Today Frank Yiannas informed Commissioner Robert Califf of the U. S. Food and Drug Administration that he will be resigning his position as Deputy Commissioner for the Office of Food Policy and Response at the FDA effective Feb. 24.
“I am honored to have served the American public, alongside each and every one of you, over these past four years,” Yiannas said in an email addressed to FDA Food Partners, colleagues, and friends.
In his letter to Commissioner Califf, Yiannis cited how he first considered leaving the FDA in February 2022, over his concern that the decentralized structure of the foods program significantly impaired the FDA’s ability to operate as an integrated food team and protect the public.
However, Yiannis delayed his resignation after learning last February of the infant formula incidents that had been reported to various parts of the FDA several months before. Yiannis postponed this decision to help tackle this crisis.
“With the Abbott facility now reopened, infant formula availability is more prevalent, and – very importantly – the necessary monitoring, data systems, and insights are now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave,” Yiannas said in his letter to Califf.
Yiannas left Califf with several two things to consider. “One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more efficiently make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century.”
Secondly, Yiannas urged Califf to consider transferring the “small, yet exceptional” staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.
Yiannas assumed the position of deputy commissioner for food policy and response at the FDA in December 2018. Since then, he has acted as the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including the implementation of the landmark FDA Food Safety Modernization Act (FSMA). His responsibilities have included food safety priorities such as outbreak response, traceback investigations, product recall activities, and supply chain innovation.
“In closing, while I’ll soon be departing the agency, rest assured that I’ll continue rooting for you,” Yiannis said in his email to colleagues and friends. “As for me, while I have no immediate plans or next steps to announce today, I’ll continue to seek ways to work together to create a safer, smarter, and more sustainable food system that will benefit consumers, food producers, and the planet for generations to come. “
The full letter can be read below:
Dr. Califf:
This letter is to inform you that I am resigning my position as FDA Deputy Commissioner for Food Policy and Response effective February 24.
In December 2018, I joined the FDA with the goal of helping to modernize the food safety oversight system in the United States and protecting the American people from contaminated food. I wanted to build on my work of protecting consumers by elevating food safety standards and building more effective, modern, and innovative food safety approaches, something I did in the private sector for more than 30 years.
Despite the unprecedented challenges we’ve faced in the past four years (such as a global pandemic, unparalleled food supply chain disruptions, and six different acting or permanent commissioners), thanks to the dedicated staff working on food safety throughout the FDA, I believe we made real improvements towards this goal.
Advancing FSMA
First, almost a decade since its passage and after the agency experienced three separate lawsuits (before my arrival) for failing to achieve several Food Safety Modernization Act (FSMA) mandates, we made needed and strategic progress by tackling two of the most critical, complicated, and outstanding FSMA rulemakings by issuing a Final Food Traceability Rule and a new, proposed Agricultural Water Standard. While the FSMA-projected reductions in foodborne illnesses have yet to be realized a decade later, these two rules, once fully implemented, will be game-changers in allowing those reductions to become a reality.
A New Era of Smarter Food Safety
But we didn’t stop there. Modern times require more modern approaches. Therefore, shortly after my arrival, we assembled some of the brightest minds in food safety from within and outside the FDA to help us prepare for the future. Based on their input, in 2020 and under the auspices of a New Era of Smarter Food Safety, we unveiled a new vision and blueprint for the next decade to modernize the way FDA does its food safety work and to bend the curve of foodborne illness once and for all in this country. And in two short years, we achieved an amazing amount of work. For example, we leveraged smarter tools for prevention used for the very first time in the FDA’s food program, such as employing Artificial Intelligence to strengthen our ability to detect and prevent violative shipments of imported seafood from reaching the U.S. consumer. We also expedited and facilitated the use of Tech-enabled Food Traceability to better track and trace foods and to create a more transparent food system. And at a time of heightened food supply chain disruptions, we unleashed the power of data with the development of 21 Forward, a first-of-its-kind food supply chain analytical platform to identify food facilities at greatest risk of food supply chain disruptions, and to provide focus to areas where we should fortify resilience. We also launched a pilot to evaluate if select third-party food safety standards aligned with FSMA and determine what role they might play in the nation’s food safety oversight system. And we advanced the concept of Food Safety Culture to achieve higher rates of compliance and to mobilize the industry to do the same, realizing that advancing food safety requires going beyond traditional approaches, through a better understanding of human behavior and organizational dynamics.
A Record of Prevention
Importantly, while regulatory activities matter, they’re not what matters most. What matters most is the outcomes or proven results that our work is achieving in reductions in foodborne illnesses. And early indications are that we’ve been successful here too, whether it’s been through our work to rally stakeholders to break the cycle of recurring outbreaks around Thanksgiving linked to fresh leafy greens through FDA’s Leafy Green Action Plan or, after 8 years and 8 outbreaks, breaking the cycle of Salmonellosis during the summer linked to imported papayas, through an enhanced Food Safety Partnership between the U.S. and Mexico, as just a couple of examples.
Tackling Foodborne Outbreaks Faster
And while prevention has been and must always be our focus, tackling foodborne outbreaks faster and revealing their root cause is also essential to preventing future outbreaks, so here too, we made significant progress. For example, we strengthened FDA’s foodborne outbreak investigations and almost doubled the number of outbreak investigation reports the agency now publishes. Also, as a commitment to greater transparency, we began a process of sharing information about the outbreaks the FDA is investigating through a weekly outbreak update table, even before there is any actionable information. And importantly, we completed an independent review of our outbreak investigation processes that led to the development of a Foodborne Outbreak Response Improvement Plan.
I want to THANK all of those in the FDA who have committed themselves to these efforts and I hope they are given the opportunity to continue this important work in the future. I hold the food safety staff throughout the agency in the highest regard, for their expertise, their experience, and – most of all – their commitment to the public.
Looking to the Future
In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the food program that you and I both inherited, significantly impaired the FDA’s ability to operate as an integrated food team and protect the public. It was also in February of 2022 that I first learned of the infant formula incidents that had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facility now reopened, infant formula availability is more prevalent, and – very importantly – the necessary monitoring, data systems, and insights are now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave.
My fervent hope is that American consumers, especially mothers and fathers of infants, never again have to face this type of preventable situation. It is incumbent on any public organization that has undergone a crisis of this magnitude to undergo an “independent” and thorough review to understand how the crisis happened, what can be done to prevent it from happening again, and that the complete findings be transparently shared with the public. I am grateful that Congressional leaders have demanded that this happen and that the Office of the Inspector General has initiated its own investigation.
Lastly, while I respect that these are decisions only you are empowered to make, I do want to leave you with a couple of thoughts for consideration. One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more efficiently make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.
In closing, I will always remain grateful for the opportunity to have served our one and only true boss, the approximate 340 million American consumers nationwide. Serving them has been an honor and a privilege.
Frank Yiannas
Deputy Commissioner, Food Policy and Response
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