In a webinar hosted by the Natural Products Association (NPA), Cara Welch, PhD, director of the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs (ODSP), discussed her office’s top priorities for 2026.

Top priorities include reform and guidance documents related to how dietary supplement ingredients are introduced to the market (including changes to both the Generally Recognized As Safe (GRAS) and New Dietary Ingredient Notification (NDIN) pathways to market), improving operational efficiency, and delivering on a 2026 Priority Deliverables directive for FDA’s Human Foods Program. 

Modernizing Oversight

These priority deliverables “are the mission, vision, and implementation of the MAHA agenda,” and are guided by pillars of risk related to food chemical safety, microbiological food safety, and nutrition, Welch noted. The food chemical safety pillar will be the primary focus at ODSP, Welch said, and the office is working on immediate solutions to improve its enforcement efforts under current regulations ahead of official regulatory changes. 

It’s been more than 30 years since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and nearly 20 years since rules enforcing Good Manufacturing Practices were introduced, Welch noted, but there are many steps FDA can take to modernize its operations in this existing framework. 

The agency plans to eliminate regulatory redundancies as part of the Trump administration’s broader deregulatory agenda, Welch said. “For instance, we recently determined that the DSHEA disclaimer doesn’t need to be on every single panel of a product.”

The agency will explore new tools to improve inspectional coverage, which, to date, amounts to a single-digit percentage of known dietary supplement facilities manufacturing products in the U.S.

“The agency has been active in promoting AI and machine learning programs, and considering how we could use some AI tools to streamline our review practice internally,” said Welch, including the ability to prioritize which facilities are in the greatest need of inspection. Enabling third-party auditors to carry out FDA’s inspections represents another potential avenue.

Finalizing NDI Guidance with Self-GRAS on the Chopping Block

Welch said that FDA will continue to prioritize the completion of its final guidance on NDINs, which it previously attempted to accomplish in 2011 and 2016 before announcing in 2024 that it would publish guidance on a section-by-section basis. 

The current goal is to publish a section of the guidance that will provide brands with clarity on how to establish the identity and safety of their ingredients in the NDIN process by the end of the year, Welch said.

Beyond providing the industry with clarity, Welch has made it a priority to improve the internal review process and deliver more consistent, comprehensive reviews of NDIN submissions, which have been increasing. A few years ago, the agency typically received 40-50 NDINs per year, but today, the average annual number of submissions has increased to 70, said Welch.

Preparing for an increase in NDIN submissions will also be essential due to the proposal to eliminate the self-GRAS pathway to market for dietary supplement ingredients. Many manufacturers have used this pathway when commercializing certain ingredients that qualify as a New Dietary Ingredient, which requires firms to notify the FDA directly. 

The agency plans to offer a period of temporary amnesty in certain circumstances, allowing ingredient suppliers to file NDI paperwork without penalties. “Should we get to a final rule where self-GRAS is not an option anymore, we expect a substantial increase in NDIN submissions, and we need to make sure we can provide a consistent and comprehensive review of all NDINs that come through,” said Welch.

Important questions still remain unanswered, Welch acknowledged. Many supplement companies are wondering if they’ll need to commercialize ingredients through food products in order to receive a “no questions” letter from FDA in response to a GRAS notification if self-GRAS is no longer an option, since GRAS status indicates that an ingredient must already have been present in the food supply.

“I’d like [new GRAS ingredients] to be able to come directly into the supplement marketplace. Stakeholders are asking us what they’re going to have to do here, and it’s a valid question that we still need to look into,” said Welch.

Ashish Talati, an attorney specializing in FDA and FTC law, noted during the session that the elimination of self-determination moves the GRAS pathway to market much closer to NDI territory, demanding a greater burden of evidence on companies which can no longer “rely solely on internal determinations … Until that rule is finalized the current GRAS framework remains in effect, but companies should already be thinking strategically about how their ingredient pipelines will be affected. It’s very important for companies to already be planning ahead,” he said, noting that many suppliers are already starting to submit GRAS notifications on behalf of customers who are asking for ingredients introduced via notification.

Regardless, “a self-GRAS dossier should be of the exact same quality as a dossier for a voluntary GRAS notification,” Talati said. “Toxicologists are very busy right now because companies are already preparing for this, so if you need more safety studies before submitting a GRAS notification to FDA, now is the time to do it.”