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  • Writer's pictureJennifer

FDA's Human Foods Program: So What? Should you Care?

A big deal has been made about FDA’s restructuring of the Human Foods Program and the new Deputy Commissioner, Jim Jones. Does the change to a government org chart in Washington DC translate into noticeable changes to the regulated industry? I believe the answer will be yes. I predict the impact of these changes could be unpleasant in the short term but worth it in the long term.

First, how we got here and what’s happened: After an April 2022 article in Politico by the fabulous Helena Bottemiller Evich revealed that the infant formula issue was illustrative of systemic issues in FDA’s management of foods, Commissioner Califf and FDA foods leadership found themselves in the hot seat. There were Congressional hearings and numerous letters from a broad swath of food system stakeholders calling for reform and accountability. FDA leadership of foods was fractured, and those leaders are now gone. Susan Mayne, now retired, led FDA CFSAN which develops food policy. Frank Yiannas led the Office of Food Policy and Response (most tightly associated with FDA’s New Era work, but not actually responsible for food policy or response, despite the name); Frank left the agency in February. The FDA investigators are part of the Office of Regulatory Affairs, which was led by Judy McMeekin until she retired from FDA. All reported to Commissioner Califf, who, last summer, asked the Reagan Udall Foundation to assess the situation and offer recommendations.

Fast forward to today. The Commissioner is consolidating CFSAN and OFPR. A few ORA functions will move to the new Human Foods Program. The head of the Human Foods Program (Jim Jones) is expected to have authority over the part of ORAs budget that deals with human foods and set their priorities. This all needs to be blessed by Congress. Food safety is typically viewed as non-partisan (nutrition less so); who knows where Congress will land on this. My short summary leaves out a lot of steps, detail and nuances but hopefully is sufficient to proceed with the impacts I foresee.

Short term: It’s going to be rough. Regardless of whether the restructuring ultimately results in greater efficiency, greater collaboration, a focus on prevention, etc., in the short term I imagine it will be tumultuous times. Deputy Commissioner for Human Foods Jim Jones is new to FDA. The new structure creates some new offices, new reporting relationships etc. If this creates uncertainty or anxiety within FDA’s current food related workforce, things could take a turn for the worse. We’ve seen an exodus of food program leadership over the past few months; will additional senior staff follow? Will FDA be able to retain historical knowledge and expertise if it does? Will new hires be able to get up to speed quickly? And as people are changing offices and letterhead and figuring out who their boss is, will they have time to do their day jobs? It’s going to be tough times. For the industry, it’s possible that figuring out your key contact at FDA on a given topic will get even more difficult, that responses from the Agency will incur additional delays, and if there are new staff, there may be more inconsistencies in how FDA addresses issues. I anticipate parts of the industry could become quite frustrated. But put yourself in their shoes—things can’t be easy over at FDA.

Medium term: As FDA staff and food system stakeholders settle into a new structure, we might start seeing an FDA that functions better. There are many “ifs” here, and a good bit of uncertainty in how things will shake out, particularly between the Human Foods Program and ORA. I’m optimistic. By all accounts, although Jim Jones is not a well known name within most of the food industry, he seems to understand bureaucracies and has a reputation for being fair. In DC, that’s about the best you can hope for! Michael Rogers is currently the Acting head of ORA (the Acting ACRA), having most recently overseen the Human and Animal Foods inspectorate. I’ve collaborated with Michael on a few innovative things, and am confident that he’ll be receptive to evolving ORA in a way that puts public health first.

How long will it take to transition from the rough road to one that smooths out? Who knows. Six months seems optimistic, especially in light of the election cycle. A year seems more likely—but then that puts us close to the election, which will likely trigger Commissioner Califf’s departure (regardless of who wins). A new Commissioner could have different ideas, resulting in more tumult. Commissioner Califf has repeatedly stated his intent to structure the Human Foods Program to stand the test of time. We’ll see. *IF* food system stakeholders see hints of hope and progress as we settle into this restructuring, it might take a renewed effort to maintain and nourish it.

Long term: This should be a good thing. Or at least better than today. Assuming a new Commissioner does not undo the restructuring and we have a chance to assess the long term impact, we could see some real improvement. Have we defined what “improvement” looks like? Do we have a means to measure progress? As we embark down this road, it would be useful for food system stakeholders to start thinking about how they will measure the success of the overhaul. This needs to be communicated with FDA and others (e.g., Congress). Then, at some point in the future we’ll be able to look back and determine if the rough patches were worth it.

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