On June 27, the U.S. Food and Drug Administration (FDA) released an update on its proposal to create a unified Human Foods Program (HFP), including potential organizational changes affecting the Office of Dietary Supplement Programs.

FDA Commissioner Robert M. Califf stated, “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 (ORA). Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges.”

Califf continued, “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.”

The Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville released a statement in response the update, noting that, “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 health care category receive appropriate attention, authority and resources within the FDA, its primary regulatory authority.

“Given the organizational announcement by FDA this week, CHPA has requested a meeting with FDA leaders to ensure the proposed structure would in no way dilute the prioritization of dietary supplements. We look forward to receiving additional insights from FDA, including the scope of each of the newly proposed offices, to gain a better understanding of the proposed changes and their effects on dietary supplement regulation.”

The American Herbal Products Association (AHPA) expressed concern about the changes.“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 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.”

“Of additional significant concern is FDA's incomprehensible proposal to place dietary supplement programs in its ‘Risk Management Functions,'” added Michael McGuffin, AHPA 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.”

The Council for Responsible Nutrition (CRN) also made its concerns known.“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 CRN President and CEO, Steve Mister. “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.”

Mister continued, “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,” added Mister. CRN Members are encouraged to identify their members of Congress and let them know that supplement company operations in their districts are responsible for jobs and for the contribution to the tax base, and that FDA’s proposed reorganization means a downgrade in the prioritization of supplements by the agency."

For more information, visit www.fda.gov, www.chpa.org, www.ahpa.org and www.crnusa.org.