— OPINION —

By Richard Smoley

The failures of the federal Food and Drug Administration (FDA) have been in plain view since at least early 2022.

At that point the public saw the FDA’s  scandalous neglect of Abbott Nutrition’s contaminated infant formula — which was reported to it five months before Abbott recalled the product — and Politico’s detailed exposé of the agency’s incompetence, which extends back through several presidential administrations. How the FDA’s food division fails to regulate health and safety hazards (politico.com)

In response, FDA commissioner Robert Cailiff ordered both an internal review of the agency’s handling of the Abbott debacle and an outside review by an expert panel from the Reagan-Udall Foundation.

Cailiff has proposed a structural reorganization: “The functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a newly envisioned organization called the Human Foods Program,” Cailiff said in a Jan. 31 press release. This agency would be headed by a new deputy commissioner. FDA proposes redesign of Human Foods Program – Produce Blue Book

Cailiff’s plan has been criticized by a number of consumer and industry organizations. Coalition speaks out against luke warm plan for proposed FDA reorganization | Food Safety News

The principal compaint is that this proposed deputy commissioner does not have direct line authority. Line authority means a clear chain of command: an official with such authority has the power to tell subordinates what to do. Both the internal and the external reviews advised giving the deputy commissioner this authority.

Cailiff didn’t think that was necessary. “We advised the Commissioner of our concerns in the attached letter and met with him on this matter on February 14,” said a letter from the protesting organizations. “Our group left with the sense that the Commissioner did not feel that direct line authority was needed but encouraged us to continue expressing our concerns.”

Even if Cailiff’s proposal were implemented with line authority, the structure would remain shaky: it is an action from the executive branch, which could be reversed by the next administration. Indeed the Politico article said the current situation was due in part to “a Trump-era change in leadership structure,” which “set up a power struggle between the two top officials, further strengthening the status quo of inaction.”

In short, a new administration could undo whatever good might be done now.

“There are basic structural problems that contribute heavily to the current failure,” noted the Politico article. “FDA is housed under the Department of Health and Human Services, which means the commissioner, while Senate confirmed, isn’t part of the Cabinet. FDA commissioners almost always come from the medical side and historically also have almost no experience with food issues. . . .  There’s a long-running joke among FDA officials that the ‘F’ in FDA is silent. Commissioners have also been known to slip up and accidentally call it the Federal Drug Administration.”

The solution to this mess is clear, obvious, and simple: the creation of an entirely new Department of Food and Nutrition, headed by a cabinet-level secretary. FDA restructuring: not good enough – Produce Blue Book It would include all of the “F” functions of the FDA, as well as administration of the Supplemental Nutritional Assistance Program (SNAP, aka food stramps), which is now conducted by the Department of Agriculture. I have always wondered what food stamps have to do with agriculture.

Such a department would treat food safety as one of its chief priorities, unlike the present FDA, for which it is a mere afterthought.

A further advantage: such a department would be better equipped to face one of the gravest health issues in the U.S.: malnutrition, which results in obesity, among other conditions. At this point, nearly 42 percent of American adults are obese. https://www.tfah.org/report-details/state-of-obesity-2022/#:~:text=Nationally%2C%2041.9%20percent%20of%20adults,obesity%20rate%20of%2041.4%20percent.

I said that the solution would be simple, but I did not say it would be easy. The present 118th Congress gives no indication of the wisdom or foresight that would be necessary to create this new department.

In any case, a new department could not be created without wide consensus — and pressure — from both the public and the food industry. The latter is often seen as the beneficiary of FDA neglect — mice playing in the absence of the cat— but the more enlightened and intelligent industry members understand that a strong and credible federal food safety agency is vital to their own interests. After all, it’s the safety of their food that is called into question.

All of this indicates that a Department of Food and Nutrition is a long-term objective rather than a short-term goal. Undoubtedly it will take years to build the consensus both in the food industry and the public for such an earthsaking move.

Let’s start now.