Speaking during a Jan. 28 webinar hosted by the Natural Products Association (NPA), Cara Welch, PhD, director of ODSP, laid out the policies and priorities coming to bear, guided by the offices three strategic priorities: safety, product integrity and informed decision-making.
She encouraged stakeholders to stay informed and up to date with FDA’s evolving priorities and compliance actions as her office works to advance mission, vision and implementation of the MAHA agenda.
Dietary supplement oversight modernization
In its deliverables, HFP signaled that efforts to modernize oversight of dietary supplements are afoot to regulate a marketplace that has exploded since the passage of the Dietary Supplement Health and Education Act.
“Given the rapid growth of the dietary supplement marketplace and the more than 30 years since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), HFP will evaluate new and modernized regulatory approaches that protect the public health while supporting a responsible dietary supplement industry,” the document reads. “HFP will continue to support dietary supplement priorities with targeted enforcement strategies on violative products.”
Dr. Welch said that the modernization initiative is broadly framed by design to allow for a wide range of activities, including reviewing and updating regulations—some of which, like the Good Manufacturing Practices (GMP) rule, are nearly 20 years old. The FDA is also actively considering deregulatory proposals to eliminate unnecessary or duplicative requirements, aiming to maintain a safe, high-quality marketplace. Recent actions include issuing enforcement discretion on DSHEA disclaimer placement and considering NPA requests to safeguard innovation in dietary ingredients.
“There’s a big push within our agency and within our administration to reduce unnecessarily and duplicative regulations,” Dr. Welch said. “We have received some deregulatory proposals, and we are giving those a close look to see what we can push forward to make sure the regulations that are on the books are the right ones—leading us to a safe high-quality marketplace—and getting rid of the ones that aren’t.”
Inspection coverage is also under review, with the agency investigating the use of artificial intelligence and third-party audit information to improve how facilities are selected for inspection. Dr. Welch also noted that FDA is prioritizing engagement with industry stakeholders to encourage compliance through transparency and clear communication of priorities, reserving enforcement for the non-compliant.
“I think for FDA, the best use of our resources is to ensure that manufacturers have the ability to be compliant, to know what the regulations are, to know what the priority for FDA is and then to keep folks in compliance with the requirements,” she said. “Then, that will maximize the impact of our enforcement tools if needed—so those that choose not to comply, enforcement is an option, but our goal is really what we can do to encourage compliance with the existing requirements and how we can better communicate our priorities with our stakeholders.”
Streamlining NDIN review for the end of self-GRAS
One of the biggest priorities is the completion of FDA’s long-awaited final guidance on New Dietary Ingredient Notifications (NDIN), a process that began in 2011 and saw a draft published in 2016. According to Dr. Welch, the agency aims to finalize and publish the next section of this guidance within the current calendar year, focusing specifically on the identity and safety requirements for NDIN submissions.
She noted that FDA has experienced a notable increase in the number of NDINs received— from an annual average of 40 to 50 submissions to over 70 last year, with many being substantive. This surge has prompted efforts to streamline internal review practices to ensure efficient evaluations. Dr. Welch also acknowledged that while the elimination of self-GRAS is still in the proposal and stakeholder feedback stage, should this pathway disappear, her office fully expects to see an increase of NDIN submissions as the appropriate path to market.
“I think there’s a lot that we can do within the NDIN review program,” she said. “Our goal here is to make sure that we are providing a consistent and comprehensive review for those notifications that come in, but we want to make sure that we’re making the best use of our resources.”
To address concerns about a potential NDIN backlog and delays that could hinder innovation, the agency is actively exploring the use of artificial intelligence and machine learning tools to enhance the efficiency a review process that gives precedence to risk mitigation activities.
“As we all know, I think the growth of the dietary supplement marketplace is impressive,” Dr. Welch said. “We are regularly seeing new ingredients come through, sometimes through the NDIN pathway, sometimes not, and being able to prioritize where we should be spending our resources is really important.”
She added that ODSP is collaborating closely with its sister office, the Office of Post-Market Assessment, to focus efforts as part of a broader food chemicals program.
“Which chemicals should we be assessing? What type of mitigation activities should we be focused on? That all sits under the regulation of NDIs,” she said.
Dr. Welch confirmed that 2026 modernization priorities do not include mandatory product listing and that deliverables will center on regulatory, communication and policy document initiatives achievable within existing authority.
