FDA’s Jones reiterated support for dietary supplement listing requirement

The human foods chief for the U.S. Food and Drug Administration on Tuesday reiterated FDA’s commitment to working with U.S. lawmakers on authority to require manufacturers of dietary supplements to list their products with the agency.

“FDA authorities and resources have not kept up with this quickly expanding marketplace,” Jim Jones said in testimony on Sept. 10 before the Health Subcommittee of the House Energy and Commerce Committee. “There are virtually no barriers to entry to the dietary supplement market. Bad actors have continued to exploit the halo created by the quality work of legitimate manufacturers by continuing to distribute and sell dangerous products that put customers at risk.”

He noted the dietary supplement market is more than 10 times bigger than when Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), and according to estimates, three out of four Americans use supplements daily.

FDA for a number of years has supported a change in the law to require a listing of dietary supplement products with FDA. In July, Sen. Dick Durbin (D-Ill.) reintroduced such a bill.

Under the Dietary Supplement Listing Act of 2024, companies would be required to provide FDA with product names, a list of all ingredients and an electronic copy of the label, Durbin's office said. Among other things, additional mandated disclosures to FDA would include allergen statements and the health and structure/function claims being made.

During the recent congressional hearing focused on FDA human foods and tobacco programs, Jones discussed the purported benefits of a dietary supplement listing requirement.

“FDA is confident that an improved framework to regulate dietary supplements would bring significant benefit to public health by promoting consumer safety, allowing FDA to quickly identify dangerous or illegal products on the market to take appropriate action, and increasing regulatory transparency,” said Jones, FDA Deputy Commissioner for Human Foods.

One of the industry’s trade groups in Washington, D.C., the Natural Products Association (NPA), which has vociferously opposed FDA’s proposal for mandatory product listing, expressed disappointment with Jones’ remarks.

“NPA held out hope for new ideas, so it’s disappointing to see new leadership hold the same antiquated views on the dietary supplement industry,” Daniel Fabricant, Ph.D., president and CEO of NPA, said in a statement. “The notion that the industry's size somehow impedes the agency from doing its job is irresponsible.”

Fabricant added, in part, “The [FDA] Commissioner is intimately familiar with the regulatory scrutiny dietary supplement manufacturers face, and to characterize the market as having ‘no barriers to entry’ is a slap in the face to our members who invest significant resources into bringing safe, effective and well-researched dietary supplements to market.”

The congressional hearing will not be the last time this year that the dietary supplement industry hears from Jones. He is scheduled to give an opening keynote on Oct. 10 during a conference in Utah hosted by another trade group based in the nation’s capital, the Council for Responsible Nutrition (CRN).

Jones is expected to share perspectives on how dietary supplement oversight fits into FDA's reorganization, as well as enforcement priorities, and legislative updates to DSHEA supported by FDA.

FDA is planning to implement a reorganization on Oct. 1, which includes the creation of a unified human foods program and restructuring of its field operations within the Office of Regulatory Affairs. In a column published last year by SupplySide Supplement Journal (then known as Natural Products Insider), Jones and another FDA official maintained implementation of the unified human foods program will strengthen the oversight of dietary supplements and the effectiveness of the Office of Dietary Supplement Programs.