FDA proposes new office combining ‘food chemical safety’ with ‘supplements’

An FDA proposal to create an office that incorporates food chemical safety and dietary supplement activities has drawn concern from industry trade associations whose members produce and sell supplements.

In announcing the creation of an “Office of Dietary Supplement Programs” in December 2015, the Food and Drug Administration predicted the action would improve “the effectiveness of dietary supplement regulation.”

In emails to Natural Products Insider, the heads of industry trade groups have expressed concerns that FDA’s new proposal will undermine the benefits of an independent dietary supplement office. Last week, FDA proposed the creation of an “Office of Food Chemical Safety, Dietary Supplements and Innovation” as part of its proposal for a unified human foods program.

“The Office of Food Chemical Safety, Dietary Supplements and Innovation will work to modernize and strengthen oversight of food chemical safety, advance dietary supplement safety, and enable the HFP [human foods program] to support and effectively regulate food ingredient innovation,” FDA stated in a proposed human foods program organization chart that it released on June 27.

FDA had no immediate details to share for this story when asked how the proposed office would impact its regulation of dietary supplement products.

“More information will be released in the coming months on the proposal, but we don’t have anything additional to add at this time,” an agency spokesperson said.

FDA in late 2015 announced elevating its dietary supplement division to an office. In a constituent update at the time, FDA said the move would “raise the profile of dietary supplements within the agency and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.”

Reaction to proposed FDA unified human foods program

FDA’s proposal for a unified human foods program—including the creation of an office combining food chemical safety, supplements and innovation—was unveiled after the agency requested an independent evaluation of its human foods program. The Reagan-Udall Foundation report excluded dietary supplements, an issue that trade associations asked about during a meeting in January with FDA officials to discuss the human foods program.

United Natural Products Alliance (UNPA) President Loren Israelsen described as “highly unusual” FDA excluding dietary supplements from its request to the Reagan-Udall Foundation for an evaluation of the human foods program. Dietary supplements are a special category of foods under U.S. law.

Israelsen, who was one of the trade association execs who met with FDA officials on Jan. 3 to discuss the human foods program, said FDA failed to provide a “satisfactory answer” when asked why supplements were excluded. In a Jan. 18 Natural Products Insider article that reported on the meeting, FDA declined to comment about the Reagan-Udall Foundation report excluding supplements.

“Our question remains open, and [we] invite the FDA to explain its reasoning to our industry,” Israelsen said.

“This leads to our second question, why are dietary supplements (foods by statutory definition) placed in the same office as food additives?” asked Israelsen, who was part of the negotiations leading to passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). “A primary objective in the passage of DSHEA was to—once and for all—stop FDA's use of the food additive provision to remove dietary supplements from the market. We now find ourselves in the same company as food additives. This is unsettling.”

Finally, he asked about the fate of ODSP under FDA’s proposal.

“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 RUF [Reagan-Udall Foundation] review and placing food additives and supplements in the same office are not welcome developments at this moment,” Israelsen concluded.

“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,” said Robert Marriott, director of regulatory affairs with the American Herbal Products Association (AHPA).

AHPA President Michael McGuffin described as “incomprehensible” FDA’s proposal (in a proposed human foods program organization chart) to place the Office of Food Chemical Safety, Dietary Supplements and Innovation within its “risk management functions.” It’s unclear what this means for FDA regulation of dietary supplement products in practical terms. Under the proposed organization chart, the “Nutrition Center of Excellence” and “Office of Microbiological Food Safety” also would fall under 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,” McGuffin declared.

Another trade association leader alarmed over FDA’s proposal is Council for Responsible Nutrition (CRN) President and CEO Steve Mister.

“We're very concerned about this proposed reorganization, primarily from the perspective of what a combined office—rather than one singularly tasked with supplements—says about the agency’s focus and prioritization of our issues,” Mister said. “The supplements sector has grown into an approximately $60 billion industry, with our members’ products on the kitchen counters of hundreds of millions of American families. In fact, in the last 12 months, we know that 75 percent of the U.S. population took a dietary supplement. People trust these products, and they should also be able to trust that the FDA is dedicating the appropriate level of attention and resources toward the effective and responsible regulation of them.”

Three of every four American consumers regularly take a dietary supplement, with the rate growing to four in five for older Americans, making it “essential that this growing consumer healthcare category receive appropriate attention, authority and resources within the FDA, its primary regulatory authority,” Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville said.

“Given the organizational announcement by FDA … CHPA has requested a meeting with FDA leaders to ensure the proposed structure would in no way dilute the prioritization of dietary supplements,” Melville added. “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.”

In a June 29 email sent to FDA Principal Deputy Commissioner Janet Woodcock, M.D., Natural Products Association (NPA) President and CEO Dan Fabricant, Ph.D., cited language in DSHEA distinguishing food additives from dietary supplements.

“FDA is directly ignoring the will of Congress on this,” said Fabricant in an interview, who planned to request a meeting with FDA to discuss its proposal and raise the issue with members of Congress as well.

“If anybody ever thought dietary supplements were a second-class citizen from FDA, now they’ve confirmed that,” added Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 until 2014 before it was elevated to an office in December 2015.