The U.S. Food and Drug Administration (FDA) recently held a stakeholder relations call on June 28 to provide updates to a proposal it introduced back in February which would restructure its Human Foods Program and Office of Regulatory Affairs. The Council for Responsible Nutrition (CRN) issued a statement that the dietary supplements industry should be concerned.
 
The key sticking point is that the proposed restructuring would eliminate the Office of Dietary Supplement Programs, and would exclude dietary supplements from the purview of the Human Food Program. Instead, dietary supplements would be regulated under a new office, the Office of Food Chemical Safety, Dietary Supplements, and Innovation. More details about the proposed restructuring can be found in an organizational chart FDA released shortly after the stakeholder call.
 
While it’s not immediately clear how the creation of this office would impact the agency’s ability to regulate dietary supplements or the amount of resources it gets for doing so, Steve Mister, president and CEO of CRN, stated concerns that the move is downgrading supplement industry enforcement.
 
“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 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 noted that the lack of an office fully dedicated to dietary supplements alone comes at a time when the industry has grown to nearly $60 billion. “Seventy-five percent of Americans use a dietary supplement. They deserve to have an agency overseeing this market that acknowledges their health benefits and devotes adequate resources to effectively regulate the market.”
 
At the same time that the industry has grown, CRN also highlighted industry-wide concerns about insufficient enforcement in the domains of labeling, misleading claims, manufacturing quality, and counterfeit products.
 
CRN was an advocate for the agency to elevate the Division of Dietary Supplements into an Office, which took place in 2015. Since the designation, the industry has lobbied Congress to more than double annual funding to the Office to support increased enforcement. The proposed reorganization, CRN argues, jeopardizes these recent advances, and can hurt consumer trust in the category of products.
 
“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,” said 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.” 
 
Mister also posted a video update expanding on the topic, which can be viewed here.