17 Sep 2024 — The US Natural Products Association (NPA) criticizes the mischaracterization of the dietary supplement market in the testimony Jim Jones, the FDA’s deputy commissioner, recently gave to the House Subcommittee on Health. He stated there are “virtually no barriers to entry to the dietary supplement market,” but the NPA says the commissioner is “dodging accountability.”
In his testimony, Jones discussed the FDA’s new Human Foods Program (HFP) and the agency’s work to help ensure the US food supply’s safety and provide consumers access to science-based information on healthful food choices. HFP will launch on October 1 of this year.
To strengthen food chemical safety oversight, Jones shared the FDA’s goal to “advance dietary supplement safety,” as the market has grown over ten times in the last twenty years and “FDA authorities and resources have not kept up with this quickly expanding marketplace.”
Daniel Fabricant, Ph.D., president and CEO of the NPA, says the association “held out hope for new ideas, so it’s disappointing to see new leadership hold the same antiquated views on the dietary supplement industry. 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 adds.
Improving supplement framework
The US regulates supplements through the Dietary Supplement Health and Education Act. Since its enactment in 1994, the industry has grown from 4,000 to over 95,000 supplements, according to the FDA.
Johnson cautions: “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.”
Fabricant notes that manufacturers and supplement brands face significant burdens to enter the industry and comply with legislation.In his testimony, he highlights that the FDA is “committed to working with Congress” to require supplement manufacturers to list their products and ingredients with the FDA.
“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.”
Significant burdens of industry
However, NPA’s Fabricant counters that the agency can get labels through inspection agencies and “should know everyone who is out there already” due to registration requirements from the FDA Food Safety Modernization Act.
“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 Federal Food, Drug and Cosmetic Act but with the Federal Trade Commission and other state and federal authorities,” says Fabricant.
“The adverse event reporting requirements are the same for supplements and over-the-counter (OTC) medicines, yet I have never heard the drug program at the FDA bash the OTC industry for having ‘virtually no barriers to entry.’”
He adds that it is more concerning 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.”
The new Human Foods Program will prioritize preventing foodborne illness, food safety and improving nutrition.Fabricant notes that a more successful supplement program would prioritize working with the industry and all stakeholders on state preemption — the legal powers of state governments to create regulations that supersede local regulations — drug preclusion interpretation and targeted inspection of current Good Manufacturing Practices enforced by the FDA.
The NPA’s dealings with the FDA focus on its aim to protect and support the food and supplement industry. For example, this summer, the association filed a lawsuit against the FDA regarding its “unlawful” retroactive application of the Food, Drug and Cosmetic Act against nicotinamide mononucleotide, a precursor for NAD+ biosynthesis. This coenzyme is essential to the body’s metabolism.
New Human Foods Program
Johnson also highlighted the new, unified HFP as part of the “largest reorganization in FDA’s recent history.” This restructuring aims to improve the FDA’s function by improving communication, streamlining leadership decision-making and implementing processes and structures needed to enable swift action.
He was one of the experts evaluating the FDA’s regulatory structure for human foods and helped develop recommendations to enable the agency to carry out its public health mission more efficiently and effectively.
“Our work in the new HFP will advance our top strategic priorities of preventing foodborne illness, ensuring exposure to chemicals in foods is safe and decreasing diet-related chronic disease through improved nutrition,” added Johnson.
Earlier this year, the FDA requested US$7.2 billion from the 2025 fiscal budget to enhance food safety and nutrition, support supply chain resilience, strengthen the FDA’s public health capacity and modernize the agency’s infrastructure and facilities.
By Jolanda van Hal