FDA’s $7.2 billion requested FY24 budget to the Biden administration includes several legislative proposals, including a request to modernize the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The agency proposed requiring that all dietary supplement products be listed with FDA. That listing information would include product labels and “other basic information."
FDA also proposed clarifying its “authorities over products marketed as dietary supplements.”
“These amendments would help FDA to know when new products are introduced and quickly identify dangerous or illegal products on the market to take appropriate action to protect consumers when necessary,” the agency added in a summary of its FY24 legislative proposals, unveiled Thursday.
FDA also proposed DSHEA modernization, including a listing requirement, during the previous administration of former President Donald Trump.
The legislative proposal to the Biden administration noted the U.S. dietary supplement market has grown from roughly 4,000 products to more than 95,000 products since enactment of DSHEA nearly 30 years ago.
“FDA is seeking to modernize DSHEA to provide for a transparent marketplace, help facilitate a risk-based regulation of dietary supplements and clarify FDA’s authorities relating to products marketed as ‘dietary supplements,’” the agency said.
In a recent blog, FDA Commissioner Robert Califf, M.D., explained his support for a dietary supplement product listing requirement.
“This enormous industry continues to grow, and it’s now part of everyday life for many families,” the commissioner wrote. “Dietary supplements should be required to list with the FDA and companies should be accountable for revealing what is in the supplement being sold.”
“In the long run, we will have more information about the benefits and risks of dietary supplements as our methods of evidence generation improve, and I hope for a regulatory regime that can encourage better information for consumers to be informed about their choices,” Califf added. “Although it will take some time to achieve the optimal regulatory framework, given the size and impact of the industry, we need to constantly update our internal approach and build awareness.”