Yiannas, who joined FDA in 2018 and has made significant strides in his goal of helping to modernize the food safety oversight system in the US, noted in a letter to FDA Commissioner Robert Califf that his resignation hangs in part on “concern that the decentralized structure of the foods program” has “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”
Based on his experience over the past four years, he said he “firmly believe[s] 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.”
He also 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.”
The recommendation to appoint a deputy commissioner for foods to oversee FDA’s currently scattered and inefficient approach to food safety and applied nutrition was in several suggestions for improving oversight of the food industry outlined by the Reagan-Udall Foundation in a scathing report published last month.
In the report, the foundation argued “the culture of the FDA human foods program is inhibiting its ability to effectively accomplish its goal. There are several factors contributing to this culture, including a lack of clear vision and mission, a disparate structure and a consensus governance model, competing priorities and lack of strong supportive leader when situations require and ultimate decision maker who was responsible for the human food program.”
It added: “The lack of a clear overarching leader of the human foods program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration.”
The independent review was conducted at the behest of Califf who said in an earlier memo that FDA’s food program “has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.”
Califf’s request also followed the infant formula recall due to safety concerns that led to massive shortages.
When the report was released late last month, the recommendation to create a deputy commissioner for food to oversee the food program, which is currently scattered across the Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition and relevant parts of the Office of Regulatory Affairs, earned accolades from industry leaders, including the Consumer Brands Association, Consumer Reports and others.
A mounting call for a single, empowered leader
Yianna’s frustrations and recommendations are shared by many former executives and industry leaders, some of whom called for even more drastic changes at the agency to better elevate and fund food safety and nutrition matters.
Among these are former Acting Commissioner of FDA Steve Ostroff who echoed Yianna’s call for a single empowered individual to oversee the food program, but he stressed that person must have a deep knowledge of the food industry and expertise of food safety, which has been missing at the top of the agency.
“The current leadership, and the leadership by and large at FDA over the years, has had expertise on the medical product side and not the food side. There are marked differences between oversight of the medical products industry and the food industry and how food is overseen. And I don’t think that you can easily translate expertise form one to the other,” Ostroff said at New Food’s Food Integrity US 2023 digital conference Jan. 24.
Under previous FDA deputy commissioner for food it ‘felt like the foods program actually had an identity’
While potentially reorganizing the food program under a unified leader may sound like a dramatic shift from FDA’s current structure, the agency has authority to do it and has done so before – in a more limited fashion – and it made strategic planning easier and more effective, Roberta Wagner, vice president of regulatory and technical affairs at the Consumer Brands Association and a former FDA official said at the conference.
She explained that during her tenure at FDA under former FDA Commissioner Margaret Hamburg’s leadership there was a deputy commissioner for food and veterinary medicine who was able to bring to the same table senior leadership from CFSAN, the Center for Veterinary Medicine, over which he had direct authority, and a Office of Regulatory Affairs via a dotted line of authority.
During that time, she said, “I felt like the foods program actually had an identity. We actually did strategic planning together … and we collectively made decisions on behalf of the program together.”
She added it was the first time in long career at FDA “where I actually heard messaging from the top penetrating all the way out to the field operations, the inspectors, the compliance force.”
As was done under Hamburg, Ostroff advocated for pulling the Center of Veterinary Medicine in “to be part of the solution” if the food program is reorganized.
“While we’re doing this unification,” he added, “there needs to be a unified lab unit. On the food side, we have the labs in the Office of Regulatory Affairs and we have labs in [the Center for Food Safety and Applied Nutrition] and they don’t talk to each other and they often don’t agree with each other. So, we need a single office that coordinates lab activities on the food side.”
‘It feels like the agency has just been paralyzed’
By improving communication within FDA, industry advocates and leaders say they are hopeful there will be more transparency and better communication between the agency and industry.
Reflecting on her experiences working the FDA under different administrations, Jennifer McEntire, chief food safely and regulatory officer with the International Fresh Produce Association, acknowledged the relationship between the agency and industry was sometimes stronger than others, but she noted: “more recently, it feels like the agency has just been paralyzed, like things have really come to a halt in terms of getting policies out,” which frustrates and hampers industry.
“We’re looking for that dialogue, that transparency, the ability to collaborate with the agency, recognizing that their scope of responsibility is quite large – there is an awful lot to do – so how can we provide resources? How can we provide that support so that the agency can focus where they need to focus and let others carry the weight on some of these other food safety issues?” she said.
With that in mind she said change is necessary at the agency, and noted it is happening, but it is still unclear what form it will take fully.
To this end, FDA’s Califf has said the agency will respond to the Reagan-Udall report by the end of the month with a new vision for the agency’s food program with more details to follow in February.