On August 14, 2023, FDA Commissioner Robert M. Califf provided further details on FDA’s dietary supplement program under its proposed human foods program redesign. The Commissioner’s statement covered three key areas: the new Office of Food Chemical Safety, Dietary Supplements, and Innovation, the agency’s risk-management framework, and the development of new surveillance methods and tools to strengthen dietary supplement oversight.
FDA’s Proposed Redesign of the Human Foods Program
Commissioner Califf announced the proposed redesign of FDA’s human foods program on January 31, 2023, stating that the proposal was based on the findings and recommendations of a Reagan-Udall Foundation expert panel charged with evaluating the agency’s existing human foods program. We provided an overview of the proposed redesign in a February 1, 2023 client alert.
FDA’s June 27, 2023 Proposed Human Foods Program Organization Chart showed that a new “Office of Food Chemical Safety, Dietary Supplements, and Innovation” will regulate dietary supplements under the proposed redesign. Stakeholders voiced concerns that under this redesign, dietary supplements would not be given the appropriate level of attention and priority. Commissioner Califf’s recent statement provides further information regarding regulation of dietary supplements under the proposed redesign.
Commissioner Califf’s Dietary Supplements Program Update
New Office of Chemical Safety, Dietary Supplements, and Innovation. Commissioner Califf’s statement confirms that the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). The OFCSDSI director will in turn report to the Deputy Commissioner for Human Foods, whereas currently, the Director of ODSP reports to the CFSAN Director. Commissioner Califf states that dietary supplements remain a “critical priority” for the agency, that the agency currently has “no plans to reduce ODSP’s resources or capabilities,” and that ODSP will “remain a distinct office” with leading responsibility for executing FDA’s responsibilities relating to dietary supplements.
Risk-Management Framework. Commissioner Califf explains that FDA’s “vision” for the new OFCSDSI is to “modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements.” FDA also believes a unified Human Foods Program will help streamline operations and facilitate a stronger and more effective risk-management framework, and that aligning the agency’s surveillance and safety assessments through the same risk management framework will create efficiencies and ensure focus on the “greatest risks to the public.”
New Surveillance Methods and Tools. Commissioner Califf explained that development of new surveillance methods and tools, as well as having access to “all available data” about dietary supplements, will improve FDA’s oversight in this area. The Commissioner’s statement concludes that the proposed redesign will “fully integrate the dietary supplement program” into the human foods program, which will strengthen dietary supplement enforcement and oversight.
The Commissioner intends to provide further information on how the dietary supplement program will be positioned within FDA’s human foods program later in the year.
If you have any questions concerning the material discussed in this client alert, please contact members of our Food, Beverage, and Dietary Supplements practice.
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