“I’m sure it hasn’t escaped your attention that we have an election coming up. And what I learned in 2016 is that when you’re in a place like the FDA, you don’t know what you’re supposed to do. This is a particularly interesting time as we are trying to predict what will change if a new government is formed. [wins] And how do we deal with it,” Khalif said Tuesday at the Reagan-Udall Foundation’s annual public conference.
With six months left until the presidential election, Khalif shared “some of the top priorities” the agency is working on, including the agency’s restructuring called for by the Reagan-Udall Foundation. The agency’s restructuring recommendation comes in the wake of a recall of contaminated infant formula that caused widespread shortages, which Khalif previously characterized as “stressed by increasing diversity and complexity.” uncovered a culture that inhibited food safety programs and the agency’s ability to effectively protect the public. health.
“As far as we know, this is the largest reorganization in the history of the FDA. There are 8,000 people participating in this, many of whom are ‘gathering at the gates and are aware of the proposed reorganization. Once we have completed the review process and ideally received approval, we are ready to lead change across all aspects that need to be engaged by Congress,” Khalif said.
“The situation right now is that we have conducted an investigation through HHS, the executive branch of the government, and have notified Congress. But…given the dynamics in which we operate, it would be clearly foolish to try to proceed without an agreement.”We have agreed with Congress that this is the right path.” said Caliph.
“Once we get through that, we’ll move on to the final stage with the unions because about 80% of our employees are unionized, so we need to make sure we get an agreement on how to get there.” he added.
Although the program is taking longer to ramp up than expected, Khalif said he is “confident” that the restructuring will move forward.
From ultra-processed foods and nutritional supplements to supply chain security, Khalif admits he’s ‘obsessed with nutrition’
Food safety, supply chain safety, increased oversight of dietary supplements, and a better understanding of the health effects of ultra-processed foods are also on the FDA’s radar, Khalif said. “I’m obsessed with nutrition,” he admitted.
He lamented, “I have recurring nightmares.” [my] Great-grandchildren will be reading history books. There was a time when the Food and Drug Administration was led by a man named Khalif, and the society’s overall goal was to create a diet that would make every American 1 pound heavier. It was something. Year. And to address that, he helped develop a drug that cost $20,000 a year to reverse engineer what industry had originally created. ”
To avoid the nightmare becoming a reality, Khalif said “ultra-processed foods are an obvious target” for government agencies to “understand better” but won’t “do anything this year.” He said he was deaf.
He pointed to “a body of observational evidence that shows a direct relationship between the consumption of large amounts of ultra-processed foods and weight gain, diabetes, and other adverse outcomes for almost all types of causal inference.” did.
Mr Khalifa said action could not be taken on ultra-processed foods and their potential health impacts “without agreement on the ground about what exactly the problem is and what needs to be done”. “Research is really needed,” he said.
Mr. Khalif: “I have great hope that one day we will have a streamlined system of nutritional supplements in the United States.”
The FDA also needs to work with Congress to create a “better pathway” to oversee other ingredients, such as marijuana and kratom, which “are almost always prohibited except in very special circumstances.” , has no medical benefit,” Khalif said.
“In essence, regulating harm reduction requires a systematic approach. For example, we found someone selling gummy bears full of delta-8, a marijuana-type product that is extremely dangerous to children. If we do, we are now taking enforcement action. But there are all kinds of variations on this theme now,” he said. “We need to work with Congress to find a better path forward.”
On the nutritional supplement front, Khalif said, “I have great hope that one day a streamlined system of nutritional supplements will be established in the United States.”
But he added: …But what I hope is that at least people think about how to more effectively regulate a $60 billion industry so that supplements that work are used more often than those that don’t. It’s a reasonable approach that can be implemented. It was ineffective and people didn’t spend money on ineffective products.
The agency included in its fiscal year 2025 budget request a requirement for additional authorities to register all dietary supplements with FDA.
Beyond U.S. Borders: Improving Monitoring and Security of International Supply Chains
Khalif also said he would like to see the FDA have a stronger international strategy to help protect supply chains and ensure the safety of ingredients and products sourced across U.S. borders. .
“We are committed to an international strategy. Our supply chain is diverse and global. Food and pharmaceutical ingredients imported from China expose us to enormous national security threats. , he said FDA inspectors take great “personal risks” to inspect companies in “very hostile conditions.”
He cited the contamination of applesauce with leaded cinnamon as an example, albeit daunting, of why an international strategy is essential.
Beyond food, nutrition, and dietary supplements, Khalif’s top priorities for the election include developing treatments for rare diseases, cracking down on tobacco, and managing misinformation where the FDA is “stalling.” He said this includes improvements to the advisory committee process.
