Jim Jones, the FDA's newly designated deputy commissioner of human foods, sees partnering with food industry stakeholders as crucial to accomplishing the food safety goals of the agency.
His early actions — including inviting regulated industry members in to hear firsthand their thoughts and concerns and seeking opportunities to work together — are getting noticed. Industry representatives and consumer advocates expressed optimism that he’s hit the ground running due to Jones’ familiarity with the corrections needed to change course at FDA.
Jones acknowledged the approach in a media roundtable last week, telling reporters, “We need to work with those who are in the business of making food if we’re going to be successful.”
And the words don’t appear to be just lip service. FDA is working with stakeholders to understand how they operate and how restrictions considered by FDA may impact the food supply chain.
“We are going to be spending a lot of energy and time working both internally in FDA and across the federal family with state partners, with the manufacturers of food [and] with the retailers to see if we can make significant progress in improving the health and well-being of Americans,” he said.
FDA Deputy Commissioner for Human Foods Jim JonesIn his discussion with reporters, Jones outlined his vision to stand up the Office of Critical Foods, decrease diet-related chronic disease through nutrition and carry out evaluations of food chemicals. Brian Ronholm, director of policy at Consumer Reports, said these priorities are all “signals that stakeholders have been craving from FDA.”
Mitzi Baum, CEO of Stop Foodborne Illness, was one of the first to sit down and meet with Jones. Baum, who was joined by three other individuals who had real-life stories to share about the impact of foodborne illnesses, said he was surrounding himself with “wise” FDA staffers and everyone “walked away feeling like it had been a very positive interaction with him.”
The infant formula shortage, recall and loss of life created the “perfect storm,” Baum said, which “illustrated the dysfunction very clearly” at FDA. Although Jones had only been on the job for a handful of days when Baum first met him, she’s “patiently waiting” to hear his strategy moving forward on how he plans to make significant changes in the infant formula sector as well as reducing foodborne illnesses overall.
Baum said as they observe the creation of the new human foods program established at FDA, she’ll be watching to see how the agency’s communication improves when issues arise. She hopes to see a strategic path forward from Jones on what he sees as opportunities that may come in quick fixes, but also how he plans to collaborate on larger issues beyond some of the systemic problems at the agency.
In the aftermath of the infant formula crisis, Jones, a former Environmental Protection Agency senior official, sat on the panel that wrote the in-depth Reagan-Udall Foundation report. Ronholm said this provided Jones “instant knowledge” of how systemic the problems are within FDA’s oversight of food and allowed him to come in with a head start on understanding what needs to be addressed.
“I think it was really important for someone like him to be in this role right now with that in-depth knowledge of what’s wrong,” Ronholm said. “He will have a clearer sense of what needs to be done to change the culture so that there is a good structure in place, better governance and improved stakeholder engagement.”
Ronholm said his group and others who have called for changes at FDA will be watching the pace at which Jones and FDA implement reorganization efforts. Ronholm said it was a herculean effort for FDA Commissioner Robert Califf to quickly implement suggestions called for in the report issued less than a year ago. Among those recommendations was the creation of a new human foods division and naming of a leader empowered to quickly take action when needed.
“I think what’s equally critical is maintaining that pace so that the implementation doesn’t drag on or get held up by internal bureaucracy,” Ronholm said.
Sarah Gallo, Consumer Brands Association's vice president of product policy, said CBA is “cautiously optimistic” that the reorganization efforts under Jones’ watch will be substantive. “The proof is going to be in how that kind of plan on paper translates into action,” she said.
She said in Jones’ “initial days of understanding,” she’s encouraged he’s listening to those up and down the food value chain as well as from the consumer perspective.
“We were very complimentary of the Reagan-Udall report when it came out because it really took that holistic view of what it was going to take to have a meaningful modernization of the human foods program,” Gallo said. Implementation will require cultural changes, breaking down internal barriers for communication and understanding how to find efficiencies within the agency, Gallo said.
The Reagan-Udall report gathered insight from FDA employees and outside stakeholders, which offers Jones' firsthand knowledge and "sets him up for success" in how to meet the challenges identified.
Sarah Gallo, Consumer Brands Association“He certainly understands the scope of work in front of him,” Gallo added. “He understands that timeliness." Gallo said industry and consumer groups will be holding him accountable for implementing changes that are meaningful as well practical for the food industry and increase consumer confidence.
Roberta Wagner, the International Dairy Foods Association's senior vice president of regulatory and scientific affairs, wants to see Jones become a "champion for shifting FDA toward a modernized, prevention-oriented model, for example, that aligns with industry's commitment to prevention and continual improvement."
Wagner, who has 33 years of public service at FDA and USDA's Food Safety Inspection Service, said she believes Jones will ensure the agency "bases its nutrition-related decisions on sound science and robust consumer research before rushing into rulemaking on issues like front of labeling, among others."
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FDA also plans to look for ways to expand partnerships with state health and agriculture departments to protect the food supply, Jones said. He wants to accomplish the greatest public health benefits for the least cost possible, something he said can only be accomplished by working with the sector being regulated. Even with voluntary programs, such as FDA’s sodium reduction targets, stakeholder engagement provides opportunities to succeed, he said.
As an example, if a voluntary program isn’t designed with the entities the agency wants to participate in mind, Jones said it's unlikely to get the buy-in from industry. Understanding what’s important to stakeholders allows the FDA and the industry to work together to achieve shared goals, Jones said.
One key element of the reorganization and proposed new Human Foods Program is the creation of a Center of Excellence in Nutrition, which may need additional resources to accomplish the goals of the center to help consumers make better informed food decisions.
“We all know resources are pretty scarce right now, and it’s probably going to be for this fiscal year or next fiscal year. We’re not likely to see any [funding] increases anywhere in government,” Jones said.
He's confident that over time Congress will provide more resources to the agency as FDA makes the case for the importance of funding the nutrition center to levels that “commensurate with the nature of the problem” of growing obesity and diet-related chronic disease rates on the rise.
FDA continues to come under fire from stakeholders, as well as Congress, in how authorized funds are used at the agency. Baum said budget transparency will be one “litmus test” in determining how Jones looks to change the tone at the agency in cooperating with stakeholders.
Ronholm said many industry stakeholders support additional FDA funding, but it’s a gradual process for the agency to provide more transparency in how resources are used.
“We understand that it’s chronically underfunded, particularly as it relates to food issues,” Ronholm said of FDA’s budget. “But given the concerns about the kind of the structure and governance of it, there’s a hesitancy to provide that additional funding until that gets sorted out and approved.
“I think we’re all encouraged by what’s going on with the redesign, their gradual increase in transparency about the budget, and I think we can eventually get to a place where there’s stakeholder agreement that we should push Congress for additional funding for the foods program, specifically because there’ll be a greater comfort level that the funding will be expended efficiently and appropriately,” Ronholm said.
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