Last week, the US Food and Drug Administration (FDA) released details regarding plans to modernise its food division. The update will see the body adopt a “unified Human Foods Program (HFP)”, led by Deputy Commissioner James Jones, who will manage the consolidation of several FDA food centres and offices under one umbrella.
From 1 October, the FDA will integrate operations in the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and the “key functions” of the Office of Regulatory Affairs (ORA), into the single Human Foods Program entity. The ORA will also be renamed to the Office of Inspections and Investigations to allow its “field operations unit to focus on inspections, investigations and imports as its core mission” and “better convey the organisation’s role as the frontline of the FDA”.
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The changes have been brought in following the aftermath of the infant-formula crisis in the US which took hold in February 2022, when the country’s largest baby food maker Abbott Laboratories’ facility in Sturgis, Michigan was shut following concerns over salmonella and Cronobacter bacteria-contamination.
Months of baby-formula shortages ensued because of the closure. The FDA was heavily critiqued for its delayed response at the time of the crisis, which resulted in President Joe Biden invoking emergency action to help import baby formula supplies from abroad.
In a bid to move forward from the past mishaps, the agency says the latest restructure will help it “be more efficient, nimble and prepared for the ever-changing and complex industries” that it regulates.
What the changes mean
Experts generally view the announcement as a good step in the right direction. The changes will grant the FDA’s food unit with a proper chain-of-command for the first time, and many believe this will help to improve operations within the agency and ultimately help prevent food safety disasters, such as infant-formula crisis, from repeating themselves.
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By GlobalDataDr Darin Detwiler, founder of Detwiler Consulting Group and food policy professor at Northeastern University tells Just Food, the move “consolidates multiple functions under a unified Human Foods Program, potentially reducing inefficiencies and improving response times to food safety incidents.”
Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest (CSPI) also sees potential in the planned reorganisation, stressing the importance of establishing a proper branch of authority within the food unit.
“The changes will be a big improvement to the old structure”, she explains. “Under the previous approach, the food programme lacked a single, unified leader. The policy-making staff reported to one centre director, and those implementing the policy through inspections and investigations reported to a different director. This meant that in times of crisis there was no one individual managing the response, leading to delays and dysfunction.
“But the breakdowns went deeper and contributed to a culture of delay and indecisiveness that has permeated the foods programme. When there is no one with clear authority to make a decision, any form of challenge or disagreement can leave the policymaking process at a standstill.”
Frank Yiannas, former deputy commissioner for food policy & response at the FDA at the time of the 2022 baby-food crisis faced the brunt of the body’s dysfunctional nature, Sorscher explains. This is because despite leading the FDA’s response to the situation, he “actually didn’t have direct line authority over any of the staff managing the response.”
Yiannas says he is “delighted” with the restructure, especially when it comes to its impact on the organisation’s food division budget. As he explains, “Before, the $1.4bn FDA foods programme budget was divided among the top three entities, with different leaders being responsible for their own budgets.
“Under the new structure, the deputy commissioner now owns the entire foods programme budget. This is something new that none of the past deputy commissioners… ever had. Oversight of the entire foods program budget is also a great thing to ensure alignment on how resources are used.”
No ‘silver bullet’
While the move is being seen by most as positive, some are cautious to say for certain that it will bring major improvements to the FDA’s food division.
“I think it’s premature to celebrate that this will lead to a more effective and efficient foods programme at the US FDA,” says Yiannas.
“Right now, before we celebrate success, I think the most important thing the FDA and stakeholders must do is identify – in a transparent way – objective metrics that will help us determine if the reorganisation is delivering on promised improvements.”
For Yiannas, some of the key metrics for the agency to focus are increasing its number of inspections, shortening the time taken to approve new food products, write new standards of identity and classify a recall. It should also look to cut the level of foodborne illnesses-related sicknesses which have been flat over the past 20-years, and assess whether US consumers are eating more nutritious, healthy foods.
Detwiler doesn’t see the restructure as an instant fix for the agency’s food division either. “No solution can be seen as a ‘silver bullet’”, he says.
“The pandemic has highlighted just how fast the food landscape can change. The future will continue to see more changes in all areas – manufacturing, supply, distribution, retail, and even with consumer behaviour/demand. As such, preventing the next crisis will require an ever-changing focus on improving supply chain transparency and resilience.”
