“More than three-quarters of Americans take dietary supplements. As a physician, I’ve seen countless patients assume these products are vetted for safety,” said Rep. Maxine Dexter, M.D. (OR-03). “Unfortunately, our regulatory bodies don’t have access to the most basic information about these products. My common sense legislation brings transparency to consumers and regulators alike to keep our communities safe.”
The bill would require companies to provide FDA with information about their products, including product names, a list of all ingredients (including details of proprietary blend), an electronic copy of the label, allergen statements, and health and structure/function claims.
The bill also calls for the creation of a database within two years of enactment and the provision of a Dietary Supplement Listing Number for each product. Failure to list would result in a product being classified as “misbranded”.
The full text for the bill can be read HERE.
AERs
To support her bill, Rep. Dexter stated in a press release that, while 75% of Americans use dietary supplements, the products are not risk-free, noting that more than 2,000 adverse event reports related to dietary supplements were received by the FDA in 2023. However, due to “significant underreporting”, Rep. Dexter claimed that the agency estimates the actual annual number of adverse events exceeds 50,000.
The same numbers were cited by Senator Dick Durbin when he introduced his own Dietary Supplement Listing Act in the U.S. Senate earlier this year. Sen. Durbin has previously pushed for a mandatory product listing in 2022 and again in 2024, but both legislative attempts ultimately failed to pass Congress.
This 50,000 adverse events number has been debunked for 20-30 years now, said Dr. Daniel Fabricant, president and CEO of the Natural Products Association, who added that NPA will be opposing the bill.
“This misguided bill would only divert critical resources away from scientific research, product innovation and quality improvements, ultimately slowing development of the next generation of dietary supplements that consumers rely on to promote their health,” said Dr. Fabricant.
“At a time when U.S. policymakers should be focused on clarifying regulations and strengthening federal uniformity, this bill is in search of a problem and would create unnecessary requirements, increase the risks of frivolous litigation, and undermine innovation across the industry.”
The chances of success for the bill are limited, said Dr. Fabricant. “But it’s never zero, so we’ve always got to stay vigilant,” he said.
Support for modernization and transparency, but avoid unintended consequences
Duffy MacKay, SVP of dietary supplements at the Consumer Healthcare Products Association (CHPA), told NI: “CHPA supports efforts to modernize the dietary supplement framework and improve transparency for consumers, but any new requirements should be carefully tailored to avoid unintended burdens on compliant manufacturers that could limit consumer access and choice, and should prioritize giving FDA the tools and resources needed to act quickly against illegal and unsafe products.”
Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA), struck a similar tone, saying that his organization appreciates Representative Dexter’s interest in dietary supplements. “UNPA has long worked to improved transparency and arm consumers with reliable information they need to advance and protect their health and wellness and stand ready to work with Congress to advance shared aims,” he added.
Striking the right balance
The Council for Responsible Nutrition is a long-term advocate for mandatory product listing. A spokesperson for the organization told NI that the introduction of this new legislation in the House further underscores the growing recognition that mandatory product listing is an issue whose time has come.
“CRN has been clear and consistent in its support for Sen. Durbin’s Senate legislation, which we believe strikes the right balance — advancing a transparent, workable framework that strengthens FDA oversight while remaining feasible for responsible manufacturers to implement,” said the spokesperson. “We look forward to working with all lawmakers on the Hill who share this commitment, and view the House bill as further evidence of the broad, cross-chamber interest in getting this done.”