This just hit my inbox. I’ll have more to say.

January 25, 2023

Dr. Califf:

This letter is to inform you that I am resigning my position as FDA Deputy Commissioner for FoodPolicy and Response effective February 24.

In December of 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 globalpandemic, unparalleled food supply chain disruptions, and six different acting or permanentcommissioners), thanks to the dedicated staff working on food safety throughout the FDA, I believewe 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, andoutstanding FSMA rulemakings by issuing a Final Food Traceability Rule and a new, proposedAgricultural Water Standard. While the FSMA-projected reductions in foodborne illnesses have yetto be realized a decade later, these two rules, once fully implemented, will be gamechangers inallowing 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 aftermy arrival, we assembled some of the brightest minds in food safety from within and outside theFDA to help us prepare for the future. Based on their input, in 2020 and under the auspices of a NewEra of Smarter Food Safety, we unveiled a new vision and blueprint for the next decade tomodernize the way FDA does its food safety work and to bend the curve of foodborne illness onceand for all in this country. And in two short years, we achieved an amazing amount of work. Forexample, we leveraged smarter tools for prevention used for the very first time in FDA’s foodprogram, such as employing Artificial Intelligence to strengthen our ability to detect and preventviolative shipments of imported seafood from reaching the U.S. consumer. We also expedited andfacilitated the use of Tech-enabled Food Traceability 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. 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 industry to do the same, realizing that advancing food safety requires going beyond traditional approaches, through a betterunderstanding of human behavior and organizational dynamics.

A Record of Prevention

Importantly, while regulatory activities matter, they’re not what matters most. What matters mostis outcomes or proven results that our work is achieving reductions in foodborne illnesses. Andearly indications are that we’ve been successful here too, whether it’s been through our work torally 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 fasterand 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 theoutbreaks 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 hopethat they are given the opportunity to continue this important work in the future. I hold the foodsafety 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 foods program that you and I bothinherited, significantly impaired FDA’s ability to operate as an integrated food team and protect thepublic.

It was also in February of 2022 that I first learned of the infant formula incidents the had beenreported to various parts of the FDA several months before, so I postponed this decision anddedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facilitynow reopened, infant formula availability more prevalent, and – very importantly – the necessarymonitoring, data systems, and insights 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 and vacate this position.

My fervent hope is that American consumers, especially mothers and fathers of infants, never againhave to face this type of preventable situation. It is incumbent on any public organization that hasundergone 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 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 owninvestigation.

Lastly, while I respect that these are decisions only you can make, I do want to leave you with acouple of points for consideration. One, based on my experience these past four years, I (as well asa diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & IndustryStakeholder Groups) firmly believe the agency would operate more effectively and be better able toprotect the American public from foodborne illness, with the creation of a more integratedoperating structure and a fully empowered and experienced Deputy Commissioner for Foods, withdirect oversight of those centers and offices responsible for human and animal foods. In thismanner, she or he can more easily make the necessary changes that are needed to transform FDA’sFood 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 theDeputy Commissioner for Foods.

In closing, I will always remain grateful for the opportunity to have served our one and only trueboss, the approximate 340 million American consumers nationwide. Serving them has been a honor and privilege.

Frank Yiannas

Deputy Commissioner, Food Policy and Response