There’s so much on the table for dietary supplement regulation that it’s hard to keep up.
Sen. Dick Durbin (D-Illinois) has another bill seeking mandatory product listings with the U.S. Food and Drug Administration (FDA).
Meanwhile, Rep. Maxine Dexter (D-Oregon) echoes the product listing charge in the House.
Rep. Nick Langworthy (R-New York) keeps pushing for federal uniformity to quiet the wild chorus of state actors fragmenting the regulatory burden on supplement brands.
To varying degrees and for various audiences, additional conversations are underway to modify FDA’s drug preclusion provision and expand the Agency’s audit capacity with third parties and third-party certifications.
There’s even discussion about how best to fund FDA and allow it to better flex its enforcement muscle after years of bellyaching from industry leadership.
Buried within this regulatory fervor is one rather nebulous phrase — “dietary supplement oversight modernization” — that now exists as a top priority for FDA’s Human Foods Program (HFP) in 2026. The savvy minds in supplements see this as both opportunity and threat.
“Modernization” is basically a crucible wherein the great battle over the industry’s future can play itself out with competing forces, ideas, and power grabs. It’s a term without definition, for now, but one that could pack a punch as the year progresses.
FDA: ‘We are increasingly interested in leveraging data’
Through an unattributed written response, the FDA offered a few small clues to provide context around its interest in modernization.
Top themes would include:
The desire to remove obsolete restrictions.
The importance of engaging with industry.
And the use of technology to amplify impact.
“Three out of four Americans rely on dietary supplements as part of their self-care routines, making proactive and informed decisions about their health and wellness,” an FDA rep wrote. “They deserve an oversight approach that evolves alongside the marketplace.”
Still no specifics, but there is a stated desire to change the status quo.
The supplement industry will likely welcome the call to modernize through deregulation.
“FDA is examining areas where regulatory requirements may have become unnecessarily burdensome without providing commensurate public health benefit,” the spokesperson wrote, citing the December 2025 move to simplify the Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer on product labels. “We are also committed to working on more formal rulemaking to adjust this requirement, which we believe will reduce label clutter and unnecessary costs for manufacturers without compromising consumer understanding.”
Fresh on the heels of its public meeting in late March, FDA is also viewing modernization as a way to engage with the industry and support a spirit of responsible innovation.
“FDA’s recent public meeting exploring the scope of dietary supplement ingredients provided an important opportunity for us to hear from stakeholders on how innovative ingredients and production methods fit within the dietary supplement framework,” said the spokesperson, further highlighting the need to embrace scientific progress while keeping consumers safe.
Finally, and perhaps most interestingly, FDA is pursuing the application of new technologies to increase its impact.
“HFP is exploring ways to operationalize third-party data to inform and improve our risk prioritization efforts,” said the spokesperson. “We are increasingly interested in leveraging data from certification programs, marketplace intelligence and robust external research to better focus our resources where they are needed most.”
What remains unclear is the specific data and methodologies that might apply here, but this is an area to watch, given the agency’s modest budget to regulate an industry as complex and burgeoning as dietary supplements.
CHPA: ‘There is growing interest in risk‑based tools that can help FDA better prioritize its limited resources’
Asked for its own interpretation of modernization, the Consumer Healthcare Products Association (CHPA) also highlighted disclaimer labeling as a recent win, and the need for national standards as an ongoing priority.
“Patchwork policymaking has begun causing significant challenges, including decreased access in some instances, consumer confusion about which products are safe and lawful, and added complexity for responsible manufacturers, while diverting attention from meaningful safety priorities,” said Duffy MacKay, CHPA’s senior vice president of dietary supplements.
CHPA supports the call for mandatory product listing, given clear guardrails, as well as clarification of the drug preclusion provision. These topics are germane to any discussion of modernization, but the rubber seems to meet the road around that “leveraging of data” mentioned by FDA above.
“There is growing interest in risk‑based tools that can help FDA better prioritize its limited resources,” said MacKay. “Any FDA use of third‑party certifications should be designed to complement, not replace, FDA oversight, with strong emphasis on accountability, consistency, and transparency to maintain confidence in the regulatory system.”
He acknowledges the role that third-party certifications can play to independently demonstrate quality and compliance to retailers and consumers, while also providing useful information to FDA.
Parsing the tea leaves a bit, could specific third-party certifications become surrogates for some de facto version of “FDA approval”? No one has said as much to date, but the reach of a term like “modernization” is broad enough to humor all comers.
Venable’s Todd Harrison: ‘I might be the only one, but I think targeted user fees make sense’
If modernization relies on some undetermined, tactical use of technology and third-party data, then what to do about the perennially modest budget at FDA for real enforcement against bad actors?
Opinions are nuanced on this point.
“FDA already has significant authority to act when products present a safety risk,” said MacKay. “As policymakers consider this issue, it is important to ensure the agency has the resources, tools, and operational flexibility to act quickly and decisively against clearly illegal products.”
Todd Harrison, co-chair of the FDA Group at Venable LLP, would tend to agree.
“In terms of any expanded recall authority for FDA, I think they already have that,” he said. “I also have no problem with third-party auditors for inspections outside of FDA, if they do it correctly. That could also be an interesting way to get people filing more NDIs.”
MacKay said, “A strong and effective FDA requires resources that are aligned with the size, scope and complexity of today’s dietary supplement marketplace.”
And therein lies the rub. What could it take under a modernized paradigm to get FDA the budget it needs to better enforce laws already on the books?
“I might be the only one, but I think targeted user fees make sense,” Harrison said, referring to the supplemental income generated by FDA for product reviews in the pharmaceutical and medical devices industries. “Nothing too expensive, but user fees are something we should at least be willing to consider.”
Federal agencies know how to play the game with the appropriations process, but user fees typically offer less wiggle room. According to Harrison, any proposed reform could designate exactly how new user fees get used and specify that money for enforcement.
Among the many forms that modernization could ultimately take at FDA, Harrison believes that the legislative approach is the right one, and he’s actively working on a draft of “DSHEA 10.0” for a comprehensive solution to regulatory reform.
“DSHEA is not a bad law,” he said, “but it was built in an analog world, and we’re living in a digital world now.”