Reorg tops FDA’s priorities ahead of presidential election, followed by raft of ‘nutrition’ issues, including ultra-processed food, dietary supplement oversight
“I am sure it has not escaped your attention that there is an election coming up. And I learned in 2016 that is a particularly interesting time to be at a place like FDA as you are trying to anticipate what needs to get done and what might change if a new administration of either party [wins] and how to deal with it,” Califf said Tuesday at Reagan-Udall Foundation’s annual public meeting.
With six months until the presidential election, Califf shared “some top priorities” that FDA is working on – including the reorganization of FDA called for by the Reagan-Udall Foundation. The recommendation to reorganize the agency followed the recall of contaminated infant formula that caused widespread shortages and revealed a food safety program that Califf previously characterized as “stressed by the increasing diversity and complexity” and a culture that inhibited the agency’s ability to effectively protect the public health.
“This is the largest reorg in the history of FDA, as far as we know. It is involving 8,000 people,” many of whom are “amassed at the gates and ready to … lead the change across every single aspect that needs to be involved” once the proposed reorg completes the review process and, ideally, earns a nod of approval by Congress, Califf said.
“The status right now is we have been through HHS, the executive branch of the government and we have notified Congress. We are not quite all the way through Congress, yet,” and while “we are not required to get permission of Congress ... given the dynamics that we operate in, it would obviously be kind of stupid to try to proceed without reaching an agreement with Congress that this is the right way to go,” Califf said.
“Assuming that we get through that, then we have a final step with the unions – about 80% of our employees are unionized – and so we have to make sure that we have agreement on how to proceed there,” he added.
While the program launch is taking longer than expected, Califf said he is “confident” the reorganization will move forward.
From ultra-processed food and dietary supplements to supply chain security, Califf admits he is ‘obsessed with nutrition’
Stepped up oversight for food safety, supply chain security, dietary supplements and better understanding the health impact of ultra-processed foods are also on FDA’s radar, said Califf, who admitted he is “obsessed with nutrition right now.”
He lamented that he has a “recurring nightmare in which [my] great grandkids are going to read a history book that said there was a time the Food and Drug Administration was led by this guy named Califf and the whole goal of society was to produce a diet that would increase the weight of every American by a pound per year. And in order to deal with that, he helped the industry develop a drug that cost $20,000 a year to try and reverse engineer what we created in the first place.”
To keep his nightmare from coming true, Califf said that “ultra-processed food is clearly a target” for the agency “to understand better,” but likely not “do something about this year.”
He pointed to “a lot of observational evidence that there is a direct relationship between ingestion of large amounts of ultra processed food and weight gain and diabetes and other bad outcomes for almost every type of causal inference.”
Unable to take action “without consensus in the field about what the exact issue is and what needs to be done,” Califf said “there is a real need for research” into ultra-processed foods and their potential health impact.
Califf: ‘I still have a great hope that one day we will have a rational system of dietary supplements in the US’
FDA also needs to work with Congress to create a “better pathway” for overseeing marijuana and other ingredients, such as kratom, which “have no medical benefit, for the most part, except under very specific situations,” said Califf.
“There needs to be a systematic approach to regulating harm reduction, essentially. For example, we do take enforcement action now when we find someone selling gummy bears full of delta-8, a marijuana-type product, which can be extremely dangerous to children. But there are all sorts of variations on the theme right now,” he said. “We need to work with Congress to come up with a better pathway.”
On the dietary supplement front, Califf said he has “a great hope that one day we will have a rational system of dietary supplements in the US.”
However, he added, “I do not expect that to get done this year. … But what I want to have is a rational approach that we can at least begin to put into play for people to think about how to regulate the $60 billion industry more effectively so that the supplements that are effective get used more often than those that are ineffective and people do not was their money on” ineffective products.
The agency included in its budget request for fiscal 2025 additional authorities to require all dietary supplements be listed with FDA.
Beyond US borders: Improving oversight, safety of international supply chains
Califf said he also would like FDA to have more robust international strategy that could help protect supply chains and ensure the safety of ingredients and products sourced beyond US borders.
“We are working on an international strategy. Our supply chains are diversified and global. We have enormous national security threats” from food and drug ingredients coming from China, where FDA investigators take great “personal risks” to inspect firms “in a setting in which there is tremendous adversarial situations,” he said.
While daunting, he pointed to the contamination of applesauce with lead-spiked cinnamon as an example of why an international strategy is essential.
Beyond food, nutrition and dietary supplements, Califf says his top priorities in the run up to the election include developing treatments for rare diseases, tobacco enforcement, managing misinformation to which FDA is “losing ground,” and improving the advisory committee process.
