.
Technology. How can we use modern technology like blockchain and artificial intelligence in a way that is maximally protective to the consumer, but also not onerous and debilitating to industry?
Innovative Products. While supporting innovations in food technology like genome-edited plants for people and animals, FDA will be focused as well on the food safety aspects. It also will continue working with other new products that present regulatory challenges, such as CBD oil, genetically modified animals, cell cultured meat/pet food.
Dietary Supplements. Modernization and reform of dietary supplement oversight also will continue. While understanding the benefits of such products, he said, “we’ll continue to protect consumers by cracking down on false and misleading claims. It’s important we stand up for the consumer and expose fraudulent products, particularly those pitched to vulnerable populations.”
Food Safety/Nutrition Modernization. Having co-chaired a trans-NIH nutrition task force, he sees the immense health impact of diet and nutrition, the importance of research, and the key role FDA plays “in improving the diet of all Americans (and therefore national well-being).” He intends to build on that work, advance FDA’s comprehensive multi-year Nutrition Innovation Strategy, and further the implementation FSMA law and other foodborne illness outbreak response efforts.
Animal health. There will continue to be a focus on FDA’s Center for Veterinary Medicine work and “One Health” approach to addressing public health including innovation in animal drugs and animal foods with new policies, approaches like “conditional approval,” and oversight of genetically altered animals.
Enforcement. Noting his excitement about working closely with ORA which conducts inspections on behalf of the entire agency, he said, “their enforcement actions – both civil and criminal – are vital tools for protecting the public health.”
The guiding principles by which all this will be accomplished, he said, “a commitment to science-based decision-making and prioritizing our efforts for the benefit of the public health.”
While the New Era of Smarter Food Safety co-statement expressed a similar trajectory, its focus was primarily on traceability and transparency using today’s available technologies and the importance of industry collaboration.
As anyone who reads our newsletter will know, I am a huge fan of better traceability systems. While many in the food system still use a largely paper-based system of one-forward, one-back traceability, the digital tracking by other industries makes it clear that we must explore how these types of technologies could improve tracking when it comes to food, the statement said. As such, the new era “will explore opportunities and specific actions to evaluate new technologies and upgrade our abilities to rapidly track and trace food through the supply chain.”
FDA also will be looking at emerging technologies and other approaches being used in society and other industries, such as distributed ledgers, sensors, the Internet of Things and artificial intelligence (AI), to assess how they could improve the food system while addressing consumer demand for transparency. As a start, the agency plans to conduct a pilot using AI and machine learning to enhance the review of imported foods at ports of entry.
Additionally, with the rise in e-commerce of food and its delivery systems, there will be a focus on those food safety challenges, novel considerations, and regulatory oversight.
All this sounds good but to a great extent FDA has its hands tied by FSMA on what is truly needed for effective product tracking. Specifically section 204 of the FSMA Statute (Enhancing Tracking and Tracing of Food and Recordkeeping) states in part (d)(1)(L) the following that FDA will not require:
"(i) a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food; (ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or (iii) product tracking to the case level by persons subject to such requirements;"
Thus, FDA could not require full pedigree blockchain even if Walmart can!
So what is the answer? In our view, it is industry and federal collaboration. FDA needs to embrace the parts of industry that are looking for solutions and not penalize them for their ability to find problems early. In the statement from the FDA leaders, emphasis also was placed on the importance of collaboration with “food companies of all sizes and technology firms, as well as local and federal agencies and other stakeholders,” and the understanding that food safety is about more than just technology. “It’s about embracing technological advancements in ways that build upon the vision FSMA set forth,” and using the vision to keep Americans safe. To do this FDA should take a leadership role in federal, state, local, and industry collaborative efforts. Not only would this help traceability challenges, it also would allow for a much more collaborative use of whole genome sequencing, which is another whole topic for a later newsletter.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com