Why the FDA reorg is the biggest story of the year

With new hires and so many moving parts, the revamp could have wide and far reaching implications, impacting everything from food additives to NDIs.

Background

Earlier this year, the FDA announced its plans to reorganize the Human Foods Program (HFP). The move followed an evaluation by an independent expert food panel that outlined deficiencies it found in FDA’s culture, structure, resources and authorities in the food space.

Specifically, the evaluation indicated that the current structure is duplicative and allows for "siloed work." FDA Commissioner Robert Califf had requested the evaluation following criticism over how the Agency handled the infant formula shortage.

To address these shortcomings, FDA will combine the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response, and certain functions of the Office of Regulatory Affairs (ORA) to form a unified Human Foods Program.

Within the unified Program, FDA will establish a Center for Excellence in Nutrition and an Office of Integrated Food Safety System Partnerships and will create a Human Foods Advisory Committee composed of external experts to advise the agency on issues in food safety, nutrition, and food technologies.

Why it matters

Under the new proposed HFP structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). On an FDA blog, Califf said it will “aim to ensure that the dietary supplements program remains a critical priority for the agency.

“There are currently no plans to reduce ODSP’s resources or capabilities, and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act. The vision for the new OFCSDSI is to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements. ODSP will remain a distinct office executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act for dietary supplement products.”

The new guy

The FDA also announced James Jones, a former Environmental Protection Agency official, to serve as the first Deputy Commissioner for HFP. Jones, who reports directly to Califf, has decision-making authority over the HFP’s policy, strategy, regulatory program activities, resources, and risk priorities.

“It's not unusual for FDA to go outside the agency, but it is a signal that they wanted some fresh thinking. And maybe indicative that they wanted to take a fresh look at some areas where they really hadn't spent much time. For me, the big question number one is, ‘what is Jim Jones there really to do?’” said Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA). “It's very clear they're working really hard on this reorganization. This is complicated. There's a lot of moving parts and things that have to happen. But I get the sense that there is a strong, esprit de corps at the moment within that foods group because they know there's a need for change. I think Jim Jones is probably setting a good tone. We can do better. We will do better.”

For the first time in his 40-plus years in the industry, Israelsen said he can see FDA honestly reflecting on themselves. “What are we doing wrong to have lost this level of public trust?”

Chemicals in focus

During a call with UNPA and four other trade associations, Jones regularly referenced “chemical risks”, noting the agency intends to be very watchful of the chemical safety space, including microbial, nutritional and foodborne illness.

With California taking matters into its own hands by banning Red Dye No. 3, potassium bromate, brominated vegetable oil and propylparaben, Califf indicated during a recent speech that consumer trust in the FDA is at an all-time low.

“Part of it is just kind of societal generational attitudes toward governments, it's not just FDA. COVID was a big issue, vaccines, yeah, that was an issue, infant formula was a really big issue. And the California decision to get rid of chemicals was one thing, but the way they said it and how they wrote their reports of why they were doing it–they were openly critical of FDA and said, if the federal regulator isn't going to do this, we are, to protect the citizens of the great state of California. And clearly the commissioner took offense at that. And he said so states, courts and judges and TikTok and pretty much everybody, basically figures they know more than we do and are making their own minds up. And so this loss of respect for authoritative scientific judgment at FDA is the big issue. And they want to restore that,” said Israelsen.

Under the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe (GRAS). This means some of these additives haven’t been reviewed in 50 or more years.

“The food industry fights like crazy to keep them there because they've learned how to work with these things and make ultra-processed foods,” said Israelsen. “So I think we have a battle coming up.”

Woodcock out, Bumpus in

Principal Deputy FDA Commissioner Janet Woodcock is slated to retire from the FDA in early 2024 and will be replaced by Namandje Bumpus, who is currently chief scientist for the FDA.

“I think it was a good time for her to retire. There has been a historic undue influence of the drug side of FDA controlling decision making over the food side of FDA with respect to policy that includes CBD. To some degree, I would even say drug exclusion and NDI-related issues. And the coming battles with other really interesting ingredients of interest to both us and the pharma industry, and Dr. Woodcock was a reliable defender of the pharmaceutical interests of FDA and industry. Her replacement couldn't be more different in every possible way. Bumpus is a brilliant person, [her] CV is amazing. Very scholastic, I would say totally different personality.

“She will bring a very different set of skills and interests, suggesting that the drug side of FDA is likely to see interesting changes in some respects. All of this tells us that there is a lot of thought and change going on within the agency,” Isrealsen said.

A new chance for a slice of CBD pie?

“You have new people, new thinking. I think a lot of the old deep prejudices that existed with that FDA seem to be going away as it relates to us. And those that were there during the times of DSHEA and Janet Woodcock–that was a deep scar. There was just an inborn dislike of DSHEA and therefore for the industry itself. And the resultant view within FDA is that we can't undo the statute, but they can certainly use discretionary policy to mitigate what they see as the misguided policy established by DSHEA. And Dr. Woodcock was, I would say, of that school.”

LDI added that while he doesn’t know much about Bumpus, he does believe she will be more open-minded about CBD.

“Whereas Dr. Woodcock felt that that would be a fundamental breach of the fortress wall to let CBD get to the public. That should be reserved for pharma, along with all the other cannabinoids, not to mention all the other fun stuff that's in nootropics and chemically active plants, which everybody's interested in and the race is on who can get there first. And that brings us straight back around to drug exclusion, NDI filings and who-gets-what and how we carve the pie,” explained Israelsen.

Time to move

The second and third leaders at the agency come in with less than 20 months of experience at FDA. This offers a fresh take–but also a good share of uncertainties. However, Israelsen said he’s more optimistic than concerned.

“They are both very experienced. I think the ship is in good hands. I don't worry about the competence of the people with that 17 months of FDA experience. Their challenge will be the learning curve to understand a vast array of things they need to know enough about to give direction to the folks to deal with it day by day. That is why the reorg is important, there is this window of time when FDA will be more open than usual for us to come to them and restate what the priorities are, what we could really use from FDA, and how we can cooperate. So this honeymoon period– let us use it well.

“That is why this is important, it is time sensitive. We need to really study up and watch really closely as this evolves. By mid-year next year, I would think we will see tangible change on the food side of FDA,” Israelsen said. “In many ways, we're at this fascinating point of time where FDA is morphing and changing, as are we. And if we happen to morph into each other, it could really yield some positive changes.”

Israelsen said the FDA reorganization is the number one story of the year because the implications are so wide and long.

“And these early days are important to try and understand where FDA is going directionally. And some of these areas are where it could get really tricky for us, we need to get going now to address those and to have plans in place.”