FDA’s food czar laments ‘virtually no barriers to entry to the dietary supplement market’

12-Sep-2024 - Last updated on 13-Sep-2024 at 13:49 GMT

FDA Deputy Commissioner Jim Jones restated the Agency’s commitment to a Mandatory Product Listing for dietary supplements as a way to counter a perceived lack of barriers to entry. The Natural Products Association called the statements a “slap in the face to our members.”

Speaking to the Subcommittee on Health, part of the Committee of Energy and Commerce in the U.S. House of Representatives, Jones stated that, “FDA authorities and resources have not kept up with this quickly expanding marketplace” and referenced the meteoric growth of the industry since the enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994.

“There are virtually no barriers to entry to the dietary supplement market,” he added. “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.”

One approach championed by the FDA for several years has been a mandatory product listing, a proposal that has divided the dietary supplement industry.

In his testimony, Jones, who is deputy director of FDA’s newly formed Human Foods Program, referenced the FDA’s FY25 legislative proposals, which laid out the Agency’s desire for the listing. The proposals also called for Congress to, “clarify FDA’s authorities over products marketed as dietary supplements.”

“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,” Jones said during his testimony.

NPA: 'A slap in the face to our members'

Responding to Jones’ testimony, the Natural Products Association called the comment about “virtually no barriers to entry” a mischaracterization of the dietary supplement market.

“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,” said Daniel Fabricant, PhD, president and CEO of the NPA. “The notion that the industry's size somehow impedes the agency from doing its job is irresponsible.”

“The 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,” he added.

“The agency can get labels now via inspection authorities and should know everyone who is out there already per the FSMA facility registration requirements. More concerning is that the agency seems more than happy to let the states run amok on developing new laws on the industry that are in contravention of the federal requirements. The agency remains silent; the ideal for them would be new authorities but no responsibility.

“Mr. Jones also seems unaware of the significant burdens that manufacturers and brands of supplements have to meet to enter the industry and be compliant with not just the FFDCA but with the FTC and other state and federal authorities. The adverse event reporting requirements are the same for supplements and OTC medicines, yet I have never heard the drug program at the FDA bash the OTC industry for having ‘virtually no barriers to entry.’ It's unfortunate but not surprising.

“For the supplement program to be more successful than it is currently regarded, better priorities would be to work with the industry and all stakeholders on state preemption, drug preclusion interpretation, and targeted cGMP inspection.”