FDA Finalizes NDI Identity and Safety Guidance, Revisits Dietary Substance Definition
FDA finalized identity and safety sections of its NDI guidance and is reexamining the dietary substance definition that governs novel ingredients.
The Food and Drug Administration (FDA) has finalized identity and safety sections of its new dietary ingredient (NDI) guidance. Separately, the agency is reexamining how it defines a dietary substance.
TLDR
- The final guidance, dated October 2026, covers identity, history of use and the basis for a safety conclusion.
- Relying on history of use alone, FDA recommends roughly 25 years of widespread use.
- FDA’s top supplement official says the agency is reviewing its dietary substance interpretation.
- Trade groups welcomed parts of the guidance but questioned the 25-year benchmark.
What the Final Guidance Covers
The document is titled New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI. It finalizes Sections VI.A, VI.B and VI.C of FDA’s revised draft, under docket FDA-2025-D-6501.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires NDI notification at least 75 days before marketing. Identity data spans composition, manufacturing, specifications, contaminants and analytical methods. NutraIngredients reports it adds category advice for botanicals, fermentation-derived ingredients, enzymes and probiotics.
Documented history of use carries significant weight. Where history falls short, FDA points to genetic toxicity tests, lab and computational methods, animal studies and human trials. Attorney Ashish Talati told NutraIngredients that FDA dropped certain long-term animal and reproductive toxicity studies from the 2016 draft.
Industry Reaction
Talati called it a positive step and cited “a more flexible, case-by-case approach.” The Council for Responsible Nutrition (CRN) expressed disappointment with the 25-year benchmark. It noted FDA’s clarification that shorter periods may be supported with added evidence. Daniel Fabricant, PhD, who leads the Natural Products Association (NPA), said it will push back on the benchmark.
Dietary Substance Under Review
Cara Welch, PhD, directs FDA’s Office of Dietary Supplement Programs. At CRN’s Convergence 2026 in Carlsbad, California, she said FDA is revisiting its longstanding interpretation of dietary substance. “What is the best interpretation of dietary substance?” she asked, according to NutraIngredients. The answer could affect novel ingredients, including microorganisms.
Welch hopes to issue a standalone draft guidance for industry feedback. None has been released. She welcomed trade group efforts to list ingredients marketed before DSHEA. She also questioned firms using the generally recognized as safe (GRAS) pathway to sidestep supplement review.
Why It Matters
For supplement R&D and regulatory teams, identity and safety expectations are now final, not draft. Botanical, fermentation-derived and probiotic ingredients have clearer data targets. History-of-use dossiers should plan around the 25-year benchmark. The dietary substance review could shape which novel ingredients qualify for supplements. Other NDI sections, including master files, remain unfinished.
Sources: NutraIngredients; NutraIngredients; FDA.