By: Robert M. Califf, M.D., Commissioner of Food and Drugs

As we announced at the start of the year, the FDA is embarking on an ambitious plan to transform our current organizational structure in the various foods programs into a unified Human Foods Program (HFP). These changes will improve how we protect the nation’s food supply, improve access to safe and nutritious foods and enhance our understanding of chemical safety and nutrition. I’d like to catch up with you to share more details about our dietary supplements program under the proposed reorganization.

Office of Food Chemical Safety, Dietary Supplements, and Innovation

Under the new proposed HFP structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency. The reporting of ODSP to the OFCSDSI director is similar to its current reporting to an individual managing several Offices; however, the current individual reports to the CFSAN Center Director while the OFCSDSI director is proposed to report to a Deputy Commissioner.

There are currently no plans to reduce ODSP’s resources or capabilities, and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act. The 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. ODSP will remain a distinct office executing the agency’s responsibilities under the Federal Food, Drug, and Cosmetic Act for dietary supplement products.

More Robust, Effective Risk-Management Framework Across the Foods Portfolio

The FDA is focused on establishing clear priorities for our programs, communicating how we are protecting public health and clarifying where we’re using our resources. A unified HFP will facilitate a stronger and effective risk-management framework across the entire foods portfolio and ensure resources are shared and coordinated across the HFP and the FDA’s Office of Regulatory Affairs. This strategic move will expedite decision-making all under one roof and help to streamline operations.

Aligning our surveillance efforts and safety assessments through the same risk management framework will advance the efficiencies of our existing programs and ensure our efforts are focused on the greatest risks to the public. The ODSP will be charged with ensuring that risks related to dietary supplements are elevated and managed using the appropriate oversight tools.

New Surveillance Methods and Tools to Enhance Reviews, Identify Threats

Developing new surveillance methods and tools will enhance our ability to make science-based decisions and initiate risk reviews, providing opportunities for the early and accurate identification of potential public health threats. It is critical that we have access to all available data about dietary supplements and the resources and tools to assess and integrate these data to sustain this high-priority program area. Leveraging modern computational, analytical, toxicology and research methods and tools across the HFP will further improve our oversight of dietary supplements.

Our proposal will fully integrate the dietary supplement program into the broader HFP, thus strengthening our enforcement and oversight of dietary supplements. I look forward to sharing more information on how the FDA’s dietary supplement program is positioned within the HFP later this year, as more details are finalized.

Catch up with you next time.