Deputy Commissioner of Human Foods Program emphasizes efficiencies behind new agency reorganization

At the recent Convergence ’24 conference hosted by the Council for Responsible Nutrition, the U.S. Food and Drug Administration’s (FDA) deputy commissioner of the newly launched Human Foods Program (HFP), Jim Jones, provided a keynote address. During the keynote, Jones discussed the priorities of the new program, namely the prevention of foodborne illnesses, ensuring chemicals in foods are safe, and the reduction of diet-related chronic diseases. The HFP is the product of a reorganization that combines the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and some functions of the Office of Regulatory Affairs (ORA). The dietary supplement industry, this means that the Office of Dietary Supplement Programs (ODSP), which previously reported to the CFSAN, now reports to a new entity, called the Office of Food and Chemical Safety, Dietary Supplements, and Innovation (OFCSFSI).

According to Jones, “By having clear strategic priorities and a streamlined organizational structure, we will be better able to address emerging and immediate public health risks and allocate resources toward the long-term research initiatives and regulatory actions to improve public health. The new human food program merges all food functions, personnel and resources that are programmatic in nature, which prior to October 1, were spread between multiple parts of the agency. It's intentionally designed to streamline operations, improve internal communications, reduce redundancies, and expedite leadership decision making.”

With this new structure, stakeholders have been concerned that dietary supplements would become a lesser priority. These concerns were shared by U.S. Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT), who sent a letter to FDA commissioner Robert M. Califf, MD, wanting more information about the reorganization’s impact on the oversight of dietary supplements. Califf for his part has made assurances that ODSP’s resources and capabilities would remain intact.

During his keynote, Jones emphasized that efficiencies of the new HFP. One example he provided was the transfer to the HFP of budget authority for inspections that was previously part of the Office of Regulatory Affairs, now the Office of Inspection and Investigations. “For example, dietary supplement complaints will now go directly to HFP to triage with the Office of Dietary Supplement Programs, evaluating and working with HFP’s Compliance Office and the Office of inspections and investigations as needed. This will allow us to respond more quickly to food dietary supplement in place,” explained Jones.

Jones also acknowledged the limitation’s of FDA’s reach and authority and emphasized the importance of the cooperation of industry stakeholders to not only comply with regulations but also self-regulate. He discusses challenges in enforcing recalls on adulterated and misbranded products that have been dangerous to consumers such as Diamond Shruumz products which were recalled in June of 2024. Recalls are more difficult to enforce on these kind of products because they are typically sold outside of traditional food outlets such as gas stations, convenience stores, smoke shop, and online, says Jones. This creates a need for more effective enforcement strategies and authorities.

One way to help modernize FDA oversight of dietary supplements, says Jones, is through the establishment of a mandatory product listing (MPL). “This would help to draw a line between companies that are reputable and those that are not,” explains Jones. “It also serves as a mechanism to define dietary supplements themselves more clearly and provides the much needed transparency for consumers on the ingredients they're ingesting. A product listing will also help strengthen our oversight of imported finished products, where we've long faced challenges in knowing what exactly is contained in these products.”

The establishment of an MPL has been a long-debated topic. CRN, which has its own voluntary product listing for members called the Supplement OWL (Online Wellness Library) has been advocating for MPL, while other groups such as the Natural Products Association (NPA; Washington, D.C.) has been vocal in its opposition to such a provision. Legislation has been introduced to establish an MPL, but have thus far not made any progress.

During his “fireside chat” with CRN’s president and CEO Steve Mister, Jones emphasized the importance of trade organizations because it was “impossible” for FDA to interface every individual company. Therefore, have associations bring companies together to speak with one voice, helps to “facilitate decision-making.” This is in line with Jones’ emphasis on efficiency as it relates to the reorganization as well. With a background in economics, Jones posited that the discipline of economists it to look for ways to maximize net social good at the lowest cost. Jones who was previously an official at the Environmental Protection Agency, was also on the Reagan-Udall Foundation panel that published an evaluation of FDA’s HFP which made recommendations for the reorganization of FDA’s HFP.

In that capacity, says Jones, it was clear to the panel that the previous structure of the HFP was “designed to fail,” acknowledging not only the vast disparity in resources and personal between the drug and food sides of FDA, but also a poor structure that led to a lack of clarity on who can make certain decisions. The role of deputy commissioner of the HFP is meant to be the person with clear decision-making authority, to increase efficiency, effectiveness, decision-making, and reduce stove-piping, explains Jones.

With regard to concerns about the level of attention and resources that will be devoted to dietary supplements, Jones explained that under this new umbrella, Cara Welch, PhD, the director of ODSP, is now one level below the Deputy Commissioner in the reporting structure. Additionally, the new structure allows different teams to exploit synergies more efficiently because they are no longer in different departments.