FDA reorg plan sent on to HHS for formal review

The FDA reorganization plan has been forwarded to the U.S. Department for Health and Human Services (HHS) for a formal review, FDA announced today. 

The proposed reorganization will create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. Under the new model, responsibility for the dietary supplement sector would be housed within a newly created office of Food Chemical Safety, Dietary Supplements and Innovation.

FDA: Plan will help fulfill FSMA vision 

FDA asserted if the reorganization is approved in its present form, it will: 

“Moving our proposal forward is an exciting milestone in our ongoing modernization initiative,” said FDA Commissioner Robert M. Califf, M.D. “This is a unique moment in the history of the FDA. We began this journey knowing we had a real opportunity in front of us to make meaningful and lasting change. By working to build a unified Human Foods Program and a more resilient model for our field operations, we also found ways to improve the way we work together as a whole—inside and outside the agency—to better meet our public health mission.”  

Related:FDA's Jim Jones engages with dietary supplement leaders on proposed reorg

In a press release announcing the move, FDA said it is hopeful the review and full implementation of the reorganization will be completed within 2024. 

The reorganization plan review process will incorporate input from an evaluation conducted for FDA by the Reagan-Udall Foundation, a nonprofit public policy group. Among the new authorities the group recommended are premarket label approval authority, expanding the criteria for the suspension of food facility licenses, and strengthening FDA’s ability to oversee medical foods. 

In addition to the HHS review, FDA’s reorganization plan must go through a review by the White House’s Office of Management and Budget, as well as a 30-day notification period to Congress, the issuance of a Federal Register notice and negotiations with labor unions, whose members will be affected by the reorganization. 

Jones: Supplement focus won’t be diluted 

At the end of November, James Jones, FDA’s first deputy commissioner for human foods, met virtually with representatives from the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), Natural Products Association (NPA) and United Natural Products Alliance (UNPA). 

Related:FDA gives update on dietary supplement office status in new Human Foods Program

Jones reportedly reassured the participants in the meeting that the reorganization will not diminish the importance of dietary supplements within the overall agency priorities. Industry stakeholders had raised concerns that a reorganization could adversely affect resources devoted to supplements at FDA. 

“In sum, our proposed structure of a larger Office of Food Chemical Safety, Dietary Supplements and Innovation will ensure that our responsiveness to dietary supplement issues and inquiries will not be diminished,” FDA officials wrote in a recent column published by Natural Products Insider. “To the contrary, we will continue to prioritize additional resources and modernized authorities to strengthen our oversight of the dietary supplement marketplace.”