The U.S. Food and Drug Administration (FDA) continues to work through the redesign of its organizational structure into one unified Human Foods Program (HFP) and recently highlighted its dietary supplements program as a critical priority.
In an update from FDA Commissioner Robert Califf, he outlined how the dietary supplements program would fit into the new proposed HFP structure, as well as previewed steps the agency was taking to improve food safety and bolster agency oversight.
The proposed new structure would see the creation of a new Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). Instead of operating as a separate entity, the Office of Dietary Supplement Programs (ODSP) would report to the OFCSDSI while still remaining “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.” With the new OFCSDSI, the FDA seeks to “modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements.”
The unified HFP will also facilitate a more effective risk management framework across the foods program and allow for resource sharing across offices, according to Commissioner Califf. The FDA is also looking to develop and adopt new surveillance methods and tools to enhance its oversight capabilities, providing for earlier and more accurate identification of potential public health threats.
As we noted in the most recent edition of the Sedgwick brand protection Recall Index report, dietary supplements have been gaining the attention of regulators for the past several quarters. There were 16 recalls for dietary supplements in Q2 2023, which is an increase from the 11 recalls in Q1 2023 and the eight recalls in Q4 2022.
While this increase in recalls may reflect recent regulatory activity, it may also result from growth in the dietary supplements market. A study from the Centers for Disease Control and Prevention (CDC) found that more than half of American adults took at least one dietary supplement each day. But this study only includes data from 2017 to 2020, and experts say it’s likely that supplement use is even higher now.
While it remains to be seen whether unifying the ODSP under the HFP will result in better regulatory outcomes for dietary supplements, the benefits that arise from increased resource and information sharing will likely have an impact on supplement quality and consumer safety. At Sedgwick, we’ll continue to watch the recall data to see how the FDA’s HFP reorganization impacts oversight of dietary supplements. As the FDA moves forward with its restructuring, manufacturers and retailers should pay close attention to updates from the agency and should consider how their operations may be impacted by a new regulatory framework.
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