A pending FDA guidance on new dietary ingredients underscores why the agency’s GRAS overhaul could determine which natural products reach market—and which are eliminated. Action Alert!
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THE TOPLINE
- FDA guidance addressing the identity and safety evidence required for new dietary ingredients is undergoing White House review.
- GRAS determinations and new dietary ingredient notifications are closely connected, underscoring why GRAS reform has such a major impact on the supplement industry.
- FDA must increase transparency without creating regulatory burdens, suppressing innovation, and reducing consumer access.
The Food and Drug Administration (FDA) is scheduled to release another set of guidance documents that will control how innovative dietary ingredients reach the market.
A guidance titled New Dietary Ingredient Notifications and Related Issues; Identity and Safety Information About the NDI has been under review at the White House Office of Information and Regulatory Affairs since June 2, 2026.
The guidance is not yet public, so we don’t know the details. But its title suggests that FDA will address the evidence companies should provide to establish a new dietary ingredient’s identity and demonstrate safety. We’re concerned these standards could significantly affect consumer access to a large swath of supplements.
The NDI Bottleneck
Under federal law, a “new dietary ingredient,” or NDI, is generally an ingredient that was not marketed as a dietary supplement in the United States before October 15, 1994.
Unless an exception applies, a company must notify FDA at least 75 days before marketing a supplement containing an NDI and provide evidence that the product can reasonably be expected to be safe.
The danger we’ve been calling out all along with regard to the NDI guidance is that the FDA is trying to turn what is meant to be a pre-market notification system into a de facto pre-market approval system. When companies can’t meet what will likely be absurd safety requirements the FDA demands, consumers will lose out on products that can support health. We’ve outlined the many problems with the NDI guidance elsewhere.
Why GRAS Matters to Supplements
GRAS stands for “Generally Recognized as Safe.” Although primarily a food pathway, it can also provide a route for supplement ingredients.
The GRAS and NDI pathways are connected. An NDI generally does not require a notification if it has been used in the conventional food supply as a lawful food ingredient—including a GRAS substance—and will be used in the supplement without chemical alteration.
For example, imagine a beneficial plant extract is first used in a nutrition drink after being determined to be GRAS. If the same extract is later sold in a capsule without being chemically altered, the company generally would not need to file a separate NDI notification. This pathway helps turn promising food ingredients into convenient supplements.
We know that many companies make use of the GRAS pathway instead of the NDI pathway because in practice they get less pushback from the FDA. One analysis found the FDA deemed approximately 30 percent of NDI submissions as favorable, whereas the agency viewed 75 percent of GRAS notifications as favorable.
This is all to say that changes to the GRAS system could make that route more difficult and expensive—and that is exactly what is happening.
FDA has now proposed requiring companies to notify the agency whenever they conclude that a substance is GRAS. As we explained in our previous coverage and our white paper, ending undisclosed self-GRAS determinations would provide welcome transparency. But FDA estimates that a full GRAS notice takes approximately 180 hours to prepare. Its proposal also retains an outdated exception focused on natural ingredients consumed before 1958 and processed using methods conventional at that time. This could subject modern extracts, standardized botanicals, concentrates, and fermented ingredients to burdens designed for genuinely novel substances.
And that’s the major problem with the proposed rule: it treats safe, natural, healthy substances the same as novel ingredients. There is no nuance, just heaps of bureaucratic red tape that will take away your supplements.
If FDA simultaneously tightens NDI evidence requirements and makes the GRAS pathway more difficult, responsible innovators could be trapped between two costly regulatory routes. Consumers could face fewer products, higher prices, and a market dominated by companies able to absorb those costs.
The final GRAS rule should create a lower-burden pathway for ingredients with at least 30 years of credible safe use, recognize appropriate modern processing methods, and protect timely filers from FDA delays.
The public has until December 9, 2026, to comment on the proposed GRAS rule. We are in the process of preparing our substantive comments to the agency. If you haven’t already, leave your own message on the official GRAS docket telling the FDA to adopt risk-based GRAS reforms that protect transparency, natural-product innovation, and consumer choice.
Action Alert!
