Out in the cold? Supplement industry concerned over product regulation in proposed FDA reorganization

10 Jul 2023 --- The FDA’s planned reorganization would eliminate the Office of Dietary Supplement Programs (ODSP) – the separate entity which currently regulates supplements. However, the Council for Responsible Nutrition (CRN) is urging the administration not to follow through with its proposal. CRN notes the move downgrades attention to the sector and “sends an unhealthy message to industry and consumers.” 

In restructuring the Human Foods Program (HFP), the FDA proposes merging the ODSP with other functions into a new Office of Food Chemical Safety, Dietary Supplements and Innovation. 

“I think what the dietary supplement industry is most concerned about is the fact that the office of dietary supplement programs is slated to go away under the reorganization,” says CRN president and CEO Steve Mister. 

“It will inevitably mean even fewer resources going to our issues, less attention going to enforcement around dietary supplements, and that’s not good for the industry.” 

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 to support and effectively regulate food ingredient innovation,” according to the FDA. 

The combined office is included in Risk Management Functions to manage public health risks. 

Supplements are used by over three-quarters of Americans and represent a US$60 billion industry.Less focus on dietary supplements 
Mister highlights that dietary supplements are used by over three-quarters of US consumers and represent a “US$60 billion industry”. He notes that consumers deserve an overseeing agency that acknowledges supplements’ health benefits and devotes adequate resources to regulate the market. 

“The FDA has never given dietary supplements the attention they deserve, and under this reorganization, we’re going to get even less focus. We’re going to compete even harder to get the scarce resources of the agency.” 

“As an industry, we’re larger than the over-the-counter (OTC) medicine industry,” Mister continues. “OTCs have their own office within the Center for Drug Evaluation and Research. It just makes sense that a product that is this ubiquitous that is relied on by so many Americans should have its own office status within the food program.” 

He explains that CRN has worked to increase funding for dietary supplements, adding that the industry was primarily responsible for getting dietary supplements elevated to a full office under the existing structure.

Robert Marriott, director of Regulatory Affairs at the American Herbal Products Association (AHPA), adds: “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 concern is FDA’s incomprehensible proposal to place dietary supplement programs in its ‘Risk Management Functions,’” adds 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.”

Separate entity 
In 2016, CRN strongly supported the elevation of the former Division of Dietary Supplements into an Office, a designation that brought more priority to FDA’s oversight. 

According to CRN, establishing the ODSP brought more priority to FDA’s oversight. Since then, the industry has lobbied Congress to more than double the annual funding to the office to ensure increasing attention and enforcement. 

CRN is concerned that the proposed reorganization jeopardizes advances reinforcing consumer trust in these products. 

CRN is concerned that the proposed reorganization jeopardizes advances reinforcing consumer trust in these products. 

Although consumer confidence in supplements has increased vastly, CRN notes that persisting issues in labeling, misleading claims, quality and counterfeit products demand FDS oversight and enforcement. 

Improving oversight 
Mister recognizes that the FDA was under pressure to improve the oversight of food, both the organization’s efficiency and effectiveness. “I think the FDA may be doing this because they think they’re being more effective on the food side, but it doesn’t help supplements.” 

“If you think back to the infant formula problems from about a year ago, that was a large impetus for this. Why they are doing the particular reorganization troubles me because of this downgrading of attention to dietary supplements.” 

“Last fall, FDA asked the Reagan-Udall Foundation to evaluate 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,” notes Mister. 

He adds that, as a result, the review’s recommendations did not mention dietary supplements. 

Call to action 
Mister emphasizes that CRN is reaching out to members of Congress to try to change the FDA’s mind about the proposed reorganization. 

“I think [CRN] members also have a role to play in this,” he continues. Companies should identify their members of Congress and let them know that supplement companies in their districts are responsible for jobs and contributions to the tax base. 

CRN advocates changing the FDA’s mind about the proposed reorganization.He urges CRN members “to write to their member of Congress and ask Congress to look into this reorganization and let the FDA know that they have downgraded supplements and that’s not a good thing.” 

Proposed reorganization 
The FDA explains the proposed changes are based on recommendations of a working group of agency officials with expertise in different functional and operational areas and the external evaluation of the Reagan-Udall Foundation. 

“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 (HFP) and Office of Regulatory Affairs (ORA),” says FDA commissioner Robert Califf.

The proposed changes in the food program aim to address these challenges and strive to unify the FDA’s fieldwork with the priorities of program offices and centers to make strategic use of resources. 

Other changes the agency proposed include establishing ORA’s core mission as conducting investigations, inspections and imports for all FDA-regulated products. It further proposes realigning the eight human and animal food laboratories managed by ORA into the HFP. 

Additionally, it plans to merge compliance functions currently managed within ORA into the HFP and product centers’ compliance functions to streamline operations and decision-making. 

“I believe these proposed changes will result in a new structure that is more nimble, better equipped to prevent and respond to emergencies like recalls and enhance the agency’s ability to align inspection resources with our center and program priorities while also supporting our employees and the public we serve,” adds Califf. 

By Jolanda van Hal