Further updates to the agency are more than likely to be announced in the future, he adds. “I can almost guarantee that we will see more changes to the FDA’s structure… As new issues arise and as the effectiveness of the new structure is evaluated, further adjustments may be necessary to ensure optimal performance.”
Sorscher agrees, noting that a rejig will likely be seen “not so much in organisational structure, but in terms of how the agency operates.
“A key change advocates are looking to see is a shift in the agency’s culture, which has been plagued by secrecy, delay and indecision. In many ways, changing the culture of the agency is more critical than any of the top-line organizational changes that have been approved so far.”
Another change the CSPI is hoping to see is “more leadership” in the FDA’s food unit, she says, “for example by putting out more effective food safety guidance to industry and moving more quickly to ban dangerous chemicals. These changes will not only benefit consumers, but industry as well, because FDA can give companies the clear guidance they need to put out products that are safe for consumers.”
If the restructure is to truly transform the food division and improve how it oversees the US food supply chain, the organisation’s internal culture requires a proper shake up. As Yiannas eloquently puts it “[The FDA] needs to strengthen its internal culture. That’s why we’ve all heard it said culture eats strategy for lunch.”
It’s a shift is easier said than done. As Brian Ronholm, food policy director at consumer advocate group Consumer Report explains, the division has a deeply imbedded “bureaucratic inertia” that needs to be tackled, but requires getting employees to work in a completely new way.
“There’s a significant group of folks within the agency that’s been used to doing things a certain way, for several decades,” he says, “so that’s going to pose the barrier to kind of shake that mentality and understand that stakeholders across the group, whether it’s consumer groups, industry, public health groups, academia, we all deserve better.”
Roadblocks ahead
The FDA faces several hurdles as it prepares to consolidate its food division.
As Detwiler explains: “While the restructuring addresses many concerns, questions will be raised over ensuring sufficient funding, staffing, and resources to implement and maintain these changes effectively.”
Sourcing funding is and will continue to be a key issue for the agency, Sorcher says. “Americans from across the political spectrum want FDA to be funded to do its job,” she notes, “but this Congress has been so divided and dysfunctional, it’s likely to be a tough fight for the agency to get the funding it needs to get the new programme off the ground”.
She adds: “After the formula crisis, FDA has committed to more proactively inspect and re-inspect infant formula makers moving forward. They are also working to stand up a new Office of Critical Foods (under direction from Congress) and will require funding to make that office effective.
“Unfortunately, FDA has proposed a tight budget this year and is warning states that it will be cutting funds for food safety inspections… Republicans are jockeying for even deeper cuts that would be devastating for the agency. This would be cutting the foods programme off at the knees before it has a chance to take its first steps.”
Another potential hitch is the upcoming election, which could even flip the FDA’s planned reorganisation on its head, according to Ronholm. “If there’s a new administration and that new administration appoints a new FDA commissioner, there’s certainly a chance that that new commissioner will scrap the plan entirely”, he says.
For Yiannis however, getting more enough money isn’t necessarily the biggest obstacle facing the agency’s food unit. “Contrary to what many believe, the FDA has been successful at obtaining modest budget increases in funding for most years”, he says.
“While they could always do more with more, my sense is that with the new structure, the agency will be expected to better demonstrate show how they’re using the existing $1.4bn annual budget effectively.
“If and once they do that, I think many political leaders on both sides of the fence would be more open to increased funding.”
Ronholm agrees, stressing that “we need to get to that point where Congress needs to trust the information that they’re getting from the FDA, if they’re even going to come through with additional funding.”
When will we see the effect?
Implementing changes will not be smooth sailing, according to Ronholm, who stresses that just like the restructure of any other major organisation, the operation will take a long time and “should be viewed primarily as a marathon”.
Speedy or not, if the reorganisation doesn’t work, some believe the country could risk seeing a complete breakup of the FDA altogether. As Yiannas says: “if things don’t dramatically improve, longer term, or of there are other catastrophic events related to food. there could be continued calls for the nation to establish a single food safety agency”.
While the new Human Food Program has the potential to fix many issues in the present structure of the FDA’s food division, the consensus is that it’s still too early to say whether the rejig will bring real positive changes to the way food safety is managed in the US. What isn’t open to question is that a restructure needs to work if the US is to successfully manage and avoid further food-linked crises in the future.
