The FDA is once again advocating for reform of DSHEA via a budget proposal released to Congress recently. As part of the FY23 proposal, FDA outlined a proposal to amend the Dietary Supplement Health and Education Act (DSHEA) of 1994 via a requirement that supplement products be listed annually with the agency. This would include basic product information about each unique supplement product. FDA is also seeking to clarify its authority over products marketed as dietary supplements to facilitate enforcement over unlawfully marked products. Industry stakeholders are divided on the advantages and disadvantages of mandatory product listing. The budget proposal makes it clear that FDA Commissioner Dr. Robert Califf views stronger oversight as a key part of FDA’s mission to advance the health of Americans.

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Posted on 11 April 2022