“While we understand the Agency's interest and need to modernize and streamline its food programs, we are deeply concerned that FDA's decision to exclude dietary supplements from the Reagan-Udall Foundation review and placing food additives and supplements in the same office are not welcome developments at this moment,” said Loren Israelsen, president at the United Natural Products Alliance (UNPA).
The proposal for reorganization responds to a report on the operational evaluation of FDA’s Human Foods Program issued last December by the Reagan-Udall Foundation – an independent organization created by Congress in 2007 “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”
For UNPA, one of the first and yet unanswered questions is why FDA specifically asked the reviewers to exclude dietary supplements from the process, calling the request “highly unusual” and a “missed or excluded opportunity”.
The update raised several additional questions that have generated a unanimous response among the dietary supplement industry’s trade associations, which view the proposal as potentially diluting the prioritization of dietary supplements that the industry has worked so hard to achieve.
What becomes of the ODSP?
The update – issued on June 27 – would relocate ODSP function within a new Office of Food Chemical Safety, Dietary Supplements, and Innovation. As Robert Marriott, director of regulatory affairs at the American Herbal Association (AHPA) pointed out, FDA created ODSP in 2015, elevating the program from its former status as a division under a parent office.
“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,” he said.
Scott Melville, president and CEO at the Consumer Healthcare Products Association (CHPA), said that given that three in four American consumers take dietary supplements, “it’s essential that the ever-growing category receive appropriate attention, authority, and resources within the FDA.”
For Natural Products Association (NPA) President and CEO Dan Fabricant, Ph.D. – who ran the Division of Dietary Supplement Programs at FDA before it became its own office – the industry should not minimize the significance of the announcement, particularly as it relates to budgetary allocations.
“At FDA, budget wise, the lowest level of the budget is the office level, so if you put one office under another, then that budget line disappears,” he said. “That’s one big concern. We would not know how those funds are being directed – whether to dietary food supplements or to food additives.”
Why grouped with food additives?
One of the other big questions that emerged is why dietary supplements (foods by statutory definition) would be placed within the same office as food additives.
“We’re very concerned about this reorganization of FDA that would take dietary supplements and combine our office with another office on food chemical safety,” said Steve Mister, president of the Council for Responsible Nutrition (CRN). “That is not a good sign for how FDA looks at dietary supplements and the future of regulation of supplements.”
Israelsen called the regrouping “unsettling”, particularly since one of the primary objectives in the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994 “was to – once and for all – stop FDA's use of the food additive provision to remove dietary supplements from the market.”
Dr. Fabricant shared a June 29 email addressed to FDA Principal Deputy Commissioner Janet Woodcock, MD, in which he referred to the combining of dietary supplements and food additives as “alarming” and stated that the funding for each should not be comingled.
Why risk management functions?
In the new organization chart accompanying the update, the Office of Food Chemical Safety, Dietary Supplements, and Innovation would sit alongside the Nutrition Center of Excellence and the Office of Microbiological Food Safety – all overseen by the Deputy Commissioner for Human Foods. Together, they make up the three areas of focus of what the FDA calls Risk Management Functions to mitigate public health risks.
“Of additional significant concern is FDA’s incomprehensible proposal to place dietary supplement programs in its ‘Risk Management Functions,’” said AHPA President Michael McGuffin. “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 industry continues to maintain that FDA already has the tools available to ensure compliance in a playing field largely made up of good actors instead of continuing to create new mechanisms accompanied by uncertainty, or as Dr. Fabricant put it “trying to impugn an entire industry as a bunch of scofflaws”.
All stakeholders called for clarification from the FDA to better understand the proposed structural changes and how they will affect dietary supplement regulation.