I’ve given this some thought and there really is no way to sugarcoat it. The federal agency responsible for the food you eat – from vegetables to fruit to meat to thousands of frozen and other processed foods – is a five-alarm dumpster fire unable to reliably protect the public from illness and death.

And the tragedy of the situation is that anybody and everybody who has had dealings with the Food and Drug Administration would most likely tell you the same. Including those who had served at FDA.

Yeah.

Even a cursory google search uncovers the scope of the problem:

The root of the problem is that for decades the FDA has focused far more attention and resources on drugs and medical devices than food safety. It’s not unfair to say that at FDA food security and safety is a second class citizen.

A new report released last December by the Reagan-Udall Foundation confirmed what everybody already knew:

“FDA has dedicated staff who are committed to protecting public health, but the current culture of the FDA Human Foods Program is inhibiting its ability to effectively accomplish this goal…There are several factors contributing to this culture, including the lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and, when the situation requires, an ultimate decision-maker, who is responsible for the Human Foods Program. The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration.”

The report makes it clear that the FDA’s current organizational structure fails to protect the public from issues surrounding the food we eat. It offers five options to reorganize the FDA to give food safety needed attention.

Many of the options nibble around the edges of the FDA table of organization, recognizing doing something is better than doing nothing and acknowledging drastic changes will require approval of Congress. But these options have downsides including that the next resident of the White 

House could undo what the Biden Administration is trying to accomplish.

By far the best solution is the report’s option A which would create separate Food and Drug administrations within the Department of Health and Human Services. The new Federal Food Administration commissioner would have direct oversight to the Center for Food Safety, Center for Nutrition, Center for Veterinary Medicine, and relevant portions of the Office of Regulatory Affairs. And the commissioner would report directly to the secretary of Health and Human Services.

Under this table of organization, the secretary of HHS manages food and drugs independent of one another including separate budgets. And it gets at the root of the deeply held cultural problems that have put drugs first at FDA for decades.

Are there downsides? Yes. For one, creating what amounts to silos for drugs and food oversight may lessen collaboration and information exchange when needed. And the new Federal Food Commission will need to fight for budget dollars with long established HHS units like the Centers for Disease Control and Prevention.

But at the end of the day, the upside for improved food safety justifies the political risks. A logical plan of attack is to implement one of the recommended options not requiring congressional approval while pushing Congress hard to approve a permanent solution.

It won’t be easy. Likely some current FDA members, lobbyists and Congress will fight the effort.   It certainly will be arduous. But to do nothing is simply not acceptable. The Reagan-Udall report makes that clear:

“While the Human Foods Program has specified functions, a clear unifying vision and mission for the entire program is not apparent. FDA should articulate the vision and mission that drive the Human Foods Program. The absence of a unifying vision and mission is exacerbated by a lack of definition regarding what components of the Agency make up the Human Foods Program. Without an internally shared identity for the program, developing and enabling an effective overarching program culture is difficult.”

Buried in the $1.7 trillion budget approved last December is an additional $41 million for food safety activities and language acknowledging the “serious consequences of FDA continuing to operate with a fragmented organizational structure and lack of accountability.” The budget recommends FDA to seriously consider the recommendations of the Reagan-Udall report and “develop a restructuring plan that includes stakeholder engagement and input, that establishes and unifies all capacities of the food program.”

It is heartwarming that FDA Commissioner Robert M. Cardiff considers the report a call to action. Last December in a press release, Cardiff made his intentions crystal clear:

“I will closely oversee the Human Foods Program until a determination is made on how we will strengthen and modernize the program. I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American.”

Cardiff promises a major announcement by the end of the month. Now is the time for bold, decisive action to improve food safety. Does the FDA have the courage? We will soon find out.

%CODEdave%

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