The U.S. Food and Drug Administration has appointed James “Jim” Jones as the first Deputy Commissioner for Human Foods. Jones will be in charge of setting and advancing priorities for a proposed unified Human Foods Program (HFP).
The U.S. Food and Drug Administration has appointed James “Jim” Jones as the first Deputy Commissioner for Human Foods. Jones will be in charge of setting and advancing priorities for a proposed unified Human Foods Program (HFP). FDA Commissioner Robert M. Califf, MD, MACC announced the proposed redesign of the HFP in January of 2023, in addition to changes to the Office of Regulatory Affairs (ORA). The decision was based on an external evaluation by an expert panel of the Reagan-Udall Foundation.
“The findings and recommendations from these reviews identified issues surrounding culture, structure, resources, and authorities,” explained Califf in a press release. “They also noted several areas of need, including modernizing data systems, providing more resources and authorities, improving emergency response systems, and building a more robust regulatory program.”
As part of this plan, the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and certain functions of ORA will be unified into an organization called the Human Foods Program. An update in July provided an organizational structure for the newly envisioned organization, revealing that dietary supplements would now be under the purview of the Office of Food Chemical Safety, Dietary Supplements & Innovation (OFCSDSI). Under the current framework, ODSP reports to the Center for Food Safety and Applied Nutrition (CFSAN).
When this update was made, industry advocates such as The Council for Responsible Nutrition (CRN; Washington, D.C.) and the American Herbal Products Association (AHPA; Silver Spring, MD) raised concerns about the reorganization, considering it a “downgrade.” “It appears now FDA has just inserted supplement oversight into another Office. For our industry, this means that the attention and priorities given to dietary supplements, even as little as it was before, will be even less in this new structure,” stated CRN’s president and CEO, Steve Mister, in a press release published after FDA’s update.
“FDA created the Office of Dietary Supplement Programs in 2015, elevating the program from its former status as a division under a parent office,” said Robert Marriott, AHPA’s director of Regulatory Affairs in a press release from the association. “Removing ODSP’s separate status and combining it with these other functions would unwind a structure that has ensured dedicated funding and attention to programs for the growing market for these health-promoting products.”
“Of additional significant concern is FDA’s incomprehensible proposal to place dietary supplement programs in its ‘Risk Management Functions,’” added Michael McGuffin, AHPA’s president. “Any review of adverse event reporting data and food recalls would demonstrate the remarkable safety record of dietary supplements over the last 30 years.”
Califf attempted to assuage concerns from industry in a segment of Catching up with Califf called “FDA’s Dietary Supplements Program Remains a Critical Priority.” In the piece, Califf writes that, “This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency. The reporting of ODSP to the OFCSDSI director is similar to its current reporting to an individual managing several Offices; however, the current individual reports to the CFSAN Center Director while the OFCSDSI director is proposed to report to a Deputy Commissioner.”
“There are currently no plans to reduce ODSP’s resources or capabilities, and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act,” added Califf. “The vision for the new OFCSDSI is to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements. ODSP will remain a distinct office executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act for dietary supplement products.”
Following the announcement appointing Jones as the Deputy Commissioner for Human Foods, trepidation remains, but industry is hopeful he will hear its concerns. “Today’s announcement reflects the FDA’s urgency to improve its oversight of food and strengthen consumer confidence in the safety of these products. We are hopeful Mr. Jones shares our interests in robust agency attention to dietary supplements as well,” said Mister in a release. “We congratulate Deputy Commissioner Jones, and look forward to discussing the many challenges that face our industry, which includes the agency’s prioritization of our needs. We are eager to share with him our concerns and the diverse needs of our membership, and to help him better understand the important space we occupy in the large category of products he now oversees.”
Jones has help various positions in the U.S. Environmental Protection Agency (EPA) over the last 30 years with a focus on lessening the impact chemicals and pollution have on the U.S. food supply. Most notably, he was an integral member the Reagan-Udall Foundation independent expert panel that suggested the reorganization he will now lead. Jones will report directly to Commissioner Califf.
The Natural Products Association's (NPA; Washington, D.C.) president and CEO, Daniel Fabricant, PhD, expressed skepticism of Jone's work experience, and how this would translate to regulating foods. “At a time where FDA foods program has a clear accountability-gap with Congress, industry, and Americans as demonstrated by the Reagan-Udall Report, which Mr. Jones was a panelist, how will a lack of technical understanding for the industries FDA regulates fill that gap," said Fabricant in a press release. "FDA needs to lay out constructive plans to address these deficiencies sooner rather than later. While the reorganization is a significant undertaking it is not going to have a positive outcome if the new commissioner for foods doesn’t engage immediately with groups like the Natural Products Association to understand the history and specific concerns."
Fabricant also questioned the logic of proposed structure. "The commodity is used by 70 percent of the country. How does that not yield a direct line to the the commissioner of foods?" he said to Nutritional Outlook. "We understand the process and proposed super office concept and the red tape it’s designed to work around. Still, when supplements have been treated as food additives [prior to DSHEA] that hasn’t gone well for us. So, without clarity in writing on how those past misgivings won’t rear their head again, seeing a benefit isn’t possible at this juncture."
Updated on 8/24/23 at 1:38PM