AHPA expresses concerns regarding proposed reorganization of FDA

• By: AHPA
• On: 07/05/2023 03:45:25
• In: Regulation / Legislation

July 5, 2023

In its updated proposal to reorganize the agency's human foods program – which includes the creation of a new Deputy Commissioner of Human Foods position – the U.S. Food and Drug Administration (FDA) suggests relocating the functions of the current Office of Dietary Supplement Programs (ODSP) within a new Office of Food Chemical Safety, Dietary Supplements, and Innovation.
 
“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.”

FDA's proposed reorganization comes in response to a report issued last December by the Reagan-Udall Foundation following a review of the agency's Human Foods Programs. One specific recommendation from that report was that the inspection and compliance activities of the Office of Regulatory Affairs (ORA) should be reorganized to ensure that fieldwork aligns with food program policies. Apparently heeding that and related recommendations, FDA's proposal also introduces a “new model” for ORA.