Silver Spring, MD—The U.S. Food and Drug Administration (FDA) recently provided an update on its proposal to create a unified Human Foods Program (HFP). This reorganization includes a new model for the Office of Regulatory Affairs (ORA). FDA said the move, which comes in addition to an FDA proposal earlier this year, will "further enhance coordination, prevention and response activities across the FDA, enabling the agency to better support its public health mission."  

The announcement follows a December 2022 report that was issued by the Reagan-Udall Foundation after a review of FDA's HFP.  At FDA's request, an independent expert panel evaluated structure/leadership, authorities, resources, and culture, and provided recommendations "that would equip FDA to carry out its regulatory responsibilities, strengthen its relationships with state and local governments, and secure the nation’s food supply for the future."

FDA also noted that a working group of agency officials with expertise in different functional and operational areas identified "additional opportunities to bolster operations within the new HFP and ORA."

“With a human food landscape that is rapidly evolving as consumer preferences, products, and manufacturing processes grow increasingly complex and public health needs increase, the FDA must build a stronger Human Foods Program and Office of Regulatory Affairs," said FDA Commissioner Robert M. Califf, M.D., in the announcement. "Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges. Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened. We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers. This is why I’m proposing a number of additional changes to ORA, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP and other agency product Centers. These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission.” 

Impact on dietary supplements

The FDA proposal outlined several changes. Among them: Relocating the functions of the current Office of Dietary Supplement Programs (ODSP) within a new Office of Food Chemical Safety, Dietary Supplements, and Innovation. Industry leaders explained the impact this could have.

“Last fall, FDA asked the Reagan-Udall Foundation to conduct an evaluation of FDA’s Foods program, but, unfortunately, they intentionally left out a review of the dietary supplement piece of CFSAN, despite the fact that supplements are regulated as food,” said Council for Responsible Nutrition President and CEO Steve Mister, in a statement. “So, when the recommendations came back, there was no mention of dietary supplements. 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.” 

Why is FDA pulling back on its responsibility to effectively regulate dietary supplements?

Why make this more to reorganize when the market for dietary supplements has grown into a nearly $60 billion industry, and at a time when supplement use is higher than ever before? Those are the questions CRN posed. “Seventy-five percent of Americans use a dietary supplement," Mister said. "They deserve to have an agency overseeing this market that acknowledges their health benefits and devotes adequate resources to effectively regulate the market.” 

In a blog post, the American Herbal Products Association (AHPA) weighed in on the proposed change, and its impact on the natural products industry. “FDA created the Office of Dietary Supplement Programs in 2015, elevating the program from its former status as a division under a parent office,” explained Robert Marriott, AHPA Director of Regulatory Affairs. “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.”
 
AHPA President Michael McGuffin added, “Of additional significant concern is FDA's incomprehensible proposal to place dietary supplement programs in its ‘Risk Management Functions. Any review of adverse event reporting data and food recalls would demonstrate the remarkable safety record of dietary supplements over the last 30 years.”

Combining dietary supplements with food additives also raises concerns for industry members, both in terms of what it might mean for funding and what it signals about how FDA views dietary supplements.

Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville released a statement on the potential organizational changes affecting the Office of Dietary Supplement Programs: “With three out of every four American consumers taking a dietary supplement on a regular basis, a rate which rises to four in five for older Americans, it’s essential that this growing consumer healthcare category receive appropriate attention, authority, and resources within the FDA, its primary regulatory authority."

Industry groups call for action, advocacy

FDA Commissioner Califf said the agency “will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations.” Natural products industry groups aim to be a central part of that conversation as well.

“Be assured that CRN is working here in Washington to try to change FDA's mind about the reorganization and we've already reached out to members of Congress,” said Mister. The trade association is encouraging its members to contact their members of Congress with a message that supplement company operations in their districts are responsible for jobs and for the contribution to the tax base, and that this proposed reorganization means a downgrade in the prioritization of supplements by the agency.

Melville noted that CHPA has requested a meeting with FDA leaders. The goal: to ensure the proposed structure "would in no way dilute the prioritization of dietary supplements." CHPA is calling on FDA to provide the scope of each of the newly proposed offices, so industry can gain a better understanding of the proposed changes and the effects this will have on dietary supplement regulation.

Ensuring that FDA is is responsive and accountable to the natural products industry is a central focus for the Natural Products Association (NPA), which made this a key focus of its recent advocacy Fly-In Day in Washington, DC. As NPA stresses: “Your voice is essential for educating our legislators on the importance of access to natural products for the nation’s health and well-being.”

Note that advocacy is needed on several fronts. NPA has an Action Center page dedicated to current pressing needs to help industry member raise their concerns. Organic & Natural Health Association also recently issued a call to action. The goal is to enhance the nutritional support provided through the farm bill's Supplemental Nutrition Assistance Program (SNAP).