Tomorrow, President Biden’s nominee to lead the U.S. Food and Drug Administration will get a chance to make his case to the Senate on why he is the best person to lead the agency at this moment. If confirmed, this would be Dr. Robert Califf’s second tenure as FDA Commissioner, having held the same job in the Obama-Biden administration. However, if Dr. Califf is confirmed, he should make every effort to chart a new path at FDA, aiming to balance the agency’s commitment to food and medicine, bring transparency and accountability to an agency with murky processes, and loosen FDA’s stranglehold on food technology and innovation. In other words, it’s time to put the F back in FDA.
The FDA is one of the most important regulatory agencies within the federal government because it ensures the safety and security of our nation’s food supply. But for decades, the top job at the FDA has been heavily weighted toward experts in medicine and pharmaceuticals, although the agency oversees 75% of the nation’s food supply, including dairy and baked goods, as well as most food imports. In a 2019 article cosigned by seven former FDA Commissioners, Dr. Califf and others argue to remake FDA from the ground up to “ensure predictable decision making, firmly grounded in scientific evidence” and to “enhance the transparency of the agency and sustain public confidence.” Yet, the argument mostly ignores FDA’s responsibility for food.
Unfortunately, in the FDA we engage with every day, the F in FDA is buried deep within the bureaucracy, often left to the rank and file who are constrained by the agency’s opaque processes which move at their own pace without accountability to the public, Congress, or private industry. In the article, Dr. Califf and others argue for a separate, independent FDA. What is needed at FDA first and foremost is not more mystery and isolation—it is management with accountability and transparency; clearly articulated processes, timelines, goals and deliverables that ensure a safe, wholesome, sustainable food supply that expands choice and allows consumers greater health and wellness.
Take yogurt—a simple, wholesome dairy product. FDA developed its first yogurt standard of identity 40 years ago. Food standards like this one are mandatory requirements set by FDA that determine what a food product must contain and how it must be made to be marketed under a product name—in this case, as yogurt. About 20 years ago, the yogurt industry petitioned FDA to update the standard of identity to keep pace with changing production practices in response to consumer demands. The agency responded 9 years later with a proposed rule. Then, just a few months ago after 11 more years, the FDA issued its final rule with little warning and instead of reflecting advances in the industry, imposes strict limitations on what can be called “yogurt.” The result is that about 25% of popular yogurts will need to be removed from store shelves unless significant changes are made in their production and labeling. Or look at the mysterious frozen cherry pie standard. From its murky inception in the 1960s to industry requests to revoke the standard in 1997 and again in 2005 to its sudden unraveling in 2020, the unclear process of federally mandating frozen cherry pies, and no other fruit pies, illustrates the agency’s confounding approach to food standards rulemaking.
After 20, 30 or 40 years, FDA’s attempt at “modernization” has not happened and there remains a lack of accountability and transparency. Timelines expressed in decades do not benefit anyone. Through many former commissioners, FDA has promised to modernize food standards while allowing food makers more flexibility to respond to shifting consumer demands. Yet food standards have become more complex and onerous, FDA’s response times on pending rules and petitions has increased and promises to streamline rulemaking have not been kept.
Dr. Califf has a second chance to change all that by leading an FDA that is built around integrity, transparency, and food modernization. It is, after all, the Food and Drug Administration.
Robb MacKie, President and CEO, American Bakers Association
Michael Dykes, D.V.M., President and CEO, International Dairy Foods Association
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